Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Askari, 2018

Type of study: RCT

Setting and country: single University, Iran.

Funding and conflicts of interest:

Inclusion criteria: 18 - 35 years, accessibility within the next six months, PMS questionnaire score 33 - 64, being  single, and regular

menstrual periods (21 - 35-day cycles and 3 - 10 days of

bleeding), no known mental and physical disorders, no adverse events during the last three months, no surgery in the past three months, and no use of antidepressants or

hormonal drugs in the past three months.

PMS questionnaire was Daily Symptom Records Questionnaire, validated Iranian questionnaire.

Exclusion criteria: alcohol addiction, absence more than three

sessions, being a student or graduated from counseling/

psychology program

N total at baseline:40

Intervention:  20

Control: 20

Important prognostic factors:

For example

age ± SD:

I: 21.55 ± 1.73

C: 21.50 ± 1.35

Sex: 100%F

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Mindfulness based cognitive therapy.

The participants in the intervention group received eight 1-hour sessions of mindfulness-based cognitive behavioural counselling presented by the corresponding author.

Mindfulness-based cognitive therapy includes training of meditation and psychoeducation on cognitive processing according to the following standard protocol:

1- Attentional control that is maintaining a moment-bymoment awareness.

2- How to disengage from judgmental and evaluative

language by processing and moving to an experiential attention of the present moment.

3- How to disengage from negative thoughts and emotions and physical sensations.

Mindfulness-based intervention allows the practitioners to act more reflectively rather than impulsively. In the

present study, MBCT was implemented within eight sessions.

The first session included rapport with the client,

gathering the information, providing psychoeducation on mindfulness, cognitive-behavioral therapy (CBT), identifying depression, stress, anxiety, and automatic thoughts,

and guiding the client through mindfulness meditation. In the next session, awareness of bodily sensations and in the third session, dealing with barriers as well as short

breathing meditation, while being compassionate with

her, was trained. In the fourth session, the client was helped to understand most of her thoughts are not necessarily a fact, and

she learned how to use the thought records; also, training on cognitive distortion was provided. In the fifth session the ability to live at the time while being aware of attachments and aversions was trained; then, deep breathing and sleep health benefits were explained and the client

learned how to have a brief body exercise. In the sixth session, the thoughts and emotions were accepted as fleeting events; then, daily mindfulness, mindful eating, and mindful labeling of thoughts, feelings, and

behaviors were also trained.

In the next session, the client was familiarized with

the symptoms of depression, stress, and rumination thinking. Also, the client was trained how to accept rumination

thinking without judgment and use the diffusion technique to reduce it. In the last session, the insights and techniques found most useful by the client as well as identifying the obstacles to practice mindfulness was reviewed, and a checklist of techniques presented in the program was provided (31-33).

Describe control (treatment/procedure/test):

No intervention.

Length of follow-up: 3 months total > baseline, post-test (2 months post baseline) and 1 month follow-up (3 months post baseline)

Loss-to-follow-up: NOT REPORTED

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Incomplete outcome data: NOT REPORTED.

Interestingly, absence from more than 3 sessions resulted in study exclusion on forehand, not reported whether this occurred. It is not listed as reason for exclusion in the flowchart.

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

1. PMS symptoms

Outcome measures below were determined based on the Daily Symptom Records questionnaire. A 32-item self-report, standard inventory developed to determine PMS. Higher score is worse symptoms. Validated questionnaire in Iranian population.

The DSR total score was used, which is a mean score of symptoms from a week prior to the menstrual bleeding to five days afterward, comprised of the physical and behavioural scores.

Post-test

I: 27.65 ± 7.43

C: 40.05 ± 7.85

Follow-up

I: 28.15 ± 7.13

C: 40.15 ± 7.71

2. Physical symptoms

The DSR subdomain physical symptoms was calculated by adding the score of the symptoms such as headache, breast tenderness, acne, swelling, bloating, palpitations.

Post-test

I: 9.55 SD 3.10

C: 15 SD 4.29

Follow-up

I: 9.95 SD 2.99

C: 15.10 SD 4.2

3. Behavioural symptoms

The DSR subdomain behavioral symptoms comprised of psychological symptoms, including irritability, tension, sleep problems, mood swings, food cravings, willingness to be alone, depression, forgetfulness, anxiety, poor concentration, crying, commitment to suicide, decreased libido, and fatigue.

Post-test

I: 18.10 ± 6.33

C: 25.55 ± 6.17

Follow-up

I: 18.20 ± 6.22

C: 25.55 ± 6.12

Basogul, 2019

Type of study: RCT

Setting and country: singly University, Turkey.

Funding and conflicts of interest: The authors declare that there are no conflict of interests. Funding not reported.

Inclusion criteria: volunteering to participate in the study and receiving 110 points and more on the

PMS scale (Premenstrual

Syndrome Questionnaire by Gencdogan et al.).

Exclusion criteria:  rejecting to participate in the

study, having an irregular menstrual cycle, the use of oral contraceptives because it affects PMS, and failure to attend the sessions.

