Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Feltz-Cornelis et al., 2010

Type of study: Systematic review and meta-analysis

Country: Netherlands

Source of funding:

This study was partly funded by Eli Lilly.

N= 14 RCTs; 1725 patients

PubMed (1949-2009), PsychInfo (1806-2009), EMBASE (1947-2009).

-Nine studies included DM Type 1 and Type 2 patients.

-Six studies only included DM Type 2 patients.

-None of the RCTs limited their sample to Type 1 DM patients.

-Two studies included only patients with serious diabetes -complications such as diabetic foot or cerebrovascular accident (CVA), and

-two focused specifically on patients in poor diabetes control.

The participants in most studies of depression treatment in Type 2 DM were between 50 and 60 years old.

Inclusion criteria:

- RCTs that evaluated treatment of depression comorbid with DM Type 1 or 2.

-Trials that focused on the effects of treatment of

depression in populations of patients with specific diabetesrelated complications (e.g., those with diabetic foot) if their focus was on DM patients with comorbid

depression.

-Studies in which the randomisation was performed

between patients, between health care settings or between health care providers such as general practitioners

-Crossover designs or waiting list as control group designs after randomisation

-Studies should include adult patients with Type 1 or Type 2 DM with comorbid depressive disorders such as MDD; minor depressive disorder, defined as the presence of two key depressive symptoms and at least three associated

symptoms, dysthymic disorder or significant depressive

symptoms, as assessed by a validated questionnaire with a cut-off score or by a diagnostic interview. In the text that

follows, these forms of depression will all be referred to as

comorbid “depression.”

Exclusion criteria: ?

psychotherapeutic intervention

n =5 studies

combined psychological

treatment with a diabetes self-management intervention (n=310)

n =3 studies

pharmacological intervention (n=281)

n= 7 studies

collaborative care intervention (n=1133)

n= 3 studies

Usual care \ placebo ?

N=?

Endpoint of follow-up: ?

Severity of depression

positive effect

-0.512; 95% CI -0.633 to

-0.390.

Q value of 17, df=13, P=0.215 (NS)

I² = 22%, indicating low to moderate heterogeneity between the different treatment

studies in terms of depression severity outcomes

Glycemic control

Positive effect

-0.274; 95% CI -0.402 to -0.147.

Q value of 14, df 11,

P=0.236 (NS)

 I²= 22%, indicating low to moderate heterogeneity between the different treatment studies in terms of glycemic control.

Per intervention

psychotherapy

-0.581 (95% CI -0.770 to

-0.391)

pharmacotherapy

-0.467 (95% CI -0.665 to

-0.270)

collaborative care

-0.292 (95% CI -0.429 to

-0.155)

The Q statistic = 6.265, df=2,  P=0.044. We could therefore

reject the hypothesis that the effect size is the same for the

three interventions.

Conclusion:

It would seem safe to conclude that treatment of depression comorbid with diabetes is effective. Based on this review psychotherapy that also provides self management education for DM

Type 2 and Type 1 would be the first choice of treatment, given its large combined effect.

-Pharmacological interventions

can be useful for depressive symptoms, and may or

may not benefit glycemic control depending on the choice of

antidepressant. The influence of antidepressants on glucose

levels is as yet unclear.

-Collaborative care, which may include a combination of psychological counseling and anti-depressant medication,

is suited for depression treatment in Type 2 diabetes where the majority of patients is being treated in primary care.

-And collaborative care may be a very useful way to provide depression treatment for this comorbid condition

to the large population of patients with diabetes treated in primary care.

Markowitz et al 2011

Type of study: Descriptive review

Setting: University

Country: US

Source of funding:

NR*

Searched in:

-Cochrane database,

PsychINFO, and Pubmed

- 1995-2008

N= 17 studies

a)      Lustman et al 1998

b)      Lamers et al 2006 à exclude for the guideline (no results published)

c)       Van Bastelaar et al 2008 à exclude for the guideline (no results published)

d)      Simon et al 2008

e)      Georgiades et al 2007

f)       Rossello & Jemenez Chafey 2006 à exclude for the guideline (uncontrolled; adolescents , puerto rican)

g)      Lustman et al, 2000;

h)      Lustman et al, 2006;

i)       Paile-Hyvarinen et al, 2003;

j)       Paile-Hyvarinen et al, 2007;

k)      Amsterdam et al,  2006;

l)       Gulseren et al, 2005à exclude for the guideline (I vs.I comparison,

 not I vs. C )

m)     Katon et al, 2004

n)      Williams et al, 2004

• o)      Bogner et al, 2007 à exclude for the guideline (no HbA1c measure or depression outcome)

Inclusion criteria studies:

-investigated individuals with type 1 or type 2 diabetes, including adults, children, and adolescents, analyzed separately from individuals without diabetes if such individuals were also included,

-depressive symptoms or a diagnosis of depression;

-included a psychosocial and/or pharmacological intervention intended to treat depressive

symptoms;

-assessed depression or depressive symptoms as a dependent measure,

- were published in peer-reviewed English-language journals,

-applied pre-post or controlled

trial design.

