<?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>IRCT20250606066093N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-05</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of two therapeutic methods in reducing concerns and improving sleep in elderly women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Acceptance and Commitment Therapy and Schema Therapy on irrational beliefs, death anxiety, psychological coherence, and sleep quality in elderly women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84184</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization was performed using the RAND function in Excel software. Participants were randomly assigned to three groups (two experimental groups and one control group), Blinding description: Double-blind randomization was achieved by concealing group assignments from both participants and evaluators. The psychologists conducting the interventions and the data analysts were also unaware of the group identities to minimize bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Death anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Acceptance and Commitment Therapy (ACT) is structured as 8 sessions, each lasting 90 minutes, with each session focusing on one of the six core processes of this approach: acceptance, cognitive defusion, self-as-context, present-moment awareness, values, and committed action. The first session introduces ACT concepts, establishes the therapeutic relationship, and identifies personal values. The second session teaches psychological acceptance, helping individuals embrace negative emotions and thoughts without resistance. The third session focuses on cognitive defusion, enabling clients to view irrational thoughts as transient mental events rather than absolute truths. The fourth session emphasizes present-moment awareness and mindfulness practices. In the fifth session, clients identify and prioritize their personal values. The sixth session involves setting value-based goals and planning committed actions. The seventh session focuses on self-as-context, helping clients distinguish themselves from their thoughts and feelings. The eighth session reviews progress, consolidates skills, and plans for ongoing application. Each session includes practical exercises, group discussions, and homework assignments to reinforce skills in daily life. Intervention 2: Intervention group 2: Schema Therapy is structured as 8 sessions, each lasting 90 minutes, focusing on identifying, understanding, and modifying maladaptive early schemas. The first session is dedicated to an initial assessment, introducing schema therapy concepts, and identifying the client’s maladaptive schemas using questionnaires and interviews. The second session focuses on psychoeducation about schemas and their impact on behavior and emotions, with clients beginning to recognize recurring patterns in their lives. The third session introduces cognitive techniques, such as cognitive restructuring, to challenge maladaptive beliefs tied to schemas. The fourth session employs experiential techniques, like imagery rescripting and empty-chair dialogues, to help clients connect with emotions linked to their schemas. The fifth session focuses on modifying schemas through behavioral techniques, such as role-playing and changing maladaptive behavioral patterns. The sixth session emphasizes fostering healthy relationships and addressing unmet emotional needs from childhood. The seventh session concentrates on consolidating changes and developing coping strategies to manage schema triggers in daily life. The eighth session reviews progress, evaluates changes in schemas, and plans for maintaining gains and preventing relapse. Each session includes practical exercises, guided discussions, and homework assignments to deepen awareness and reinforce changes.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Individual participant data (IPD) will not be shared due to confidentiality concerns and the lack of prior participant consent for data sharing. Furthermore, there are no institutional guidelines or requirements mandating the availability of these data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kobra Kazemian moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Farhang Shahr</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937333</zip>
        <telephone>+98 61 3334 8420</telephone>
        <email>Kazemian174@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kobra Kazemian moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Farhang Shahr</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937333</zip>
        <telephone>+98 61 3334 8420</telephone>
        <email>Kazemian174@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Reading and writing
Age above 60 years
A tendency to cooperate
Not smoking