N total at baseline: 90

Intervention: 45

Control: 45

Important prognostic factors²:

For example

age ± SD: 19.09 SD 1.69 years

I: not reported

C: not reported

Sex: 100%F

Groups comparable at baseline? Yes (only reported in text, not shown).

Describe intervention (treatment/procedure/test):

Cognitive-behavioural approach psychoeducation

A booklet entitled “How can I cope with PMS?” was

prepared for distribution to participants in the psychoeducation group. The booklet included  information about the content of the sessions, worksheets, exercises, and assignments.

The students in the psychoeducation group were contacted via the nicknames and signs used in the forms. This group attended psychoeducation meetings that lasted 40 to

50 minutes. The program consisted of five sessions performed over a 4‐week period. A nurse researcher with a doctorate degree

in psychiatry nursing and who received education in this field applied the psychoeducation. The psychoeducation included verbal instruction, question and answer, and assignments. The participants were given the booklet entitled “How can I cope with PMS?”

They were asked to fill in the tables in the workbook, which were related to the topic, and complete the assignments, which were all

assessed in the following sessions. No fees were asked from the participants for the booklets. See table 1 in the fulltext paper for elaborate description of each session.

Describe  control (treatment/procedure/test):

No intervention.

NB. It is not explicitly explained whether the control group received no intervention at all, but it can be assumed based on the text.

Length of follow-up: 3 months (baseline – and 3 months post-test (follow-up measurement).

Loss-to-follow-up:

Intervention:

N (%) 2 (4.4%)

Reasons (describe) discontinued intervention (absence more then session in the intervention period n=2).

Control:

N (%) 0

Reasons (describe)

Incomplete outcome data: NOT reported.

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

1. PMS symptoms

The PMS scale was developed by Gençdoğan and included 9

subscales and 44 items. Participants responded on a 5‐point Likert scale (never, rarely, sometimes, frequently, and always). The lowest

and highest scores obtained from each subscale were 7 to 35, respectively, for depressive affect, 7 to 35 for anxiety, 6 to 30 for fatigue, 5 to 25 for anger, 7 to 35 for depressive thoughts, 3 to 15 for pain, 3 to 15 for appetite changes, 3 to 15 for sleep changes, and 3 to

15 for bloating. The lowest score obtained from the total scale was 44, and the highest score was 220. The presence of PMS was indicated when the highest score from the total scores and subscales exceeded 50%.

The PMS symptoms were experienced during the week

before menstruation.

Total score, see above.

Post-test

I: 124.88 ± 24.29

C: 135.71 ± 24.41

2. Physical symptoms

Pain

Not further defined, see above.

Post-test

I: 9.41 ± 2.92 (3‐15)

C: 9.71 ± 2.66 (5‐15)

Bloating

Not further defined, see above.

Post-test

I: 8.09 ± 3.21 (3‐15)

C: 8.02 ± 3.71 (3‐15)

3. Depressive symptoms

Depressive affect

Not further defined, see above.

Post-test

I: 22.35 (SD 5.88)

C: 22.16 (SD 4.01)

Depressive thoughts

Not further defined, see above.

Post-test

I: 18.65 ± 5.90

C: 20.98 ± 5.14

Blake, 1998

Type of study: RCT

Setting and country:

Funding and conflicts of interest: The study was supported by the Medical research Council and the Oxford Regional Health Authority. Paul Salkovskis is a Wellcome Trust Senior Research Fellow.

Inclusion criteria: women with regular menstruation, 6-month history of PMS symptoms occurring in the second half of the cycle. A diary based on a modified Moos Menstrual Distress Questionnaire was used as a selection tool, (a) the woman had consistently experienced symptoms during the luteal phase of the cycle; and (b) the diagnosis of PMS was prospectively confirmed from two consecutive cycles recorded in the diaries. If the woman was to be admitted to the study, the diaries must fulfill two previously determined criteria. First, there should be four symptoms of severity of >4 (moderate) for 4 of the 6 premenstrual days. Also, there should be no more than two symptoms of severity >4

on no more than 2 days in the 6 days following the menstrual week.

Exclusion criteria: major psychiatric disorder, other gynaecological disorder, drugs or alcohol abuse, or any other condition requiring psychotropic medication.

N total at baseline: 24 (1 refused trial participation)

Intervention: 11

Control: 12

Important prognostic factors²:

For example

age ± SD: 31.7 SD 6.4

I: not reported per group

C: not reported per group

Sex: 100%F

Groups comparable at baseline? Yes.

Describe intervention (treatment/procedure/test):

Cognitive therapy

Twelve weekly sessions of individual cognitive therapy, each session lasted about 1 hour.

The reality of their symptoms and the associated distress was explicitly acknowledged. Therapy was based on the establishment of a good therapeutic alliance involving collaboration between therapist and patient. The model was explained, and was usually highly acceptable. As the therapeutic relationship

was established, therapist and patient set treatment goals and agreed upon a formulation of the problems, their likely origins, and the key current maintaining factors, which were to be the target of therapy. The therapist encouraged the patient to face the problem of PMS squarely, to clarify precipitating and

perpetuating factors, and to identify unhelpful or restrictive attitudes. The therapy was collaborative and

educational and the patient was asked to set the agenda for the session, to determine priorities, and to

collect information. Each patient was asked to try out new behaviors between sessions as homework.

