ADAPT: Addressing Depression and Pain Together

Condition(s) targeted: Depression; Back Pain

Intervention: Combination Treatment with Higher-dose venlafaxine + PST-DP (Other); Higher-dose venlafaxine and supportive management (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Jordan F Karp, MD, Principal Investigator, Affiliation: University of Pittsburgh

Overall contact:
Barbara A Postol, MS, Phone: 412-246-6006, Email: postolba@upmc.edu

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?

Official title: Optimizing Care for Older Adults With Back Pain and Depression

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

Primary outcome:

Depression: Patient Health Questionnaire-9

Pain: 20-Point Numeric Rating Scale

Secondary outcome: Self-Efficacy: Chronic Pain Self-Efficacy Scale

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.

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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).

Barbara A Postol, MS, Phone: 412-246-6006, Email: postolba@upmc.edu

University of Pittsburgh Late Life Depression Program, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Dana Barvincak, MS, Phone: 412-246-6015, Email: barvdm@upmc.edu
Chloe Bolon, BS, Phone: 412-246-6018, Email: bolonc@upmc.edu
Jordan F Karp, MD, Principal Investigator

The University of Pittsburgh Institute on Aging provides access to a multidisciplinary network of comprehensive clinical care.

The American Association for Geriatric Psychiatry is a national association representing and serving its members and the field of geriatric psychiatry.

website describing the study

Related publications:

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. Epub 2008 May 16. Review.

Starting date: May 2010
Last updated: March 15, 2012