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Modeling the vulnerability to extramarital relationships and the effectiveness of couple therapy based on the acceptance and commitment therapy with schema awareness on couples with extramarital relationships experience and relational obsessive-compulsive symptoms

Protocol summary

Study aim
- Determining the Effectiveness of Acceptance and Commitment Couple Therapy with schema awareness Compared to Acceptance and Commitment Couple Therapy on Couples with extramarital relationships experience and relational obsessive-compulsive symptoms
Design
This study is a randomized controlled trial (RCT) using a pre-test-post-test design. This clinical trial includes a control group, parallel groups, double-blinding, randomization, and consists of 32 couples. Block randomization will be used for randomization.
Settings and conduct
The proposed research sites will include the clinic of the Faculty of Behavioral Sciences and Mental Health and cooperating counseling centers in Tehran. After explaining the objectives and treatment and obtaining informed consent, 32 couples will be randomly assigned to two groups. To minimize bias and ensure the validity of the results, a double-blind design will be used. In a double-blind study, both participants and outcome assessors will be blinded to group assignment. Participants will be asked to complete the questionnaires before and after the intervention to measure the effectiveness of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Legally married, no substance dependence, willingness to participate in sessions. Exclusion Criteria: Psychological disorder, serious suicidal ideation, absence from more than 3 sessions.
Intervention groups
The intervention for the experimental group will be acceptance and commitment couple therapy with schema awareness , and for the control group will be acceptance and commitment couple therapy.
Main outcome variables
In this study, the primary outcome variables include changes in the severity of anxiety, depression, marital adjustment, relationship-related obsessive-compulsive symptoms, psychological inflexibility, conflict resolution styles, and early maladaptive schemas.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250129064559N1
Registration date: 2025-03-02, 1403/12/12
Registration timing: prospective

Last update: 2025-03-02, 1403/12/12
Update count: 0
Registration date
2025-03-02, 1403/12/12
Registrant information
Name
Seyede Ayda Mousavi moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 6009
Email address
mousavi.ay@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-22, 1404/04/01
Expected recruitment end date
2025-06-30, 1404/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Modeling the vulnerability to extramarital relationships and the effectiveness of couple therapy based on the acceptance and commitment therapy with schema awareness on couples with extramarital relationships experience and relational obsessive-compulsive symptoms
Public title
Modeling the vulnerability to extramarital relationships and the effectiveness of couple therapy based on the acceptance and commitment therapy with schema awareness on couples with extramarital relationships experience and relational obsessive-compulsive symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Couples must be legally married and have been in a committed relationship for at least one year. Both partners must have a minimum of a high school diploma (or equivalent). Both partners must be between the ages of 20 and 60 years old. Couples must not have a history of alcohol, drug, or psychotropic substance abuse or dependence. Both partners must be willing to participate in couple therapy sessions and be able to attend sessions consistently and regularly. Couples must be living together at the time of enrollment and throughout the study, and must not be in the process of legal divorce. Couples should not be experiencing significant stressors such as unemployment or remarriage (for either partner). Couples must have experienced at least one instance of sexual or emotional infidelity in their current marital relationship and express a desire to increase marital satisfaction and address the negative consequences of the infidelity experience (e.g., anxiety, depression, marital dissatisfaction). At least 6 months and no more than 5 years must have passed since the disclosure of the extramarital affair within their relationship. Based on the results of the SCID-5/RV interview (and the Relationship-Focused and Partner-Focused Obsessive-Compulsive Questionnaires), couples must report relationship-related or partner-focused obsessive-compulsive beliefs, but not meet the full diagnostic criteria for Obsessive-Compulsive Disorder.
Exclusion criteria:
- Presence of a psychological disorder in either partner - Use of any type of psychiatric medication - Use of any psychological or psychotherapeutic services for Axis I and II disorders and marital problems within the 6 months prior to the start of treatment - Presence of serious suicidal ideation - Absence from more than 3 treatment sessions - Initiation of drug or substance use during the intervention - Diagnosis of an acute psychiatric or physical illness during the intervention
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization will be used for randomization purposes. Eligible participants will be assigned to either the experimental group (n=16) or the control group (n=16) using block randomization. The block size will be set to 4, and the selection of each block will also be done randomly. (It is explained that, considering the sample size of the study (32 couples), the number of blocks is estimated to be 8 blocks. Each block is numbered and used for 4 couples, the order of which will be different in the blocks. Each block will include an equal number of couples from each treatment group. In total, the possible arrangement is as follows: BBAA, ABAB, BABA, ABBA, BAAB, AABB. Each of these combinations is assigned a number from 1 to 6. Then, 8 blocks of four are randomly selected. For this purpose, a random number between 1 and 6 is selected 8 times. Neither the research participants nor the researchers will be aware of which treatment group each couple will be assigned to until the randomization process is complete. This will prevent selection bias.)
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will implement a double-blind design to minimize bias and ensure the validity of results. In a double-blind study, both the participants and the outcome assessors will be blinded to the group allocation throughout the study. This means: The couples participating in the study will not be informed about whether they have been assigned to the experimental group or the control group. The randomization process, as detailed, will ensure that group assignment is kept confidential until the study is completed. The individual responsible for assessing the outcomes will also remain blinded to the group assignment. They will conduct the assessments without knowledge of whether the participant belongs to the experimental or control group. This ensures that the outcome measures are unbiased and unaffected by any preconceptions about the treatment condition. In addition, the data analysis and statistical evaluation of the results will be conducted without access to the group’s information, preventing any unconscious bias in the interpretation of the data. By maintaining this double-blind approach, the study will minimize potential biases in treatment administration, outcome assessment, and data interpretation, ensuring that the findings accurately reflect the effects of the treatment intervention rather than pre-existing expectations or assumptions.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran Medical Sciences University
Street address
Iran Medical Sciences University, shahid Hemat highway,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-04-29, 1403/02/10
Ethics committee reference number
1403.097.IR.IUMS.REC

