Protocol summary

Study aim
The effect of Acceptance and Commitment Therapy on Rumination and Distress Tolerance of divorced women
Design
This research was a quasi-experimental before - after with the control group study, that was performed as a randomized clinical trial.
Settings and conduct
This study was conducted in Bawar Counseling Center and the meetings were held in one of the rooms of the center. In the intervention group, two groups of 9 and 8 people received training by one person. In each session, one of the concepts of ACT therapy was taught and repeated and practiced. In this study, the control group did not receive any intervention and they did not participate in any non-pharmacological intervention until the end of the study
Participants/Inclusion and exclusion criteria
The Inclusion criteria: not using psychiatric drugs, being in the age range of 20 to 50 years، minimum education of reading and writing, at least 2 years have passed since the divorce, failure to complete a training course or any similar intervention during treatment . Exclusion criteria:remarriage, unwillingness to participate in the study and participating in other non-pharmacological treatments during the study.
Intervention groups
Intervention group: Act therapy was performed during 8 sessions of 90 minutes for the participants in the intervention group. Each session, a discussion was started on a specific topic, which included familiarity, acceptance, mindfulness, familiarity with the concepts of value and need, focus on breathing, teaching commitment and action, which were practiced in each session. and it was repeated and finally in the last meeting the contents were summed up and summarized. Control group: No intervention was performed in the control group and they did not participate in any other non-pharmacological treatments at the same time.
Main outcome variables
Rumination , Distress Tolerance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231219060475N1
Registration date: 2024-01-20, 1402/10/30
Registration timing: retrospective

Last update: 2024-01-20, 1402/10/30
Update count: 0
Registration date
2024-01-20, 1402/10/30
Registrant information
Name
Maryam Bajelani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3457 5044
Email address
marjanbajelani4030@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
2023-06-20, 1402/03/30
Actual recruitment end date
2023-07-21, 1402/04/30
Trial completion date
2023-07-21, 1402/04/30
Scientific title
The effect of Acceptance and Commitment Therapy on Rumination and Distress Tolerance of divorced women
Public title
The Effect Of ACT on Rumination and Distress Tolerance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not using psychiatric drugs Being in the age range of 20 to 50 years Minimum education of reading and writing At least 2 years have passed since the divorce Failure to complete a training course or any similar intervention during treatment. Proficient in Persian language
Exclusion criteria:
Remarriage, Unwillingness to participate in the study Participating in other non-pharmacological treatments during the study
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 34
Actual sample size reached: 34
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 34 sample from divorced woman who had the criteria to enter were selected by simple random sampling. Each of these woman had equal chance to be selected in intervention and control groups. Each women’s name was on a separate card and placed in a box. Then we mixed the cards and drew out the first 18 cards as the intervention group and the second 18 cards as the control group.
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
Ethics committee of Islamic Azad University Arak Branch
Street address
Islamic Azad University Arak Branch, 3rd km of Khomein road, Imam Khomeini Square , Arak, Iran
City
Arak
Province
Markazi
Postal code
38361-1-9131
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
IR.IAU.ARAK.REC.1402.075

Health conditions studied

1

Description of health condition studied
Rumination and Distress Tolerance
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Rumination
Timepoint
Measurement of Rumination before intervention and one week after intervention
Method of measurement
The rumination questionnaires of Nalen Hogsma

2

Description
Distress Tolerance
Timepoint
Measurement of Distress Tolerance before intervention and one week after intervention
Method of measurement
The Distress Tolerance questionnaires of Simmons and Gaher

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Act therapy was performed during 8 sessions of 90 minutes for the participants in the intervention group. Each session, the topics of the previous sessions were reviewed and a discussion was started on a specific topic, which included familiarity, acceptance, mindfulness, familiarity with the concepts of value and need, focus on breathing, teaching commitment and action, which were practiced in each session. and it was repeated and finally in the last meeting the contents were summed up and summarized.
Category
Treatment - Other

2

Description
Control group: it was selected as a comparison group and received no intervention and there was no other non-pharmacological intervention until the end of the study.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Bawar Counseling Center
Full name of responsible person
کیانوش امینی
Street address
Abbas Abad Street,Haj Agha Shams Alley, Sinohe Doctors Building 2, Arak
City
Arak
Province
Markazi
Postal code
1474673776
Phone
+98 86 3221 4433
Email
Bavarcounseling123@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Arak Branch
Full name of responsible person
Vice President of Research and Technology of Islamic Azad University Arak Branch
Street address
Islamic Azad University Arak Branch, 3rd km of Khomein road, Imam Khomeini Square , Arak, Iran
City
Arak
Province
Markazi
Postal code
38361-1-9131
Phone
+98 86 3413 2451
Email
ipd@iau-arak.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 Arak Branch
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
Islamic Azad University Arak Branch
Full name of responsible person
Maryam Bajelani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Karahrood Street, Farhadi Alley, Arak
City
Arak
Province
Markazi
Postal code
3831667539
Phone
+98 86 3457 5044
Email
Marjanbajelani4030@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Arak Branch
Full name of responsible person
Maryam Bajelani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Karahrood Street, Farhadi Alley, Arak
City
Arak
Province
Markazi
Postal code
3831667539
Phone
+98 86 3457 5044
Email
marjanbajelani4030@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Arak Branch
Full name of responsible person
Maryam Bajelani
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Karahrood Steet, Farhadi Alley, Arak
City
Arak
Province
Markazi
Postal code
3831667539
Phone
+98 86 3457 5044
Email
marjanbajelani4030@gmail.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
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