Each woman was encouraged to focus on specific incidents that illustrated particular target problems, and from these specific examples the therapist explored the wider issues of present  circumstances, stressors, relationships, and the patient’s reactions to these. Attention was drawn to specific links between

thoughts, feelings, behaviors and physical symptoms. Particular attention was paid to how changes in thoughts and beliefs can improve feelings and lead to new, more helpful behavior. Thought records collected between sessions were used to help the patient to learn more about her thoughts and beliefs as mediators of distress and to modify these. Incidents noted frequently revealed

repeated patterns of distress and vicious circles that prevented the crucial negative thoughts from changing, thus blocking the development of more adaptive coping strategies. As therapy progressed, reviewing several such specific incidents commonly revealed attitudes and assumptions underlying the problematic reactions characteristic of premenstrual distress. In the later stages of therapy, the woman gained ideas about actively limiting the effects of her premenstrual change, together with new perspectives on her concept of control. In addition to changing attitudes in herself, she was encouraged to elicit the help of other people more assertively.

Describe  control (treatment/procedure/test):

Waitlist-control group

Length of follow-up: 28 weeks.

Baseline – post-test (12 weeks post-baseline)-  2 months follow-up (20 weeks post-baseline) – 4 months follow-up (28 weeks post-baseline).

Loss-to-follow-up: 1, not reported to which group this woman was allocated. In total 24 women entered the trial, 1 woman refused. There was no reported lost to follow-up during the trial.

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Incomplete outcome data: NOT reported.

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

1. PMS symptoms

Blake et al. studied the outcome based on daily diary data. However, no exact data can be extracted from text. Descriptively can be concluded that:

Treatment was associated with an overall reduction in symptoms reported in the diary. Analyses indicated a consistent pattern of association between the treatment and significant overall improvement in symptoms (premenstrual, menstrual and severe symptoms).

2. Physical symptoms

Not specified.

3. Depressive symptoms

Based on Beck Depression Inventory

Post-test

I: mean 4.1 (SD 7.4)

C: mean 14.1 (SD 10.5)

Anxiety

Based on Beck Anxiety Inventory

Post-test

I: mean 5.6 (SD 6.8)

C: mean 12.5 (SD 9.1)

Blake et al. also studied the effects of PMS measured on the Social adjustment scale:

There was a significant effect of treatment on global ratings of difficulties experienced premenstrually (F(1, 19)56.73, p,0.01), and on global ratings of interference

with life F(1, 19)54.85, p,0.05). Ratings of impairment in ability to work were not

significantly different between treatment groups (F(1, 19)52.16, p.0.1). Similarly,

ratings of impairment were not significant for social leisure life (F(1, 19)51.11,

p.0.3) or for leisure activities (F(1, 19)52.87, p.0.1). Treatment was associated

with significant improvements in PMS-related impairment of home management

(F(1, 19)55.9, p.0.025) and in general relationship with partner (F(1, 17)56.47,

p,0.025). Sexual relationship was not significantly changed, although there was a

nonsignificant trend (F(1, 17)53.66, p50.074). In each instance, treatment effects

indicated that the treated group had improved relative to the waitlist control group

Panahi, 2016

Type of study: RCT

Setting and country: students from 1 University, Iran.

Funding and conflicts of interest: The authors declare that there is no conflict of interests

regarding the publication of this paper. Funding details not reported.

Inclusion criteria: normal menstruation for at least two years, willingness to participate in the study, a diagnosis of PMS and mild or

moderate depression (Beck score 16–47), and not currently

taking any psychotherapy, not using any support group or relaxation technique, and not taking any antidepressant

drugs. Premenstrual Assessment Scale (PAS) for diagnosis and severity of PMS for at least two menstrual cycles. The students were asked to complete the PAS one week before and after menstruation (17). A diagnosis of PMS

was confirmed with at least two symptoms (one physical and one psychological), according to the American College

of Obstetricians and Gynecologists criteria (17).

Exclusion criteria: Women with no depressive symptoms (BDI score

less than 16), severe depressive symptoms (BDI greater than

47), or PMDD (exhibiting more than five of the following

symptoms: depressed mood, hopelessness, humiliation, anxiety, tension, irritability, excitement, mood swings, withdrawal

from people, marked anger, increased conflict, and restlessness.

N total at baseline: 60

Intervention: 30

Control: 30

Important prognostic factors²:

For example

Age =< 20 years

I: 8 (26.6%)

C: 6 (20.0%)

>20 years

I: 22 (73.4%)

C: 24 (80%)

Sex: 100% F

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Intervention = mindfulness-based cognitive therapy.

8 group sessions, 120 min. each, over 8 weeks. 8-12 participants per group.

A female therapist trained in MBCT by a supervisor (M. Faramarzi) before the trial conducted the

sessions. The MBCT program consisted of integrating elements of mindfulness-based stress reduction and CBT with

guided depression/anxiety meditations. The program drew on traditional mindfulness meditation techniques, as well as guided meditation (daily activity related to  depression/anxiety), to address specific issues pertaining to depression/anxiety.

