ADAPT: Addressing Depression and Pain Together

Phase 4

Completed

• Conditions: Depression; Back Pain
• Interventions: Drug: Higher-dose venlafaxine; Behavioral: Problem Solving Therapy for Depression and Pain; Behavioral: Supportive management

• Registration Number: NCT01124188
• Lead Sponsor: University of Pittsburgh

Brief Summary

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?

Detailed Description

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-14
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2016-12-15
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Results First Posted: 2017-05-12
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

1. Age 60 or older
2. Scores 10 or higher on the Patient Health Questionnaire-9 (PHQ-9). This is consistent with at least moderate depression severity.
3. Endorses low back pain more days than not, of at least moderate severity, for at least the past 3 months.
4. If venlafaxine up to 150 mg/day has been tried for at least 6 weeks, subjects must have been *completely* unresponsive for both depression and low back pain (based on subject report).
5. During this episode of CLBP, must have tried without continued success any of the following: 1) prescription or over the counter analgesics, 2) physical therapy, 3) acupuncture, 4) injection therapy, 5) had back surgery, 6) multidisciplinary pain program, 7) psychological treatment for chronic pain such as cognitive behavioral therapy or biofeedback, or 8) any other physician-prescribed treatment for chronic low back pain.

Upon meeting, after obtaining written informed consent, the following inclusion criteria are administered to determine protocol-eligibility:

1. Repeat PHQ-9 with score
2. Current depression (major depression, partial remission of major depression, minor depression, or dysthymia) diagnosed with the PRIMEMD
3. 20-item Numeric Rating Scale for low back pain
4. The Montreal Cognitive Assessment (MoCA). Eligibility requires score of at least 24
5. No history of alcohol/substance abuse or dependence for the past six months. If subjects took more analgesics than prescribed for CLBP but there was no other evidence of abuse, they will be included. Alcohol and substance abuse will be assessed with the MINI-International Neuropsychiatric Interview.

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Exclusion Criteria

The following exclusion criteria will be assessed during telephone screening. If the individual responds in the affirmative to any of these conditions, they will not be eligible:

1. Wheelchair-bound as this level of disability does not represent most older adults living with CLBP.
2. Diagnosed with fibromyalgia; there is evidence that individuals with fibromyalgia may have a differential treatment response to SNRIs.
3. Involved in a lawsuit related to back pain and/or receiving workers compensation.

Subjects must also not meet any of the following exclusion criteria:

1. Current or past psychotic-spectrum disorder or current or past bipolar disorder. This will be determined with the PRIME-MD and MINI-Neuropsychiatric interview.
2. Medically unstable, delirious, or terminally ill; or medical contraindication to use of venlafaxine therapy, including hypersensitivity, history of venlafaxine-induced SIADH, uncontrolled narrow angle glaucoma, AST or ALT > 1.5x upper limit of normal.
3. Acute low back pain "red flag" superimposed on chronic low back pain suggesting medically emergent condition (e.g., vertebral fracture, infection, cauda equina syndrome, disk herniation, cancer).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Intervention Arm	Problem Solving Therapy for Depression and Pain	Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Active Control	Supportive management	Higher-dose venlafaxine and supportive management (SM)
Active Control	Higher-dose venlafaxine	Higher-dose venlafaxine and supportive management (SM)
Study Intervention Arm	Higher-dose venlafaxine	Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)

Primary Outcome Measures

Name	Time	Method
Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization	14 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks	Baseline and 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
Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks	Baseline and 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

Trial Locations

Locations (1)

University of Pittsburgh Late Life Depression Program; 🇺🇸 Pittsburgh, Pennsylvania, United States