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The Effectiveness of Acceptance and Commitment Therapy on Dyadic Functioning, Emotion Regulation, and Symptoms of Secondary Post-Traumatic Stress Disorder in Spouses of Military Personnel with PTSD

Protocol summary

Study aim
Determining the effectiveness of Acceptance and Commitment Therapy on dyadic functioning, emotion regulation, and symptoms of secondary post-traumatic stress disorder in spouses of military personnel with PTSD.
Design
Initially, 52 participants are randomly selected and assigned to experimental and control groups through random allocation.
Settings and conduct
In the orientation session, the experimental group receives information about PTSD and the study, while the control group is provided with non-interventional content. Then, the main variables—dyadic functioning (ECS), emotion regulation (DERS), and secondary trauma (STQ)—are assessed at pretest, and PTSD diagnosis is confirmed using the PCL-5. The experimental group receives seven weekly ACT sessions (60–90 minutes each). The control group is followed without receiving intervention (but receives the treatment after the study). Assessments are conducted again at post-test and at a three-month follow-up.
Participants/Inclusion and exclusion criteria
The study population comprised spouses of military personnel with PTSD in Yazd (2025) referred by the Treatment Deputy of the Islamic Revolutionary Guard Corps and the Law Enforcement Forces. Inclusion criteria were being the spouse of a living military member with PTSD and meeting the study eligibility criteria. Exclusion criteria included hospitalization, major life events (e.g., divorce), or poor adherence to the intervention.
Intervention groups
Intervention group: Participants received 7 weekly group ACT sessions (60–90 min). Outcomes were assessed at baseline, post-intervention, and 3-month follow-up. Control group: Participants were assigned to a wait-list control and assessed at the same time points. ACT was offered after study completion.
Main outcome variables
Dyadic functioning – Emotion regulation – Symptoms of secondary post-traumatic stress disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210708051815N3
Registration date: 2026-07-15, 1405/04/24
Registration timing: retrospective

Last update: 2026-07-15, 1405/04/24
Update count: 0
Registration date
2026-07-15, 1405/04/24
Registrant information
Name
Amir masoud Mirbagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3823 6421
Email address
goosheamm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
2025-08-23, 1404/06/01
Actual recruitment end date
2025-10-07, 1404/07/15
Trial completion date
2026-09-22, 1405/06/31
Scientific title
The Effectiveness of Acceptance and Commitment Therapy on Dyadic Functioning, Emotion Regulation, and Symptoms of Secondary Post-Traumatic Stress Disorder in Spouses of Military Personnel with PTSD
Public title
Effectiveness of ACT in Spouses of Military Personnel with PTSD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Spouses of military personnel with PTSD whose partners are still alive. The spouses must not have a history of major psychiatric disorders or hospitalization due to psychological problems. In addition, during the pre-intervention assessment, these individuals must score above the cut-off point on the research instruments, indicating the presence of the symptom. A score higher than 50 on the PCL-5 for the military individual.
Exclusion criteria:
Development of a physical or psychological illness during the study leading to hospitalization and discontinuation of the ACT treatment process. Changes in life structure, such as divorce during the study. Dropping out of therapy sessions or عدم adherence to therapeutic assignments.
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 52
Actual sample size reached: 49
Randomization (investigator's opinion)
Randomized
Randomization description
After confirming eligibility criteria and obtaining written informed consent, participants were randomly allocated to either the intervention group (Acceptance and Commitment Therapy [ACT]) or the wait-list control group with a 1:1 allocation ratio. Randomization was performed using a computer-generated random number table. Each participant was assigned a unique identification code, and allocation to the study groups was carried out according to the predetermined random sequence. To ensure balanced group sizes, participant allocation continued until 26 individuals were assigned to each group. The allocation list was maintained by the principal investigator, and all outcome assessments were conducted at baseline (pretest), post-intervention (posttest), and the three-month follow-up according to the assigned group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation and sessions were conducted under blinding by a clinical supervisor.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of baghyatallah university of medical sciences
Street address
Mollasadra st, vanak sq sheykh bahayi st,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1435915381
Approval date
2026-03-17, 1404/12/26
Ethics committee reference number
IR.BMSU.REC.1404.210

Health conditions studied

1

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

Primary outcomes

1

Description
Dyadic functioning: The World Health Organization states that the health and dynamics of couples depend on their patterns of perception, cognition, emotional system, and behavior, all of which are structural components of dyadic functioning
Timepoint
PreTest-PostTest-fallow up
Method of measurement
ECS

2

Description
Emotion Regulation: Emotion regulation refers to any process or action through which a person influences their emotions or emotional expression.
Timepoint
PreTest-PostTest-fallow up
Method of measurement
DERS

3

Description
Secondary Post-Traumatic Stress Disorder Syndrome: Secondary trauma refers to the transmission of symptoms similar to PTSD from the affected person to someone who is in close proximity to these symptoms.
Timepoint
PreTest-PostTest-fallow up
Method of measurement
STQ

Secondary outcomes

empty

Intervention groups

1

Description
Participants in the intervention group received group-based Acceptance and Commitment Therapy (ACT) based on the standard protocol developed by Hayes and colleagues. The intervention consisted of eight weekly sessions, each lasting 90 minutes, delivered by a clinical psychologist trained in ACT. The sessions covered the six core ACT processes, including acceptance, cognitive defusion, present-moment awareness, self-as-context, values clarification, and committed action. Homework assignments and experiential exercises were provided at the end of each session to facilitate the application of therapeutic skills in daily life. The total duration of the intervention was 8 weeks. No medications or medical devices were used during the intervention.
Category
Treatment - Other

2

Description
Control group: Participants in the control group did not receive Acceptance and Commitment Therapy during the study period and continued to receive routine care, if needed. For ethical considerations, they were offered the ACT program after completion of the post-intervention assessments.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Deputy Director of Medical Affairs, Yazd Veterans Affairs Organization
Full name of responsible person
Amirmasoud Mirbagheri
Street address
Yazd-Safaieh-End of Shahid Ghandi Boulevard-Soroush Street-Arash Complex-Unit 164
City
Yazd
Province
Yazd
Postal code
8949193775
Phone
+98 35 3833 6981
Email
goosheamm@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Abbasali Imani Fooladi
Street address
Tehran, Vanak Square, Mulla Sadra Street, South Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435915381
Phone
+98 21 8804 0060
Email
researchcenter@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Amirmasoud Mirbagheri
Position
Elite soldier
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Yazd-Safaieh-End of Shahid Ghandi Boulevard-Soroush Street-Arash Complex-Unit 164
City
Yazd
Province
Yazd
Postal code
894913775
Phone
+98 936 300 8905
Email
goosheamm@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Esfandiar Azad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
Tehran, Vanak Square, Mulla Sadra Street, South Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۵۳۸۱
Phone
+98 21 8804 0060
Email
sfazad13@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Amirmasoud Mirbagheri
Position
Elite soldier
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Yazd-Safaieh-End of Shahid Ghandi Boulevard-Soroush Street-Arash Complex-Unit 164
City
Yazd
Province
Yazd
Postal code
8949193775
Phone
+98 936 300 8905
Email
goosheamm@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Upon request from the corresponding author and research supervisor, access to data is possible, subject to confidentiality.
When the data will become available and for how long
Up to 5 years after the research is completed
To whom data/document is available
Researchers and university faculty members
Under which criteria data/document could be used
Conducting additional scientific research
From where data/document is obtainable
Responsible author
What processes are involved for a request to access data/document
First, a written request via email or post to the responsible author / review by the research team / submission of documents
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