Addressing both depression and pain in late life: the methodology of the ADAPT study.
OBJECTIVE
To describe the methodology of the first NIH-funded clinical trial for seniors with comorbid depression and chronic low back pain.


METHODS
Randomized controlled effectiveness trial using stepped care methodology. Participants are ≥60 years old. Phase 1 (6 weeks) is open treatment with venlafaxine xr 150 mg/day and supportive management (SM). Response is 2 weeks of PHQ-9 ≤5 and at least 30% improvement in the average numeric rating scale for pain. Nonresponders progress to phase 2 (14 weeks) in which they are randomized to high-dose venlafaxine xr (up to 300 mg/day) with problem solving therapy for depression and pain (PST-DP) or high-dose venlafaxine xr and continued SM. Primary outcomes are the univariate pain and depression response and both observed and self-reported disability. Survival analytic techniques will be used, and the clinical effect size will be estimated with the number needed to treat. We hypothesize that self-efficacy for pain management will mediate response for subjects randomized to venlafaxine xr and PST-DP.


RESULTS
Not applicable.


CONCLUSIONS
The results of this trial will inform the care of these complex patients and further understanding of comorbid pain and depression in late life.
Departments of Psychiatry, University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. karpjf@upmc.edu
Jordan F
JF
Karp
Bruce L
BL
Rollman
Charles F
CF
Reynolds
Jennifer Q
JQ
Morse
Frank
F
Lotrich
Sati
S
Mazumdar
Natalia
N
Morone
Debra K
DK
Weiner
D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D001521:Behavior Therapy / Q000379:methods*; D015897:Comorbidity; D003511:Cyclohexanols / Q000627:therapeutic use*; D003863:Depression / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000453:epidemiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011340:Problem Solving; D012107:Research Design; D000069470:Venlafaxine Hydrochloride
D018687:Antidepressive Agents, Second-Generation; D003511:Cyclohexanols; D000069470:Venlafaxine Hydrochloride