Effect of group counseling based on dialectical behavior therapy compared to a control group on stress and sexual quality of life of pregnant women with a history of failed pregnancy: A randomized clinical trial
To assess the effect of group counseling based on dialectical behavior therapy compared to a control group on stress and sexual quality of life of pregnant women with a history of failed pregnancy
Design
This is a randomized clinical trial with a control group with parallel groups without blinding, in which 76 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Comprehensive Health Centers in Hamadan, involving 76 eligible pregnant women with a history of failed pregnancy. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 45 years,
Gestational age 12 to 20 weeks,
Pregnant woman with a history of failed pregnancy,
Being literate,
Exclusion criteria:
Drug addiction,
Mental and psychiatric disorder,
Neurological disease
Intervention groups
Intervention group:
Routine prenatal care plus group counseling sessions based on dialectical behavior therapy for 60 to 75 minutes, once a week for 6 weeks (including basic concepts of mindfulness and the chain model
Control group:
Routine prenatal care
Main outcome variables
Primary outcome:
Mean stress score; Mean sexual quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N619
Registration date:2026-07-25, 1405/05/03
Registration timing:prospective
Last update:2026-07-25, 1405/05/03
Update count:0
Registration date
2026-07-25, 1405/05/03
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-23, 1405/06/01
Expected recruitment end date
2026-12-21, 1405/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group counseling based on dialectical behavior therapy compared to a control group on stress and sexual quality of life of pregnant women with a history of failed pregnancy: A randomized clinical trial
Public title
Effect of group counseling based on dialectical behavior therapy compared to a control group on stress and sexual quality of life of pregnant women with a history of failed pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 45 years,
Gestational age 12 to 20 weeks,
Pregnant woman with a history of failed pregnancy,
Being literate,
Exclusion criteria:
Drug addiction,
Mental and psychiatric disorder,
Neurological disease
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2026-07-25, 1405/05/03
Ethics committee reference number
IR.UMSHA.REC.1405.291
Health conditions studied
1
Description of health condition studied
Perceived stress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders
Primary outcomes
1
Description
Mean perceived stress score
Timepoint
Before intervention and 6 weeks after
Method of measurement
Using the Cohen Perceived Stress Questionnaire
2
Description
Mean sexual quality of life score
Timepoint
Before intervention and 6 weeks after
Method of measurement
Using the Sexual Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine prenatal care plus group counseling sessions based on dialectical behavior therapy for 60 to 75 minutes, once a week for 6 weeks (including basic concepts of mindfulness and the chain model (stimulus, thoughts, emotion, physical response, behavior, and consequences), distress tolerance skills with special emphasis on managing thoughts related to the experience of a failed pregnancy, emotional regulation skills, identifying and naming emotions with an emphasis on non-sexual intimacy, effective communication skills, requesting support and co-regulation in the marital relationship, designing an immediate action plan to manage stressful situations, strengthening motivation to continue practicing and planning to maintain skills in the postpartum period, in all sessions, practical mindfulness exercises, radical acceptance, emotion regulation, and homework are continuously followed up.)
Category
Treatment - Other
2
Description
Control group: Routine prenatal care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan
Full name of responsible person
Fatemeh Arianfar
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fatemeharianfar.1870422351@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Arianfar
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fatemeharianfar.1870422351@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Zahra Masoumi
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Zahramid2001@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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