<?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>IRCT20130904014564N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-31</date_registration>
      <primary_sponsor>Vice-chancellor for Research and Technology, Kharazmi University</primary_sponsor>
      <public_title>Effectiveness Meta-Inner Humor Therapy (MIHT) in Obsessive Compulsive ‎Disorder</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness and Mechanisms of Action of Meta-Inner Humor Therapy (MIHT) in Obsessive Compulsive ‎Disorder: Evidence from Ecological Momentary Assessment and Multilevel Network Modeling</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90392</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Obsessive Compulsive Disorder.</hc_freetext>
      <i_freetext>Intervention group: Meta-Inner Humor Therapy (MIHT): This treatment is a structured ten-session intervention ‎based on active mindfulness that uses humor as a metacognitive tool to revise the individual’s relationship with ‎thoughts and emotions (Akbari et al., 2026). MIHT unfolds across three therapeutic phases, as described below. ‎Phase 1: awareness and pattern recognition (sessions 1–3): This phase embodies self-criticism, RNT, and cognitive ‎rigidity and begins by framing negative thoughts as a universal human experience. Participants learn to notice ‎typical tone, triggers, and repetitive narra­tives of negative thoughts without judgment. To make the negative ‎in­ternal voice, or Inner Fool, more recognizable, a simple, gloomy character—such as a Glum-like figure or other ‎culturally familiar example like Eeyore—is used as a metaphor. For example, instead of automatically accepting a ‎thought like “I’m incompetent” or “If I speak, everyone will notice my anxiety,” participants visualize The Inner ‎Fool saying it aloud, exaggerating the certainty and gloom of the thought. By externalizing it in this way, the ‎thought can be clearly recognized as a thought, not an objective fact. This allows clients to give distinct persona to ‎their negative thinking and helps them conceptualize thoughts as mental events rather than objective reality, ‎reducing emotional intensity and fostering cognitive distancing. The exercise turns RNT into some­thing ‎observable, approachable, and open to compassionate engagement. Phase 2: playful reframing (sessions 4–7): In ‎this phase, clients develop an Inner Humorous character—often a familiar, playful figure such as a cartoon or ‎culturally known charac­ter—to counter the rigid, gloomy tone of the Inner Fool. Importantly, playful reframing ‎in MIHT does not involve replacing a negative thought with a more rational statement, as in traditional cognitive ‎restructuring. Instead, the intervention invites clients to relate to the thought with humor and lightness, often by ‎exaggerating, personifying, or gently parodying the thought pattern. This approach aims to reduce cognitive fusion ‎and rigidity while maintaining awareness of the emotional experience. The goal is not to argue with negative ‎thoughts but to mock the entire persona of the Inner Fool in a light, non-hostile way. By using humor rather than ‎logic, clients gain cognitive distance from RNT and cultivate a flexible, resilient stance toward distressing ‎thoughts. Instead of responding rationally to statements like “You’re incompetent,” the Inner Humorous playfully ‎exaggerates and teases the Inner Fool, turning its certainty into something predictable and harmless. Playful ‎reframing helps clients observe RNT with curiosity and levity, reducing its power and laying the groundwork for a ‎wiser, more compassionate inner dia­logue. For example, if the Inner Fool says, “You’re incompetent,” the Inner ‎Humorous does not respond logically (“No, I am competent because I did X task well”). Phase 3: integration and ‎application (Sessions 8–10): In this phase, clients learn to cultivate two complementary inner capacities, The ‎Inner Nurturer and the Inner Humorous, which together form the balanced voice of the Inner Wise, or the ‎integration of humor and compassion. While the Inner Humorous playfully disrupts RNT, the Inner Nurturer ‎responds to difficult emotions—fear, sadness, or frus­tration—with warmth, validation, and gentle reassurance. ‎Clients ima­gine the Inner Nurturer as a caring friend, parent, or compassionate figure who helps regulate ‎emotional distress. Through guided examples, clients practice shifting between these inner voices depending on ‎what the moment requires. Over time, clients learn to alternate or integrate these voices fluidly, enabling them to ‎neutralize negative thoughts, calm emotional intensity, and restore psychological balance. This phase em­phasizes ‎flexibility. Sometimes humor is enough, sometimes compassion is needed, and sometimes the integrated Inner ‎Wise leads both. Here is a brief example of the conversion between different mindsets when the client comes up ‎with a thought that begins with the Inner Fool..</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:
Information on the main outcome of the research will be shared.

