Investigating the effect of acceptance and commitment therapy on changing the decision of pregnant women seeking abortion to continue their pregnancy, acceptance of the maternal role and adaptation to pregnancy
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General information
2026-08-11, 1405/05/20
2026-10-10, 1405/07/18
2026-0810-1110 00:00:00
2026-12-11, 1405/09/20
2027-01-20, 1405/10/30
20262027-1201-1120 00:00:00
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Due to a technical issue with the IRCT system, the registration and approval process of the study was delayed. As a result, the participant recruitment start date entered when initially completing the registration form does not correspond to the final approval date of the study.
Since participant recruitment has not yet started, I would like to correct the participant recruitment start date registered in the system so that it accurately reflects the actual status of the study and is consistent with the approval date of the clinical trial.
Due to a technical issue with the IRCT system, the registration and approval process of the study was delayed. As a result, the participant recruitment start date entered when initially completing the registration form does not correspond to the final approval date of the study. Since participant recruitment has not yet started, I would like to correct the participant recruitment start date registered in the system so that it accurately reflects the actual status of the study and is consistent with the approval date of the clinical trial.
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با توجه به اینکه فرایند ثبت و تأیید مطالعه در سامانه IRCT به دلیل بروز مشکل در سامانه با تأخیر انجام شد، تاریخ شروع نمونه‌گیری که در زمان تکمیل اولیه فرم وارد شده بود، با تاریخ تأیید نهایی مطالعه مطابقت ندارد. با توجه به اینکه تاکنون نمونه‌گیری مطالعه آغاز نشده است، مایل هستم زمان شروع نمونه‌گیری ثبت‌شده در سامانه را اصلاح نمایم تا با وضعیت واقعی مطالعه و تاریخ تأیید کارآزمایی مطابقت داشته باشد.
با توجه به اینکه فرایند ثبت و تأیید مطالعه در سامانه IRCT به دلیل بروز مشکل در سامانه با تأخیر انجام شد، تاریخ شروع نمونه‌گیری که در زمان تکمیل اولیه فرم وارد شده بود، با تاریخ تأیید نهایی مطالعه مطابقت ندارد. با توجه به اینکه تاکنون نمونه‌گیری مطالعه آغاز نشده است، مایل هستم زمان شروع نمونه‌گیری ثبت‌شده در سامانه را اصلاح نمایم تا با وضعیت واقعی مطالعه و تاریخ تأیید کارآزمایی مطابقت داشته باشد.
Protocol summary
Study aim
To determine the effect of Acceptance and Commitment Therapy on changing the decision of pregnant women seeking abortion to continue their pregnancy, acceptance of the maternal role, and adaptation to pregnancy.
Design
This is a randomized controlled clinical trial with two parallel groups and no blinding, with an anticipated sample size of 112 participants (56 per group). Participants will be allocated using block randomization with blocks of six and a 1:1 allocation ratio. The randomization sequence will be generated by an independent individual, and allocation will be concealed using opaque, sealed, sequentially numbered envelopes. Study phase: Not applicable.
Settings and conduct
This randomized controlled clinical trial will be conducted at the Nafas Center in Ahvaz. After obtaining informed consent, participants will be randomly allocated to the intervention and control groups. The intervention group will receive 8 weekly 90-minute sessions of acceptance and commitment therapy (ACT)-based education, while the control group will receive routine services provided by the center. This study will be conducted without blinding.
Participants/Inclusion and exclusion criteria
Inclusion: Women 18–48y, 4–20wks gestation, intrauterine pregnancy, Persian literacy, consent; Exclusion: acute psych/med/obstetric conditions, pregnancy/fetal complications, substance abuse, major stressors, concurrent psychotherapy, incomplete data.
Intervention groups
Intervention group: Group-based acceptance and commitment therapy (ACT) education will be provided in 8 weekly 90-minute sessions, delivered in 6 groups. The control group will receive routine services at the Nafas Center in Ahvaz, including routine prenatal care and psychosocial support, and will not receive the ACT intervention.
