Depression Clinical Trial
Official title:
Optimizing Care for Older Adults With Back Pain and Depression
The primary question addressed by this study is: Using a stepped care approach in primary care, what is the value of the combination of an antidepressant medication (Venlafaxine) and psychotherapy for seniors living with depression and chronic lower back pain when treatment with a low-dose of venlafaxine and supportive management (SM) has led to only a partial or non-response?
The primary aims of the study are:
1. To test the efficacy of higher-dose Venlafaxine and Problem Solving Therapy for
Depression and Pain (VEN/PST-DP) in reducing depression and pain.
2. To test the efficacy of higher-dose VEN/PST-DP in reducing back-related disability and
improving physical functioning.
Primary Hypotheses:
1. During the 14 weeks of step 2, patients receiving VEN/PST-DP, compared to those
receiving VEN/SM, will respond faster and have a higher rate of response.
2. During the 14 weeks of phase 2, patients receiving VEN/PST-DP, compared to those
receiving VEN/SM, will have better self-reported physical functioning.
Secondary Hypothesis:
3. Self-efficacy has been shown to predict treatment outcomes for both depression and
pain. We have observed that the self-efficacy for pain management of these patients
improves with antidepressant pharmacotherapy. We hypothesize that for subjects assigned
to receive treatment with VEN/PST-DP, self-efficacy will mediate treatment response.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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