MBCT is conceptualized as a way of increasing the awareness of automatic patterns and then to disengage undesirable

reactivity (36). For individual practice, participants read

printed copies of material about an important part of the program, did daily formal practice for 30 minutes, did informal practice, and listened to a 20–60-minute prerecorded

CD two times daily over a period of 8 weeks (37). At the beginning of each session, the therapist asked the patients to do mindfulness skills during class and described one person’s individual experience with mindfulness out of class. The therapist then helped the patients to archive the corrected mindfulness skills

See full text paper for detailed session description (or guideline module).

Describe  control (treatment/procedure/test):

Control = Patients in the control group did not receive any intervention

Length of follow-up: 8 weeks (baseline and 8 weeks post-baseline).

Loss-to-follow-up: NOT REPORTED.

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Incomplete outcome data: NOT REPORTED

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

1. PMS symptoms

Based on PAS (Premenstrual Assessment Scale), higher score is worse. Iranian questionnaire, validity 0.92 and reliability 0.84. Covers somatic and psychological symptoms.

Post-test

I: 42.86 (SD 8.02)

C: 58.93 (SD 8.47)

2. Physical symptoms

Not specified

3. Depressive symptoms

Depression

Based on BDI (Beck Depression Inventory). Validated Persian was used. Higher score is worse symptoms.

Post-test:

I: 15.73 (SD 6.99)

C: 25.36 (SD 7.14)

Anxiety

Based on BAI (Beck Anxiety Inventory). Validated Persian was used. Higher score is worse symptoms.

Post-test

I: 16.96 (SD 7.78)

C: 26.60 (SD 9.38)

Sepehrirad (2018)

Type of study: quasi-experimental RCT

Setting and country: single centre, Iran.

Funding and conflicts of interest: not reported.

Inclusion criteria: Women with moderate to severe PMS who did

not have physical and psychological illness (death of

relatives, divorce, marriage) and were not pregnant and

did not receive any other treatment were included in

the study. The diagnosis of moderate to severe PMS was based on the Premenstrual Symptom Screening

Tool (PSST) questionnaire.

Exclusion criteria: Women who needed to take medication for any

reason and had specific psychiatric conditions,

pregnant women, and were reluctant to participate in

the project were excluded.

N total at baseline: 45

Intervention – CBT : 15

Intervention – CBT + nutrion: 15

Control: 15

Important prognostic factors²:

For example

Age:

20-30 years

CBT: 1(6.6)

CBT +N: 1(6.6)

Control: 3(20)

31-40 years:

CBT: 8(53)

CBT+N: 11(73.3) Control: 7(47)

41-50 years:

CBT: 6(40.1)

CBT+N: 3(20)

Control: 5(33)

Sex: 100%F

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Intervention group – CBT: The test group received 8 sessions of 90 minutes

and received training for 2 months.

See full text or guideline module for full description of each session.

Intervention group – CBT + nutrition: The test group received 8 sessions of 90 minutes and received training for 2 months.  This group also received a food program along with CBT

 The nutrition program was provided in a form in

order to subject begins the program two weeks before

the menstruation and observes it until the end of the menstrual period and write and mark all used

materials. The recommendations include the use of  five dried fig daily, daily servings of milk in the evening, egg yolk and carrot jam for breakfast two

days in between, rice milk or porridge with almonds,

saffron and cinnamon at dinner or breakfast, sweat or dip of Citrus aurantium daily one to two times in the morning and at night, sesame oil as an used oil,

avoiding the pumpkin, cucumber, watermelon, thyme, ginger, chicory, sour foods, salty foods, verjuice,

lentils, eggplants, fast foods, protein and industrial drinks. If they had headache, it was recommended to

avoid cinnamon, saffron, walnuts, cumin, garlic,

onions and pepper due to its Temperament quality and excessive heat production

Describe  control (treatment/procedure/test):

Control group: no intervention took place.

Length of follow-up: baseline, 2 month intervention (post-test), 2 month follow-up post-intervention (follow-up). Total 4 months.

Loss-to-follow-up: NOT REPORTED.

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Incomplete outcome data:  NOT REPORTED.

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

1. PMS symptoms

Not specified.

2. Physical symptoms

Not specified

3. Depressive symptoms

Anxiety

Based on Beck Anxiety Inventory  (BAI)

Post-test

I CBT: 15.7 SD 8.15

I CBT + nutrition: 13.8 SD 6

Control: 26.2 SD 8.15

2 month follow-up measurement

I CBT: 15.1 SD 7.16

I CBT + nutrition: 13.8 SD 6.1

Control: 25.1 SD 7.59

P-value CBT versus control: 0.018

Aggression

Based on Aggression Questionnaire (AGQ)

Post-test

I CBT: 42.2 SD 3.21

I CBT + nutrition: 41.8 SD 6.68

Control: 49 SD 5.86

2 month follow-up measurement

I CBT: 41.8 SD 2.24

I CBT + nutrition: 40.3 SD 6

Control: 48.9 SD 5.01

P-value CBT versus control: 0.018

Ussher, 2017

Type of study: RCT

Setting and country: single centre, Australia.

