Treatment of Mood and Marriage Study (TOMMS)

June 17, 2013 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Child & Family Studies Center; Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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)

Behavioral: Weekly marital therapy
Weekly marital therapy for 6 months.
Other Names:
  • Integrative Behavioral Couple Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-treatment, monthly, post-treatment, 6 month follow-up
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.
pre-treatment, monthly, post-treatment, 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency & Acceptability of Partner Behavior
Time Frame: Pre-treatment, post-treatment, 6 month follow-up
Pre-treatment, post-treatment, 6 month follow-up
Conflict Tactics Scale
Time Frame: pre-treatment, post-treatment, 6 month follow-up
pre-treatment, post-treatment, 6 month follow-up
SCID Mood Disorders
Time Frame: pre-treatment, post-treatment, 6 month follow-up
pre-treatment, post-treatment, 6 month follow-up
Personal Assessment of Intimacy in Relationships
Time Frame: pre-treatment, post-treatment, 6 month-followup
pre-treatment, post-treatment, 6 month-followup
Beck Anxiety Inventory
Time Frame: pre-treatment, post-treatment, 6 month follow-up
pre-treatment, post-treatment, 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Jill S. Compton, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

January 2, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (ESTIMATE)

February 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00008099
  • R34MH073677-01A2 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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