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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

Protocol summary

Study aim
To determine the effectiveness of Mindfulness-integrated Cognitive Behavioral Therapy and Spiritually based Psychotherapy on reducing Post-traumatic stress disorder, sleep disturbance, anxiety, depression, and somatic complaints among civilians, following the 40-day War
Design
A randomized controlled trial with two intervention groups and one control group, parallel groups, unblinded, with 105 participants. Randomization was performed using STATA software.
Settings and conduct
Civilian residents of Shiraz who resided in the city during the 40-day war will be included in the study if eligible and will be randomly assigned to three intervention and control groups. Screening, clinical interviews, interventions, and assessments will be conducted online. This study will be unblinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Residence in Shiraz; age 18 years and older; scoring above the clinical cut-off on pre-test screening and confirmation in clinical interview; informed consent; no concurrent receipt of other psychological interventions; no use of medications affecting consciousness; internet access; no active psychotic disorder. Exclusion criteria: Presence of comorbid disorders (psychosis, substance use)
Intervention groups
Group 1: Eight weekly 90-minute online sessions of group Mindfulness-integrated Cognitive Behavioral Therapy. Group 2: Eight weekly 90-minute online sessions of spiritually based psychotherapy. Control group: Receives no intervention. After the study, one of the effective interventions will be offered based on participant choice.
Main outcome variables
Post-Traumatic Stress Disorder; Sleep Disturbance; Depression, Anxiety and Stress Disorders; Somatic Complaints

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220903055860N3
Registration date: 2026-08-13, 1405/05/22
Registration timing: registered_while_recruiting

Last update: 2026-08-13, 1405/05/22
Update count: 0
Registration date
2026-08-13, 1405/05/22
Registrant information
Name
Mohsen Arefian
Name of organization / entity
The University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 4050
Email address
m.arefian92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-08-01, 1405/05/10
Expected recruitment end date
2026-08-21, 1405/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Comparing the Effectiveness of Two Psychotherapy Approaches (Mindfulness-Integrated and Spiritually-Based) on War-Related Psychological Symptoms in Citizens
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Islamic Azad University, Marvdasht Branch
Street address
Islamic Azad University of Marvdasht, Three kilometers of Persepolis Boulevard, Marvdasht, Fars, Iran
City
Marvdasht
Province
Fars
Postal code
73711-13119
Approval date
2026-07-15, 1405/04/24
Ethics committee reference number
IR.IAU.M.REC.1405.284

Health conditions studied

1

Description of health condition studied
Post Traumatic Stress Disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)

Primary outcomes

1

Description
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.

2

Description
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.

Secondary outcomes

1

Description
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.

2

Description
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.

3

Description
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.

4

Description
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.

Intervention groups

1

Description
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.
Category
Behavior

2

Description
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.
Category
Behavior

3

Description
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.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Center for Behavioral and Cognitive Sciences, Jahrom University
Full name of responsible person
Mohsen Arefian
Street address
Jahrom University, Persian Gulf Boulevard, Persian Gulf Square, Professor Motahari Boulevard, Jahrom, Fars
City
Shiraz
Province
Fars
Postal code
۷۴۱۳۱۸۸۹۴۱
Phone
+98 71 5437 2252
Email
arefian@jahromu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Jahrom
Full name of responsible person
Mohammad Ali Naghi-Pour
Street address
Jahrom University, Persian Gulf Boulevard, Persian Gulf Square, Professor Motahari Boulevard, Jahrom, Fars
City
Jahrom
Province
Fars
Postal code
۷۴۱۳۱۸۸۹۴۱
Phone
+98 71 5437 2252
Email
ma_naghipoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Jahrom
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Jahrom
Full name of responsible person
Mohsen Arefian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jahrom University, Persian Gulf Boulevard, Persian Gulf Square, Professor Motahari Boulevard, Jahrom, Fars
City
Jahrom
Province
Fars
Postal code
۷۴۱۳۱۸۸۹۴۱
Phone
+98 71 5437 2252
Email
arefian@jahromu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Jahrom
Full name of responsible person
Mohsen Arefian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jahrom University, Persian Gulf Boulevard, Persian Gulf Square, Professor Motahari Boulevard, Jahrom, Fars
City
Jahrom
Province
Fars
Postal code
۷۴۱۳۱۸۸۹۴۱
Phone
+98 71 5437 2252
Email
m.arefian92@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Jahrom
Full name of responsible person
Mohsen Arefian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jahrom University, Persian Gulf Boulevard, Persian Gulf Square, Professor Motahari Boulevard, Jahrom, Fars
City
Jahrom
Province
Fars
Postal code
۷۴۱۳۱۸۸۹۴۱
Phone
+98 71 5437 2252
Email
m.arefian92@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
Access to the anonymized data from this study will begin 6 months after the end of the study.
To whom data/document is available
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.
Under which criteria data/document could be used
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.
From where data/document is obtainable
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.
What processes are involved for a request to access data/document
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.
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