Protocol summary

Study aim
In this study, we compare the effectiveness of commitment-based therapy and compassion-focused therapy and therapy based on compassion-enriched acceptance and commitment on social adjustment, mental well-being, and improving communication patterns in married women with depression and marital conflict.
Design
A clinical trial with a control group will be performed on married women with depression and marital conflicts referred to counseling centers.
Settings and conduct
The sampling method is as follows: from among the counseling centers of Mashhad, three centers are randomly selected. They have 20 people and a total of 60 people are selected and randomly divided into 4 groups (three experiments and one control group). Group intervention in 8 90-minute training sessionsIt will be performed for the subjects of the experimental groups.
Participants/Inclusion and exclusion criteria
Existence of marital conflicts Diagnosis of moderate depression based on structured interview based on DSM-V and Beck test 3. The duration of marriage is between 5-25 years 4- Age range 25-45 5. Minimum diploma education 6- Consent and personal consent to participate in the research 7. The subject should not be under medical treatment to reduce anxiety and depression.
Intervention groups
1: Acceptance and Commitment Treatment 2: Compassion-focused therapy 3: Treat Compassion Enriched Acceptance and Commitment
Main outcome variables
Participants were assessed at three time intervals before , after and 30 days after the intervention with Social Adjustment Questionnaire, mental well-being and communication patterns.

General information

Reason for update
Acronym
اثربخشی درمان پذیرش و تعهد با تمرکز بر شفقت
IRCT registration information
IRCT registration number: IRCT20210704051776N1
Registration date: 2021-07-12, 1400/04/21
Registration timing: registered_while_recruiting

Last update: 2021-07-12, 1400/04/21
Update count: 0
Registration date
2021-07-12, 1400/04/21
Registrant information
Name
Mahdieh sadat Mosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 7443
Email address
mahdieh.mmosavi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Acceptance and Commitment-Based Therapy (ACT) and Compassion-Focused Therapy and acceptance and commitment therapy enriched with compassion on Social Cohesion, Mental Well-being, and Improving Communication Patterns of Married Women with Depression and Marital Conflicts
Public title
Comparing the Effectiveness of Acceptance and Commitment-Based Therapy (ACT) and Compassion-Focused Therapy and acceptance and commitment therapy enriched with compassion on Social Cohesion, Mental Well-being, and Improving Communication Patterns of Married Women with Depression and Marital Conflicts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of marital conflicts (people who received a minimum score above the average in the Marital Conflict Questionnaire). Diagnosis of moderate depression based on structured interview based on DSM-V and Beck test Duration of marriage between 5-25 years - Age range 25-45 Minimum diploma education Personal consent to participate in the research The subject should not be treated with medication to reduce anxiety and depression.
Exclusion criteria:
Initiate or continue attending psychological treatments other than acceptance, commitment, and compassion therapy from three months prior to participating in the study. Diagnosis of Borderline Personality Disorder - Bipolar Disorder - Psychosis or Mental Retardation Based on Structured Interview Addiction to any substance Existence of hospitalization history.
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the inclusion and exclusion criteria of the study and conducting a pre-test session, 60 women who are selected in the initial screening test, which includes clinical interview and completion of Beck Depression Inventory and Marital Conflict MCQ-Marital Confict Questionnaire, by purposive sampling method. Considering that the study groups have an equal sample size, we use the simple random allocation law, which is one of the limited randomization methods, and divide the individuals into 3 intervention groups and a control group.Participants will be assigned to the control group (without therapeutic intervention), acceptance and commitment therapy (ACT), compassion-focused therapy (CFT), and compassion-enriched acceptance and commitment therapy with the help of a random number table.In this way, a number is assigned to each individual and using the table of random numbers of each selected number, it is randomly assigned to one of the groups and this work continues until the end of the number of people in each group..Therefore, the researcher will not have the option to change the status of individuals or predict it. For concealment, the method of opaque sealed envelopes with random sequence is used.So randomization in three steps: 1- Creating a random sequence: This is a simple or limited randomization step based on a table of random numbers. 2- Hide random assignment which is done in the form of coded boxes with random sequence. 3- Execution of random assignment process: A: Identify the person who creates the random sequence B: The person who evaluates and registers the researchers in terms of entry and exit criteria C: The person who assigns the participants to the groups
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
Islamic Azad University-Bojnourd Branch
Street address
University St. - Islamic Azad University, Bojnourd Branch
City
Boujnourd
Province
Razavi Khorasan
Postal code
9417697796
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.IAU.BOJNOURD.REC.1399.035

