Protocol summary

Study aim
Determining the effectiveness of the relationship enhancement intervention based on mindfulness and compassion on the quality of the relationship of distant married people
Design
A clinical trial with a control group (waiting list) with parallel groups, without blinding, on 24 long distant couples.
Settings and conduct
The intervention is held online on Skype and Google Meet platforms. Couples who have met the criteria via online questionnaire and confirming for participation in the study will be assigned to two intervention and control groups in a quasi random method while blinding will not be done. Participants in intervention group will be participate in 8 sessions individually.
Participants/Inclusion and exclusion criteria
Inclusion criteria include being in a long-distance relationship and having at least a middle school education. Exclusion criteria are not having more than one spouse and not having a physical or psychiatric illness.
Intervention groups
In the intervention group, the relationship enhancement intervention based on mindfulness and compassion will be implemented in eight 1-hour sessions for couples in the experimental group (including men and women) on the Skype or Google Meet platform separately. In the control group (waiting list), no intervention will be implemented.
Main outcome variables
Marital intimacy, marital satisfaction, trait mindfulness, relational mindfulness, sexual mindfulness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230801059002N1
Registration date: 2023-09-04, 1402/06/13
Registration timing: prospective

Last update: 2023-09-04, 1402/06/13
Update count: 0
Registration date
2023-09-04, 1402/06/13
Registrant information
Name
Mojtaba Tashkeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1655
Email address
tashkeh.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the mindfulness and compassion based intervention on marital relationship quality.
Public title
Efficacy of the mindfulness and compassion based intervention on marital relationship quality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All married people living in Tehran with their spouses who are away from each other for several days a week or a month. Having at least middle school education Not participating in psychotherapy sessions or psychiatric drug treatment at the same time
Exclusion criteria:
Having more than one wife (for men) Suffering from physical and mental diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Iran University of Medical Sciences
Street address
Central Headquarters Building., Iran University of Medical Sciences., Hemat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-06-17, 1402/03/27
Ethics committee reference number
IR.IUMS.REC.1402.232

Health conditions studied

1

Description of health condition studied
Long distant couples
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Marital Satisfaction
Timepoint
The evaluation will be done three times before the start of the intervention, immediately after the end of the intervention, 2 months after the end of the intervention.
Method of measurement
Couple Satisfaction Inventory

2

Description
Marital Intimacy
Timepoint
The evaluation will be done three times before the start of the intervention, immediately after the end of the intervention, 2 months after the end of the intervention.
Method of measurement
Marital Intimacy Questionnaire

Secondary outcomes

1

Description
Trait Mindfulness
Timepoint
The evaluation will be done three times i.e. before the start of the intervention, immediately after the end of the intervention, 2 months after the end of the intervention.
Method of measurement
Five-Faceted Mindfulness Questionnaire

2

Description
Relational Mindfulness
Timepoint
The evaluation will be done three times i.e. before the start of the intervention, immediately after the end of the intervention, 2 months after the end of the intervention.
Method of measurement
Relational Mindfulness Measure

3

Description
Sexual Mindfulness
Timepoint
The evaluation will be done three times i.e. before the start of the intervention, immediately after the end of the intervention, 2 months after the end of the intervention.
Method of measurement
Sexual Mindfulness Measure

Intervention groups

1

Description
Intervention group: The relationship enhancement intervention based on mindfulness and compassion will be implemented in eight 1-hour weekly sessions for the people of the experimental group on the Skype or Google Meet platform individually and separately. The contents of the sessions include body scanning meditation with yoga, love meditation with a focus on the spouse, sitting with awareness of breathing, practicing gazing at each other, practicing interaction with spouse, investigating obstacles and possibilities of mindfulness.
Category
Behavior

2

Description
Control group: It is in the form of a waiting list and during the study, they will not receive any intervention, but after the study, if the intervention is effective, the same sessions as the experimental group will be held for them.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Social network platforms like Telegram, WhatsApp, Eta.
Full name of responsible person
Mojtaba Tashkeh
Street address
No. 1, Shahid Mansouri St., Niayesh St., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
tashkeh.m@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
Central Headquarters Building., Iran University of Medical Sciences., Hemat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
falak.r@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
Mojtaba Tashkeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1, Shahid Mansouri St., Niayesh St., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
tashkeh.m@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Tashkeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1, Shahid Mansouri St., Niayesh St., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
tashkeh.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Tashkeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1, Shahid Mansouri St., Niayesh St., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
14445613111
Phone
+98 21 6655 1655
Email
tashkeh.m@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no publication plan due to possible misuse of raw research data.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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