When:
Access begins 6 months after results are published.

To whom:
Data and other scientific documentation can be made available to any person who requests it.

Conditions:
There are no specific restrictions.

Where to obtain:
To access the data, you can send a message to Dr.Mehdi Akbari's email address: Akbari.psy@gmail.com or m.akbari@khu.ac.ir

How to obtain:
One month after the requester sends a message to one of the two emails mentioned in the previous section, individuals can receive the requested information.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.43, South Mofateh St, Kharazmi University, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15719-14911</zip>
        <telephone>+98 21 8832 9220</telephone>
        <email>m.akbari@khu.ac.ir</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.43, South Mofateh St, Kharazmi University, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15719-14911</zip>
        <telephone>+98 21 6655 2336</telephone>
        <email>m.akbari@khu.ac.ir</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A primary diagnosis of OCD based on DSM-5
Age between 18 and 70 years
Full proficiency in the Persian language
The ability and willingness to complete smartphone-based EMA prompts multiple times daily throughout the study period
Participants receiving psychiatric medication are eligible provided that their medication regimen has remained stable for at least four weeks prior to the baseline assessment</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Receiving concurrent psychological treatment
Any past or present Bipolar or Schizophrenia disorders
Acute suicidal ideation or recent attempts
Substance use disorder within the past three months
Cluster A or B personality disorders
Physical conditions that could interfere with participation in MIHT exercises (e.g., uncontrolled neurological or cardiovascular diseases)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obsessive-compulsive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Meta-Inner Humor Therapy (MIHT): This treatment is a structured ten-session intervention ‎based on active mindfulness that uses humor as a metacognitive tool to revise the individual’s relationship with ‎thoughts and emotions (Akbari et al., 2026). MIHT unfolds across three therapeutic phases, as described below. ‎Phase 1: awareness and pattern recognition (sessions 1–3): This phase embodies self-criticism, RNT, and cognitive ‎rigidity and begins by framing negative thoughts as a universal human experience. Participants learn to notice ‎typical tone, triggers, and repetitive narra­tives of negative thoughts without judgment. To make the negative ‎in­ternal voice, or Inner Fool, more recognizable, a simple, gloomy character—such as a Glum-like figure or other ‎culturally familiar example like Eeyore—is used as a metaphor. For example, instead of automatically accepting a ‎thought like “I’m incompetent” or “If I speak, everyone will notice my anxiety,” participants visualize The Inner ‎Fool saying it aloud, exaggerating the certainty and gloom of the thought. By externalizing it in this way, the ‎thought can be clearly recognized as a thought, not an objective fact. This allows clients to give distinct persona to ‎their negative thinking and helps them conceptualize thoughts as mental events rather than objective reality, ‎reducing emotional intensity and fostering cognitive distancing. The exercise turns RNT into some­thing ‎observable, approachable, and open to compassionate engagement. Phase 2: playful reframing (sessions 4–7): In ‎this phase, clients develop an Inner Humorous character—often a familiar, playful figure such as a cartoon or ‎culturally known charac­ter—to counter the rigid, gloomy tone of the Inner Fool. Importantly, playful reframing ‎in MIHT does not involve replacing a negative thought with a more rational statement, as in traditional cognitive ‎restructuring. Instead, the intervention invites clients to relate to the thought with humor and lightness, often by ‎exaggerating, personifying, or gently parodying the thought pattern. This approach aims to reduce cognitive fusion ‎and rigidity while maintaining awareness of the emotional experience. The goal is not to argue with negative ‎thoughts but to mock the entire persona of the Inner Fool in a light, non-hostile way. By using humor rather than ‎logic, clients gain cognitive distance from RNT and cultivate a flexible, resilient stance toward distressing ‎thoughts. Instead of responding rationally to statements like “You’re incompetent,” the Inner Humorous playfully ‎exaggerates and teases the Inner Fool, turning its certainty into something predictable and harmless. Playful ‎reframing helps