Exploring the impact of the Adaptive Disclosure technique on reducing the severity of post-traumatic stress disorder symptoms in veterans: a randomized controlled trial
The impact of the adaptive disclosure technique on the severity of post-traumatic stress disorder symptoms in veterans with psychological injuries.
Design
Block randomization will be conducted with a total sample size of 58 participants, consisting of two groups: intervention and control, with 29 participants in each group.
Settings and conduct
This study will be conducted over a period of 6 weeks at Salman Hospital and Shahid Rajaee Hospital in Yasuj, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria include veterans with psychological injuries diagnosed with post-traumatic stress disorder (co-occurring disorders such as depression, anxiety, or substance abuse are permitted if treated or if there are no ongoing dependency issues).
Exclusion criteria include individuals with severe Axis I psychiatric disorders, such as psychotic disorders or Type I bipolar disorder, who are not eligible for inclusion.
6-Inability to communicate.
Intervention groups
For the intervention group, which consists of veterans with psychological injuries diagnosed with PTSD, the adaptive disclosure technique will be implemented in six weekly sessions, each lasting one and a half hours. The details of each session are as follows:
Session 1: Assessment of the patient's current symptoms.
Session 2: In-depth exploration of the patient's experiences related to the traumatic events experienced by veterans.
Session 3: Addressing harmful thought patterns, developing effective coping strategies, and creating a trauma narrative.
Session 4: Identifying core beliefs and challenges.
Session 5: Setting new and positive goals, enhancing self-esteem, and reinforcing new behavioral patterns.
Session 6: Strengthening new behavioral patterns and assisting the patient in adapting to life after trauma.
Main outcome variables
severity of post-traumatic stress disorder symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160815029377N4
Registration date:2025-03-05, 1403/12/15
Registration timing:registered_while_recruiting
Last update:2025-03-05, 1403/12/15
Update count:0
Registration date
2025-03-05, 1403/12/15
Registrant information
Name
Mohammad Malekzadeh
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3332 3379
Email address
mohamad.malekzadeh@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploring the impact of the Adaptive Disclosure technique on reducing the severity of post-traumatic stress disorder symptoms in veterans: a randomized controlled trial
Public title
Exploring the impact of the Adaptive Disclosure technique on reducing the severity of post-traumatic stress disorder symptoms in veterans: a randomized controlled trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years or older
Psychiatric veterans with a diagnosis of post-traumatic stress disorder (co-occurring disorders such as depression, anxiety, or treated substance abuse or dependency problems are permitted.)
Have sufficient insight to receive the adaptive disclosure technique through the Mental State Examination (MSE)
Have informed consent to enter the study
Exclusion criteria:
Lack of interest in continuing participation in the study.
Suicidal behavior or homicide, requiring urgent or emergency evaluation or treatment within the past three months.
Serious Axis I mental disorders such as psychotic disorders or Bipolar I disorder are not eligible.
Simultaneous enrollment in any cognitive-behavioral therapy, group therapy, or any other treatment involving systematic disclosure of disturbing memories related to the establishment.
Loss of self-insight.
Inability to communicate.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block assignment will be carried out using the online platform Sealedenvelope. For this purpose, considering the total sample size of 58 participants and the existence of two groups (intervention and control), the block sizes will be multiples of two (either 2 or 4). Therefore, based on the number of blocks, the resulting sequence, and the predefined code, participants will be allocated to the two groups: intervention (A) and control (B).
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 Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Research Deputy of Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2023-07-09, 1402/04/18
Ethics committee reference number
IR.YUMS.REC.1402.063
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
قبل The severity of post-traumatic stress disorder (PTSD) symptoms is measured using the Post-Traumatic Stress Disorder Checklist (PCL), with a score range of 17 to 85. The score is obtained by summing the responses to 17 items based on a Likert scale. The cutoff score for diagnosing PTSD is set at 50 for military personnel samples and has been validated exclusively for military populations.
Timepoint
Before the intervention begins and immediately after the intervention ends
Method of measurement
Post-Traumatic Stress Disorder Checklist (PCL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After obtaining the ethical approval code, clinical trial registration code, and other necessary permissions from Yasuj University of Medical Sciences, the researcher will visit Shahid Rajaee Hospital and Salman Hospital in Yasuj to collect data. Following coordination with hospital and department authorities, and providing adequate information regarding the nature of the research, as well as necessary explanations about the relevant questionnaire, the questionnaire will be distributed among veterans with post-traumatic stress disorder (PTSD) who meet the inclusion criteria and give informed consent. The completed questionnaires will be collected by the researcher.For the intervention group, the adaptive disclosure technique will be implemented in six weekly sessions, each lasting one and a half hours. In the first session, the patient's current symptoms will be assessed, a detailed history will be collected, and trauma exposure will be reviewed. In the second session, the patient’s experiences with veterans' traumatic events will be explored in-depth, along with addressing “hot cognitions” that negatively affect emotions, interpersonal communication in decision-making, and problem-solving abilities. In the third session, harmful thought patterns will be addressed, effective coping strategies will be developed, and the trauma narrative will be constructed. In the fourth session, core beliefs and challenges will be identified, the impact of the trauma will be further explored, and healthier ways of thinking will be introduced. In the fifth session, new and positive goals will be set, self-esteem will be enhanced, and new behavioral patterns will be reinforced. The final session will focus on strengthening new behavioral patterns and assisting the patient in adapting to life after trauma. Through this session, the therapist will address any persistent symptoms or destructive behaviors while helping the patient develop a sense of self-efficacy and increase their ability to manage PTSD symptoms. The therapist will also guide the patient in anticipating and coping with potential difficulties, as well as provide resources for long-term support. During this period, no intervention will be provided to the control group. Immediately after the intervention, both groups will complete the research questionnaire again, and the collected data will be analyzed.
Category
Treatment - Other
2
Description
Control group: During the intervention period, no intervention will be provided to the control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital and Salman Hospital
Full name of responsible person
Mohammad Malekzadeh
Street address
Kohgiluyeh and Boyer-Ahmad, Yasuj, Motahari Boulevard, Takhteh Street, below the Municipality Traffic Department.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 1333 1759
Email
mzh541@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Yasuj, Mehran, Abu Zar Boulevard, Eram Boulevard, Research and Technology Department, Yasuj University of Medical Sciences.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Malekzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Psychology
Street address
Yasuj, Mehran, Abu Zar Boulevard, Eram Boulevard, Research and Technology Department, Yasuj University of Medical Sciences.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
mzh541@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Malekzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Yasuj, Mehran, Abu Zar Boulevard, Eram Boulevard, Research and Technology Department, Yasuj University of Medical Sciences.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6079
Email
mzh541@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Malekzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Yasuj, Mehran, Abu Zar Boulevard, Eram Boulevard, Research and Technology Department, Yasuj University of Medical Sciences.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
mzh541@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available