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Completed

NCT Number: NCT00612807

Treatment of Mood and Marriage Study (TOMMS)

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Duke Child & Family Studies Center; Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weekly marital therapy

Behavioral

Weekly marital therapy for 6 months.

Other names: Integrative Behavioral Couple Therapy

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

Drug

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)

Primary outcomes

  1. Hamilton Depression Rating Scale (HDRS)

    Time frame: 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.

  2. Dyadic Adjustment Scale (DAS)

    Time frame: 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 outcomes

  1. Frequency & Acceptability of Partner Behavior

    Time frame: Pre-treatment, post-treatment, 6 month follow-up

  2. Conflict Tactics Scale

    Time frame: pre-treatment, post-treatment, 6 month follow-up

  3. SCID Mood Disorders

    Time frame: pre-treatment, post-treatment, 6 month follow-up

  4. Personal Assessment of Intimacy in Relationships

    Time frame: pre-treatment, post-treatment, 6 month-followup

  5. Beck Anxiety Inventory

    Time frame: pre-treatment, post-treatment, 6 month follow-up

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Adapting Marital Therapy in Older Adults With Depression

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Feb 12, 2008
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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