ADAPT: Addressing Depression and Pain Together
Condition: Depression; Back Pain
MeSH terms: Back Pain; Depression; Depressive Disorder
Intervention: Higher-dose venlafaxine; Supportive management; Problem Solving Therapy for Depression and Pain
Intervention description: Dosing of venlafaxine will range from 187.5-300 mg/day.; 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.; 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.
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 263.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Geriatric psychiatry; Aged; Elderly; Venlafaxine; Self efficacy; Pain; Psychotherapy; Effexor

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?
    

Eligibility 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).