Protocol summary

Study aim
The primary aim of this study is to compare the efficacy of ACT group Therapy with CFT group Therapy on psychological distress, work-family conflict, parenting stress, self-compassion, psychological flexibility, and quality of life among employed mothers.
Design
A single-blind, parallel-group, randomized controlled trial with paired randomization based on age (In order to control for the effects of age variation across the intervention groups), conducted on 56 participants.
Settings and conduct
The intervention sessions will be conducted on the Google Meet audio-visual online platform under the supervision of the supervisor at Taleghani Hospital, Tehran. The study population consists of employed mothers. Regarding blinding, a single-blind design will be used, meaning the individual responsible for data analysis will be unaware of which intervention each group received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Employed and married mothers in Tehran; at least one child under the age of 18; aged between 25 and 50; stable internet and devices such as a smartphone or computer; providing informed consent to participate in online sessions and to complete assessment tools. Exclusion criteria: Concurrent psychological or pharmacological treatment; substance or alcohol abuse.
Intervention groups
Intervention group 1: Ten 120-minute online sessions of ACT group therapy; Intervention group 2: Ten 120-minute online sessions of CFT group therapy.
Main outcome variables
Psychological Distress; Work-Family Conflict; Parenting Stress; Self- compassion; Psychological flexibility; Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260106068572N1
Registration date: 2026-01-27, 1404/11/07
Registration timing: prospective

Last update: 2026-01-27, 1404/11/07
Update count: 0
Registration date
2026-01-27, 1404/11/07
Registrant information
Name
Negin Sayqalzanan Mashhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 904 539 0822
Email address
negin.sayqalzanan@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-04-19, 1405/01/30
Expected recruitment end date
2026-07-21, 1405/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of group-based acceptance and commitment therapy (ACT) and compassion-focused therapy (CFT) on psychological distress, work-family conflict, parenting stress, and quality of life in working mothers
Public title
Comparison of the effectiveness of Acceptance and Commitment group therapy (ACT) and Compassion-Focused group therapy (CFT) on the psychological well-being of employed mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Married mothers with at least one child under the age of 18 Currently employed Access to stable internet and suitable equipment (such as a smartphone or computer) and commitment to regular attendance in online group therapy sessions Informed consent to participate in online therapy sessions and complete assessment tools at the pre-test, post-test, and follow-up stages
Exclusion criteria:
Concurrent receipt of psychological therapy or pharmacotherapy (or at least three months without a change in medication dosage). Substance or alcohol use. Work schedules or personal commitments that conflict with the individual's weekly online group therapy session times.
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
- Phase 1 (Targeted Sampling): Employed mothers are selected based on specific criteria through online announcements (such as social media, relevant working mothers' groups, or online psychology clinics) or via local organizations and companies in Tehran. - Phase 2 (Paired Block Randomization): A finalized list of 56 selected participants is compiled and sorted in descending order of age. They are then divided into 28 paired blocks based on age proximity (the two oldest participants form the first pair, followed by the next two, and so on, until the final pair with the youngest participants). Within each paired block, one participant is randomly assigned to the Acceptance and Commitment Therapy (ACT) intervention group and the other to the Compassion-Focused Therapy (CFT) intervention group. This method ensures statistical balance between the two groups regarding age and controls for the confounding effects of the age variable.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will utilize a single-blind design, in which the data analyst will be blinded to the type of intervention received by the participants.The final data obtained from the two different intervention groups will be provided to the statistical analyst as numeric codes, and they will not be informed which code corresponds to which therapy group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
13th Floor, Block A, Headquarters of the Ministry of Health, Treatment and Medical Education, Iran Sima Street, between Falamak South and Zarfashan Streets, Ghods (West) Town, Tehran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2026-01-05, 1404/10/15
Ethics committee reference number
IR.SBMU.MSP.REC.1404.671

Health conditions studied

1

Description of health condition studied
Mothers Employed Outside the Home
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Psychological Distress: individual's overall psychological state across three key domains—self-reported perceived stress, perceived anxiety, and perceived depression, in DASS-21 Scale
Timepoint
Prior to the commencement of group therapy interventions (pre-test), immediately following the completion of group therapy interventions (post-test), and four months after the conclusion of group therapy interventions (follow-up).
Method of measurement
The 21-item Depression, Anxiety and Stress Scale (DASS-21), developed by Lovibond and Lovibond (1995).

2

Description
Work-Family Conflict: A type of inter-role conflict in which the pressures arising from work and family domains are in some aspects incompatible or contradictory. Consequently, fulfilling one role (work or family) makes it difficult or problematic to fulfill the other role. This conflict can manifest as work-to-family interference (when work demands hinder the performance of family roles) or family-to-work interference (when family responsibilities disrupt work performance).
Timepoint
Prior to the commencement of group therapy interventions (pre-test), immediately following the completion of group therapy interventions (post-test), and four months after the conclusion of group therapy interventions (follow-up).
Method of measurement
The Work–Family Conflict Scale, developed by Carlson et al. in 2000, which consists of 18 items.

3

Description
Score in the Parenting Stress Index - Short Form (PSI-SF)
Timepoint
Prior to the commencement of group therapy interventions (pre-test), immediately following the completion of group therapy interventions (post-test), and four months after the conclusion of group therapy interventions (follow-up).
Method of measurement
The Parenting Stress Index-Short Form (PSI-SF) was developed by Abidin (1995). It is the abbreviated version of the original scale and consists of 36 items.

