Acceptance and commitment therapy versus mindfulness-based stress reduction for newly diagnosed head and neck cancer patients: A randomized controlled trial assessing efficacy for positive psychology, depression, anxiety, and quality of life.

BACKGROUND AND

aimHead and neck cancer patients are vulnerable to various psychological complications due to the effects of both cancer itself and cancer treatment on patients' appearance and physical well-being. Nevertheless, few data have been obtained on effective psychosocial interventions that could protect this group of cancer patients' psychological well-being. Therefore, this three-armed, parallel-group, double-blind, randomized control trial (RCT) aims to evaluate and compare the effects of acceptance and commitment therapy (ACT) and mindfulness-based stress reduction (MBSR) on positive psychology (such as posttraumatic growth [PTG], hope, and optimism), quality of life (QoL), and psychological complications (depression, anxiety, and experiential avoidance) among newly diagnosed head and neck cancer patients. METHODS AND ANALYSIS: This RCT will target newly diagnosed head and neck cancer patients who have been treated only with surgery or who have not yet received any treatment. In total, 120 patients who meet all of the study's inclusion criteria and none of its exclusion criteria will be randomly assigned into three groups-an ACT group, an MBSR group, and a treatment-as-usual control group-at a 1:1:1 allocation ratio. Participants in the two intervention groups (the ACT and MBSR groups) will undergo an eight-week group intervention program. During this program, each intervention will comprise eight modules based on ACT and MBSR, respectively. Outcome assessments will be performed across a three-point timeline, including before the intervention (t0), immediately after the psychosocial intervention at eight weeks (t1), and six months after the intervention (t2). The primary outcome that will be assessed during this RCT is PTG. Meanwhile, the secondary outcomes that will be evaluated in this study are such as QoL, hope, optimism, depression, anxiety, and experiential avoidance. TRIAL REGISTRATION NUMBER: NCT04800419 (ClinicalTrials.gov). Registered on March 16, 2021.