The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations...
Date First Received: January 2, 2008
Last Updated: February 11, 2008
Verified by: Duke University, January 2008
Clinical Trial Phase: Phase 1/Phase 2 | Start Date: July 2006
Overall Status: Recruiting
Estimated Enrollment: 70
Brief Summary
Official Title: “Adapting Marital Therapy in Older Adults With Depression”
Condition Keyword(s):
Intervention(s):
The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Study Primary Completion Date: January 2010
Detailed Clinical Trial Description
Major depression has been associated with many individual and interpersonal problems in later life, including inadequate social support, marital distress, spousal depression, poor physical health, and higher rates of mortality. Marital therapy has shown promise as a treatment for depression and coexisting marital distress in younger cohorts, and there is a robust association between social support and depressive symptoms in older adults. The combination of couple therapy and antidepressant medication may provide an ideal treatment for older adults by targeting interpersonal and biochemical aspects of depression.
Couples interested in this study will complete an initial assessment with study personnel.
In Phase I, eligible couples will receive weekly marital therapy and the depressed partner will receive medication management with a study doctor for 6 months. In Phase II, couples will be randomly assigned to either the combination treatment (marital therapy plus medication management) or medication management alone for 6 months. At the end of the treatment phase, a thorough assessment will be completed. A follow-up assessment will be completed 6 months after completion of treatment.
Intervention(s) in this Clinical Trial
- Behavioral: Marital Therapy
- Weekly marital therapy for 6 months.
- Drug: Antidepressant Medication Management
- Study doctor may prescribe antidepressant medication for the treatment of depression. Medications will be prescribed according to empirically supported guidelines outlined in the Duke Somatic Treatment Algorithm for Geriatric Depression (STAGED Approach; Steffens, 2002). SSRIs- e.g. Citalopram, sertraline, fluoxetine, SNRIs- e.g. venlafaxine Bupropion Mirtazapine Tricyclic antidepressants Lithium augmentation T3 (triiodothyronine) augmentation
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Control
- Medication management with a study doctor every other week.
- Experimental: Combination
- Medication management with a study doctor every other week plus weekly marital therapy.
Outcome Measures for this Clinical Trial
Primary Measures
- Hamilton Depression Rating Scale
- Time Frame: pre-treatment, monthly, post-treatment, 6 month follow-up
Safety Issue?: Yes
- Time Frame: pre-treatment, monthly, post-treatment, 6 month follow-up
- Dyadic Adjustment Scale
- Time Frame: pre-treatment, monthly, post-treatment, 6 month follow-up
Safety Issue?: No
- Time Frame: pre-treatment, monthly, post-treatment, 6 month follow-up
Secondary Measures
- Frequency & Acceptability of Partner Behavior
- Time Frame: Pre-treatment, post-treatment, 6 month follow-up
Safety Issue?: No
- Time Frame: Pre-treatment, post-treatment, 6 month follow-up
- Conflict Tactics Scale
- Time Frame: pre-treatment, post-treatment, 6 month follow-up
Safety Issue?: Yes
- Time Frame: pre-treatment, post-treatment, 6 month follow-up
- SCID Mood Disorders
- Time Frame: pre-treatment, post-treatment, 6 month follow-up
Safety Issue?: Yes
- Time Frame: pre-treatment, post-treatment, 6 month follow-up
- Personal Assessment of Intimacy in Relationships
- Time Frame: pre-treatment, post-treatment, 6 month-followup
Safety Issue?: No
- Time Frame: pre-treatment, post-treatment, 6 month-followup
- Beck Anxiety Inventory
- Time Frame: pre-treatment, post-treatment, 6 month follow-up
Safety Issue?: No
- Time Frame: pre-treatment, post-treatment, 6 month follow-up
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- One partner must receive a clinical diagnosis of major depressive disorder based upon our assessment
- Couples must be living together
- Either partner must report marital distress or tension
- Willing to take antidepressant medication and participate in weekly marital therapy and assessments
- The depressed partner cannot be involved in any other psychosocial treatment
- Score above 24 on the Mini Mental Status Exam
Exclusion Criteria:
- Both partners meet diagnostic criteria for major depressive disorder based on our evaluation
- Coexisting bipolar or psychotic disorder
- Evidence of a primary substance abuse or dependence disorder
- Current ECT treatment
- Evidence of active and severe domestic violence
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 60 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Duke University
Overall Clinical Trial Officials and Contacts
Jill S. Compton, PhD Principal Investigator Duke University
Overall Contact: Heather L Bergida, Ph.D. 919-286-5264 heather.bergida@duke.edu
Related Publications
References
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Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00612807
Study ID Number: 8636
ClinicalTrials.gov Identifier: NCT00612807
Health Authority: United States: Institutional Review Board
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