: A Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Cognitive Therapy (MBCT) on Self-Esteem and Perceived Stress in Infertile Women
Compare the effectiveness of ACT and MBCT on self-esteem and perceived stress in infertile women
Design
. The study population consisted of all infertile women referring to the Reyhaneh Infertility Treatment Center in Ardabil from the first half to the second half of 2026. Using a non-probability volunteer sampling method, 45 participants will randomly assigned to three groups (two experimental groups and one control group). The experimental groups received the standard ACT and MBCT protocols, respectively, in eight 90-minute sessions.
Settings and conduct
“The Acceptance and Commitment Therapy and Mindfulness Therapy protocols will be administered during 8 weekly 90-minute sessions at the Reihaneh Infertility Center. This study is conducted as a single-blind trial; the outcome assessor will be blinded to group allocation.
Participants/Inclusion and exclusion criteria
“Medical history of infertility (≥1 year); severe physical/psychiatric comorbidities precluding regular participation.”
Intervention groups
Intervention Group 1 (ACT):Participants in this group will receive the Acceptance and Commitment Therapy (ACT) protocol. This intervention consists of eight 45-minute sessions, focusing on key concepts such as acceptance, cognitive defusion, present-moment awareness, self-as-context, and values.
Intervention Group 2 (MBCT):Participants in this group will receive the Mindfulness-Based Cognitive Therapy (MBCT) protocol. This program consists of eight 45-minute sessions, integrating mindfulness techniques with cognitive therapy principles, with a focus on non-judgmental awareness of present-moment experiences.
Control Group (Waitlist):This study employs a waitlist control group design. Participants in this group will not receive any specific therapeutic intervention during the study period. considerations.
Main outcome variables
Self-esteem; Perceived stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260824070771N1
Registration date:2026-09-07, 1405/06/16
Registration timing:prospective
Last update:2026-09-07, 1405/06/16
Update count:0
Registration date
2026-09-07, 1405/06/16
Registrant information
Name
Fatemeh Shahbazi
Name of organization / entity
, Roudehen Branch, Islamic Azad University, Roudehen, Iran
Country
Iran (Islamic Republic of)
Phone
+98 45 3381 9888
Email address
fatemeh.shahbazi93@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-11, 1405/06/20
Expected recruitment end date
2026-12-11, 1405/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: A Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Cognitive Therapy (MBCT) on Self-Esteem and Perceived Stress in Infertile Women
Public title
Psychological interventions for infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20–45 years
who had a medical record documenting infertility with their treating physician
had experienced infertility for at least one year
had a minimum educational level of junior high school
were in good psychiatric health
are willing to participate in the sessions
Exclusion criteria:
Presence of severe psychiatric disorders (e.g., psychosis, bipolar disorder, active suicidal ideation) that prevent group participation.
Concurrent participation in any other structured psychological intervention or mindfulness-based training.
Initiation or significant adjustment of psychotropic medication dosage within the last 3 month
Current diagnosis of substance use disorder
Presence of severe cognitive impairment interfering with the ability to understand and perform therapeutic exercises.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
After screening and obtaining written informed consent, 45 eligible participants were enrolled. Participants were randomly assigned to three groups (Acceptance and Commitment Therapy, Mindfulness-Based Cognitive Therapy, and control) using random block randomization with a block size of 15, ensuring equal allocation (15 per group). A computer-generated random number sequence (SPSS; Random Number Generator) was produced by an independent statistician not involved in recruitment or intervention delivery. Group allocation was concealed using sequentially numbered, opaque, sealed envelopes (SNOSE), which were opened only after baseline assessment was completed. Consequently, the outcome assessor and the intervention provider were blinded to the allocation sequence prior to assignment, ensuring allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will randomly assigned to the experimental and control groups using a lottery method. Due to the nature of the psychological interventions (MBCT and ACT), participants could not be blinded to the intervention; however, all assessments were conducted by an independent researcher who will blind to the group allocations (single-blind design)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Working Group, Islamic Azad University, Roudehen Branch
Street address
Paveh، Rudehen
City
Roudehen
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Approval date
2025-09-15, 1404/06/24
Ethics committee reference number
IR.IAU.R.REC.1404.022
Health conditions studied
1
Description of health condition studied
Perceived Stress in Infertile Women
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Self-esteem:Mean score on the Rosenberg Self-Esteem Scale (RSES; range 10–40about) after the intervention.
Timepoint
pretest, posttest, and a three-month follow-up
Method of measurement
the Rosenberg Self-Esteem Scale (RSES)
2
Description
Perceived stress:Mean score on the Cohen Perceived Stress Scale (PSS; range 0–40about) after the intervention.
Timepoint
pretest, posttest, and a three-month follow-up
Method of measurement
The Cohen Perceived Stress Scale (PSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1:The Acceptance and Commitment Therapy (ACT) protocol will be administered by the researcher to the experimental group in 8 sessions of 90 minutes each, held once per week. Immediately upon completion of the sessions, a post-test will be conducted, and a three-month follow-up assessment will be carried out for all groups after the end of the interventions.
Category
Rehabilitation
2
Description
Intervention Group 2:The Mindfulness-Based Cognitive Therapy (MBCT) protocol will be administered by the researcher to the experimental group in 8 sessions of 90 minutes each, held once per week. Immediately upon completion of the sessions, a post-test will be conducted, and a three-month follow-up assessment will be carried out for all groups after the end of the interventions.
Category
Rehabilitation
3
Description
Control group:The control group will not receive any intervention.