Funding and conflicts of interest: This study was funded by an Australian

Research Council Discovery Grant DP0984913

awarded to JU and JP. The authors have declared

that no competing interests exist.

Inclusion criteria: Participants were eligible if they were aged between 18–45 years, having regular cycles (21–35 days); presently not taking  hormonal medication (excluding contraceptives),

psychotropic medication, or having been diagnosed with a major psychiatric illness; not having been pregnant or lactating within the previous 12 months. Criteria for a PMDs diagnosis

were assessed with the Premenstrual Symptoms Screening Tool (PSST) (50), with confirmation by daily diary measures (51), demonstrating a 30% difference in symptoms between the pre- and post-menstrual period, for two consecutive months, which cause moderate-severe impairment (3, 52, 53). If women did not report a 30% increase in premenstrual symptoms after two cycles, they were invited to complete a third, and sometimes fourth, cycle of daily diaries.

Exclusion criteria:

N total at baseline: 83

Intervention – couple version: 28

Intervention – one to one version: 30

Control: 25

Important prognostic factors²:

For example

age ± SD:

I- couple: 35.14 (SD 7.67)

I-one to one: 34.67 (SD 8.07)

C: 34.56 (SD 8.29)

Sex: 100%F

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Intervention – one to one therapy:

Based on a woman-centred PMDs CBT intervention previously demonstrated to be effective in reducing premenstrual distress in both a face-to face (17)

and self-help modality (56). It consisted of four 90-minute sessions, conducted over a five month period (three sessions offered on a monthly basis, and one session at two month follow-up), delivered by a woman clinical psychologist. The aims of the intervention were to examine women’s attributions for  premenstrual distress within a bio-psycho-social framework, and to challenge negative self-blaming beliefs that may exacerbate  symptomatology,

such as “I should be calm and controlled all of the time”, “I should always be able to cope”, “I

shouldn’t be angry or irritable”. Behavioural coping skills, including relaxation training, taking

time out for self-care, diet and exercise were also examined and encouraged across the menstrual cycle. Finally, the relational context of premenstrual distress was explored, and assertiveness training techniques used to encourage calm expression of emotion, concerns or needs throughout the month (22). Women were given homework following each of the sessions and

a written booklet containing detailed information about each session, to supplement the meetings with the psychologist.

Intervention – couple version: followed the same format as one-to-one therapy, with inclusion of Couples Dialogue techniques to facilitate couple communication. This allows for the active involvement of the woman’s partner in understanding PMDs, and in strategies of prevention and amelioration.

Describe  control (treatment/procedure/test):

Wait-list control

Length of follow-up: baseline-5 month intervention- 3 months follow-up (control group not tested at 3 months follow-up, probably started their own treatment then). Total 8 month follow-up intervention group; until 5 months for the control group.

Loss-to-follow-up:

After allocation: n=13 (presumably, n=4 couple based therapy; n=2 one-to-one therapy; n= 7 waitlist control).

Reasons: declined to participate when contacted (n=?); withdrew participation after allocation (n=?).

During 5 month intervention

Intervention -couple:

N (%) 9/28

Reasons (describe): n=2 discontinued; n=7 lost to follow. Not described in more detail.

Intervention – one-to-one therapy:

N (%) 7/30

Reasons (describe); n=3 lost to follow-up; n=4 discontinued. Not described in more detail.

Control:

N (%) 4/25

Reasons (describe): n=3 lost to follow-up; n=1 discontinued.

During 3 month follow-up

Intervention -couple:

N (%) 4/19

Reasons (describe): n=4 lost to follow. Not described in more detail.

Intervention – one-to-one therapy:

N (%) 2/23

Reasons (describe); n=2 lost to follow-up. Not described in more detail.

Control:

N (%) 0/21

Reasons (describe): n.a.

Total lost to follow-up:

I – couple: 13/28 (46%)

I – one-to-one: 9/30 (30%)

Control: 4/25 (16%)

Incomplete outcome data:

Intervention:

N (%) 0

Reasons (describe)

Control:

N (%) 0

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

1. PMS symptoms

Not specified

2. Physical symptoms

Based on PSTT score (higher score = worse symptoms)

Post-score

I – couple: 5.19 (SD 2.87)

I – one-to-one: 5.55 (SD 2.54)

C: 7.30 (SD 2.89)

Total premenstrual symptoms

Based on PSTT score (higher score = worse symptoms). Emotional reactivity/mood (5 items); Lack of energy/interest (5 items); and Physical symptoms (4 items)

Post-score

I – couple: 20.0 (SD 8.12)

I – one-to-one: 21.86 (SD 6.97)

C: 26.25 (SD 8.48)

Post-hoc ANOVA:

I couple versus control: MD = 6.25, SE = 2.55, p = .045

I one to one versus control: P>0.05 (data not shown)

Premenstrual distress

Based on Subjective Evaluation of PMDs questionnaire (SEPQ), subdomain premenstrual distress. (higher score = worse symptoms)

