Treatment of Mood and Marriage Study (TOMMS)

Phase 1

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Combination	Weekly marital therapy	Medication management with a study doctor every other week plus weekly marital therapy.

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HDRS)	pre-treatment, monthly, post-treatment, 6 month follow-up	The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression.
Dyadic Adjustment Scale (DAS)	pre-treatment, monthly, post-treatment, 6 month follow-up	The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning.

Secondary Outcome Measures

Name	Time	Method
Frequency & Acceptability of Partner Behavior	Pre-treatment, post-treatment, 6 month follow-up
Conflict Tactics Scale	pre-treatment, post-treatment, 6 month follow-up
SCID Mood Disorders	pre-treatment, post-treatment, 6 month follow-up
Personal Assessment of Intimacy in Relationships	pre-treatment, post-treatment, 6 month-followup
Beck Anxiety Inventory	pre-treatment, post-treatment, 6 month follow-up