Clinical trial NCT00612807: Treatment of Mood and Marriage Study (TOMMS)
Official title: Adapting Marital Therapy in Older Adults With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Partner Relational Disorder (V61.10)
Keywords: Older Adults
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-02-12
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: pre-treatment, monthly, post-treatment, 6 month follow-up
measure: Dyadic Adjustment Scale (DAS)
timeFrame: pre-treatment, monthly, post-treatment, 6 month follow-up
Secondary outcomes:
measure: Frequency & Acceptability of Partner Behavior
timeFrame: Pre-treatment, post-treatment, 6 month follow-up
measure: Conflict Tactics Scale
timeFrame: pre-treatment, post-treatment, 6 month follow-up
measure: SCID Mood Disorders
timeFrame: pre-treatment, post-treatment, 6 month follow-up
measure: Personal Assessment of Intimacy in Relationships
timeFrame: pre-treatment, post-treatment, 6 month-followup
measure: Beck Anxiety Inventory
timeFrame: pre-treatment, post-treatment, 6 month follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Child & Family Studies Center; Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jill S. Compton, PhD
role: PRINCIPAL_INVESTIGATOR
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