Health conditions studied

1

Description of health condition studied
extramarital relationships
ICD-10 code
Z63.0
ICD-10 code description
Problems in relationship with spouse or partner

Primary outcomes

1

Description
Anxiety score on the Beck Anxiety Inventory
Timepoint
Before the intervention, after the intervention, and 3 months after the intervention is completed
Method of measurement
Beck anxiety inventory

2

Description
Depression score on the Beck Depression Inventory
Timepoint
Before the intervention, after the intervention, and 3 months after the intervention is completed
Method of measurement
Beck depression inventory

3

Description
Marital adjustment score on the Dyadic Adjustment Scale (DAS)
Timepoint
Before the intervention, after the intervention, and 3 months after the intervention is completed
Method of measurement
Dyadic Adjustment Scale (DAS)

4

Description
Psychological Inflexibility
Timepoint
Before the intervention, after the intervention, and 3 months after the intervention is completed
Method of measurement
The Multidimensional Psychological Flexibility Inventory (MPFI)

Secondary outcomes

1

Description
Conflict resolution styles score on Rahim Organizational Conflict Inventory–II (ROCI-II)
Timepoint
Before the intervention, after the intervention, and 3 months after the intervention is completed
Method of measurement
Rahim Organizational Conflict Inventory–II(ROCI-II)

2

Description
Relational Obsessive-Compulsive Disorder score on the The Relationship Obsessive–Compulsive Inventory and the The Partner-Related Obsessive–Compulsive Symptoms Inventory
Timepoint
Before the intervention, after the intervention, and 3 months after the intervention is completed
Method of measurement
The Relationship Obsessive–Compulsive Inventory (ROCI) and The Partner-Related Obsessive–Compulsive Symptoms Inventory (PROCSI)

