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
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