Protocol summary

Study aim
Comparison of the effect of grief counseling based on Compassion-Focused Therapy and counseling based on Acceptance and Commitment Therapy on self-compassion and self-efficacy of women who experienced fetal loss
Design
A parallel clinical trial with a single-blind control group (participants) on 90 women will be assigned to two intervention groups and a control group in a ratio of 1:1:1 using a random block design of 4 and 6. To conceal the allocation, consecutively numbered, sealed opaque envelopes will be used.
Settings and conduct
Among mothers who have experienced fetal loss during pregnancy from 8 weeks to 40 weeks and are hospitalized in the obstetrics and surgery departments of Al-Zahra and Taleghani hospitals, after completing the forms through an interview or virtual press line. Group counseling for both groups will last 45-60 minutes, sessions will be held in a combined (in-person or virtual) and group (4-5 people) format on Google Meet or at the request of the women (the location of the in-person sessions will be determined) twice a week. The post-test will be taken one week after the intervention is completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: desired pregnancy, having a smartphone, access to the internet, at least literacy; Non inclusion criteria: abortion with the patient's own consent due to family conflicts, divorce, etc. death of a first-degree relative within the last 6 months, participation in two studies simultaneously, history of proven mental illness, psychiatric treatment and use of psychotropic medications
Intervention groups
Intervention 1: Grief counseling based on a CFT Intervention 2: Grief group counseling based on ACT Control: Receiving routine obstetric counseling
Main outcome variables
Comparing the average self-compassion score; Comparing the average self-efficacy score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241115063717N1
Registration date: 2025-04-23, 1404/02/03
Registration timing: registered_while_recruiting

Last update: 2025-04-23, 1404/02/03
Update count: 0
Registration date
2025-04-23, 1404/02/03
Registrant information
Name
Elham Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 463 3116
Email address
rezai520@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-04, 1404/01/15
Expected recruitment end date
2025-08-28, 1404/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of grief counseling based on Compassion-Focused Therapy and counseling based on Acceptance and Commitment Therapy on self-compassion and self-efficacy of women who experienced fetal loss: a randomized controlled trial.
Public title
Comparison of the effect of grief counseling based on Compassion-Focused Therapy and counseling based on Acceptance and Commitment Therapy on self-compassion and self-efficacy of women who experienced fetal loss: a randomized controlled trial.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Desired pregnancy Having a smartphone Access to the internet At least literacy
Exclusion criteria:
Abortion with the patient's own consent due to family conflicts, divorce, etc Death of a first-degree relative within the last 6 months Participation in two studies simultaneously Proven history of psychiatric illness and use of psychotherapeutic medications
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were divided into the first and second intervention groups using the random block method of 4 and 6 (recipients of bereavement counseling with a compassion-based treatment approach and those receiving bereavement counseling with an acceptance and commitment-based approach, respectively) and the control group. They will be allocated by a person not involved in other stages of the research in the ratio of 1:1:1. In order to hide the allocation (allocation concealment), the types of groups will be written on paper by a person not involved in the research and numbered consecutively inside sealed opaque envelopes. The envelopes will be opened in the order in which the participants enter the research, and in this way the type of group of people will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
Because this study is a randomized controlled trial of psychological interventions, the blinding method is designed so that participants are unaware of their grouping, but the therapists and researchers are aware of it. Therefore, this study is conducted in a single-blind manner. Participants are unaware of the type of treatment they are receiving. They only know that they are participating in a counseling program to help them cope with the loss of the fetus, but they are not told whether they are in the compassion focused therapy group, acceptance and commitment therapy group or the control group. To ensure blinding, the names of the counseling sessions are presented to participants in a generic and non-differentiated manner (e.g., “Post-Bereavement Psychological Support Program,” without reference to the type of therapy).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
Tabriz Faculty of Nursing and Midwifery, Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.TBZMED.REC.1403.1077

Health conditions studied

1

Description of health condition studied
self-compassion
ICD-10 code
F33
ICD-10 code description
Major depressive disorder, recurrent

2

Description of health condition studied
self-efficacy
ICD-10 code
F33
ICD-10 code description
Major depressive disorder, recurrent

Primary outcomes

1

Description
Self-compassion score in the Neff questionnaire
Timepoint
Measurements before the start of the intervention and one week after the end of the intervention.
Method of measurement
NEFF Self-Compassion Questionnaire

2

Description
Self-efficacy score in the Sherer questionnaire
Timepoint
Measurements before the start of the intervention and one week after the end of the intervention.
Method of measurement
General Self-Efficacy Questionnaire by Sherer

Secondary outcomes

1

Description
perinatal grief score
Timepoint
Before the start of the intervention and one week after the end of the intervention
Method of measurement
Perinatal Grief Scale

2

Description
rumination score
Timepoint
Before the start of the intervention and one week after the end of the intervention
Method of measurement
Nolen-Hoeksema Rumination Questionnaire

Intervention groups

1

Description
Intervention group1: Recipient of grief counseling with a compassion-focused therapy approach. Eight group counseling sessions based on the compassion-focused therapy protocol (Gilbert, 2010) for 45-60 minutes, with the first session being held individually and in person at the hospital to gain trust between the researcher and the patient and establish a good relationship, and the remaining sessions will be held in a combined (in-person or virtual) and group format (4-5 people) on Google Meet or at the request of the women (the location of the in-person sessions will be determined) twice a week.
Category
Prevention

2

Description
Intervention group2: Recipient of grief counseling with an acceptance and commitment therapy approach. Eight group counseling sessions lasting 45-60 minutes based on the acceptance and commitment therapy protocol (Hayes, 2016). The first session will be held individually and in person at the hospital to gain trust between the researcher and the patient and establish a good relationship. The remaining sessions will be held in a combined (in-person or virtual) and group format (4-5 people) on Google Meet or at the request of the women (the location of the in-person sessions will be determined) twice a week.
Category
Prevention

3

Description
Control group: Receive counseling on routine obstetric care tailored to their specific circumstances
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospitals
Full name of responsible person
Elham Rezaei
Street address
Tabriz Faculty of Nursing and Midwifery, South Shariati Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 0364
Fax
+98 41 3479 6969
Email
rezai520@yahoo.com

2

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Elham Rezaei
Street address
Tabriz Faculty of Nursing and Midwifery, South Shariati Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 0364
Fax
+98 41 3479 6969
Email
rezai520@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khosrow Adibkia
Street address
Third Floor, Vice President for Research and Technology/ Tabriz University of Medical Sciences, Central Building No. 2 /Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7311
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Elham Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shariati
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 914 463 3116
Fax
Email
rezai520@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elham Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shariati
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 914 463 3116
Fax
Email
rezai520@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elham Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shariati
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 914 463 3116
Fax
Email
rezai520@yahoo.com

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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