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ADAPT: Addressing Depression and Pain Together (ADAPT)

Primary Purpose

Depression, Back Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Higher-dose venlafaxine
Supportive management
Problem Solving Therapy for Depression and Pain
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Geriatric psychiatry, Aged, Elderly, Venlafaxine, Self efficacy, Pain, Psychotherapy, Effexor

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Pittsburgh Late Life Depression Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Intervention Arm

Active Control

Arm Description

Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)

Higher-dose venlafaxine and supportive management (SM)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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

Full Information

First Posted
May 13, 2010
Last Updated
April 4, 2017
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01124188
Brief Title
ADAPT: Addressing Depression and Pain Together
Acronym
ADAPT
Official Title
Optimizing Care for Older Adults With Back Pain and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: To test the efficacy of higher-dose Venlafaxine and Problem Solving Therapy for Depression and Pain (VEN/PST-DP) in reducing depression and pain. To test the efficacy of higher-dose VEN/PST-DP in reducing back-related disability and improving physical functioning. Primary Hypotheses: 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. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Back Pain
Keywords
Geriatric psychiatry, Aged, Elderly, Venlafaxine, Self efficacy, Pain, Psychotherapy, Effexor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Intervention Arm
Arm Type
Experimental
Arm Description
Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Higher-dose venlafaxine and supportive management (SM)
Intervention Type
Drug
Intervention Name(s)
Higher-dose venlafaxine
Other Intervention Name(s)
Effexor
Intervention Description
Dosing of venlafaxine will range from 187.5-300 mg/day.
Intervention Type
Behavioral
Intervention Name(s)
Supportive management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Therapy for Depression and Pain
Other Intervention Name(s)
PST-DP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization
Description
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
Secondary Outcome Measure Information:
Title
Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks
Description
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
Title
Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 60 or older Scores 10 or higher on the Patient Health Questionnaire-9 (PHQ-9). This is consistent with at least moderate depression severity. Endorses low back pain more days than not, of at least moderate severity, for at least the past 3 months. 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). 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: Repeat PHQ-9 with score Current depression (major depression, partial remission of major depression, minor depression, or dysthymia) diagnosed with the PRIMEMD 20-item Numeric Rating Scale for low back pain The Montreal Cognitive Assessment (MoCA). Eligibility requires score of at least 24 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: Wheelchair-bound as this level of disability does not represent most older adults living with CLBP. Diagnosed with fibromyalgia; there is evidence that individuals with fibromyalgia may have a differential treatment response to SNRIs. Involved in a lawsuit related to back pain and/or receiving workers compensation. Subjects must also not meet any of the following exclusion criteria: Current or past psychotic-spectrum disorder or current or past bipolar disorder. This will be determined with the PRIME-MD and MINI-Neuropsychiatric interview. 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan F Karp, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Late Life Depression Program
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19750557
Citation
Karp JF, Weiner DK, Dew MA, Begley A, Miller MD, Reynolds CF 3rd. Duloxetine and care management treatment of older adults with comorbid major depressive disorder and chronic low back pain: results of an open-label pilot study. Int J Geriatr Psychiatry. 2010 Jun;25(6):633-42. doi: 10.1002/gps.2386.
Results Reference
background
PubMed Identifier
19682111
Citation
Karp JF, Skidmore E, Lotz M, Lenze E, Dew MA, Reynolds CF 3rd. Use of the late-life function and disability instrument to assess disability in major depression. J Am Geriatr Soc. 2009 Sep;57(9):1612-9. doi: 10.1111/j.1532-5415.2009.02398.x. Epub 2009 Jul 21.
Results Reference
background
PubMed Identifier
17014605
Citation
Karp JF, Reynolds CF 3rd, Butters MA, Dew MA, Mazumdar S, Begley AE, Lenze E, Weiner DK. The relationship between pain and mental flexibility in older adult pain clinic patients. Pain Med. 2006 Sep-Oct;7(5):444-52. doi: 10.1111/j.1526-4637.2006.00212.x.
Results Reference
background
PubMed Identifier
15728749
Citation
Karp JF, Weiner D, Seligman K, Butters M, Miller M, Frank E, Stack J, Mulsant BH, Pollock B, Dew MA, Kupfer DJ, Reynolds CF 3rd. Body pain and treatment response in late-life depression. Am J Geriatr Psychiatry. 2005 Mar;13(3):188-94. doi: 10.1176/appi.ajgp.13.3.188.
Results Reference
background
PubMed Identifier
18591356
Citation
Arean P, Hegel M, Vannoy S, Fan MY, Unuzter J. Effectiveness of problem-solving therapy for older, primary care patients with depression: results from the IMPACT project. Gerontologist. 2008 Jun;48(3):311-23. doi: 10.1093/geront/48.3.311.
Results Reference
background
PubMed Identifier
18487247
Citation
Karp JF, Shega JW, Morone NE, Weiner DK. Advances in understanding the mechanisms and management of persistent pain in older adults. Br J Anaesth. 2008 Jul;101(1):111-20. doi: 10.1093/bja/aen090. Epub 2008 May 16.
Results Reference
background
PubMed Identifier
31633789
Citation
Stahl ST, Jung C, Weiner DK, Pecina M, Karp JF. Opioid Exposure Negatively Affects Antidepressant Response to Venlafaxine in Older Adults with Chronic Low Back Pain and Depression. Pain Med. 2020 Aug 1;21(8):1538-1545. doi: 10.1093/pm/pnz279.
Results Reference
derived
PubMed Identifier
30358242
Citation
Wei W, Karim HT, Lin C, Mizuno A, Andreescu C, Karp JF, Reynolds CF 3rd, Aizenstein HJ. Trajectories in Cerebral Blood Flow Following Antidepressant Treatment in Late-Life Depression: Support for the Vascular Depression Hypothesis. J Clin Psychiatry. 2018 Oct 23;79(6):18m12106. doi: 10.4088/JCP.18m12106.
Results Reference
derived
PubMed Identifier
25040462
Citation
Rej S, Dew MA, Karp JF. Treating concurrent chronic low back pain and depression with low-dose venlafaxine: an initial identification of "easy-to-use" clinical predictors of early response. Pain Med. 2014 Jul;15(7):1154-62. doi: 10.1111/pme.12456. Epub 2014 Jul 4.
Results Reference
derived
Links:
URL
http://www.wpic.pitt.edu/research/
Description
The Late-Life Depression Evaluation and Treatment Center provides information and treatment for depression, anxiety disorders, and insomnia in older Americans.
URL
http://www.aging.pitt.edu/
Description
The University of Pittsburgh Institute on Aging provides access to a multidisciplinary network of comprehensive clinical care.
URL
http://www.aagpgpa.org/
Description
The American Association for Geriatric Psychiatry is a national association representing and serving its members and the field of geriatric psychiatry.
URL
http://www.ADAPTstudy.com
Description
website describing the study

Learn more about this trial

ADAPT: Addressing Depression and Pain Together

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