<?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>IRCT20260721070286N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of a Systemic Acceptance and Commitment Therapy (ACT) and Life Review therapy on Social Cognition, Emotional Adaptation, and Experiential Avoidance in Older Adults</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of a Systemic Acceptance and Commitment Therapy (ACT) and Life Review therapy on Social Cognition, Emotional Adaptation, and Experiential Avoidance in Older Adults with Mild Cognitive Impairment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91918</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Participants in the intervention group will receive a combined intervention consisting of Acceptance and Commitment Therapy (ACT) and Life Review Therapy. The ACT sessions will be conducted by the therapist at Yas Comprehensive Rehabilitation Center in Tehran, in a group format, consisting of 10 sessions held twice weekly, with each session lasting one hour.The Life Review intervention will be conducted over 6 one-hour sessions. For participants who have a family caregiver, caregivers will initially receive two one-hour online training sessions on how to conduct the life review process. Subsequently, caregivers will implement the life review sessions at home with the older adults, and the implementation process will be monitored by the researcher, Randomization description: Randomization method: Simple randomization.

Unit of randomization: Individual participant.

Randomization tool: A random allocation sequence will be generated using a random numbers table.

Generation of the random allocation sequence: A unique identification code will be assigned to each participant, and based on the generated random allocation sequence, participants will be allocated to the intervention and control groups in a 1:1 ratio.

Allocation concealment: The allocation sequence will be maintained by an individual who is not involved in delivering the intervention or assessing the study outcomes. The allocation assignments will be placed in sequentially numbered, opaque, sealed envelopes. After completion of each participant's baseline assessment, the corresponding envelope will be opened in numerical order, and the participant's group allocation will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mild Cognitive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Participants will receive a combined intervention consisting of Acceptance and Commitment Therapy (ACT) and Butler's Life Review protocol delivered by a family member. ACT will be delivered by a therapist in 10 group sessions (60 minutes each, twice weekly) at Yas Comprehensive Rehabilitation Center, Tehran. Butler's Life Review will consist of six 60-minute sessions. Family members will first receive two online training sessions on Butler's Life Review protocol and will then conduct the Life Review sessions at home with the older adult. Intervention implementation will be regularly monitored by the researcher. Intervention 2: Control group: Participants in the control group will receive usual care provided by Yas Comprehensive Rehabilitation Center, Tehran, and will not receive the study interventions (Acceptance and Commitment Therapy [ACT] or Butler's Life Review protocol) during the study period.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No additional information is available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Delara Soleimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, Ayin Residential Complex, 63 Edalat Street, Nahar Khoran Boulevard, Gorgan, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917844436</zip>
        <telephone>+98 17 3253 1697</telephone>
        <email>delisoleimani76@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Delara Soleimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, Ayin Residential Complex, 63 Edalat Street, Nahar Khoran Boulevard, Gorgan, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917844436</zip>
        <telephone>+98 17 3523 1697</telephone>
        <email>delisoleimani76@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>men and women aged ≥60 years
A diagnosis of Mild Cognitive Impairment (MCI) confirmed by a specialist physician
the ability to read and write
a Mini-Mental State Examination (MMSE) score of 24 or above</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>severe cognitive problems, sensorimotor impairments, or psychological disorder
absence from more than two intervention sessions
failure to complete the assigned homework</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>A disorder characterized by impairment of memory, learning difficulties, and reduced ability to concentrate on a task for more than brief periods. There is often a marked feeling of mental fatigue when mental tasks are attempted, and new learning is found</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Participants will receive a combined intervention consisting of Acceptance and Commitment Therapy (ACT) and Butler's Life Review protocol delivered by a family member. ACT will be delivered by a therapist in 10 group sessions (60 minutes each, twice weekly) at Yas Comprehensive Rehabilitation Center, Tehran. Butler's Life Review will consist of six 60-minute sessions. Family members will first receive two online training sessions on Butler's Life Review protocol and will then conduct the Life Review sessions at home with the older adult. Intervention implementation will be regularly monitored by the researcher.</i_keyword>
      <i_keyword>Control group: Participants in the control group will receive usual care provided by Yas Comprehensive Rehabilitation Center, Tehran, and will not receive the study interventions (Acceptance and Commitment Therapy [ACT] or Butler's Life Review protocol) during the study period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social cognition. Timepoint: At baseline (pre-intervention), immediately after completion of the intervention (post-intervention), and at follow-up (1 months after the intervention). Method of measurement: 1- Social cognition score measured by the Bar-On/Cohen Empathy Quotient (EQ). 2- Theory of Mind score measured by the Revised Reading the Mind in the Eyes Test (RMET).</prim_outcome>
      <prim_outcome>Emotional adaptation. Timepoint: At baseline (pre-intervention), immediately after completion of the intervention (post-intervention), and at follow-up (1 months after the intervention). Method of measurement: Emotional adaptation score measured by the Rabiu et al. Emotional Adaptation Scale.</prim_outcome>
      <prim_outcome>Experiential avoidance. Timepoint: At baseline (pre-intervention), immediately after completion of the intervention (post-intervention), and at follow-up (1 months after the intervention). Method of measurement: Experiential avoidance score measured by the Acceptance and Action Questionnaire-II (AAQ-II).</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>The Islamic Azad University, Tehran Medical Sciences Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-15</approval_date>
        <contact_name>Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences</contact_name>
        <contact_address>Tehran Azad University of Medical Sciences, Headquarters Building, Corner of Gol Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Qolhak Junction, Dr. Shariati Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
