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IRCT20250801066714N1 IRCT 2026-08-29 University of Tehran Research Vice-Chancellor Effectiveness of Emotional Awareness and Expression Therapy and Acceptance and Commitment Therapy in Students with Chronic Pain EAET vs ACT 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 2026-09-23 anticipated 45 Pending https://irct.ir/trial/88616 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Chronic musculoskeletal pains. Intervention 1: Intervention Group 1: Emotional Awareness and Expression Therapy (EAET); number of sessions: 8 sessions; duration of each session: 90 minutes; frequency: twice weekly; total intervention duration: 4 weeks; delivery format: group-based, with 15 participants per group; treatment protocol: the Lumley et al. protocol for Emotional Awareness and Expression Therapy; intervention description: the treatment focuses on identifying and increasing awareness of emotions, understanding the relationship between emotions, pain, and physical symptoms, processing and expressing emotions related to difficult experiences, and reducing emotional avoidance, using psychoeducation, emotional exercises, and emotion-expression techniques; therapists: therapists trained in Emotional Awareness and Expression Therapy and supervised by the study supervisor. Intervention 2: Intervention Group 2: Acceptance and Commitment Therapy (ACT); number of sessions: 8 sessions; duration of each session: 90 minutes; frequency: twice weekly; total intervention duration: 4 weeks; delivery format: group-based, with 15 participants per group; treatment protocol: the protocol developed by Hayes et al.; intervention description: the treatment focuses on acceptance of unpleasant experiences, increasing psychological flexibility, cognitive defusion, connection with personal values, and commitment to value-based actions, and includes mindfulness exercises, therapeutic metaphors, experiential exercises, and identification of personal values; therapists: therapists trained in Acceptance and Commitment Therapy and supervised by the study supervisor. Intervention 3: Control Group: Usual care; number of sessions: no structured psychological sessions; intervention duration: 4 weeks; delivery format: participants will continue their usual medical or psychological care received outside the study and will not receive a structured psychological intervention from the research team. This group will be assessed at pre-test, post-test, and 3-month follow-up. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public ِSeyed Hasan Taghavi
Faculty of Foreign Languages and Literatures, North Kargar St., between 15th and 16th St
Tehran Iran (Islamic Republic of) 1439813164 +98 21 8822 9175 hasantaghavi56@gmail.com The University of Tehran scientific Bagher ghobri bonab
North Kargar
Tehran Iran (Islamic Republic of) 1439813164 +98 21 8822 9175 bghobari@ut.ac.ir The University of Tehran Iran (Islamic Republic of) Students enrolled in public universities in Tehran Chronic musculoskeletal pain lasting at least 3 months Significant pain interference in quality of life Providing informed consent No use of medications that severely alter psychological or pain function 18 years no limit Both Excessive absence from treatment sessions Starting new pain treatment or psychotropic medications during the study Voluntary withdrawal Development of new medical conditions making continuation inappropriate Providing incomplete data M54.5 Chronic musculoskeletal pains Treatment - Other Treatment - Other Treatment - Other Intervention Group 1: Emotional Awareness and Expression Therapy (EAET); number of sessions: 8 sessions; duration of each session: 90 minutes; frequency: twice weekly; total intervention duration: 4 weeks; delivery format: group-based, with 15 participants per group; treatment protocol: the Lumley et al. protocol for Emotional Awareness and Expression Therapy; intervention description: the treatment focuses on identifying and increasing awareness of emotions, understanding the relationship between emotions, pain, and physical symptoms, processing and expressing emotions related to difficult experiences, and reducing emotional avoidance, using psychoeducation, emotional exercises, and emotion-expression techniques; therapists: therapists trained in Emotional Awareness and Expression Therapy and supervised by the study supervisor. Intervention Group 2: Acceptance and Commitment Therapy (ACT); number of sessions: 8 sessions; duration of each session: 90 minutes; frequency: twice weekly; total intervention duration: 4 weeks; delivery format: group-based, with 15 participants per group; treatment protocol: the protocol developed by Hayes et al.; intervention description: the treatment focuses on acceptance of unpleasant experiences, increasing psychological flexibility, cognitive defusion, connection with personal values, and commitment to value-based actions, and includes mindfulness exercises, therapeutic metaphors, experiential exercises, and identification of personal values; therapists: therapists trained in Acceptance and Commitment Therapy and supervised by the study supervisor. Control Group: Usual care; number of sessions: no structured psychological sessions; intervention duration: 4 weeks; delivery format: participants will continue their usual medical or psychological care received outside the study and will not receive a structured psychological intervention from the research team. This group will be assessed at pre-test, post-test, and 3-month follow-up. Pain Severity: Change in pain severity score on the Pain Severity subscale of the West Haven-Yale Multidimensional Pain Inventory; the score is measured on a 7-point Likert scale ranging from 0 to 6, with higher scores indicating greater pain severity. Timepoint: Pre-test, before the beginning of the intervention; post-test, immediately after completion of the intervention at week 8; follow-up, 3 months after completion of the intervention. Method of measurement: The Pain Severity subscale of the West Haven-Yale Multidimensional Pain Inventory, consisting of 3 items rated on a 7-point Likert scale ranging from 0 to 6; higher scores indicate greater pain severity. Pain Interference: Change in pain interference score on the Pain Interference subscale of the West Haven-Yale Multidimensional Pain Inventory; the score is measured on a 7-point Likert scale ranging from 0 to 6, with higher scores indicating greater interference of pain with daily functioning. Timepoint: Pre-test, before the beginning of the intervention; post-test, immediately after completion of the intervention at week 8; follow-up, 3 months after completion of the intervention. Method of measurement: The Pain Interference subscale of the West Haven-Yale Multidimensional Pain Inventory, consisting of 9 items rated on a 7-point Likert scale ranging from 0 to 6; higher scores indicate greater interference of pain with daily functioning. Quality of Life: Change in quality of life score measured by the World Health Organization Quality of Life Questionnaire; scores are rated on a 5-point Likert scale, with higher scores indicating better quality of life. Timepoint: Pre-test, before the beginning of the intervention; post-test, immediately after completion of the intervention at week 8; follow-up, 3 months after completion of the intervention. Method of measurement: The World Health Organization Quality of Life Questionnaire, consisting of 26 items covering four domains: physical health, psychological health, social relationships, and environment, is rated on a 5-point Likert scale. personal Approved 2026-03-01 Ethics committee of Shiraz University of Tehran Faculty of Foreign Languages and Literatures, North Kargar St., between 15th and 16th St Tehran Tehran Iran (Islamic Republic of)