3. Depressive symptoms

Emotional reactivity/mood

Based on Premenstrual Symptoms Screening Tool (PSTT) score (higher score = worse symptoms)

Post-score

I – couple: 8.67 (SD 3.68)

I – one-to-one: 10.10 (SD 3.22)

C: 11.30 (SD3.87)

Lack of energy/interest

Based on PSTT score (higher score = worse symptoms)

Post-score

I – couple: 6.14 (SD 2.75)

I – one-to-one: 6.22 (SD 3.07)

C: 7.65 (SD 2.85)

Depression

Based on HADS (higher score = worse symptoms)

Post-score:

I – couple: 3.0  (SD 3.14)

I – one-to-one: 4.96 (SD 4.25)

C: 5.50 (SD 4.75)

Anxiety

Based on HADS (higher score = worse symptoms)

Post-score:

I – couple: 5.84  (SD 2.93)

I – one-to-one: 7.78 (SD 3.25)

C: 9.31 (SD 5.48)

PMDs = women with PMS or PMDD.

% of PMDD in this cohort is not reported.

Study reference

(first author, publication year)

Was the allocation sequence adequately generated?

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

LOW

Some concerns

HIGH

Askari, 2018

Probably yes.

Reason: table of random numbers

Probably yes

Reason: table of random numbers

Probably no

Reasons: patients and health care providers could not be blinded. However, the health care provider was also the first author and therefore probably the outcome assessor and data analysist. Risk of bias.

No information

Reason: not reported whether patients were lost to follow-up, presumably all patients completed the trial. In addition, it was not reported whether there were incomplete data.

Probably yes

Reason: previously reported study protocol.

No information

Reason: not reported

HIGH (PMS symptoms)

Blake, 1998

Probably yes.

Reason: not clearly stated, otherwise than that ‘patients were randomly allocated’.

No information

Reason: study doesn’t provide information on how trial was performed.

Probably not

Reason: patients and health care providers couldn’t be blinded. No information provided whether other parties involved were blinded.

No information

Reason: not reported whether patients were lost to follow-up, presumably all patients completed the trial. In addition, it was not reported whether there were incomplete data.

No information

Reason: not reported

No information

Reason: not reported

Basogul, 2019

Probably yes.

Reason: The identification of

the intervention and control groups was performed using a simple

randomization method. This calculation was performed using

the http://www.randomizer.org/form.htm web site. The students were ranked by the school number before the randomization. Ninety students to be involved in the study were divided into two groups (intervention and control). The number of participants in each group was 45, and the set range was between 1 and 90 (2 sets of 45 unique numbers per set range: from 1 to 90). The intervention and control groups were formed according to the numbers given by the program.

No information

Reason: study doesn’t provide information on how trial was performed.

Probably not

Reasons: patients and health care providers could not be blinded. Not reported whether others involved in data measurement and analyses were blinded. Risk of bias.

Probably not.

Reason: 4% lost to follow-up in the intervention compared to 0% in the control group can be judged as insignificant.

No information

Reason: not reported

No information

Reason: not reported

HIGH (PMS symptoms)

Panahi, 2016

Probably yes.

Reason: Block randomization was done based on paper list. Random numbers were supplied from 1 to 60 by the trial statistician and prepared by an investigator with no clinical involvement in the trial. Odd numbers were assigned to the

experimental group and even numbers to the control group.

Probably yes

Reason: Block randomization was done based on paper list. Random numbers were supplied from 1 to 60 by the trial statistician and prepared by an investigator with no clinical involvement in the trial. Odd numbers were assigned to the

experimental group and even numbers to the control group.

Probably no

Reason: patient and health care providers couldn’t be blinded. Data collectors were blinded (reported in text). Unclear whether outcome assessors and data analyst were blinded.

No information

Reason: not reported whether patients were lost to follow-up, presumably all patients completed the trial. In addition, it was not reported whether there were incomplete data.

No information

Reason: not reported, this paper was part of masters thesis and no study protocol was previously published.

No information

Reason: not reported

HIGH (PMS symptoms)

Sepehrirad (2018)

Probably yes

Reason: only reported that patients were randomized to one of three arms, using random numbers table

No information

Reason: not reported

No information

Reason: not reported

No information

Reason: not reported whether patients were lost to follow-up, presumably all patients completed the trial. In addition, it was not reported whether there were incomplete data.

No information

Reason: not reported

No information

Reason: not reported

HIGH (PMS symptoms)

Ussher, 2017

Definitely yes;

Reason: Generation of the random allocation sequence, using permuted block randomization, was conducted by the second author (JP). Allocation of participants to

conditions was conducted by a researcher who was not involved in the delivery of intervention.

Definitely yes

Reason: Generation of the random allocation sequence, using permuted block randomization, was conducted by the second author (JP). Allocation of participants to

conditions was conducted by a researcher who was not involved in the delivery of intervention.

Probably no;

Reason: Patients and health care providers could not be blinded due to the nature of the intervention. Blinding of outcome assessors not reported, but presumably not relevant due to solely use of questionnaires. Blinding of data collectors and analysts not reported, therefore small risk of bias.