clients observe RNT with curiosity and levity, reducing its power and laying the groundwork for a ‎wiser, more compassionate inner dia­logue. For example, if the Inner Fool says, “You’re incompetent,” the Inner ‎Humorous does not respond logically (“No, I am competent because I did X task well”). Phase 3: integration and ‎application (Sessions 8–10): In this phase, clients learn to cultivate two complementary inner capacities, The ‎Inner Nurturer and the Inner Humorous, which together form the balanced voice of the Inner Wise, or the ‎integration of humor and compassion. While the Inner Humorous playfully disrupts RNT, the Inner Nurturer ‎responds to difficult emotions—fear, sadness, or frus­tration—with warmth, validation, and gentle reassurance. ‎Clients ima­gine the Inner Nurturer as a caring friend, parent, or compassionate figure who helps regulate ‎emotional distress. Through guided examples, clients practice shifting between these inner voices depending on ‎what the moment requires. Over time, clients learn to alternate or integrate these voices fluidly, enabling them to ‎neutralize negative thoughts, calm emotional intensity, and restore psychological balance. This phase em­phasizes ‎flexibility. Sometimes humor is enough, sometimes compassion is needed, and sometimes the integrated Inner ‎Wise leads both. Here is a brief example of the conversion between different mindsets when the client comes up ‎with a thought that begins with the Inner Fool.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Obsessive compulsive symptoms. Timepoint: Pre-treatment (baseline) and post-treatment (end of week9). Method of measurement: Yale Brown Obsessive-Compulsive Scale (Y-BOCS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Momentary severity of the participant’s current obsession, assessed daily via an Ecological Momentary Assessment (EMA) protocol. Timepoint: Four times daily, for 14 days prior to the intervention (baseline) and 14 days following the intervention (follow-up). Method of measurement: This variable is assessed using a single-item 0–10 numeric rating scale. The item is: “How intense is this obsession right now?” with 0 indicating “not at all” and 10 indicating “very much.”.</sec_outcome>
      <sec_outcome>Momentary believability or perceived realism of the current obsession, assessed daily via an Ecological Momentary Assessment (EMA) protocol. Timepoint: Four times daily, for 14 days prior to the intervention and 14 days following the intervention. Method of measurement: This variable is measured using a single-item 0–10 numeric rating scale. The item is: “How real or believable does this obsession feel right now?” Higher scores indicate greater believability of the obsession.</sec_outcome>
      <sec_outcome>Momentary urge to perform a compulsion related to the current obsession. Timepoint: Four times daily, for 14 days prior to the intervention (baseline) and 14 days following the intervention (follow-up). Method of measurement: This variable is assessed using a single-item 0–10 numeric rating scale. The item is: “Because of this obsession, how strongly do you feel the need to perform a compulsion right now?” Higher scores indicate a stronger compulsive urge.</sec_outcome>
      <sec_outcome>Expected distress when resisting responding to the current obsession. Timepoint: Four times daily, for 14 days prior to the intervention (baseline) and 14 days following the intervention (follow-up). Method of measurement: This variable is measured using a single-item 0–10 numeric rating scale. The item is: “If you tried not to respond to this obsession right now, how distressed would you feel?” Higher scores indicate greater distress during resistance.</sec_outcome>
      <sec_outcome>Momentary change in the participant’s urge or perspective toward the obsession following the delivery of a humorous defusion-based audiovisual educational content. Timepoint: Four times daily, for 14 days prior to the intervention (baseline) and 14 days following the intervention (follow-up). Method of measurement: How much did this humorous defusion-based audiovisual educational content change your urge or perspective toward this obsession right now on a 0 to 10 numeric scale?” Higher scores indicate a greater change in the individual’s cognitive-emotional experience in relation to the obsession.</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>Vice-chancellor for Research and Technology, Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-05-13</approval_date>
        <contact_name>Ethics committee of Kharazmi University</contact_name>
        <contact_address>No.43, South Mofateh St, Kharazmi University, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
