Treatment of Mood and Marriage Study (TOMMS)

• ClinicalTrials.gov Identifier: NCT00612807
• Recruitment Status: Completed
• First Posted: February 12, 2008
• Results First Posted: April 26, 2011
• Last Update Posted: June 24, 2013
• Sponsor: Duke University
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	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

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Adapting Marital Therapy in Older Adults With Depression
• Study Start Date: July 2006
• Actual Primary Completion Date: June 2010
• Actual Study Completion Date: June 2010

Arms and Interventions

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.	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)

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• 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

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:

Futterman A, Gallagher D, Thompson LW, Lovett S, Gilewski M. Retrospective assessment of marital adjustment and depression during the first 2 years of spousal bereavement. Psychol Aging. 1990 Jun;5(2):277-83.

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.

Oxman TE, Berkman LF, Kasl S, Freeman DH Jr, Barrett J. Social support and depressive symptoms in the elderly. Am J Epidemiol. 1992 Feb 15;135(4):356-68.

Tower RB, Kasl SV. Depressive symptoms across older spouses and the moderating effect of marital closeness. Psychol Aging. 1995 Dec;10(4):625-38.

Gerson S, Belin TR, Kaufman A, Mintz J, Jarvik L. Pharmacological and psychological treatments for depressed older patients: a meta-analysis and overview of recent findings. Harv Rev Psychiatry. 1999 May-Jun;7(1):1-28.

Murrell SA, Himmelfarb S, Wright K. Prevalence of depression and its correlates in older adults. Am J Epidemiol. 1983 Feb;117(2):173-85.

Simons AD, Murphy GE, Levine JL, Wetzel RD. Cognitive therapy and pharmacotherapy for depression. Sustained improvement over one year. Arch Gen Psychiatry. 1986 Jan;43(1):43-8.

Baldessarini RJ. Current status of antidepressants: clinical pharmacology and therapy. J Clin Psychiatry. 1989 Apr;50(4):117-26. Review.

Scogin F, McElreath L. Efficacy of psychosocial treatments for geriatric depression: a quantitative review. J Consult Clin Psychol. 1994 Feb;62(1):69-74. Review.

Thase ME, Greenhouse JB, Frank E, Reynolds CF 3rd, Pilkonis PA, Hurley K, Grochocinski V, Kupfer DJ. Treatment of major depression with psychotherapy or psychotherapy-pharmacotherapy combinations. Arch Gen Psychiatry. 1997 Nov;54(11):1009-15.

Reynolds CF 3rd, Frank E, Perel JM, Imber SD, Cornes C, Miller MD, Mazumdar S, Houck PR, Dew MA, Stack JA, Pollock BG, Kupfer DJ. Nortriptyline and interpersonal psychotherapy as maintenance therapies for recurrent major depression: a randomized controlled trial in patients older than 59 years. JAMA. 1999 Jan 6;281(1):39-45.

Holahan CJ, Moos RH. Social support and psychological distress: a longitudinal analysis. J Abnorm Psychol. 1981 Aug;90(4):365-70.

George LK, Blazer DG, Hughes DC, Fowler N. Social support and the outcome of major depression. Br J Psychiatry. 1989 Apr;154:478-85.

Levenson RW, Carstensen LL, Gottman JM. The influence of age and gender on affect, physiology, and their interrelations: a study of long-term marriages. J Pers Soc Psychol. 1994 Jul;67(1):56-68.

Jacobson NS, Holtzworth-Munroe A, Schmaling KB. Marital therapy and spouse involvement in the treatment of depression, agoraphobia, and alcoholism. J Consult Clin Psychol. 1989 Feb;57(1):5-10. Review.

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.

Jacobson NS, Dobson K, Fruzzetti AE, Schmaling KB, Salusky S. Marital therapy as a treatment for depression. J Consult Clin Psychol. 1991 Aug;59(4):547-57.

Jacobson NS, Fruzzetti AE, Dobson K, Whisman M, Hops H. Couple therapy as a treatment for depression: II. The effects of relationship quality and therapy on depressive relapse. J Consult Clin Psychol. 1993 Jun;61(3):516-9.

O'Leary KD, Beach SR. Marital therapy: a viable treatment for depression and marital discord. Am J Psychiatry. 1990 Feb;147(2):183-6.

Leff J, Vearnals S, Brewin CR, Wolff G, Alexander B, Asen E, Dayson D, Jones E, Chisholm D, Everitt B. The London Depression Intervention Trial. Randomised controlled trial of antidepressants v. couple therapy in the treatment and maintenance of people with depression living with a partner: clinical outcome and costs. Br J Psychiatry. 2000 Aug;177:95-100. Erratum in: Br J Psychiatry 2000 Sep;177:284.

Jacobson NS, Christensen A, Prince SE, Cordova J, Eldridge K. Integrative behavioral couple therapy: an acceptance-based, promising new treatment for couple discord. J Consult Clin Psychol. 2000 Apr;68(2):351-5.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00612807
• Other Study ID Numbers: Pro00008099; R34MH073677-01A2 ( U.S. NIH Grant/Contract )
• First Posted: February 12, 2008
• 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; Depressive Disorder, Major; Pathologic Processes; Mood Disorders; Mental Disorders; Tranylcypromine; Bupropion; Venlafaxine Hydrochloride; Sertraline; Nortriptyline; 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; Tranquilizing Agents; Central Nervous System Depressants; Serotonin and Noradrenaline Reuptake Inhibitors; Antidepressive Agents, Tricyclic