Treatment of Mood and Marriage Study (TOMMS)

Duke University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Major Depressive Disorder; Partner Relational Disorder (V61.10)

Treatments: Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.; Behavioral: Weekly marital therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00612807

R34MH073677-01A2 (U.S. NIH Grant/Contract)

Pro00008099

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Control

Active Comparator group

Description:

Medication management with a study doctor every other week.

Treatment:

Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.

Combination

Experimental group

Description:

Medication management with a study doctor every other week plus weekly marital therapy.

Treatment:

Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.

Behavioral: Weekly marital therapy