ADAPT: Addressing Depression and Pain Together (ADAPT)
Depression, Back Pain
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
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).
Sites / Locations
- University of Pittsburgh Late Life Depression Program
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Study Intervention Arm
Active Control
Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Higher-dose venlafaxine and supportive management (SM)