Treatment of Mood and Marriage Study (TOMMS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adapting Marital Therapy in Older Adults With Depression

Conditions
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Major Depressive Disorder, Partner Relational Disorder (V61.10)

Intervention / Treatment
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* Behavioral: Weekly marital therapy
* Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Medication management with a study doctor every other week. | Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.<br>* 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 (daily dose of at least 20 mg for citalopram, 20 mg for fluoxetine, 100 mg for sertraline, 20 mg for paroxetine) SNRIs (e.g., venlafaxine) Bupropion SR (achieve dose of at least 150 mg BID) Mirtazapine Tricyclic antidepressants (nortriptyline with drug levels 80-120 ng/dl) Lithium augmentation MAOI (daily dose of at least 30 mg tranylcypromine or 45 mg of phenelzine)<br>|
| Experimental: Combination<br>Medication management with a study doctor every other week plus weekly marital therapy. | Behavioral: Weekly marital therapy<br>* Weekly marital therapy for 6 months.<br>* Other names: Integrative Behavioral Couple Therapy;Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.<br>* 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 (daily dose of at least 20 mg for citalopram, 20 mg for fluoxetine, 100 mg for sertraline, 20 mg for paroxetine) SNRIs (e.g., venlafaxine) Bupropion SR (achieve dose of at least 150 mg BID) Mirtazapine Tricyclic antidepressants (nortriptyline with drug levels 80-120 ng/dl) Lithium augmentation MAOI (daily dose of at least 30 mg tranylcypromine or 45 mg of phenelzine)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HDRS) | 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. | pre-treatment, monthly, post-treatment, 6 month follow-up | 
| Dyadic Adjustment Scale (DAS) | 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. | pre-treatment, monthly, post-treatment, 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older Adults