Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612807

Locations
United States, North Carolina
Duke Child & Family Studies Center; Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Jill S. Compton, PhD Duke University
  More Information

Publications:
Jacobson, N.S. & Christensen, A. (1996). Acceptance and Change in Couple Therapy: A Therapist's Guide to Transforming Relationships. New York: W.W. Norton & Company, Inc.
O'Leary, KD, Christian, JL, & Mendell, NR (1994). A closer look at the link between marital discord and depressive symptomatology. Journal of Social and Clinical Psychology, 13, 33-41.

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00612807     History of Changes
Other Study ID Numbers: Pro00008099, R34 MH073677-01A2
Study First Received: January 2, 2008
Results First Received: February 16, 2011
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Older Adults

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Bupropion
Nortriptyline
Sertraline
Tranylcypromine
Venlafaxine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Anxiety Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014