Probably yes

Reason: lost to follow-up was high and infrequent between groups, adequate reasons for drop-out not reported. Analysis not corrected via imputation. Therefore risk of bias.

Definitely yes

Reason: All relevant outcomes were reported;

Definitely yes

Reason: No other problems noted

HIGH (PMS symptoms)

Author (year of publication)

Intervention

Control condition

Askari, 2018

The participants in the intervention group received eight 1-hour sessions of mindfulness-based cognitive behavioural counselling presented by the corresponding author.

Mindfulness-based cognitive therapy includes training of meditation and psychoeducation on cognitive processing according to the following standard protocol:

1- Attentional control that is maintaining a moment-by moment awareness.

2- How to disengage from judgmental and evaluative

language by processing and moving to an experiential attention of the present moment.

3- How to disengage from negative thoughts and emotions and physical sensations.

The first session included rapport with the client, gathering the information, providing psychoeducation on mindfulness, cognitive-behavioral therapy (CBT), identifying depression, stress, anxiety, and automatic thoughts, and guiding the client through mindfulness meditation. In the next session, awareness of bodily sensations and in the third session, dealing with barriers as well as short breathing meditation, while being compassionate with her, was trained. In the fourth session, the client was helped to understand most of her thoughts are not necessarily a fact, and she learned how to use the thought records; also, training on cognitive distortion was provided. In the fifth session the ability to live at the time while being aware of attachments and aversions was trained; then, deep breathing and sleep health benefits were explained and the client learned how to have a brief body exercise. In the sixth session, the thoughts and emotions were accepted as fleeting events; then, daily mindfulness, mindful eating, and mindful labeling of thoughts, feelings, and behaviors were also trained. In the next session, the client was familiarized with the symptoms of depression, stress, and rumination thinking. Also, the client was trained how to accept rumination thinking without judgment and use the diffusion technique to reduce it. In the last session, the insights and techniques found most useful by the client as well as identifying the obstacles to practice mindfulness was reviewed, and a checklist of techniques presented in the program was provided.

No intervention.

Basogul, 2019

Five sessions of 40-50 minute meetings, scheduled over a 4-week period.

Session 1 – introduction + knowing about PMS + health behaviours: Meeting the group members, introducing psychoeducation, and sharing information about premenstrual syndrome, reasons, symptoms, and health behaviors in PMS (exercises, nutrition, sleep quality, and relaxation with breathing techniques to reduce anxiety). Assignment: writing on the premenstrual symptom diary

Session 2 – cognitive strategies (coping with depressive thoughts in PMS): Effects of thoughts on emotions, establishing connections between automatic thoughts, feelings and thought,s and relationships of emotions‐thoughts‐behaviors; sharing information in relation to the cycle of automatic thoughts and psychological state in PMS. Assignment: exercises about establishing connections between thoughts and emotions

Session 3 - Cognitive strategies (coping with depressive thoughts in PMS): Exploring automatic thoughts in PMS, evaluating automatic thoughts and cognitive distortions, exploring unhelpful thoughts in PMS (I am losing control; it should not be like this; I should not have gotten angry; I cannot cope), analyzing automatic thoughts and challenging them, and sharing information about the identification of the fundamental beliefs. Assignment: exploration and analysis of automatic thoughts, exercises for changing with alternative thoughts.

Session 4 - Behavioral strategies (increasing mobility): Developing behavioral changes and analyzing the effects of this change to settle helpful and balanced thoughts instead of unhelpful automatic thoughts, evaluating personal responsibility, investigating the positive effects of social activities on the emotional state in PMS. Assignment: exercises about planning and applying social activities and evaluating its effects

Session 5 - Problem solving + evaluation: Evaluation of the group members’ problem‐solving methods, sharing effective problem‐ solving steps, general revision, and evaluation of the psychoeducation.

Blake, 1998

Twelve weekly sessions of individual cognitive therapy, each session lasted about 1 hour.

The reality of their symptoms and the associated distress was explicitly acknowledged. Therapy was based on the establishment of a good therapeutic alliance involving collaboration between therapist and patient. The model was explained, and was usually highly acceptable. As the therapeutic relationship was established, therapist and patient set treatment goals and agreed upon a formulation of the problems, their likely origins, and the key current maintaining factors, which were to be the target of therapy. The therapist encouraged the patient to face the problem of PMS squarely, to clarify precipitating and perpetuating factors, and to identify unhelpful or restrictive attitudes. The therapy was collaborative and educational and the patient was asked to set the agenda for the session, to determine priorities, and to collect information. Each patient was asked to try out new behaviors between sessions as homework. Each woman was encouraged to focus on specific incidents that illustrated particular target problems, and from these specific examples the therapist explored the wider issues of present  circumstances, stressors, relationships, and the patient’s reactions to these. Attention was drawn to specific links between thoughts, feelings, behaviors and physical symptoms. Particular attention was paid to how changes in thoughts and beliefs can improve feelings and lead to new, more helpful behavior. Thought records collected between sessions were used to help the patient to learn more about her thoughts and beliefs as mediators of distress and to modify these. Incidents noted frequently revealed repeated patterns of distress and vicious circles that prevented the crucial negative thoughts from changing, thus blocking the development of more adaptive coping strategies. As therapy progressed, reviewing several such specific incidents commonly revealed attitudes and assumptions underlying the problematic reactions characteristic of premenstrual distress. In the later stages of therapy, the woman gained ideas about actively limiting the effects of her premenstrual change, together with new perspectives on her concept of control. In addition to changing attitudes in herself, she was encouraged to elicit the help of other people more assertively.

