<?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>IRCT20241026063497N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-13</date_registration>
      <primary_sponsor>Urmia University</primary_sponsor>
      <public_title>Comparison of effectiveness of interpretation bias correction training and acceptance and commitment therapy on patients with multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effectiveness of interpretation bias correction training and acceptance and commitment therapy (ACT) on cognitive-behavioral and emotional symptoms of patients with multiple sclerosis (M.S).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80870</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method was considered as simple randomization with individual random units. Subsequently, the final sample was divided into two experimental groups and one control group. The randomization process was carried out using the website www.randomization.com.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Training in interpretation bias modification: In the present study, while providing necessary explanations to patients and ensuring the confidentiality of their information, patients are trained over 4 weeks with 2 individual sessions of 90 minutes each per week in the form of cognitive-behavioral therapy to identify their negative interpretations and then be able to reconstruct them into more logical interpretations. The term 'interpretation bias' in this research refers to individuals' tendency to interpret ambiguous and neutral events negatively and threateningly. This bias can manifest in various areas such as social relationships, health, and job performance. During therapy sessions, various cognitive-behavioral techniques are used, such as thought recording, Socratic questioning, identifying cognitive errors (especially errors related to interpretation), providing supporting and opposing evidence, creating alternative perspectives, and behavioral exercises. Intervention 2: Acceptance and Commitment Therapy: In the present study, while providing the necessary explanations to the group members and ensuring the confidentiality of their information, patients are treated in a group setting and over 4 weeks, with 2 sessions per week lasting 90 minutes, under Acceptance and Commitment Therapy. The content of these sessions includes the 6 main components of the Acceptance and Commitment approach, along with the use of metaphors related to the sessions and practical exercises. During the sessions, various metaphors are used to facilitate understanding of Acceptance and Commitment approach concepts. For example, the metaphor of "quicksand" is used to show that trying to control unpleasant thoughts and feelings can lead to becoming more submerged in them, the metaphor of the "bus" is used to show that thoughts and feelings are the passengers on the bus and the individual is the driver and can choose their route, and the metaphor of "tug-of-war with a monster" is used to show that fighting unpleasant thoughts and feelings takes a lot of energy and it is better to drop the rope. During the sessions, the therapist plays the role of a facilitator and helps the members to identify their values, set committed goals, and face their unpleasant experiences with more acceptance and flexibility. The therapist also provides a safe and supportive environment so that members can share their experiences and support each other. Intervention 3: Control group: In this study, no intervention is performed for the control group, and it is initially considered solely for measurement and observation purposes.</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:
Pre-test, Post-test, Retention test

When:
6 months after the results are published

To whom:
All researchers

Conditions:
Can be used for therapists in this field as well as researchers of review research, meta-analysis, etc.

Where to obtain:
Saleh Sadighi

How to obtain:
Official Request Letter.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saleh Sadighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mir building, 55.3 Side alley, 55 Darya, Kelkaser, Amol</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4617139606</zip>
        <telephone>+98 11 4308 0317</telephone>
        <email>salehsadighi@gmail.com</email>
        <affiliation>Urmia University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saleh Sadighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mir building, 55.3 Side alley, 55 Darya, Kelakaser, Amol</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4617139606</zip>
        <telephone>+98 11 4308 0317</telephone>
        <email>salehsadighi@gmail.com</email>
        <affiliation>Urmia University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Must have a definitive diagnosis of multiple sclerosis.
Must be at least 18 and at most 45 years old.
Have at least a diploma.
Damage in cognitive, behavioral and emotional symptoms examined in this research should be diagnosed by interview and test.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Receive other concurrent treatment.
The symptoms are due to drug use and bereavement.
Have a history of receiving similar interventions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Training in interpretation bias modification: In the present study, while providing necessary explanations to patients and ensuring the confidentiality of their information, patients are trained over 4 weeks with 2 individual sessions of 90 minutes each per week in the form of cognitive-behavioral therapy to identify their negative interpretations and then be able to reconstruct them into more logical interpretations. The term 'interpretation bias' in this research refers to individuals' tendency to interpret ambiguous and neutral events negatively and threateningly. This bias can manifest in various areas such as social relationships, health, and job performance. During therapy sessions, various cognitive-behavioral techniques are used, such as thought recording, Socratic questioning, identifying cognitive errors (especially errors related to interpretation), providing supporting and opposing evidence, creating alternative perspectives, and behavioral exercises.</i_keyword>
      <i_keyword>Acceptance and Commitment Therapy: In the present study, while providing the necessary explanations to the group members and ensuring the confidentiality of their information, patients are treated in a group setting and over 4 weeks, with 2 sessions per week lasting 90 minutes, under Acceptance and Commitment Therapy. The content of these sessions includes the 6 main components of the Acceptance and Commitment approach, along with the use of metaphors related to the sessions and practical exercises. During the sessions, various metaphors are used to facilitate understanding of Acceptance and Commitment approach concepts. For example, the metaphor of "quicksand" is used to show that trying to control unpleasant thoughts and feelings can lead to becoming more submerged in them, the metaphor of the "bus" is used to show that thoughts and feelings are the passengers on the bus and the individual is the driver and can choose their route, and the metaphor of "tug-of-war with a monster" is used to show that fighting unpleasant thoughts and feelings takes a lot of energy and it is better to drop the rope. During the sessions, the therapist plays the role of a facilitator and helps the members to identify their values, set committed goals, and face their unpleasant experiences with more acceptance and flexibility. The therapist also provides a safe and supportive environment so that members can share their experiences and support each other.</i_keyword>
      <i_keyword>Control group: In this study, no intervention is performed for the control group, and it is initially considered solely for measurement and observation purposes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive bias. Timepoint: Before the intervention, the last intervention session and 2 months after the last intervention session. Method of measurement: Cognitive bias questionnaire of Woody, Chambless and Glass.</prim_outcome>
      <prim_outcome>Profile of psychosis. Timepoint: Before the intervention, the last intervention session and 2 months after the last intervention session. Method of measurement: Depression, Anxiety, Stress Scale (DASS) Lavibond and Lavibond.</prim_outcome>
      <prim_outcome>Emotional information processing. Timepoint: Before the intervention, the last intervention session and 2 months after the last intervention session. Method of measurement: Emotional Information Processing Questionnaire Baker et al.'s.</prim_outcome>
      <prim_outcome>M.S self-efficacy. Timepoint: Before the intervention, the last intervention session and 2 months after the last intervention session. Method of measurement: Multiple Sclerosis Self-Efficacy Questionnaire (MSSS).</prim_outcome>
      <prim_outcome>Acceptance of illness. Timepoint: Before the intervention, the last intervention session and 2 months after the last intervention session. Method of measurement: Disease Acceptance Scale (ALS).</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>Urmia University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-18</approval_date>
        <contact_name>Research Ethical Committee of Urmia University</contact_name>
        <contact_address>University of Urmia, 11 km Sero Road, Azerbaijangharbi Province - Urmia urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
