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IRCT20220903055860N3 IRCT 2026-08-13 The University of Jahrom Comparing the Effectiveness of Two Psychotherapy Approaches (Mindfulness-Integrated and Spiritually-Based) on War-Related Psychological Symptoms in Citizens Effectiveness of Mindfulness-Integrated Cognitive Behaviour Therapy (MiCBT) and Spiritually based Psychotherapy on Post-Traumatic Stress, Sleep Disturbance, Anxiety, Depression, and Somatic Complaints among Civilian, Following the 40-Day War 2026-08-01 anticipated 105 Complete https://irct.ir/trial/91648 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization method is block randomization with variable block sizes (3 and 6) and a 1:1:1 allocation ratio. The unit of randomization is the individual, and no stratified randomization is used. The random sequence will be generated using STATA software version 17, employing the random number generation function with a system-time-based seed. The randomization process and sequence generation will be performed by an independent statistician who has no role in intervention delivery or data analysis. For allocation concealment, the generated sequence will be kept in coded, opaque, sealed envelopes held by a third party and will not be disclosed to the interventionists or the principal investigator until after final eligibility confirmation and completion of baseline assessments. Following final confirmation, the third party will assign each participant sequentially to one of the three groups (MiCBT, Spiritually Integrated Psychotherapy, or Control) based on the predetermined sequence. N/A Post Traumatic Stress Disorder. Intervention 1: Intervention group 1: Receives 8 sessions of 120 minutes each of group Mindfulness-Integrated Cognitive Behaviour Therapy (MiCBT) delivered online (weekly). This intervention is based on Cayoun's co-emergence model of reinforcement. Session content includes: session 1, introduction to the group and treatment rationale; session 2, progressive muscle relaxation; session 3, breathing meditation; session 4, body scanning (somatic awareness); session 5, Mindfulness-Integrated Exposure Therapy (MIET); session 6, deepening of exposure techniques; session 7, equanimity-based interpersonal skills; and session 8, empathic skills, consolidation, and relapse prevention. Each session is delivered via video conferencing. Intervention 2: Intervention group 2: Receives 8 sessions of 120 minutes each of group spiritually integrated psychotherapy delivered online (weekly). This intervention is designed based on Pargament's (2007) spiritually integrated psychotherapy framework and Rajaei's (2010) Religious Cognitive‑Emotional Therapy model, adapted to the dominant religious beliefs in Iranian‑Islamic society. Session content includes: session 1, introduction, treatment rationale, and group rules; session 2, positive thinking about God and meaning‑making after trauma; session 3, attention to the presence of a higher power; session 4, trust in God (part 1); session 5, trust in God (part 2); session 6, God's caregiving (part 1); session 7, God's caregiving (part 2): gratitude and forgiveness; and session 8, consolidation, relapse prevention, and closure. Participation in religious content is voluntary and implemented with sensitivity to participants' diverse beliefs. Each session is delivered via video conferencing. Intervention 3: Control group: No active intervention (waitlist control). Participants in this group receive no therapy sessions and only complete pretest, posttest, and followup assessments. During the waiting period, this group is under passive monitoring for acute crises. For ethical reasons, after the data collection is completed, one of the two interventions (based on participant's preference) will be offered to them free of charge. Yes - There is a plan to make this available What will be shared: Data from this study include scores for all outcome variables (PTSD, sleep disturbance, anxiety, depression, and somatic complaints) at three assessment time points (preintervention, postintervention, and 2month followup). These data will be shared with other researchers after complete anonymization (removal of all identifying information). No data that could lead to participant identification will be shared. When: Access to the anonymized data from this study will begin 6 months after the end of the study. To whom: All researchers working in academic, scientific, or research institutions (both public and private) may request access to the anonymized data from this study. Researchers working in the nonacademic sector may also request access if they have valid scientific aims. Conditions: Additional conditions for using the anonymized data from this study are as follows: 1. Requesters must submit a research proposal clearly stating their scientific aims. 2. The request must include ethics approval from the requester's institution. 3. Data will only be used for the approved purposes. 4. Any publication resulting from these data must cite the original study. 5. Any attempt to reidentify participants is prohibited. 6. Sharing the received data with third parties without permission of the original study team is not allowed. Where to obtain: Applicants requesting anonymized data from this study should send a written request, including a research proposal and ethics approval, to the email address of the responsible author, Dr. Mohsen Arefian, at arefian@jahromu.ac.ir. The research team will respond to requests within a maximum of 4 weeks. How to obtain: The applicant must first send a written request including a research proposal and ethics approval to the responsible author's email address. The research team reviews the request. If approved, a data sharing agreement will be sent to the applicant. After signing the agreement, anonymized data will be provided within a maximum of 4 weeks from the date of final approval. The entire process from request submission to data receipt takes 6 to 8 weeks. Comments:
public Mohsen Arefian
Jahrom University, Persian Gulf Boulevard, Persian Gulf Square, Professor Motahari Boulevard, Jahrom, Fars
Jahrom Iran (Islamic Republic of) ۷۴۱۳۱۸۸۹۴۱ +98 71 5437 2252 arefian@jahromu.ac.ir The University of Jahrom scientific Mohsen Arefian
Jahrom University, Persian Gulf Boulevard, Persian Gulf Square, Professor Motahari Boulevard, Jahrom, Fars
Jahrom Iran (Islamic Republic of) ۷۴۱۳۱۸۸۹۴۱ +98 71 5437 2252 m.arefian92@gmail.com The University of Jahrom Iran (Islamic Republic of) Residence in Shiraz during the 40day war period full fluency in Persian Age 18 years and older Scoring above 14 for depressive symptoms on the Depression, Anxiety, and Stress Scale (DASS-21) at the screening stage. Scoring above 10 for anxiety symptoms on the DASS-21 at the screening stage. Scoring above 18 for stress symptoms on the DASS-21 at the screening stage. Scoring above 33 on the Post-Traumatic Stress Disorder Checklist at the screening stage. Symptom severity confirmed during the initial clinical interview. Informed consent and voluntary willingness to participate in all study phases No concurrent receipt of other structured psychological interventions for trauma-related symptoms during the intervention period Access to internet, computer, or suitable smartphone for participating in online sessions No acute suicide risk requiring immediate intervention 18 years 65 years Both Presence of an active psychotic disorder Presence of a severe substance use disorder Use of medications affecting consciousness level without a stable dose for at least four weeks F43.1 Post-traumatic stress disorder (PTSD) Behavior Behavior N/A Intervention group 1: Receives 8 sessions of 120 minutes each of group Mindfulness-Integrated Cognitive Behaviour Therapy (MiCBT) delivered online (weekly). This intervention is based on Cayoun's co-emergence model of reinforcement. Session content includes: session 1, introduction to the group and treatment rationale; session 2, progressive muscle relaxation; session 3, breathing meditation; session 4, body scanning (somatic awareness); session 5, Mindfulness-Integrated Exposure Therapy (MIET); session 6, deepening of exposure techniques; session 7, equanimity-based interpersonal skills; and session 8, empathic skills, consolidation, and relapse prevention. Each session is delivered via video conferencing. Intervention group 2: Receives 8 sessions of 120 minutes each of group spiritually integrated psychotherapy delivered online (weekly). This intervention is designed based on Pargament's (2007) spiritually integrated psychotherapy framework and Rajaei's (2010) Religious Cognitive‑Emotional Therapy model, adapted to the dominant religious beliefs in Iranian‑Islamic society. Session content includes: session 1, introduction, treatment rationale, and group rules; session 2, positive thinking about God and meaning‑making after trauma; session 3, attention to the presence of a higher power; session 4, trust in God (part 1); session 5, trust in God (part 2); session 6, God's caregiving (part 1); session 7, God's caregiving (part 2): gratitude and forgiveness; and session 8, consolidation, relapse prevention, and closure. Participation in religious content is voluntary and implemented with sensitivity to participants' diverse beliefs. Each session is delivered via video conferencing. Control group: No active intervention (waitlist control). Participants in this group receive no therapy sessions and only complete pretest, posttest, and followup assessments. During the waiting period, this group is under passive monitoring for acute crises. For ethical reasons, after the data collection is completed, one of the two interventions (based on participant's preference) will be offered to them free of charge. Post Traumatic Stress Disorder. Timepoint: Before intervention, immediately after intervention, 2 months after intervention. Method of measurement: Total score on the Persian version of the Post Traumatic Stress Disorder Checklist for DSM5, with scores ranging from 0 to 80; higher scores indicate greater symptom severity. Sleep Disturbance (Insomnia). Timepoint: Before intervention, immediately after intervention, 2 months after intervention. Method of measurement: Total score on the Persian version of the Insomnia Severity Index, with scores ranging from 0 to 28; higher scores indicate greater insomnia severity. Depression. Timepoint: Before intervention, immediately after intervention, 2 months after intervention. Method of measurement: Score on the Depression subscale of the Persian version of the 21-item Depression, Anxiety, and Stress Scale, with scores ranging from 0 to 21; higher scores indicate greater Depression. Somatic Complaints. Timepoint: Before intervention, immediately after intervention, 2 months after intervention. Method of measurement: Total score on the Persian version of the Somatic Symptom Scale8 (SSS8), with scores ranging from 0 to 32; higher scores indicate greater somatic symptom burden. Anxiety. Timepoint: Before intervention, immediately after intervention, 2 months after intervention. Method of measurement: Score on the anxiety subscale of the Persian version of the 21-item Depression, Anxiety, and Stress Scale, with scores ranging from 0 to 21; higher scores indicate greater anxiety. Stress. Timepoint: Before intervention, immediately after intervention, 2 months after intervention. Method of measurement: Score on the Stress subscale of the Persian version of the 21-item Depression, Anxiety, and Stress Scale, with scores ranging from 0 to 21; higher scores indicate greater Stress. The University of Jahrom Approved 2026-07-15 Research Ethics Committee of Islamic Azad University, Marvdasht Branch Islamic Azad University of Marvdasht, Three kilometers of Persepolis Boulevard, Marvdasht, Fars, Iran Marvdasht Fars Iran (Islamic Republic of)