Treatment of Mood and Marriage Study (TOMMS)

Major Depressive Disorder Clinical Trial

Official title:

Adapting Marital Therapy in Older Adults With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612807
• Other study ID #: Pro00008099
• Secondary ID: R34MH073677-01A2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 2, 2008
• Last updated: June 17, 2013
• Start date: July 2006
• Est. completion date: June 2010

Study information

• Verified date: March 2011
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Partner Relational Disorder (V61.10)

Intervention

Behavioral:
• Weekly marital therapy
Weekly marital therapy for 6 months.

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)

Locations

Country	Name	City	State
United States	Duke Child & Family Studies Center; Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (21)

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

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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

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

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HDRS)	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	Yes
Primary	Dyadic Adjustment Scale (DAS)	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	No
Secondary	Frequency & Acceptability of Partner Behavior		Pre-treatment, post-treatment, 6 month follow-up	No
Secondary	Conflict Tactics Scale		pre-treatment, post-treatment, 6 month follow-up	Yes
Secondary	SCID Mood Disorders		pre-treatment, post-treatment, 6 month follow-up	Yes
Secondary	Personal Assessment of Intimacy in Relationships		pre-treatment, post-treatment, 6 month-followup	No
Secondary	Beck Anxiety Inventory		pre-treatment, post-treatment, 6 month follow-up	No