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Treatment of Mood and Marriage Study (TOMMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00612807
First Posted: February 12, 2008
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Duke University
  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 (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adapting Marital Therapy in Older Adults With Depression

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 ]
    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 ]
    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 ]
  • Conflict Tactics Scale [ Time Frame: pre-treatment, post-treatment, 6 month follow-up ]
  • SCID Mood Disorders [ Time Frame: pre-treatment, post-treatment, 6 month follow-up ]
  • Personal Assessment of Intimacy in Relationships [ Time Frame: pre-treatment, post-treatment, 6 month-followup ]
  • Beck Anxiety Inventory [ Time Frame: pre-treatment, post-treatment, 6 month follow-up ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institutes of Health (NIH)
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
R34MH073677-01A2 ( U.S. NIH Grant/Contract )
First Submitted: January 2, 2008
First Posted: February 12, 2008
Results First Submitted: February 16, 2011
Results First Posted: April 26, 2011
Last Update Posted: June 24, 2013
Last Verified: March 2011

Keywords provided by Duke University:
Older Adults

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bupropion
Venlafaxine Hydrochloride
Sertraline
Lithium Carbonate
Nortriptyline
Tranylcypromine
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Uptake Inhibitors
Serotonin Agents
Antimanic Agents