Improving functioning in HIV+ patients with chronic pain and comorbid depression: Protocol for a randomized clinical trial testing a collaborative behavioral health intervention based on behavioral activation

Objective: Persons living with HIV (PWH) experience a disproportionate level of comorbid chronic pain and depression compared to individuals who do not have a diagnosis of HIV. Many PWH report pain that impairs daily function, is severe, and requires medical management. Depression alone is associated with HIV disease progression, medication non-adherence, and increased mortality. Given that numerous studies show that PWHs have chronic pain and depression despite pharmacologic treatment, there is a clear need for additional treatment modalities to address these conditions.

Design: In this paper, we describe our protocol for a multisite, randomized controlled trial of the effectiveness of a collaborative behavioral intervention, called HIV-Pain and Sadness Support (HIVPASS), designed for PWH who endorse chronic pain and depressive symptoms, as compared to an attention matched Health Education (HE) condition. The HIVPASS intervention is based on Behavioral Activation and designed to target both pain and depression using an integrated model that promotes collaboration between HIV medical and psychological providers.

Setting and methods: We plan to (1) recruit PWH who endorse chronic pain and depression in three sites located in New England and the Midwestern United States and (2) compare our HIVPASS intervention to a full attention matched HE intervention with the primary outcome of pain interference, and secondary outcomes of depression, physical activity, HIV medication adherence, and health-related quality of life. Follow-up assessments will occur monthly for three months during the intervention phase and then during the post-intervention phase at months four, six, nine and twelve.

Conclusions: We provide descriptions of our protocol and interventions of our randomized controlled trial for comorbid chronic pain and depression in PWH.

Trial registration: http://ClinicalTrials.govNCT02766751 https://clinicaltrials.gov/ct2/show/NCT02766751?term=stein%2C+michael&draw=2&rank=5.