Intervention groups

1

Description
Intervention group: Contents of the intervention sessions for Acceptance and Commitment Couple Therapy with schema awareness (Experimental Group):1. Establishing rapport, explaining the importance of participation and homework completion, agreeing on scheduling and rules, providing an overview of the treatment, and administering the pre-test. 2. Psychoeducation on and identification of communication schemas, discussion of their development and manifestation in marital life. 3. Identifying coping behaviors, educating about the impact of schemas, addressing coping behaviors and the negative role of avoidance. 4. Exploring coping behaviors, addressing out-of-session results of coping behaviors, introducing metaphors. 5. Clarifying values, identifying values related to the communication domain. 6. Identifying cognitive barriers to value-based responses and identifying moments of choice, psychoeducation on barriers. 7. Addressing cognitive barriers to value-based responses, teaching cognitive defusion and practicing cognitive defusion strategies. 8. Mindfulness training, teaching loving-kindness breathing and mindful affect, emotional confrontation of the schema to cultivate mindfulness of schema-related pain. 9. Communication skills training, teaching about expressing needs, effective communication, pausing with a time interval, and appreciation. 10. Teaching values-based and flexible problem-solving skills for couples. 11. Teaching the best choice for achieving values, using reverse role-playing to create empathy. 12. Reviewing and summarizing treatment sessions, addressing participants' questions, and administering the post-test.
Category
Treatment - Other

2

Description
Control group: Contents of the intervention sessions for Acceptance and Commitment Couple Therapy (Control Group):1.Assessment, strengthening the therapeutic relationship, and determining treatment direction. Gathering details, introducing treatment goals, and explaining the focus on practice. 2. Individual assessments, couple formulation, integrating individual and couple assessments. 3. Examining the costs of couples' conflict and avoidance, creating creative hopelessness, using metaphors and practice. 4. Mindfulness and acceptance. 5. Cognitive fusion, explaining the negative relationship of thoughts for couples, practice. 6. Creating an observer perspective and comparing one's own and self's reactions in relation to the spouse. Practice. 7. Helping to clarify and identify values and doing exercises. 8. Reviewing values worksheets, discussing barriers to life values. 9. Creating flexible behavioral patterns in relationships. 10. The nature of choice and the ability to respond, using metaphors. 11. Reviewing emotional willingness in the context of committed action. 12. Reviewing relationship values and committed action, preparing for future committed action, and terminating treatment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
درمانگاه دانشکده علوم رفتاری و سلامت روان (و کلیه مراکز مشاوره و خدمات روانشناختی خصوصی و دولتی در ش
Full name of responsible person
Dr. Veisi
Street address
Moghimiān Educational and Therapeutic Center (affiliated with Iran University of Medical Sciences), 3rd Floor, No. 16, Khalid Islamboli Street, Beheshti Avenue, next to Tejarat Bank, Tehran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8870 3126
Email
info@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Majid Safa
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
mhrc@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyede Ayda Mousavi Moghadam
Position
PhD candidate in Clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
4th Floor, Unit 7, No. 49, Heshmat Alley, Beginning of Tabatabaei Nasab Boulevard, Farjam Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1685965418
Phone
+98 21 6692 6608
Email
mousavi.ay@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyede Ayda Mousavi Moghadam
Position
PhD candidate in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
4th Floor, Unit 7, No. 49, Heshmat Alley, Beginning of Tabatabaei Nasab Boulevard, Farjam Street, Tehran
City
Tehran
Province
Tehran
Postal code
1685965418
Phone
+98 21 6692 6608
Email
mousavi.ay@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
seyede Ayda Mousavi Moghadam
Position
PhD candidate in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
4th Floor, Unit 7, No. 49, Heshmat Alley, Beginning of Tabatabaei Nasab Boulevard, Farjam Street, Tehran
City
Tehran
Province
Tehran
Postal code
1685965418
Phone
+98 21 6692 6608
Email
mousavi.ay@iums.ac.ir

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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