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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
263
Dosing of venlafaxine will range from 187.5-300 mg/day.
Supportive management encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.
PST-DP will be delivered over the course of 10 sessions over 14 weeks. Along with teaching the participant 7 steps of problem solving, PST-DP also includes a medication support and management component.
University of Pittsburgh Late Life Depression Program
Pittsburgh, Pennsylvania, United States
Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization
The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores \< or = to 5 AND Numeric Rating Scale for pain (NRS) \> or = 30% reduction from study entry.
Time frame: 14 weeks
Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks
Change in RMDQ from randomization to 14 weeks. The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Improvement of 30% is clinically meaningful
Time frame: Baseline and 14 weeks
Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks
Change in SPPB scores from randomization to 14 weeks for both arms. The Short Physical Performance Battery (SPPB) assesses physical performance. The SPPB scores range from 0-12 and assess lower extremity strength, balance, and gait speed, three meaningful predictors of morbidity and mortality in late-life. Lower scores on the SPPB indicates greater limitations. Improvement of 0.5 points indicate clinically meaningful improvement in physical performance
Time frame: Baseline and 14 weeks
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