Failure to receive psychological services over the past 3 months</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>85 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Acceptance and Commitment Therapy (ACT) is structured as 8 sessions, each lasting 90 minutes, with each session focusing on one of the six core processes of this approach: acceptance, cognitive defusion, self-as-context, present-moment awareness, values, and committed action. The first session introduces ACT concepts, establishes the therapeutic relationship, and identifies personal values. The second session teaches psychological acceptance, helping individuals embrace negative emotions and thoughts without resistance. The third session focuses on cognitive defusion, enabling clients to view irrational thoughts as transient mental events rather than absolute truths. The fourth session emphasizes present-moment awareness and mindfulness practices. In the fifth session, clients identify and prioritize their personal values. The sixth session involves setting value-based goals and planning committed actions. The seventh session focuses on self-as-context, helping clients distinguish themselves from their thoughts and feelings. The eighth session reviews progress, consolidates skills, and plans for ongoing application. Each session includes practical exercises, group discussions, and homework assignments to reinforce skills in daily life.</i_keyword>
      <i_keyword>Intervention group 2: Schema Therapy is structured as 8 sessions, each lasting 90 minutes, focusing on identifying, understanding, and modifying maladaptive early schemas. The first session is dedicated to an initial assessment, introducing schema therapy concepts, and identifying the client’s maladaptive schemas using questionnaires and interviews. The second session focuses on psychoeducation about schemas and their impact on behavior and emotions, with clients beginning to recognize recurring patterns in their lives. The third session introduces cognitive techniques, such as cognitive restructuring, to challenge maladaptive beliefs tied to schemas. The fourth session employs experiential techniques, like imagery rescripting and empty-chair dialogues, to help clients connect with emotions linked to their schemas. The fifth session focuses on modifying schemas through behavioral techniques, such as role-playing and changing maladaptive behavioral patterns. The sixth session emphasizes fostering healthy relationships and addressing unmet emotional needs from childhood. The seventh session concentrates on consolidating changes and developing coping strategies to manage schema triggers in daily life. The eighth session reviews progress, evaluates changes in schemas, and plans for maintaining gains and preventing relapse. Each session includes practical exercises, guided discussions, and homework assignments to deepen awareness and reinforce changes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Irrational beliefs. Timepoint: Irrational beliefs are measured at three time points: pretest (before the start of interventions), posttest (immediately after the completion of 8 therapy sessions), and follow-up (90 days after the posttest). Method of measurement: Irrational beliefs are measured using the standardized Jones Irrational Beliefs Test (IBT) or similar validated tools. This questionnaire includes items that assess the intensity of irrational beliefs such as the need for approval, unrealistic expectations, and perfectionism on a Likert scale. Data are collected through self-reporting by participants, with higher scores indicating greater intensity of irrational beliefs. Data analysis is conducted using statistical methods such as analysis of variance.</prim_outcome>
      <prim_outcome>Death anxiety. Timepoint: Death anxiety is measured at three time points: pretest (before the start of interventions), posttest (immediately after the completion of 8 therapy sessions), and follow-up (90 days after the posttest). Method of measurement: Death anxiety is measured using the standardized Templer Death Anxiety Scale (DAS) or similar validated tools. This questionnaire includes items that assess the intensity of fear and concerns related to death on a Likert scale. Data are collected through self-reporting by participants, with higher scores indicating greater levels of death anxiety. Data analysis is conducted using statistical methods such as analysis of variance.</prim_outcome>
      <prim_outcome>Psychological coherence. Timepoint: Psychological coherence is measured at three time points: pretest (before the start of interventions), posttest (immediately after the completion of 8 therapy sessions), and follow-up (90 days after the posttest). Method of measurement: Psychological coherence is measured using the standardized Sense of Coherence Scale (SOC) by Antonovsky or similar validated tools. This questionnaire includes items that assess the three main components of psychological coherence (comprehensibility, manageability, and meaningfulness) on a Likert scale. Data are collected through self-reporting by participants, with higher scores indicating greater levels of psychological coherence. Data analysis is conducted using statistical methods such as analysis of variance.</prim_outcome>
      <prim_outcome>Sleep quality. Timepoint: Sleep quality is measured at three time points: pretest (before the start of interventions), posttest (immediately after the completion of 8 therapy sessions), and follow-up (90 days after the posttest). Method of measurement: Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). This instrument consists of 19 items that assess seven components of sleep quality over the past month. A higher total score indicates poorer sleep quality. The PSQI has demonstrated good reliability and validity in both domestic and international research.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-23</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Ahvaz Branch</contact_name>
        <contact_address>Islamic Azad University, Farhang Shahr Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
