A randomized clinical trial to assess feasibility, acceptability and preliminary effects of telehealth-delivered cognitive-behavioral therapy for perceived social isolation among individuals with opioid use disorders

Background: The purpose of this study was to report on feasibility, acceptability, and initial efficacy data cognitive -behavioral therapy for perceived isolation (CBT-PSI) compared to health education among individuals with opioid use disorders (OUD) reporting elevated loneliness. Methods: Participants (n = 125) with OUD reporting elevated loneliness were recruited using online advertising to participate in a telehealth-delivered randomized clinical trial. Participants received either a 6 -session CBT-PSI (n = 63) or health education (n = 62). Measures assessing loneliness, quantity of social interactions, perceived social support, substance use, substance use consequences, and treatment engagement among others, were completed at baseline, post -intervention, and 1- and 2-months post -intervention. Participants also reported on treatment acceptability for both conditions. Results: Target enrollment was met with loneliness, social disconnectedness measures, and substance use reflecting a clinically severe sample. Retention was high (> 80%) for both conditions. Participants rated both Health Education and CBT-PSI as acceptable, helpful, and useful interventions to address loneliness and opioid use. Loneliness was reduced and quantity of social interactions and perceived social support were increased to the same extent for both conditions and across the follow-up assessments. Opioid use and overall substance use were reduced in both conditions; however, the reductions among participants received CBT-PSI were significantly greater compared to Health Education. Conclusions: This study supports the feasibility and acceptability of CBT-PSI. CBT-PSI findings related to loneliness, substance use, and other social connectedness outcomes are encouraging. Additional testing of CBT-PSI in a fully-powered trial is warranted.