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ADAPT: Addressing Depression and Pain Together (ADAPT)

This study has been completed.
Information provided by (Responsible Party):
Jordan F. Karp, University of Pittsburgh Identifier:
First received: May 13, 2010
Last updated: August 10, 2016
Last verified: August 2016
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?

Condition Intervention Phase
Back Pain
Other: Combination Treatment with Higher-dose venlafaxine + PST-DP
Drug: Higher-dose venlafaxine and supportive management
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Care for Older Adults With Back Pain and Depression

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Depression: Patient Health Questionnaire-9 [ Time Frame: 3 minutes ]
  • Pain: 20-Point Numeric Rating Scale [ Time Frame: 3 minutes ]

Secondary Outcome Measures:
  • Self-Efficacy: Chronic Pain Self-Efficacy Scale [ Time Frame: 3 minutes ]

Estimated Enrollment: 250
Study Start Date: May 2010
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Intervention Arm
Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Other: Combination Treatment with Higher-dose venlafaxine + PST-DP
Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks.
Other Name: Effexor
Active Comparator: Active Control
Higher-dose venlafaxine and supportive management (SM)
Drug: Higher-dose venlafaxine and supportive management
The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.
Other Name: Effexor

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.

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01124188

United States, Pennsylvania
University of Pittsburgh Late Life Depression Program
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Jordan F Karp, MD University of Pittsburgh
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jordan F. Karp, Associate Professor of Psychiatry, Anesthesiology, and Clinical and Translational Science, University of Pittsburgh Identifier: NCT01124188     History of Changes
Other Study ID Numbers: AG033575
Study First Received: May 13, 2010
Last Updated: August 10, 2016

Keywords provided by University of Pittsburgh:
Geriatric psychiatry
Self efficacy

Additional relevant MeSH terms:
Depressive Disorder
Back Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs processed this record on March 29, 2017