Main outcome variables
Change in the decision to continue pregnancy; acceptance of the maternal role; adaptation to pregnancy
General information
Reason for update
Due to a technical issue with the IRCT system, the registration and approval process of the study was delayed. As a result, the participant recruitment start date entered when initially completing the registration form does not correspond to the final approval date of the study.
Since participant recruitment has not yet started, I would like to correct the participant recruitment start date registered in the system so that it accurately reflects the actual status of the study and is consistent with the approval date of the clinical trial.
Acronym
IRCT registration information
IRCT registration number:IRCT20260719070262N1
Registration date:2026-09-18, 1405/06/27
Registration timing:prospective
Last update:2026-09-27, 1405/07/05
Update count:1
Registration date
2026-09-18, 1405/06/27
Registrant information
Name
Shafa Rahmani Tabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 619 9850
Email address
shafa823@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-10, 1405/07/18
Expected recruitment end date
2027-01-20, 1405/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of acceptance and commitment therapy on changing the decision of pregnant women seeking abortion to continue their pregnancy, acceptance of the maternal role and adaptation to pregnancy
Public title
The Effect of an Acceptance and Commitment Therapy-Based Counseling Program on the Decision to Continue Pregnancy and Psychological Adaptation to Pregnancy among Pregnant Women Seeking Abortion
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age aged 18 to 48 years
gestational age of 4 to 20 weeks
confirmed intrauterine pregnancy
literacy in reading and writing in Persian
provision of written informed consent
Exclusion criteria:
Presence of acute psychiatric disorders
Presence of medical or obstetric complications
Presence of acute pregnancy complications, such as bleeding or threatened abortion
Fetal abnormalities
Addiction to alcohol, illicit drugs, or other psychotropic substances
Occurrence of significant stressful life events, such as the death of a spouse or a family member
Concurrent participation in a similar psychotherapy program
Failure to complete the study questionnaires
Age
From 18 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated to two groups using block randomization with blocks of six and a 1:1 allocation ratio: an acceptance and commitment therapy-based counseling group (n = 56) and a control group (n = 56). The randomization sequence will be generated using blocks of six by an individual independent of the research team. To ensure allocation concealment, each allocation will be placed separately in an opaque, sealed, light-proof, sequentially numbered envelope, with only one allocation code (A or B) inside each envelope. After eligibility criteria have been confirmed and informed consent has been obtained, the next envelope will be opened in sequential numerical order, and the participant will be assigned to either the intervention or control group according to the allocation code contained in the envelope.
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 Ahvaz University of Medical Sciences
Street address
Golestan Blvd., Ahvaz University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6166654181
Approval date
2026-07-25, 1405/05/03
Ethics committee reference number
IR.AJUMS.REC.1405.189
Health conditions studied
1
Description of health condition studied
unwanted pregnancy
ICD-10 code
Z64.0
ICD-10 code description
Problems related to unwanted pregnancy
Primary outcomes
1
Description
Score of change in the decision of pregnant women seeking abortion to continue the pregnancy and acceptance of pregnancy based on the Lederman Prenatal Self-Evaluation Questionnaire (PSEQ)
Timepoint
Measurement of the score of change in the decision of pregnant women seeking abortion to continue the pregnancy and acceptance of pregnancy using the Lederman Prenatal Self-Evaluation Questionnaire (PSEQ) at baseline (pre-test), immediately after completion of the 8 intervention sessions (post-test), and one month after the end of the intervention (follow-up).
Method of measurement
Lederman Prenatal Self-Evaluation Questionnaire
Secondary outcomes
1
Description
Maternal role acceptance (maternal role identification) score based on the Lederman Prenatal Self-Evaluation Questionnaire
Timepoint
Measurement of the score of maternal role acceptance (identification with the maternal role) using the Lederman Prenatal Self-Evaluation Questionnaire at baseline (pre-test), immediately after completion of the 8 intervention sessions (post-test), and one month after the end of the intervention (follow-up).
