<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20260106068572N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-01-27</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <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</public_title>
      <acronym></acronym>
      <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</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/88582</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mothers Employed Outside the Home.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
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:
Six months after the completion of the clinical trial.

To whom:
Only researchers affiliated with academic or scientific institutions will have access to the data.

Conditions:
Data access will be granted exclusively for ethical and permissible scientific research purposes.

Where to obtain:
Negin Sayalzanan Mashhadi
sayqalzanannegin@gmail.com

How to obtain:
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.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negin Sayqalzanan Mashhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ferdows Boulevard, Vafaazar Shomali, Yas Dead End, No. 3, Doorbell 14</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1481863141</zip>
        <telephone>+98 904 539 0822</telephone>
        <email>negin.sayqalzanan@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negin Sayqalzanan Mashhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ferdows Boulevard, Vafaazar Shomali, Yas Dead End, No. 3, Doorbell 14</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1481863141</zip>
        <telephone>+98 904 539 0822</telephone>
        <email>negin.sayqalzanan@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <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.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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).</prim_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-01-05</approval_date>
        <contact_name>The Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_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 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
