ADAPT: Addressing Depression and Pain Together

Depression Clinical Trial

— ADAPT  

Official title:

Optimizing Care for Older Adults With Back Pain and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124188
• Other study ID #: AG033575
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2010
• Last updated: August 10, 2016
• Start date: May 2010
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Depression
• Depressive Disorder

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Late Life Depression Program	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. Review. — View 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 — View 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. — View 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression: Patient Health Questionnaire-9		3 minutes	No
Primary	Pain: 20-Point Numeric Rating Scale		3 minutes	No
Secondary	Self-Efficacy: Chronic Pain Self-Efficacy Scale		3 minutes	No

External Links

•   The American Association for Geriatric Psychiatry is a national association representing and serving its members and the field of geriatric psychiatry.
•   The University of Pittsburgh Institute on Aging provides access to a multidisciplinary network of comprehensive clinical care.
•   website describing the study