Treatment of Mood and Marriage Study (TOMMS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00612807
First received: January 2, 2008
Last updated: June 17, 2013
Last verified: March 2011

January 2, 2008
June 17, 2013
July 2006
June 2010   (final data collection date for primary outcome measure)
  • 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.
  • Hamilton Depression Rating Scale [ Time Frame: pre-treatment, monthly, post-treatment, 6 month follow-up ] [ Designated as safety issue: Yes ]
  • Dyadic Adjustment Scale [ Time Frame: pre-treatment, monthly, post-treatment, 6 month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00612807 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Treatment of Mood and Marriage Study (TOMMS)
Adapting Marital Therapy in Older Adults With Depression

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Major Depressive Disorder
  • Partner Relational Disorder (V61.10)
  • 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)

  • Active Comparator: Control
    Medication management with a study doctor every other week.
    Intervention: Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
  • Experimental: Combination
    Medication management with a study doctor every other week plus weekly marital therapy.
    Interventions:
    • Behavioral: Weekly marital therapy
    • Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00612807
Pro00008099, R34 MH073677-01A2
Yes
Duke University
Duke University
National Institutes of Health (NIH)
Principal Investigator: Jill S. Compton, PhD Duke University
Duke University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP