Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
42 participants
INTERVENTIONAL
2006-07-31
2010-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Medication management with a study doctor every other week.
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)
Combination
Medication management with a study doctor every other week plus weekly marital therapy.
Weekly marital therapy
Weekly marital therapy for 6 months.
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)
Interventions
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Weekly marital therapy
Weekly marital therapy for 6 months.
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Coexisting bipolar or psychotic disorder
* Evidence of a primary substance abuse or dependence disorder
* Current ECT treatment
* Evidence of active and severe domestic violence
60 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Jill S. Compton, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Child & Family Studies Center; Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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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. doi: 10.1037//0882-7974.5.2.277.
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. doi: 10.1093/oxfordjournals.aje.a116297.
Tower RB, Kasl SV. Depressive symptoms across older spouses and the moderating effect of marital closeness. Psychol Aging. 1995 Dec;10(4):625-38. doi: 10.1037//0882-7974.10.4.625.
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. doi: 10.1093/oxfordjournals.aje.a113528.
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. doi: 10.1001/archpsyc.1986.01800010045006.
Baldessarini RJ. Current status of antidepressants: clinical pharmacology and therapy. J Clin Psychiatry. 1989 Apr;50(4):117-26.
Scogin F, McElreath L. Efficacy of psychosocial treatments for geriatric depression: a quantitative review. J Consult Clin Psychol. 1994 Feb;62(1):69-74. doi: 10.1037//0022-006x.62.1.69.
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. doi: 10.1001/archpsyc.1997.01830230043006.
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. doi: 10.1001/jama.281.1.39.
Holahan CJ, Moos RH. Social support and psychological distress: a longitudinal analysis. J Abnorm Psychol. 1981 Aug;90(4):365-70. doi: 10.1037//0021-843x.90.4.365. No abstract available.
George LK, Blazer DG, Hughes DC, Fowler N. Social support and the outcome of major depression. Br J Psychiatry. 1989 Apr;154:478-85. doi: 10.1192/bjp.154.4.478.
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. doi: 10.1037//0022-3514.67.1.56.
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. doi: 10.1037//0022-006x.57.1.5.
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. doi: 10.1037//0022-006x.59.4.547.
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. doi: 10.1037//0022-006x.61.3.516.
O'Leary KD, Beach SR. Marital therapy: a viable treatment for depression and marital discord. Am J Psychiatry. 1990 Feb;147(2):183-6. doi: 10.1176/ajp.147.2.183.
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. doi: 10.1192/bjp.177.2.95.
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. doi: 10.1037//0022-006x.68.2.351.
Other Identifiers
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Pro00008099
Identifier Type: -
Identifier Source: org_study_id
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