Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/01/2006
Date assigned
20/01/2006
Last edited
27/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Frank Petrak

ORCID ID

Contact details

Clinic of Psychosomatic Medicine and Psychotherapy
LWL-University Clinic Bochum
Ruhr-University Bochum
Alexandrinenstr. 1-3
Bochum
44791
Germany
+49 (0)611 174 7841
mail@dr-frank-petrak.de

Additional identifiers

EudraCT number

2005-004525-26

ClinicalTrials.gov number

Protocol/serial number

01KG0505

Study information

Scientific title

Diabetes And Depression Study

Acronym

DAD

Study hypothesis

Study hypotheses: As of 11/11/2010 this record has been updated based on an amendment from 12/11/2008; all updates can be found in the relevant section with the above update date. At this time the target number of participants was decreased from 304 - 230.

Current hypothesis as of 11/11/2010 due to the amendment of 12/11/2008:
A diabetes-specific cognitive behavioural therapy (CBT) leads to a clinically important improvement of glycaemic control when compared with sertraline. This is then measured by a one-year follow-up in patients who initially responded to short-term therapy (CBT or sertraline) with regards to improvement in depression.

Initial information at time of registration:
A diabetes-specific cognitive behavioural therapy (CBT) leads to a greater proportion of patients achieving clinically important improvement of glycaemic control when compared with sertraline. This is then measured by a one-year follow-up in patients who initially responded to short-term therapy (CBT or sertraline) with regards to improvement in depression.

On 12/11/2008 the target number of participants was changed from 304 to 230.

Ethics approval

Ethics approval received from the local Medical Ethics Committee (Ethik-Kommission der Landesärztekammer Hessen) on the 21st February 2006 (EudraCT: 2005-004525-26). Last amendment approved on 12/11/2008.

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Type 1 or type 2 diabetes mellitus

Intervention

Please note that as of 08/05/2008 the anticipated end date of this trial was extended. The previous anticipated end date of this trial was 31/01/2009.

1. Ten sessions (20 hours) of diabetes-specific CBT in an outpatient setting within a 12-week time period. This treatment will comprise of manualised semi-structured standard CBT for depression. In addition, it will include diabetes-specific aspects. Cognitive and behavioural techniques (cognitive restructuring, stress management, cueing) are used in this intervention to help patients diminish diabetes-related distress, reduce perceived barriers to various aspects of self-management, and enhance coping skills. The aim is to improve self-care behaviour and consequently improve glycaemic control.

2. Anti-depressive medication, with the selective serotonin reuptake inhibitor (SSRI) sertraline. Sertraline will be started at 50 mg per day in the morning. If no clinical response is achieved within 2-4 weeks, the dose may be raised to 100 mg per day in the morning. Further dose escalation is possible up to 200 mg per day at the clinician's discretion with changes not more rapidly than 50 mg per week.

After 12 weeks of open-label therapy, only the treatment-responders, showing 50% improvement of depression, in both groups will be included in the one-year long-term phase of the study.

In the long-term phase, diabetological treatment as usual will be given to both groups. CBT-responders will receive no further treatment, while patients responding to Selective Serotonin Reuptake Inhibitor (SSRI) will be given a sustained sertraline regimen as a relapse prevention.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Current information as of 11/11/2010 due to the amendment of 12/11/2008:
Change of glycaemic control (difference in HbA1c value from baseline to the end of the long term phase).

Initial information at time of registration:
Improvement of glycaemic control (minimum 1% decrease in glycosylated haemoglobin A1c test [HbA1c value]) from baseline.

Secondary outcome measures

Current information as of 11/11/2010 due to the amendment of 12/11/2008:
1. "Improvement of glycaemic control" defined as a decrease of at least 1% in HbA1c value from baseline to the end of the long-term phase
2. Remission of depression, not fulfilling the DSM-IV-TR criteria for depression according to the Structured Clinical Interview Diagnosis (SCID) and depression score Hamilton Rating Scale (HAMD) Interview less than or equal to 7
3. Improvement of depression, i.e. a reduction of the HAMD-score from baseline to the end of study by at least 50%
4. Change from baseline to end of study in generic HRQoL as assessed per SF-36
5. Change from baseline to end of study regarding problems in daily living with diabetes as assessed per PAID

Initial information at time of registration:
1. Remission of depression: no longer fulfilling the DSM-IV-TR criteria for depression according to the Structured Clinical Interview Diagnosis (SCID), and depression score on the Hamilton Depression Rating Scale (HAMD) Interview less than or equal to 7
2. Improvement of depression (greater than or equal to 50% reduction on the HAMD-baseline score)
3. Improved generic Health-Related Quality of Life (HRQoL), per SF-3
4. Decreased problems in daily living with diabetes, per Problem Areas In Diabetes scale (PAID)

Overall trial start date

01/03/2006

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 08/05/2008:
1. Type 1 or type 2 diabetes mellitus diagnosed at least 12 months beforehand
2. Insulin treatment for at least the past six months
3. 21 to 69 years of age
4. Poor glycaemic control (HbA1c level greater than 7.5% measured twice within the preceding nine months)
5. Current major depression - Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV-TR) criteria

Previous inclusion criteria:
1. Type 1 or type 2 diabetes mellitus diagnosed at least 12 months beforehand
2. Insulin treatment for at least the past six months
3. 21 to 65 years of age
4. Poor glycaemic control (HbA1c level >8% measured twice within the preceding nine months)
5. Current major depression - Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV-TR) criteria

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

230

Participant exclusion criteria

1. Clinically significant suicide risk or history of attempted suicide
2. History of schizophrenia or psychotic symptoms
3. Bipolar disorder
4. Organic brain syndrome or dementia
5. Alcohol or substance abuse or dependence in the past 6 months

Recruitment start date

01/03/2006

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Germany

Trial participating centre

LWL-University Clinic Bochum
Bochum
44791
Germany

Sponsor information

Organisation

Ruhr University of Bochum (Germany)

Sponsor details

Universitaetsstrasse 150
Bochum
44801
Germany

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01KG0505)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23915015
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25690005

Publication citations

Additional files

Editorial Notes