Comparison of the Effectiveness of Emotional Awareness and Expression Therapy (EAET) with Acceptance and Commitment Therapy (ACT) and Usual Care in Pain Severity, Pain Interference, and Quality of Life among Students with Chronic Pain

The primary objective of this study is to compare the effectiveness of Emotional Awareness and Expression Therapy (EAET) and Acceptance and Commitment Therapy (ACT) with usual care in reducing pain severity and pain interference and improving quality of life among students with chronic musculoskeletal pain.

A randomized controlled clinical trial with a three-group parallel design, including pre-test, post-test, and 3-month follow-up; simple computer-based randomization; blinded outcome assessors; 15 participants per group, 45 participants in total; analysis using repeated-measures analysis of variance and hierarchical regression in SPSS and AMOS at a significance level of 0.05.

دانشجویان دارای سابقه درد مزمن اسکلتی‌عضلانی از طرح پایش سلامت دانشگاه‌های تهران از طریق ایمیل دعوت می‌شوند. پس از بررسی شرایط و تکمیل ارزیابی پایه، شرکت‌کنندگان به‌صورت تصادفی تخصیص می‌یابند. EAET و ACT توسط درمانگران آموزش‌دیده در مرکز مشاوره دانشگاه تهران اجرا می‌شوند و گروه کنترل درمان معمول دریافت می‌کند. ارزیابی‌ها در پیش‌آزمون، پس‌آزمون و پیگیری ۳ ماهه انجام شده و ارزیاب‌ها از تخصیص گروهی بی‌اطلاع خواهند بود.

Students with chronic musculoskeletal pain for at least 3 months; informed consent; no use of medications affecting psychological functioning or pain; excessive absence; initiation of a new treatment; voluntary withdrawal; development of a new medical condition; incomplete data.

Participants will be randomly allocated to three groups: EAET based on the Lumley protocol, delivered in 90-minute group sessions; ACT based on the Hayes protocol, delivered in 90-minute group sessions; and a usual-care control group.

Pain severity; pain interference; quality of life; alexithymia; psychological flexibility

Randomization will be performed at the individual level using simple randomization. After eligibility criteria are assessed and the baseline assessment is completed, each participant will be assigned a unique identification code. A computer-generated random sequence will then be used to allocate participants with equal probability to one of three groups: the Emotional Awareness and Expression Therapy (EAET) group, the Acceptance and Commitment Therapy (ACT) group, or the usual-care control group. The generation of the random sequence and group allocation will be performed by an individual independent of the principal investigator and therapists. The person responsible for randomization will not be involved in the assessment process, intervention delivery, or data collection. The unit of randomization is the individual, and neither cluster nor stratified randomization will be used. To reduce the risk of selection bias, group allocation will remain concealed from the assessors and the investigator responsible for assessment until completion of the baseline assessment. The participant's allocation will be disclosed after enrollment in the study and completion of the baseline assessment.

Due to the nature of the group-based psychological interventions, blinding of participants and therapists to treatment allocation will not be possible. Participants will be informed of their assigned intervention after allocation, and therapists will be aware of group assignment because of the distinct content and procedures of the interventions. However, outcome assessors and the data analyst will be blinded to participants' group allocation. Pre- and post-intervention assessments will be conducted by assessors who are not involved in treatment allocation or intervention delivery and who will not have access to participants' treatment-group information. To maintain assessor blinding, each participant will be identified by a unique study code, and information regarding treatment allocation will be stored separately from assessment data. Outcome assessors will have access only to coded assessment data and will not be provided with information regarding treatment assignment. Statistical analyses will be conducted using coded data by an analyst who is unaware of treatment allocation. Outcome assessors and the data analyst will be instructed not to ask about or seek information regarding participants' treatment assignments. The principal investigator and therapists will not be blinded to treatment allocation. If an adverse event or other clinical circumstance requires disclosure of a participant's treatment assignment, unblinding will be documented and managed in accordance with the study's ethical procedures.