The ADAPT research study (Addressing Depression and Pain Together) is a clinical trial funded by the National Institute of Aging for older adults living with low back pain and depression. During Stage 1, all participants receive open treatment with lower-dose venlafaxine up to 150 mg/day. Low back pain and/or depression non-responders progress to Stage 2, during which they are randomized to either: 1) higher-dose venlafaxine (up to 300 mg/day), or 2) higher-dose venlafaxine (up to 300 mg/day) + Problem Solving Therapy for Depression and Pain. In addition to low back pain and depression, we are assessing improvement in disability. Participants receive medication and study intervention (Problem Solving Therapy for Depression and Pain) at no cost and can be compensated up to $130 for participating. Entry criteria include: 1) age 60 and older; 2) low back pain of at least moderate severity, more days than not, for at least the last three months, and 3) depressed mood. The duration of the study participants receive interventions and assessments at our offices in the Oakland area of Pittsburgh. The duration of the study is 20 weeks. We also see participants at the office of some of some of our primary care partners and occasionally in their homes.
The following diagram illustrates how people progress through the study:
VENLAFAXINE:We chose venlafaxine (the brand name is Effexor) for this study because it is approved for the treatment of both depression and anxiety. In our extensive work with people 60 and older, we have observed that venlafaxine is effective for many people living with these disorders and is well-tolerated and safe. Venlafaxine has few drug interactions. However, before entry into the study we review everyone's current medication regiment to assure that they can safely participate.
Another reason for selecting venlafaxine is because it acts differently in the body when taken at lower and higher doses. During phase 1, venlafaxine is prescribed up to 150 mg/day. At this lower dose, venlafaxine increases the level of serotonin in the body. Serotonin is a neurotransmitter (a chemical messenger in the brain) that regulates mood and pain.
For those participants who progress to phase 2, venlafaxine is prescribed up to 300 mg/day. At this higher dose, venlafaxine increases the levels of both serotonin and norepinephrine. This other neurotransmitter, norepinephrine, also regulates mood and pain.
Problem Solving Therapy for Depression and Pain (PST-DP): During phase 2 of the study, in addition to higher-dose venlafaxine, ½ of the participants receive Problem Solving Therapy for Depression and Pain (PST-DP). This talk therapy aims to teach participants how to 1) more effectively solve problems that may be contributing to low back pain and depression, 2) more effectively manage pain, 3) become more active and consistently schedule movement and pleasurable activities, 4) improve insomnia and daytime fatigue without the use of sleeping pills, 5) improve communication about their pain and emotions to physicians and family members, and 6) incorporate relaxation techniques into their lives. PST-DP is a flexible and time-limited intervention that aims to make people feel better about themselves (thus improving mood) and more in control of their problems (like low back pain, reducing its "bothersomeness").