Health conditions studied

1

Description of health condition studied
Social adjustment
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Mental well-being
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Communication patterns
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Social adjustment
Timepoint
The evaluation will be done in three rounds of pre-test-post-test-follow-up (one month after the end of the last session)
Method of measurement
questionnaire

Secondary outcomes

1

Description
Mental well-being
Timepoint
The evaluation will be done in three rounds of pre-test-post-test-follow-up (one month after the end of the last session)
Method of measurement
Keyes & Magyar-Mae Questionnaire

2

Description
Communication patterns
Timepoint
The evaluation will be done in three rounds of pre-test-post-test-follow-up (one month after the end of the last session)
Method of measurement
Communication Pattern Questionnaire

Intervention groups

1

Description
Acceptance and commitment therapy intervention group - Psychological-educational interventions include acceptance and commitment therapy techniques. The interventions will be performed in groups in 8 training sessions of 90 minutes once a week for the subjects of the experimental group . Experiments before the intervention, At the end of the intervention and 30 days after the intervention (in the follow-up stage), they will answer the Bell Form Adult Social Adjustment Questionnaires, Keys and Magyarmo Mental Well-Being Questionnaire and CPQ Communication Patterns. The content of the sessions will be as follows: Session 1: Introduction and acquintance - Pre-test Session 2: Analyzing members' issues and relationships - Examining their willingness to stay in the relationship and the amount of effort to improve the relationship - Discussion about experiences and ways of response (avoidance responses) - Difference in emotional pain and suffering - making creative frustration - Introducing the inevitable schema pain control as an issue - Identifying ineffective control strategies and its consequences. Session 3: Introducing acceptance and praying for peace- Performing (NAME) exercises .Session 4: Introducing layers of psychological fog and cognitive barriers and filling in the table of getting hooks into the mind outside the session. Session 5: Introducing the change of perspective of oneself as content towards oneself as context Session 6: Introducing the application of mindfulness technique in psychological flexibility - Performing conscious breathing exercise Session 7: Explaining the clarification of individual values in the field of marriage as a compass of life-Filling in the table of values the fieeld of marriage and examining and measuring appropriate behaviors to values. Session 8: Creating readiness for committed action and filling out the commitment form in the path of a worthwhile life - Post-test - Coordinating the date of fulfillment the questionnaire to follow up with clients
Category
Behavior

