<?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>IRCT20131128015577N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-19</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Evaluation of the protocol of ACT in patients with obssesion</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of the integrated protocol of the Acceptance and Commitment Therapy (ACT) for OCD and couple therapy in patients with Relationship Obsessive-Compulsive Disorder (ROCD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42982</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Design of integrated protocol of the Acceptance and Commitment Therapy (ACT) for OCD and couple therapy, Randomization description: Simple random method with the help of lottery, Blinding description: Participants were not aware of the types of interventions in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Relationship Obsessive Compulsive Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Integrated intervention of the Acceptance and Commitment Therapy (ACT) for OCD and couple therapy: This intervention consists of 20 sessions that summarize the sessions of this intervention as follows: Sessions 1-4: Two sessions of OCD therapy (assessment  of obssesion and introduction of treatment structure, creative frustration) and two sessions of couples therapy (assessment  of couples and introduction of couple therapy orientation of ACT). Sessions 5 and 6: One OCD therapy (keep up the creative frustration) and one couple therapy (constructive frustration); Sessions 7-9: Two OCD therapy (realizing control and acceptance, mindfulness) and one couple therapy (acceptance and mindfulness training); Sessions 10-13: Two sessions of OCD therapy (introducing  self as context and defusion) and two sessions of couple therapy (defusion and observation of thoughts); sessions 14-20: Three sessions of OCD therapy (focus on value and examine the barriers to value, committed action) and four sessions of couple therapy (focus on value and examine the barriers to value, committed action and self as context). Intervention 2: Intervention group: Couple therapy of ACT:The number of sessions of this intervention is 10. Summary of Acceptance and Commitment Therapy (ACT) sessions are as follows: Session 1: Getting to know couples and presenting orientation of ACT; Session 2: Individual assessment; Session 3: Creative frustration, reviewing options and what issues are controllable and uncontrollable; Session 4: Mindfulness and Acceptance Training; Session 5: Cognitive defusion, Examining the barriers to paying thoughts, tagging thoughts and moving away from thoughts; Session 6: Observing thoughts; Session 7: Choosing valuable orientations; Session 8: Exploring the barriers to a worthy life; Session 9: Describing yourself as a texture in communication; Session 10: Committed action, end of treatment and prevention of recurrence. Intervention 3: Intervention group: ACT for OCD: This intervention contains 10 sessions of Acceptance and Commitment Therapy (ACT) for OCD. At each meeting, the client's reactions to the previous meeting are first reviewed, a new issue raised, a new assignment determined, and a behavioral commitment agreed. At first, the type of therapeutic relationship is specified by metaphor of the "two mountains". Then, the treatment begins by gathering information about the obsessive thoughts and actions. The difference between obsessive thoughts and actions arises and shows how one happens without the other, but in the lives of their clients, they usually happen together. Then ask the clients what has been done so far to reduce obsessive thinking, what has been effective and what has not been effective. This shows that the only way to get rid of obsessive thinking is to do obsessive action, but it only works for a short period of time. The metaphor of "Obsessive Well" and "Monster Draw" was used to illustrate the ineffectiveness of one's attempts to control obsessive thinking. The function of these metaphors was to reduce the focus of the client on the decline of obsessive-compulsive thinking and to become aware of the difficulty of controlling it, which is called the Creative frustration in ACT. Sessions 3, 4, and 5 deal with how trying to control obsessive thinking rather than being the solution is the problem. The purpose of these sessions was to emphasize the limitations of control when internal events occure. Sessions 6, 7, and 8 focused on changing the psychological function of obsessive thinking from what is threatening to merely another verbal event. These sessions include training of defusion, communication with the present or mindfulness exercises and working on the self as a background. The last session (9 and 10) included discussions about the values of the client and increased behavioral commitments to pursue those values.</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:
The results of this research will be presented in paper form