Method of measurement
Lederman Prenatal Self-Evaluation Questionnaire
2
Description
Score of relationship with the partner based on the Lederman Prenatal Self-Evaluation Questionnaire
Timepoint
Measurement of the score of relationship with the partner using the Lederman Prenatal Self-Evaluation Questionnaire at baseline (pre-test), immediately after completion of the 8 intervention sessions (post-test), and one month after the end of the intervention (follow-up).
Method of measurement
Lederman Prenatal Self-Evaluation Questionnaire
3
Description
Score of preparation for childbirth based on the Lederman Prenatal Self-Evaluation Questionnaire
Timepoint
At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of the intervention.
Method of measurement
Lederman Prenatal Self-Evaluation Questionnaire
4
Description
Score of sense of control during the childbirth process based on the Lederman Prenatal Self-Evaluation Questionnaire
Timepoint
At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of the intervention.
Method of measurement
Lederman Prenatal Self-Evaluation Questionnaire
5
Description
Score of well-being of self and baby based on the Lederman Prenatal Self-Evaluation Questionnaire
Timepoint
At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of the intervention.
Method of measurement
Lederman Prenatal Self-Evaluation Questionnaire
6
Description
Score of relationship with mother based on the Lederman Prenatal Self-Evaluation Questionnaire
Timepoint
At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of the intervention.
Method of measurement
Lederman Prenatal Self-Evaluation Questionnaire
7
Description
Score of adaptation to pregnancy based on the Lederman Prenatal Self-Evaluation Questionnaire
Timepoint
At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of the intervention.
Method of measurement
Lederman Prenatal Self-Evaluation Questionnaire
8
Description
Score of psychological adaptation to pregnancy based on the Lederman Prenatal Self-Evaluation Questionnaire
Timepoint
At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of
Method of measurement
Lederman Prenatal Self-Evaluation Questionnaire
Intervention groups
1
Description
Intervention group: Group-based Acceptance and Commitment Therapy (ACT) delivered in 8 weekly 90-minute sessions, conducted in 6 groups of 8–9 participants, aiming to improve psychological adaptation to pregnancy, maternal role acceptance, and decision-making regarding continuation of pregnancy. The sessions will cover introduction to ACT, acceptance, cognitive defusion, self-as-context, present-moment awareness, values, and committed action.
Category
Treatment - Other
2
Description
Control group: Participants will receive routine services provided by Nafas Center, including routine prenatal care and usual psychosocial support. The control group will not receive ACT during the study.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nafas Center, East Ahvaz
Full name of responsible person
Somayeh Ghobaiti
Street address
Rastgari Street, Si Metri, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6187653599
Phone
+98 916 305 7872
Email
somayehghobeyty@gmail.com
2
Recruitment center
Name of recruitment center
Nafas Center, West Ahvaz
Full name of responsible person
Laleh Jafari
Street address
Kamplo, Enghelab St., Corner of Shahid Hatef St., Opposite District 6 Municipality
City
Ahvaz
Province
Khouzestan
Postal code
6187653599
Phone
+98 901 960 4993
Email
somayehghobeyty@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Abdollah Rafiei
Street address
Jundishapur University of Medical Sciences in Ahvaz, Golestan Boulevard, opposite the Water and Electricity Organization
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8300
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Shafa Rahmanitabar
Position
Master's Student in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Golestan, Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6166654181
Phone
+98 916 619 9850
Email
shafa823@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Eirvani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan, Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
616664181
Phone
+98 916 322 2899
Email
iravani-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shafa Rahmanitabar
Position
Master's Student in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan, Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6166654181
Phone
+98 916 619 9850
Email
shafa823@gmail.com
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
Due to the need to maintain the confidentiality of participants' information and the limitations arising from informed consent and ethical considerations of the study, de-identified individual participant data will not be shared with other researchers.