Exclusion criteria:

-intervention consisted of only diabetes education or adherence training,

-depression or depression severity was not a main

outcome measure.

Characteristics

a) RCT;  n= 51 (age 21-70), DM Type 2 and MDD;;

d) RCT design w/TAU comparison, pre-post completer analyses, n= 60 (Hospitalized for diabetic foot syndrome), age <= 75 years, type 1 or 2, elevated depressive symptoms, HbA1c

not an outcome measure

e) Single-group open-label quasi-experimental design,

pre-post completer analyses, age 18 and over, type 1 and 2, depressive symptoms,

HbA1c outcome measure; n=65

pharmacological interventions

g) Double-blind placebo-controlled RCT; Enrolled/

Completed (60/54); age 21-64, MDD inclusion criterion, type 1 or 2, HbA1c outcome-measure

h) Double-blind placebo-controlled RCT, age 18-80, type 1 or 2, MDD inclusion criterion, HbA1c outcome

measure; Enrolled/

Completed  (152/130).

I) Single-blind placebo-controlled RCT design, ITT

analyses, post-menopausal women over 50, type 2, mild depressive symptoms,

HbA1c outcome measure, Enrolled/Completed(15/13)

j) Double-blind placebo-controlled RCT design, age 50-70, type 2, mild depressive symptoms, HbA1c outcome- measure,Enrolled/Completed (49/37)

k) Open-label uncontrolled trial, pre-post completer analyses, age 18 or over, MDD diagnosis, type 1 or 2, HbA1c outcome measure, Enrolled/Completed (17/14)

m) RCT design with TAU comparison, type 1 or 2, depressive symptoms, HbA1c outcome measure, Enrolled/Completed (329/288)

n) RCT design with TAU comparison, ITT analyses, age 60 and over, type 1 and 2, MDD or dysthymia criterion, HbA1c outcome measure, Enrolled/Completed (417/350)

Psychosocial intervention

n= 6 studies (a t/m f)

a) I + C: one-hour diabetes education sessions I:extra 10 weeks of individual CBT for depression.

d) I: Supportive psychotherapy, weekly (avg. 5)  sessions, individual

C: usual treatment

e) treatment: CBT, 16 sessions over 14 weeks for 90 min.

pharmacological interventions for depression

n= 8 studies (g t/m l)

g) I: fluoxetine 8 weeksC: placebo

h) I: Sertraline C: placebo

I) I: paroxetine C: placebo

j) I: paroxetine C: placebo

k) treatment: S-citalopram 10-20mg up to 16 weeks

collaborative care

n= 3 studies (m t/m o)

m) I: Depression care management, pharmacotherapy or education/ problem solving C: treatment as usual (TAU)

n) Depression care management, pharmacotherapy or education/ problem solving C: TAU

Endpoint of follow-up:

a) 6 month

d) limited

e) 12-month

g) no follow-up interval

h) 1 year

I) no follow-up interval

j) 6-month

k) no follow-up

m) 12-month

n) 12-month

a) Pre-treatment mean

HbA1c levels

I: 10.2% +/- 3.6%

C: 10.4% +/- 3.1%

clinically sig. improvement (≥50% reduction BDI score)

I: 66%

C: 29.6%

d)  HADS depression change SP: -1.6 TAU: 0.3, p=.02 HADS anxiety change SP: -0.5 TAU: 1.6, p=.02 PAID change SP: -5.5 TAU: 2.1, p=.008

e) BDI decreased significantly from baseline to 12-month follow-up (p<.001). HDRS decreased significantly from baseline to 3-month follow-up (p<.001) No significant change on HbA1c. Within subjects changes on BDI had no significant effect on HbA1c

g) Greater reduction in BDI (-14 v. –8.8, p=.03) and HDRS (-10.7 v. –5.2, p=.01) score in fluoxetine than placebo; HbA1c improved non-significantly (p=.13) more in fluoxetine (-.4%) than placebo (-.07%)

h) Patients in sertraline group less likely to relapse (HR=.

51, p=.01); HbA1c level did not differ between groups

I) No difference in BDI or MADRS between groups; HbA1c improved non-significantly (p=.08) more in

paroxetine (-.44%) than placebo (-.07%)

j) No significant difference in HADS depression, At 3 months, but not 6 monthss, HbA1c was significantly (p=.018)

lower in paroxetine group (7.9) than placebo (8.5)

k) Significant reduction in HDRS score, Non-significant reduction in HbA1c

m) Patients in depression care management had less depression severity over time than those in TAU (z=2.84, p=.04).No difference in HBA1c

n) Depression care management patients had lower rate of depression

(0.43 on 0-4 scale) than TAU, No difference in HBA1c

Methodological

a) use of RCT

design with education-only comparison group and 6-month follow-up, intent-to-treat analyses, and use of HbA1c levels as a primary outcome measure. Adding to the internal validity and the clinical significance, only patients with a diagnosis of MDD and type 2 diabetes were included. Poorly controlled diabetes was not an inclusion criterion, though it was common among patients in the study. This allowed for the possibility that improving

depressive symptoms could have an effect on glucose control.

d) As a pilot study, this study has the methodological strength of RCT design with usual care comparison group, though it lacked a follow-up interval. Additionally, likely due to power, it is limited by the use of pre-post analyses instead of comparing the treatment conditions to each other, and the inability to test for HbA1c as an outcome measure.

e) This study was designed to test differences in response to treatment between patients with type 1 and type 2 diabetes, so it is limited by its open-label design without a comparison group and use of a pre-post completer analyses.

