<?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>IRCT20230806059054N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-12</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acceptance and commitment group therapy on chronic musculoskeletal pain</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of group therapy based on acceptance and commitment compared to critical thinking skills on improving pain self-efficacy, psychological distress, difficulty in regulating excitement and quality of life of people with chronic musculoskeletal pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72217</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The people who meet the entry criteria are randomly assigned and using the randomization internet site in psychological experiments, medical trials and field studies at www.randomization.com , online in two treatment groups based on Acceptance and commitment (ACT) and control group are included.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Musculoskeletal Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Treatment based on acceptance and commitment is one of the third wave psychological approaches that seeks comprehensive awareness and education to patients in the field of controlling the controllable aspects, acceptance and openness to the uncontrollable aspects of the disease, that is, the person without trying to controlling the thoughts related to the disease allows them to be present in the mind. It has six central processes, which are acceptance, disfusion, self as background, present time, values and committed action, the goal of which is psychological flexibility. The participants based on Hayes and Strosahl's acceptance and commitment group treatment protocol in 8 sessions. They will participate in 1.5 hour group therapy weekly. Content of the sessions: First session: presenting the basic concepts of treatment; Familiarizing people with the subject of research; Examining chronic pain in each member of the group and the measures taken; discussion about experiential avoidance and the creation of creative helplessness; Explaining the importance of homework. The second session: regaining the relationship with values (what values are important to them), examining the actions they want to take in the rest of their lives to discover values; How well controlling pain is consistent with their values; Are there other options for living with pain and discomfort? Initial practice of mindfulness (eating raisins) and presenting homework (eating food consciously even in pain). The third session: - Assignment review; awareness of inner experiences; A thought about the door is just a thought; having a thought against the contents of a thought; distancing from self-conceptualized harm; living with chronic pain and discomfort; Practicing body inspection and offering meditation at home (paying attention to the body parts while sleeping, even in the presence of pain). Fourth session: - Review homework at home, mindfulness and conscious breathing practice; Being in the present moment and exercises; Non-judgment of thoughts and feelings about chronic pain and only observing them; Examining the existing obstacles on the way of values; Providing homework at home (paying attention to breathing while sleeping). The fifth session: - review of the previous session, homework and expressing the experiences of the homework about conscious breathing; What goals in your life are in line with the values that chronic pain does not allow you to move towards? moving step by step towards the goal; practicing mindfulness of conscious movement; Providing homework at home (consciously lying down and paying attention to the rise and fall of the abdomen during sleep). The sixth session: - Reviewing homework at home; What measures have you taken to achieve your values and goals? planning to achieve the goal with committed action; Providing homework at home. Seventh session: Having awareness in life and daily activities (informal exercises); Having a beginner's mind and familiarity with language barriers and the metaphor of the lion, giving homework at home. Eighth session: review of past sessions, the importance of consistency in doing exercises; The importance of just observing thoughts; The importance of having commitment in achieving values even in spite of pain and life goals. Intervention 2: Control group: Critical thinking skill training is conducted based on the Hyper protocol in six sessions: First session: Analysis of topics and experiences. The second session: the concept of interpretation, interpretation of experiences and renewal of views. The third session: The role of evaluation in the development of thinking. The fourth session: exchange of code signs to speech signs. The fifth session: Drawing the concept in the form of a whole, explaining the appropriate introduction of the skill of explanation for the material, speaking and its principles. The sixth session: Understanding and recognizing one's own mental abilities, the role of self-management skill attitude in self-confidence.</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:
All data related to participants can be shared after being anonymized.

When:
Access starts 6 months after results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
By sending your request, the researcher's email will be allowed to be used

Where to obtain:
Send an email to researcher Zahra Ajdani to the address: 
Ajdani-z@Kaums.ac.ir
Call the researcher's mobile number: 09039274424
Visit in person to Kashan University of Medical Sciences - Doctor Blvd - Qutb Ravandi Blvd - Kashan

How to obtain:
2 working days after sending an email or contacting the researcher or visiting in person, the data file will be provided to the applicant

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Hamid Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctor's Blvd - Qutb Ravandi Blvd - Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 31 5510 9999</telephone>
        <email>amiri.kaums@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Hamid Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pezeshk Blvd; Qutb Ravandi Blvd - Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 31 5510 9999</telephone>
        <email>amiri.kaums@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a diagnosis of chronic pain by a specialzed doctor in physical medicine and rehabilitation
Age range from 35 to 65 years
Having a minimum level of literacy</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of motivation and satisfaction to participate in the research
Infectious diseases such as Malt fever

