Diabetes And Depression Study

ISRCTN ISRCTN89333241
DOI https://doi.org/10.1186/ISRCTN89333241
EudraCT/CTIS number 2005-004525-26
Secondary identifying numbers 01KG0505
Submission date
04/01/2006
Registration date
20/01/2006
Last edited
27/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Frank Petrak
Scientific

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

Study information

Study designMulticentre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleDiabetes And Depression Study
Study acronymDAD
Study objectivesStudy 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(s)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.
Health condition(s) or problem(s) studiedType 1 or type 2 diabetes mellitus
InterventionPlease 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 typeMixed
Primary outcome measureCurrent 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 measuresCurrent 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 study start date01/03/2006
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants230
Key inclusion criteriaCurrent 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
Key exclusion criteria1. 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
Date of first enrolment01/03/2006
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

LWL-University Clinic Bochum
Bochum
44791
Germany

Sponsor information

Ruhr University of Bochum (Germany)
University/education

Universitaetsstrasse 150
Bochum
44801
Germany

ROR logo https://ror.org/04tsk2644

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 06/08/2013 Yes No
Results article results 01/05/2015 Yes No
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