ADAPT: Addressing Depression and Pain Together (ADAPT)

April 4, 2017 updated by: Jordan F. Karp, University of Pittsburgh

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Late Life Depression Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Intervention Arm
Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Drug: Higher-dose venlafaxine
Dosing of venlafaxine will range from 187.5-300 mg/day.
Other Names:
  • Effexor
Behavioral: Problem Solving Therapy for Depression and Pain
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.
Other Names:
  • PST-DP
Active Comparator: Active Control
Higher-dose venlafaxine and supportive management (SM)
Drug: Higher-dose venlafaxine
Dosing of venlafaxine will range from 187.5-300 mg/day.
Other Names:
  • Effexor
Behavioral: Supportive management
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization
Time Frame: 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.
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks
Time Frame: 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
Baseline and 14 weeks
Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks
Time Frame: 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
Baseline and 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Jordan F Karp, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 13, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG033575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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