Duke Child & Family Studies Center; Duke University Medical Center
Durham, North Carolina, 27705, United States
NCT Number: NCT00612807
The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.
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Notify Me60 year and older
All sexes
Interventional
Phase 1 / Phase 2
Durham, North Carolina, 27705, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly marital therapy for 6 months.
Other names: Integrative Behavioral Couple Therapy
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)
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.
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.
Time frame: Pre-treatment, post-treatment, 6 month follow-up
Time frame: pre-treatment, post-treatment, 6 month follow-up
Time frame: pre-treatment, post-treatment, 6 month follow-up
Time frame: pre-treatment, post-treatment, 6 month-followup
Time frame: pre-treatment, post-treatment, 6 month follow-up
Duke University
Other
Adapting Marital Therapy in Older Adults With Depression
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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