Treatment of Mood and Marriage Study (TOMMS)
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Purpose
The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder Partner Relational Disorder (V61.10) |
Behavioral: Weekly marital therapy Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc. |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Adapting Marital Therapy in Older Adults With Depression |
- Hamilton Depression Rating Scale (HDRS) [ Time Frame: pre-treatment, monthly, post-treatment, 6 month follow-up ] [ Designated as safety issue: Yes ]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) [ Time Frame: pre-treatment, monthly, post-treatment, 6 month follow-up ] [ Designated as safety issue: No ]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.
- Frequency & Acceptability of Partner Behavior [ Time Frame: Pre-treatment, post-treatment, 6 month follow-up ] [ Designated as safety issue: No ]
- Conflict Tactics Scale [ Time Frame: pre-treatment, post-treatment, 6 month follow-up ] [ Designated as safety issue: Yes ]
- SCID Mood Disorders [ Time Frame: pre-treatment, post-treatment, 6 month follow-up ] [ Designated as safety issue: Yes ]
- Personal Assessment of Intimacy in Relationships [ Time Frame: pre-treatment, post-treatment, 6 month-followup ] [ Designated as safety issue: No ]
- Beck Anxiety Inventory [ Time Frame: pre-treatment, post-treatment, 6 month follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | July 2006 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control
Medication management with a study doctor every other week.
|
Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
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) |
|
Experimental: Combination
Medication management with a study doctor every other week plus weekly marital therapy.
|
Behavioral: Weekly marital therapy
Weekly marital therapy for 6 months.
Other Name: Integrative Behavioral Couple Therapy
Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
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) |
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| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Duke Child & Family Studies Center; Duke University Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| Principal Investigator: | Jill S. Compton, PhD | Duke University |
More Information
Publications:
| Responsible Party: | Jill S. Compton, Ph.D., Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00612807 History of Changes |
| Other Study ID Numbers: | 8636, R34 MH073677-01A2 |
| Study First Received: | January 2, 2008 |
| Results First Received: | February 16, 2011 |
| Last Updated: | March 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Older Adults |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Lithium Nortriptyline Tranylcypromine Sertraline Venlafaxine Bupropion Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antimanic Agents Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Antidepressive Agents, Tricyclic Antidepressive Agents Monoamine Oxidase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013