The objective of this study is to evaluate the effectiveness of Acceptance and Commitment Therapy on quality of life, resilience, and post-traumatic stress symptoms in survivors of road-traffic accidents.
Design
This study is a randomized controlled trial with a parallel-group design and a control group. 30 participants are randomly assigned to the intervention group (ACT) or control group (usual care/waiting list). Allocation is concealed using sealed envelopes, and the outcome assessor is blinded. The study is conducted as a pilot RCT.
Settings and conduct
The study will be conducted in Saravan city at Razi and Iranmehr hospitals. Interventions and assessments will take place at these treatment centers.
Participants/Inclusion and exclusion criteria
Age 18–60 years, history of road-traffic accident with PTSD symptoms, above cut-off score on PTSD scale, ability to attend sessions, basic literacy, and informed consent.
Exclusion Criteria:
Severe psychiatric disorders, unstable psychiatric medication, active substance abuse, concurrent psychological treatment, inability to attend sessions, or unwillingness to continue participation.
Intervention groups
Receive Acceptance and Commitment Therapy (ACT) based on a structured protocol with fixed session number and duration.
Control Group:
Receive no active psychological intervention and only usual care or placement on a waiting list.
Main outcome variables
Quality of life
Resilience
Severity of post-traumatic stress disorder (PTSD) symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251201068175N1
Registration date:2025-12-19, 1404/09/28
Registration timing:registered_while_recruiting
Last update:2025-12-19, 1404/09/28
Update count:0
Registration date
2025-12-19, 1404/09/28
Registrant information
Name
Tahereh Sepahi Sarjo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3762 0000
Email address
moslem.rigi67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-06, 1404/09/15
Expected recruitment end date
2026-01-05, 1404/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Acceptance and Commitment Therapy(ACT) on Quality Of Life, Resilience and Post Traumatic Stress Disorder in road accident victims
Public title
Effectiveness of Acceptance and Commitment Therapy on Quality of Life, Resilience, and Post-Traumatic Stress Symptoms in Road-Traffic Accident Survivors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All road accident casualties in Saravan have occurred since September 1403.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Committees of Islamic Azad University-Zahedan Branch
Street address
University Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743545
Approval date
2025-12-10, 1404/09/19
Ethics committee reference number
IR.IAU.ZAH.REC.1404.103
Health conditions studied
1
Description of health condition studied
road accident victims
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
At the beginning of the study, all road accident victims from the Saravan road who were able to collaborate with the researcher completed questionnaires on quality of life, resilience, and post-traumatic stress disorder. Then, based on the scores obtained, 30 individuals were randomly selected and matched into two groups: the experimental group, which received an intervention based on Acceptance and Commitment Therapy (ACT), and the control group, which did not receive any specific intervention. At the end of the study, both groups were reassessed on the dependent variables (quality of life, resilience, and post-traumatic stress disorder) to determine whether the intervention had the necessary effectiveness.
Timepoint
After the initial assessment and gathering of pre-test data, and selecting the participants based on the scores obtained in the dependent variables, the Acceptance and Commitment Therapy (ACT) is implemented over 10 sessions, each lasting 90 minutes, for the experimental group.
Method of measurement
A pre-test is conducted using the Quality of Life, Resilience, and Post-Traumatic Stress Disorder questionnaires. After the intervention is implemented in the experimental group and completed, both the experimental and control groups are reassessed using the same questionnaires from the pre-test phase in a post-test to evaluate the effects of the intervention.
Secondary outcomes
1
Description
Depression, Anxiety,Life satisfaction
Timepoint
Baseline (T1): before the intervention Post-intervention (T2): immediately after completion of the therapy sessions Follow-up (T3, if applicable): three months after the intervention
Method of measurement
Quality of life: WHOQOL-BREF questionnaire Resilience: Connor-Davidson Resilience Scale (CD-RISC) PTSD symptoms: PTSD scale by Foa et al. based on DSM-IV-TR criteria
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان های رازی وایرانمهر
Full name of responsible person
طاهره سپاهی سرجو
Street address
Razi Hospitan and Iranmehr Hospital
City
Saravan
Province
Sistan-va-Balouchestan
Postal code
9816784545
Phone
+98 54 3762 3004
Email
kahraz.farhad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
فرهاد کهرازئی
Street address
daneshgah
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9845212541
Phone
+98 54 3113 6224
Email
farhad_kahraz@ped.usb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Tahereh Sepahi Sarjo
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Nabovat19
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9852145236
Phone
+98 54 3762 0000
Fax
+98 54 3762 0000
Email
moslem.rigi67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tahereh Sepahi Sarjo
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Nabovat19
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9854217456
Phone
+98 54 3762 0000
Fax
+98 54 3762 0000
Email
moslem.rigi67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tahereh Sepahi Sarjo
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Nabovat19
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9854217456
Phone
+98 54 3762 0000
Fax
+98 54 3762 0000
Email
moslem.rigi67@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The individual participant data (IPD) include sensitive personal and clinical information. To protect participants’ privacy and comply with ethical standards, these data will not be publicly shared. Therefore, there is no plan for IPD sharing.