Waitlist control

Panahi, 2016

Mindfulness-based cognitive therapy (MBCT) (8 group sessions, 120 min. each, over 8 weeks. 8-12 participants per group).

MBCT is conceptualized as a way of increasing the awareness of automatic patterns and then to disengage undesirable reactivity. For individual practice, participants read printed copies of material about an important part of the program, did daily formal practice for 30  minutes, did informal practice, and listened to a 20–60-minute  prerecorded CD two times daily over a period of 8 weeks. At the beginning of each session, the therapist asked the patients to do mindfulness skills during class and described one person’s individual experience with mindfulness out of class. The therapist then helped the patients to archive the corrected mindfulness skills

Session 1: building a therapeutic alliance and obtaining information from the client, identifying automatic thoughts, introducing the body scan, raisin exercise, and introducing mindfulness meditation with in session practice. Assignment: reading about the body scan meditation technique, 30-minute daily formal practice (body scan meditation), informal practice, and awareness to some routine activity such as washing dishes or eating a meal (continued throughout trial period).

Session 2: helping the client recognize that thoughts are not facts, teaching use of the thought record, sitting meditation using breath as the primary object of awareness, and alternating this with the body scan (sitting one day, body scan the next, etc.). Assignment: reading about and doing formal and informal sitting meditation.

Session 3: dealing with automatic thoughts in life and in meditation and walking meditation. Assignment: mindful yoga.

Session 4: stopping one-minute breathing space. Assignment: mindful yoga and sitting meditation (continued throughout trial period).

Session 5: dealing with difficult emotions, wisdom meditation, and walking meditation. Assignment: mindful yoga.

Session 6: communication. Assignment: listening to others carefully and mindful yoga

Session 7: self-compassion. Assignment: loving yourself and mindful Yoga

Session 8: helping the client develop a practice of her own, reviewing progress, insights, and techniques, and individual evaluation of the sessions.

No intervention

Sepehrirad (2018)

The test group received 8 sessions of 90 minutes and received training for 2 months.

First session: Familiarity with each other, explaining the process of work and its components.

Second session: Natural menstrual cycle training, symptoms of PMS

Third session: Introducing CBT, anxiety model and its components

Fourth session: Psychological education: the importance of thoughts in creating excitement and cognitive errors (mindfulness, prophecy,

disaster, extreme extension)

Fifth session: Introducing how to write thoughts and strategies to deal with anxious thoughts

Sixth session: Interventional cognitive training (disaster relief, foot, evidence survey ...)

Sevenths session: Deep cognitions (conditional assumptions and underlying beliefs) and related techniques and problem solving methods

Eighth session: Anger management training and its components

No intervention

Ussher (2017)

In the intervention groups, women received four 90 minute sessions, conducted over 5 months.  Aims of the CBT intervention were to examine women’s attributions for premenstrual distress within a bio-psycho-social framework, and to challenge negative self-blaming beliefs that may exacerbate symptomatology. Behavioral coping skills, including relaxation training, taking time out for self-care, diet and exercise were also examined and encouraged across the menstrual cycle. Finally, the relational context of premenstrual distress was explored, and assertiveness training techniques used to encourage calm expression of emotion, concerns or needs throughout the month. Women were given homework following each of the sessions and a written booklet containing detailed information about each session, to supplement the meetings with the psychologist. The couple intervention followed the same format, with inclusion of Couples Dialogue techniques to facilitate couple communication.

Waitlist control

Author and year

Reason for exclusion

Al Kiyumi, 2021

Same article as 2020

Alevizou, 2018

Narrative review

Chai, 2018

Does not comply to PICO (all women got CGT, comparison between mode of delivery (telephone or face-to-face)

Chin, 2017

Narrative review

Freeman, 2010

Narrative review

Hofmeister, 2016

Narrative review

Izadi-Mazidi, 2016

Does not comply to PICO (did not report on one of the prespecified outcomes)

Kancheva Landolt, 2020

Review of low quality (no methods, no search, no selection criteria, no descriptive analyses)

Kleinstuber, 2021

Included articles in review do not comply to PICO.

Kues, 2014

Study protocol

Lanza di Scalea, 2019

Narrative review

Nevatte, 2013

Does not comply to PICO (consensus paper)

Pearlstein, 2012

Narrative review

Sepede, 2016

Systematic review about treatment options PMDD

Shulman, 2010

Narrative review

Taghizadeh, 2012

Does not comply to PICO (psychoeducation instead of CGT)

Weise, 2019

Does not comply to PICO (women with PMDD; internet CBT versus waiting list)