Cognitive behavioral therapy combined with head and face tuina/massage for negative emotions and sleep disorders in patients with protracted withdrawal symptoms: a study protocol for a randomized controlled trial

Abstract Background: Protracted withdrawal symptoms(PWS) play a crucial role in relapse. While medication maintenance or behavioral therapies such as cognitive behavioral therapy (CBT) can alleviate these symptoms, their implementation is still limited. Evidence suggests that Chinese tuina / massage therapy can improve mood and sleep quality in individuals experiencing PWS. However, high-quality, evidence-based studies supporting this claim are still lacking. Methods and analysis A prospective, parallel, three-armed, single-center, assessor-blinded, randomized controlled trial will be conducted with 69 patients at the Sichuan Ziyang Drug Rehabilitation Center (SZDRC). Patients undergoing PWS will be randomly assigned in a 1:1:1 ratio to three groups: CBT+tuina (Group A), CBT only (Group B), and waitlist (Group C). Group A will receive 2 sessions of CBT and 12 sessions of head and face massage for 4 weeks, while Group B will receive only 2 sessions of CBT over the same period. Group C will not receive any intervention during the treatment period and will receive the same compensatory treatment as Group A after the trial.The primary outcome will be measured using the Symptom Checklist 90 (SCL-90), and secondary outcomes will include the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and Pittsburgh Sleep Quality Index (PSQI). Measurements will be obtained at baseline, 1 week after treatment completion, and at the end of follow-up. Data analysis will be conducted by independent statisticians using intention-to-treat analysis. Discussion: This study aims to investigate the efficacy and safety of CBT combined with head tuina/massage for protracted withdrawal symptoms. Questionnaires will be used to assess the degree of improvement in negative mood and sleep status. High-quality, evidence-based evidence will be obtained to reduce the pressure on the development of addiction treatment. Trial registration number: This study has been registered on Chinese Clinical Trials.gov with number ChiCTR2200058212 and has obtained ethics approvals from the Ethics Committee of the People's Hospital of Ziyang with number 2021-K-LS-2.