Having a mental disorder that requires immediate treatment, such as drug and alcohol use disorder and psychotic disorders
Intense thoughts about self-harm or suicide
Concurrently participating in another treatment program
receiving drug treatment related to the disorder, at least one month before the pre-test phase until the end of the follow-up phase
Receiving psychological interventions during the last year</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other chronic pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Treatment based on acceptance and commitment is one of the third wave psychological approaches that seeks comprehensive awareness and education to patients in the field of controlling the controllable aspects, acceptance and openness to the uncontrollable aspects of the disease, that is, the person without trying to controlling the thoughts related to the disease allows them to be present in the mind. It has six central processes, which are acceptance, disfusion, self as background, present time, values and committed action, the goal of which is psychological flexibility. The participants based on Hayes and Strosahl's acceptance and commitment group treatment protocol in 8 sessions. They will participate in 1.5 hour group therapy weekly. Content of the sessions: First session: presenting the basic concepts of treatment; Familiarizing people with the subject of research; Examining chronic pain in each member of the group and the measures taken; discussion about experiential avoidance and the creation of creative helplessness; Explaining the importance of homework. The second session: regaining the relationship with values (what values are important to them), examining the actions they want to take in the rest of their lives to discover values; How well controlling pain is consistent with their values; Are there other options for living with pain and discomfort? Initial practice of mindfulness (eating raisins) and presenting homework (eating food consciously even in pain). The third session: - Assignment review; awareness of inner experiences; A thought about the door is just a thought; having a thought against the contents of a thought; distancing from self-conceptualized harm; living with chronic pain and discomfort; Practicing body inspection and offering meditation at home (paying attention to the body parts while sleeping, even in the presence of pain). Fourth session: - Review homework at home, mindfulness and conscious breathing practice; Being in the present moment and exercises; Non-judgment of thoughts and feelings about chronic pain and only observing them; Examining the existing obstacles on the way of values; Providing homework at home (paying attention to breathing while sleeping). The fifth session: - review of the previous session, homework and expressing the experiences of the homework about conscious breathing; What goals in your life are in line with the values that chronic pain does not allow you to move towards? moving step by step towards the goal; practicing mindfulness of conscious movement; Providing homework at home (consciously lying down and paying attention to the rise and fall of the abdomen during sleep). The sixth session: - Reviewing homework at home; What measures have you taken to achieve your values and goals? planning to achieve the goal with committed action; Providing homework at home. Seventh session: Having awareness in life and daily activities (informal exercises); Having a beginner's mind and familiarity with language barriers and the metaphor of the lion, giving homework at home. Eighth session: review of past sessions, the importance of consistency in doing exercises; The importance of just observing thoughts; The importance of having commitment in achieving values even in spite of pain and life goals.</i_keyword>
      <i_keyword>Control group: Critical thinking skill training is conducted based on the Hyper protocol in six sessions: First session: Analysis of topics and experiences. The second session: the concept of interpretation, interpretation of experiences and renewal of views. The third session: The role of evaluation in the development of thinking. The fourth session: exchange of code signs to speech signs. The fifth session: Drawing the concept in the form of a whole, explaining the appropriate introduction of the skill of explanation for the material, speaking and its principles. The sixth session: Understanding and recognizing one's own mental abilities, the role of self-management skill attitude in self-confidence.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain self-efficacy score. Timepoint: Before the intervention, after the intervention, in the follow-up phase. Method of measurement: PSEQ.</prim_outcome>
      <prim_outcome>DASS-21 questionnaire score. Timepoint: Before the intervention, after the intervention, in the follow-up phase. Method of measurement: DASS-21 questionnaire.</prim_outcome>
      <prim_outcome>DERS score. Timepoint: Before the intervention, after the intervention, in the follow-up phase. Method of measurement: DERS questionnaire.</prim_outcome>
      <prim_outcome>WHOQOL-BREF score. Timepoint: Before the intervention, after the intervention, in the follow-up phase. Method of measurement: WHOQOL-BREF questionnaire.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-08</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Kashan - Qutb Ravandi Boulevard - Doctor's Boulevard kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