However, it used HbA1c levels as a primary outcome measure.

g) The inclusion of type 1 and type 2 diabetes patients, however, could possibly have reduced the ability to find HbA1c outcomes.

h) ?

I) The focus on type 2 post-menopausal

women with mild depressive symptoms may limit its generalizability, though internal validity is increased.

j) the inclusion of only patients with non-optimallycontrolled diabetes provided the opportunity to demonstrate improvement in glucose control, and a difference between groups was observed.

k) As a pilot study, without

comparison group or follow-up interval, the results require replication and extension.

m) ?

n) ?

Snoek & Skinner 2002

Type of study:  Descriptive review

Setting: University

Country: The Netherlands

Source of funding:

NR*

Searched in:

-MedLine and PsychINFO

- limited to English articles

- were published in peer-reviewed journals,

- 1990-2001

N= 11 studies

1) Depression

a) Lustman et al 1998 (see above Markowitz et al 2011 )

2) eating disorders

b) Henry et al, 1997

c) Mains et al, 2001 à exclude for the guideline (small study n=6, adolescents, no medical outcome reported)

d) Spiess et al, 1995.

e) Zettler et al, 1995

f) Olmsted et al, 1997

g) Kenardy et al, 2000

Inclusion criteria studies:

Not mentioned.

Exclusion criteria:

Case studies

Characteristics

b) RCT, n= 19, aged 47-74 years, type 2 diabetes.

d) RCT, distress, adult Type 1 diabetic patients. Mean age 24 years, mean duration of diabetes-associated symptoms of 4.3 weeks;all patients were on multiple insulin injections.

e) pilot, n= 17, Type 1 diabetes (mean age 58 years)

f)RCT, young women with

Type 1 diabetes with disturbed eating attitudes and behaviours.

N=  85 patients who showed ‘any sign’ of disordered eating attitudes or behaviour participated (aged 12–20 years; mean HbA1c 9.1 ± 1.5%). The dropout rate was high (31.4%) in the latter condition, compared with the experimental group (6%), limiting the statistical power of

the study.

g) RCT, binge eating in women with Type 2 diabetes (n = 34),  assessments posttreatment. Frequency of binge

eating, especially subjective bulimic episodes, predicted

HbA1c

1) Depression

(see above Markowitz et al 2011 )

2) anxiety/stress

b) I: combined cognitive behavoiur stress managementC:waiting list 

d) I:  stress reduction programme (

n= 10) C: conventional education (

n= 13),

e) I:  group behaviour modification programme C: ?

3) eating disorders

f) I: psychoeducational programme

of 6-weekly 90-min group sessions

C: treatment as usual

g) I: a 10-week group CBT C: non-prescriptive therapy (NPT)

 Endpoint of follow-up:

b) ?

d) 15 month

e) 3 months

f) 6-month

g) 6 months

b) significant effects of therapy were found in stress and anxiety, bud not on glycaemic controle.

d) at 3-months follow-up the control group had less favourable levels of depression,

anxiety and more denial than the experimental group. Disappointingly, at 9 and 15 months follow-up, only the effects in the field of denial persisted, and metabolic control did not differ between the groups.

e) participants showed

significant reduction in fear of complications and improved

acceptance of diabetes. Marked improvements in glycaemic control were observed in some individuals, but mean reduction

after 3 months in HbA1c was non-significant.

f) Although there were some indications of improved attitudes,

no improvement was found in frequency of purging by insulin

omission or HbA1c levels.

g) Binge eating decreased significantly in both groups

from pre to post in both groups, with significantly fewer relapses observed in the CBT condition.

Study reference

(first author, year of publication)

Research question clear?

(yes/no/unclear)

Search adequate?

(yes/no/unclear)

Selectees articles adequate?

(yes/no/unclear)

Quality assessment adequate?

(yes/no/unclear)

 Data-extraction adequate?

(yes/no/unclear)

Important characteristics individual studies inscribes?

(yes/no/unclear)

Has they circumvented correctly with clinical and statistical heterogeneity of the studies?

(yes/no/unclear)

Is the statistic pooling done correctly?

(yes/no/unclear)

Other limitations

(yes/no/unclear)

Feltz-Cornelis et al., 2010

yes

yes

yes

yes

yes

yes

yes

yes

Unclear control group, and amount of patients in control group.

Unclear follow-up.

Markowitz et al 2011

no

yes

Unclear

No

No

Yes

no

-

it is not a systematic review, but a descriptive review.

Snoek & Skinner 2002

Yes

Yes

Unclear

No

No

Yes

no

-

it is not a systematic review, but a descriptive review