When:
About a year

To whom:
Psychologists

Conditions:
Certain conditions are not considered

Where to obtain:
Soheila Ghomian

How to obtain:
It will be answered by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soheila Ghomian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 5080</telephone>
        <email>Soheila_Ghomian@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Ghomian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 5080</telephone>
        <email>Soheila_Ghomian@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being married (male or female)
Diagnosis of OCD
Diagnosis of ROCD (score above one standard deviation of the ROCI and PROCSI)
To lapse at least 6 months from marriage; consent to participate in the research and to sign a written consent</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Being treated for the past 6 months
History of substance abuse (due to interference with treatment sessions)
Diagnosis of psychiatric disorders other than obsessive spectrum disorders based on SCID-5-RV interview
Absence of the treatment in three consecutive sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Compulsion mixed with obsessional thoughts</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Integrated intervention of the Acceptance and Commitment Therapy (ACT) for OCD and couple therapy: This intervention consists of 20 sessions that summarize the sessions of this intervention as follows: Sessions 1-4: Two sessions of OCD therapy (assessment  of obssesion and introduction of treatment structure, creative frustration) and two sessions of couples therapy (assessment  of couples and introduction of couple therapy orientation of ACT). Sessions 5 and 6: One OCD therapy (keep up the creative frustration) and one couple therapy (constructive frustration); Sessions 7-9: Two OCD therapy (realizing control and acceptance, mindfulness) and one couple therapy (acceptance and mindfulness training); Sessions 10-13: Two sessions of OCD therapy (introducing  self as context and defusion) and two sessions of couple therapy (defusion and observation of thoughts); sessions 14-20: Three sessions of OCD therapy (focus on value and examine the barriers to value, committed action) and four sessions of couple therapy (focus on value and examine the barriers to value, committed action and self as context).</i_keyword>
      <i_keyword>Intervention group: Couple therapy of ACT:The number of sessions of this intervention is 10. Summary of Acceptance and Commitment Therapy (ACT) sessions are as follows: Session 1: Getting to know couples and presenting orientation of ACT; Session 2: Individual assessment; Session 3: Creative frustration, reviewing options and what issues are controllable and uncontrollable; Session 4: Mindfulness and Acceptance Training; Session 5: Cognitive defusion, Examining the barriers to paying thoughts, tagging thoughts and moving away from thoughts; Session 6: Observing thoughts; Session 7: Choosing valuable orientations; Session 8: Exploring the barriers to a worthy life; Session 9: Describing yourself as a texture in communication; Session 10: Committed action, end of treatment and prevention of recurrence.</i_keyword>
      <i_keyword>Intervention group: ACT for OCD: This intervention contains 10 sessions of Acceptance and Commitment Therapy (ACT) for OCD. At each meeting, the client's reactions to the previous meeting are first reviewed, a new issue raised, a new assignment determined, and a behavioral commitment agreed. At first, the type of therapeutic relationship is specified by metaphor of the "two mountains". Then, the treatment begins by gathering information about the obsessive thoughts and actions. The difference between obsessive thoughts and actions arises and shows how one happens without the other, but in the lives of their clients, they usually happen together. Then ask the clients what has been done so far to reduce obsessive thinking, what has been effective and what has not been effective. This shows that the only way to get rid of obsessive thinking is to do obsessive action, but it only works for a short period of time. The metaphor of "Obsessive Well" and "Monster Draw" was used to illustrate the ineffectiveness of one's attempts to control obsessive thinking. The function of these metaphors was to reduce the focus of the client on the decline of obsessive-compulsive thinking and to become aware of the difficulty of controlling it, which is called the Creative frustration in ACT. Sessions 3, 4, and 5 deal with how trying to control obsessive thinking rather than being the solution is the problem. The purpose of these sessions was to emphasize the limitations of control when internal events occure. Sessions 6, 7, and 8 focused on changing the psychological function of obsessive thinking from what is threatening to merely another verbal event. These sessions include training of defusion, communication with the present or mindfulness exercises and working on the self as a background. The last session (9 and 10) included discussions about the values of the client and increased behavioral commitments to pursue those values.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological Flexibility. Timepoint: Twice at baseline; three times during treatment; twice at follow-up (two weeks and four weeks after treatment). Method of measurement: Acceptance and Action Questionnaire II (AAQ-II).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Relationship Obsessive and Compulsive Disorder. Timepoint: Twice at baseline; three times during treatment; twice at follow-up (two weeks and four weeks after treatment). Method of measurement: Relationship Obsessive Compulsive Inventpry; Partner Related Obsessive Compulsive Symptom Inventory.</sec_outcome>
      <sec_outcome>Marital Satisfaction. Timepoint: Twice at baseline; three times during treatment; twice at follow-up (two weeks and four weeks after treatment). Method of measurement: Enrich Scale.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-03</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
