IRCT | Investigating the effect of spiritual therapy and therapy based on acceptance and commitment on the psychological well-being of spouses of veterans with post-traumatic stress disorder.

Protocol summary

Study aim: -Implementation of a program designed for the psychological well-being of spouses of veterans with post-traumatic stress disorder -Evaluation of a program designed for the psychological well-being of spouses of veterans with post-traumatic stress disorder
Design: A clinical trial with a control and intervention group, a blind strain, randomized using block randomization, the intervention will be conducted on 20spouses of veterans with post-traumatic stress disorder.
Settings and conduct: The place of conducting the research is the Foundation of Martyrs and Veteran Affairs of Saveh city. Before starting the intervention, the researcher will take a pre-test from both the intervention and control groups using a psychological well-being tool, and this tool will be completed 1 and 3 months after the intervention.
Participants/Inclusion and exclusion criteria: Spouses of veterans with post-traumatic stress disorder whose diagnosis of veterans' post-traumatic stress disorder has been confirmed by a neurologist
Intervention groups: The test group will receive the intervention made by the researcher, which includes increasing the quality of life and mental well-being based on the spiritual therapy of Richards and Briggs and the third wave therapies, especially the therapy based on acceptance and commitment, and the control group will receive the usual interventions at Shahid Saveh Foundation. they do.
Main outcome variables: Improving mental health and psychological well-being of spouses of veterans with post-traumatic stress disorder

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20231028059879N1

Registration date: 2023-12-16, 1402/09/25

Registration timing: retrospective

Last update: 2023-12-16, 1402/09/25

Update count: 0
Registration date: 2023-12-16, 1402/09/25

Registrant information: Name

zahra maddah

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 6692 7171

Email address

maddah_z550@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-11-04, 1402/08/13
Expected recruitment end date: 2023-12-09, 1402/09/18
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the effect of spiritual therapy and therapy based on acceptance and commitment on the psychological well-being of spouses of veterans with post-traumatic stress disorder.

Public title: "Intervention Based on Commitment and Acceptance on Psychological Well-Being"
Purpose: Education/Guidance
Inclusion/Exclusion criteria: Inclusion criteria:

Women whose husbands have suffered from post-traumatic stress disorder as diagnosed by a psychiatrist Live together at the time of research Be able to speak Persian and have no hearing problems At least have reading and writing literacy

Exclusion criteria:

Spouses of veterans suffering from severe mental disorders and receiving psychiatric treatment Marked physical disorder Attending similar training sessions or programs at the same time Desire to withdraw from the study
Age: No age limit
Gender: Female

Phase

N/A

Groups that have been masked

Data analyser

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

The Samples Were Selected Based on The Inclusion Criteria and Available Sampling Method, and After Obtaining Written Consent, They Were Divided into Two Control and Intervention Groups Using Random Block Allocation Method. According to The Sample Size, 30 Blocks of 4 Are Needed For Random Block Allocation. The Intervention Group Was Represented By A And The Control Group By B. According to The Number of Study Groups, The Size of The Blocks Is Considered to be 4, And Thus, The 6 Modes of Placement of The Samples in The Two Test And Control Groups Were as Follows. Then, Each Mode Is Assigned a Number From 1 to 6. 1AABB 2ABAB 3BBAA 4BABA 5ABBA 6BAAB In Order to Hide The Random Allocation, 120 Dark Envelopes Were Prepared And Each of The Random Sequences Created Was Recorded On a Card And Placed Inside The Envelope, And Finally The Lids of The Envelopes Were Glued. The Samples Were Randomly Assigned to Two Test and Control Groups By The Supervisor. At The Time of Starting The Registration of People, Based On The Order of The Samples, An Envelope Whose Number Is The Same As The Order Of The Samples Was Opened And The Group of That Sample Was Determined.

Blinding (investigator's opinion)

Single blinded

Blinding description

Due to The Nature of The Intervention, Blinding Is Not Possible For The Participant And The Researcher, Only The Data Analyst Is Unaware Of The Research Conditions.

Placebo

Not used

Assignment

Other

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Joint Organizational Ethics Committee of Nursing, Midwifery and Rehabilitation Faculties of Tehran U

Street address

Tawheed Square, Dr. Mirkhani St. (East Nusrat)

City

Tehran

Province

Tehran

Postal code

1419733171
Approval date: 2022-03-13, 1400/12/22
Ethics committee reference number: IR.TUMS.FNM.REC.1400.225

Health conditions studied

1

Description of health condition studied: Psychological well-being of spouses of veterans with post-traumatic stress disorder
ICD-10 code: -
ICD-10 code description: -

Primary outcomes

1

Description: Increasing the psychological well-being score to a score above 18, according to the RIF psychological well-being questionnaire
Timepoint: 1 month and 3 months after the intervention
Method of measurement: RYFF psychological well-being questionnaire

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: Intervention group: The intervention will be held in 11 sessions, 2 sessions per week, each session will last 60 minutes at the Martyr and Martyr Affairs Foundation of Saveh city.
Category: Behavior

Recruitment centers

1

Recruitment center: Name of recruitment center

Saveh Martyrs and Martyrs' Affairs Foundation

Full name of responsible person

Shahzad Pashaeypoor

Street address

Tawheed Square, Dr. Mirkhani St. (East Nusrat)

City

Tehran

Province

Tehran

Postal code

1419733171

Phone

+98 21 6692 7171

Email

maddah_z550@yahoo.com

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Shahzad Pashaeypoor

Street address

Tawheed Square, Dr. Mirkhani St. (East Nusrat)

City

Tehran

Province

Tehran

Postal code

1419733171

Phone

+98 21 6692 7171

Email

sh-pashaeipour@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tehran 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

Tehran University of Medical Sciences

Full name of responsible person

Shahzad Pashaeypoor

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nursery

Street address

Tawheed Square, Dr. Mirkhani St. (East Nusrat)

City

Tehran

Province

Tehran

Postal code

1419733171

Phone

+98 21 6692 7171

Email

sh-pashaeipour@tums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Zahra maddah

Position

PhD Candidate

Latest degree

Master

Other areas of specialty/work

Nursery

Street address

Tawheed Square, Dr. Mirkhani St. (East Nusrat)

City

Tehran

Province

Tehran

Postal code

1419733171

Phone

+98 21 6692 7171

Email

maddah_z550@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

zahra maddah

Position

PhD Candidate

Latest degree

Master

Other areas of specialty/work

Nursery

Street address

Tawheed Square, Dr. Mirkhani St. (East Nusrat)

City

Tehran

Province

Tehran

Postal code

1419733171

Phone

+98 21 6692 7171

Email

maddah_z550@yahoo.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: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: All data is potentially shareable after de-identifying individuals
When the data will become available and for how long: Start access after printing the results
To whom data/document is available: Participants, if they wish, the officials of the Shahid Foundation and Martyrs Affairs, researchers working in academic institutions
Under which criteria data/document could be used: It is possible to use documents by mentioning the source
From where data/document is obtainable: Zahra Maddah Mobile: 09124557287
What processes are involved for a request to access data/document: To receive the data, send a message to the email below and mention the method and reason for using the documents maddah_z550@yahoo.com
Comments

Investigating the effect of spiritual therapy and therapy based on acceptance and commitment on the psychological well-being of spouses of veterans with post-traumatic stress disorder.