ADAPT: Addressing Depression and Pain Together

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01124188
First received: May 13, 2010
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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
Depression
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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Pain: 20-Point Numeric Rating Scale [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-Efficacy: Chronic Pain Self-Efficacy Scale [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: May 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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.
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124188

Contacts
Contact: Barbara A Postol, MS 412-246-6006 postolba@upmc.edu
Contact: Jill A Houle, MEd 412-246-6003 houleja@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Late Life Depression Program Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Dana Barvincak, MS    412-246-6015    barvdm@upmc.edu   
Contact: Chloe Bolon, BS    412-246-6018    bolonc@upmc.edu   
Principal Investigator: Jordan F Karp, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Jordan F Karp, MD University of Pittsburgh
  More Information

Additional Information:
Publications:
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01124188     History of Changes
Other Study ID Numbers: AG033575
Study First Received: May 13, 2010
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Geriatric psychiatry
Aged
Elderly
Venlafaxine
Self efficacy
Pain
Psychotherapy
Effexor

Additional relevant MeSH terms:
Back Pain
Depression
Depressive Disorder
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014