4

Description
Score in the Self-Compassion Scale - Short Form (SCS-SF)
Timepoint
Prior to the commencement of group therapy interventions (pre-test), immediately following the completion of group therapy interventions (post-test), and four months after the conclusion of group therapy interventions (follow-up).
Method of measurement
The Self-Compassion Scale (SCS) was initially developed by Neff (2003) with 26 items. Subsequently, Raes et al. (2011) introduced its short-form version (SCS-SF) comprising 12 items.

5

Description
Psychological flexibility score based on the Acceptance and Action Questionnaire - Second Edition (AAQ-II).
Timepoint
Prior to the commencement of group therapy interventions (pre-test), immediately following the completion of group therapy interventions (post-test), and four months after the conclusion of group therapy interventions (follow-up).
Method of measurement
The Acceptance and Action Questionnaire (AAQ-II) was developed by Bond et al. to measure psychological flexibility and experiential avoidance. This questionnaire consists of 10 items.

6

Description
Quality of life score based on the World Health Organization Quality of Life questionnaire - Brief Version (WHOQOL-BREF).
Timepoint
Prior to the commencement of group therapy interventions (pre-test), immediately following the completion of group therapy interventions (post-test), and four months after the conclusion of group therapy interventions (follow-up).
Method of measurement
The World Health Organization Quality of Life-BREF questionnaire (WHOQOL-BREF)

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention Group: The ACT group therapy will be conducted in 10 sessions, each lasting 120 minutes, based on the protocol published by Dara Wistrup and JoAnn Wright in 2017. ACT group therapy is a psychological intervention conducted in a group format, grounded in the principles of ACT. This approach, by focusing on accepting negative thoughts and emotions rather than combating them, encourages individuals to align their actions with their personal values and to engage in committed behaviors toward value-driven goals. Within this group therapy model, participants learn skills such as cognitive defusion, acceptance, and committed action through interpersonal interactions and mindfulness-based exercises, leading to enhanced psychological flexibility. Emphasizing six core processes (acceptance, cognitive defusion, being present in the moment, self-as-context, values, and committed action), this approach aims to improve quality of life and reduce the negative impacts of psychological distress.
Category
Treatment - Other

2

Description
Second Intervention Group: The CFT group therapy will be conducted in 10 sessions, each lasting 120 minutes, based on the protocol published by Nicola Petrocchi and colleagues in 2024. CFT group therapy is a therapeutic group approach designed based on the compassion-focused therapy theory developed by Paul Gilbert. This method aims to cultivate compassion towards oneself and others, helping individuals manage difficult emotions such as shame, self-criticism, and anxiety using compassion-based techniques. In this form of group therapy, participants enhance their emotional regulation and self-acceptance skills through mindfulness exercises, guided imagery, and group discussions, which leads to reduced psychological distress and improved mental health. Utilizing the tripartite model of emotion regulation (threat system, drive system, and soothing system), this approach assists individuals in experiencing greater psychological balance.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran city
Full name of responsible person
Negin Sayqalzanan Mashhadi
Street address
Tehran - Shahid Chamran Highway - Yemen Street - Shahid A'rabi Street, adjacent to (next to) Ayatollah Taleghani Hospital.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2561
Email
info@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hoda Doosalivand
Street address
Psychology Department, Fourth Floor, Taleghani Hospital, E'rabi Street, Daneshjou Boulevard, Velenjac
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 993 051 8701
Email
hoda.doosalivand@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negin Sayqalzanan Mashhadi
Position
PhD Assistant in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ferdows Boulevard, Vafaazar Shomali, Yas Dead End, No. 3, Doorbell 14
City
Tehran
Province
Tehran
Postal code
1481863141
Phone
+98 904 539 0822
Fax
Email
negin.sayqalzanan@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negin Sayqalzanan Mashhadi
Position
PhD Assistant in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ferdows Boulevard, Vafaazar Shomali, Yas Dead End, No. 3, Doorbell 14
City
Tehran
Province
Tehran
Postal code
1481863141
Phone
+98 904 539 0822
Fax
Email
negin.sayqalzanan@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negin Sayqalzanan Mashhadi
Position
PhD Assistant in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ferdows Boulevard, Vafaazar Shomali, Yas Dead End, No. 3, Doorbell 14
City
Tehran
Province
Tehran
Postal code
1481863141
Phone
+98 904 539 0822
Fax
Email
negin.sayqalzanan@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
Our research team is able to share the final research data files as well as the results of statistical analyses upon completion of all implementation and writing phases of the study. However, no personally identifiable information of participants will be published in any reports or datasets. Confidentiality will be strictly maintained, and research data will only be released using randomly assigned numerical codes for each participant.
When the data will become available and for how long
Six months after the completion of the clinical trial.
To whom data/document is available
Only researchers affiliated with academic or scientific institutions will have access to the data.
Under which criteria data/document could be used
Data access will be granted exclusively for ethical and permissible scientific research purposes.
From where data/document is obtainable
Negin Sayalzanan Mashhadi sayqalzanannegin@gmail.com
What processes are involved for a request to access data/document
The interested researcher must email the designated contact person. After the research team approves the request, verifies the applicant's identity as a formal researcher affiliated with a reputable university or research institution, and clarifies their scientific purpose for accessing the data and documents, the raw research data files will be made available to them.
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