2

Description
The intervention group focused on compassion-psychological-educational interventions, including compassion-based treatment techniques. The interventions will be performed in groups in 8 training sessions of 90 minutes once a week for the subjects of the experimental group . Experiments before the intervention, end of the intervention And 30 days after the intervention (in the follow-up phase), they will answer the Bell Form Adult Social Adjustment Questionnaires, the Keys and Magyarmo Mental Well-Being Questionnaire, and the CPQ Communication Patterns. The content of the sessions will be as follows: Session 1: Introduction and acquaintance - Pre-test. Session 2: Definition and explanation of the mind and types of mind products - Identification of different shovels (ineffective methods of dealing with problems) of life. Session 3: Definition and interpretation of three emotional regulation systems (defense, motivation, security) and the characteristics of each system and the role of security system in psychological well-being. Session 4: Explain the concepts of pure and impure suffering and its relationship with emotion regulation systems and introduction Three brains (old, analytical and conscious) . Session 5: Explaining the characteristics of a compassionate person - Encouraging self-knowledge and examining one's personality as a compassionate person and cultivating and understanding that others also have flaws and problems (cultivating a sense of human commonalities) in the face of self-destructive feelings and shame - Performing mindful breathing practice . Session 6: Introducing the six skills of cultivating a compassionate mind. Session 7: Introducing kind behaviors that include 4 behaviors (1 - caressing, 2-giving opportunities, 3-structuring and 4-creating challenges). -Performing exercises of sensitivity to suffering and empathy and empathy with oneself and others -Compassionate notes for oneself and others and daily recording of real situations based on compassion and their performance in that situation.Session 8: Reviewing the issues raised in the previous sessions - Summarizing the sessions - Post-test - Coordinating the date of the questionnaire to follow up with clients.
Category
Behavior

3

Description
Compassion-Enriched Acceptance and Commitment Treatment Psycho-educational interventions include compassion-enriched acceptance and commitment treatment techniques. The interventions will be performed in groups in 8 training sessions of 90 minutes once a week for the subjects of the experimental group The content of treatment sessions based on acceptance and commitment enriched with compassion was prepared by combining the content sessions of two approaches.. From the beginning of the intervention, the end of the intervention and 30 days after the intervention (in the follow-up stage), they will answer the Bell Form Adult Social Adjustment Questionnaire, Keys and Magyarmo Mental Well-Being Questionnaire and CPQ communication patterns.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sorosh Clinic
Full name of responsible person
Mahdieh Sadat Mosavi
Street address
Mashhad-Vakil Abad 13-15
City
Mashhad
Province
Razavi Khorasan
Postal code
9176757968
Phone
+98 51 3840 7443
Email
mahdieh.mmosavi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Abolfazl Bakhshipour
Street address
University Street - Islamic Azad University, Bojnourd Branch
City
Bojnourd
Province
North Khorasan
Postal code
9417697796
Phone
+98 58 3229 6983
Fax
Email
Ab8boj@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Islamic Azad University, Bojnourd Branch
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
Other

2

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Hossein Mahdian
Street address
University Street - Islamic Azad University, Bojnourd Branch
City
Bojnourd
Province
North Khorasan
Postal code
9417697796
Phone
+98 58 3229 6983
Email
mahdian_hossein@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Islamic Azad University, Bojnourd Branch
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
Other

3

Sponsor
Name of organization / entity
sorosh clinic
Full name of responsible person
Mahdieh sadat mosavi
Street address
Reza 13-Nomber11/1
City
Mashhad
Province
Razavi Khorasan
Postal code
9176757968
Phone
+98 51 3840 7443
Email
mahdieh.mmosavi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Islamic Azad University, Bojnourd Branch
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abolfazl Bakhshipour
Position
Assistant Professor, Counseling Department, Islamic Azad University, Bojnourd Branch, Bojnourd, Iran
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University St. - Islamic Azad University, Bojnourd Branch
City
Bojnourd
Province
North Khorasan
Postal code
9417697796
Phone
+98 58 3229 6383
Email
Ab8boj@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Abolfazl Bakhshipour
Position
Assistant Professor, Counseling Department, Islamic Azad University, Bojnourd Branch, Bojnourd, Iran
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University St. - Islamic Azad University, Bojnourd Branch
City
Bojnourd
Province
North Khorasan
Postal code
9417697796
Phone
+98 58 3229 6983
Email
Ab8boj@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahdieh Sadat Mosavi
Position
PhD Student in Counseling, Faculty of Humanities and Counseling, Islamic Azad University,Bojnourd,Ir
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mashhad-Reza13-Nomber11/1
City
Mashhad
Province
Razavi Khorasan
Postal code
9176757968
Phone
+98 51 3840 7443
Email
mahdieh.mmosavi@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
Loading...