<?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>IRCT20160716028953N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-30</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Studying the effect of a short-term suicide prevention program on suicidal thoughts, reasons for living, coping styles, and help-seeking intention in women and men with a history of suicide attempt</public_title>
      <acronym></acronym>
      <scientific_title>Comprrison of Effectiveness of Attempted Suicide Short Intervention Program (ASSIP) on Suicidal Ideation, Reasons for Living, Coping Styles, Help Seeking Intention and Prevention of Suicide Attempt between Women and Men Suicide Attempters</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84937</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting 52 eligible participants, the allocation of individuals to 4 groups will be done by simple random method. The random sequence will be done by an independent person using a random number table ( SPSS/Random Allocation software). Then, based on this sequence, the participants will be equally placed into 4 groups (female experimental, female control, male experimental, male control) groups. To conceal allocation, the sequencing results will be placed in opaque, sealed envelopes and opened in the order in which participants arrive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>suicide attempt.</hc_freetext>
      <i_freetext>Intervention 1: 1. Women experimental Group (ASSIP): Female suicide attempters who receive the ASSIP intervention. ASSIP (Attempted Suicide Short Intervention Program) is an ultra-brief psychotherapy consisting of 3 to 4 weekly face-to-face sessions, each lasting 60 to 90 minutes, conducted over the course of approximately one month. The intervention follows a narrative-based therapeutic approach and is delivered by a trained clinician. Session 1 involves video or audio recording of the participant’s personal narrative, focusing on the background, crisis experience, and suicidal behavior. In Session 2, the participant and therapist review the recorded material together, engaging in a collaborative reflection and dual processing of the narrative to gain insight. Session 3 focuses on the development of an individualized safety plan, identifying personal warning signs and adaptive coping strategies, with the guidance of the therapist. Session 4 includes a review of key insights, consolidation of safety strategies and coping mechanisms, and preparation for ongoing support through continued therapeutic contact. Intervention 2: 2. Men experimental Group (ASSIP): Male suicide attempters who receive the ASSIP intervention. ASSIP (Attempted Suicide Short Intervention Program) is an ultra-brief psychotherapy consisting of 3 to 4 weekly face-to-face sessions, each lasting 60 to 90 minutes, conducted over the course of approximately one month. The intervention follows a narrative-based therapeutic approach and is delivered by a trained clinician. Session 1 involves video or audio recording of the participant’s personal narrative, focusing on the background, crisis experience, and suicidal behavior. In Session 2, the participant and therapist review the recorded material together, engaging in a collaborative reflection and dual processing of the narrative to gain insight. Session 3 focuses on the development of an individualized safety plan, identifying personal warning signs and adaptive coping strategies, with the guidance of the therapist. Session 4 includes a review of key insights, consolidation of safety strategies and coping mechanisms, and preparation for ongoing support through continued therapeutic contact. Intervention 3: 3- Women Control Group (TAU): Women in this group will receive the standard care typically provided for suicide attempters in the selected clinical setting. TAU may include psychiatric evaluation, pharmacotherapy, crisis intervention, or referral to outpatient mental health services, as deemed appropriate by clinical staff. No ASSIP sessions and other standard psychotherapies will be provided. Intervention 4: 4- Men Control Group (TAU): Men in this group will receive the standard care typically provided for suicide attempters in the selected clinical setting. TAU may include psychiatric evaluation, pharmacotherapy, crisis intervention, or referral to outpatient mental health services, as deemed appropriate by clinical staff. No ASSIP sessions and other standard psychotherapies will be provided.</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:
Yes – De-identified individual participant data (IPD), including demographic data, primary and secondary outcome measures, and relevant statistical data, will be shared upon reasonable request. Data will be available after publication of the main results. Researchers interested in accessing the data must submit a methodologically sound research proposal and obtain approval from the principal investigator. Data will be shared via secure electronic platforms while ensuring confidentiality.

When:
Access to de-identified participant data (including demographic information, primary and secondary outcomes, and relevant statistical data) will begin 6 months after publication of the main results and will remain available for a period of 5 years.

To whom:
Access will be granted to qualified researchers from academic institutions, research centers, and industry who submit a methodologically sound research proposal. All requests must be approved by the principal investigator.

Conditions:
The data and related documents may only be used for scientific and research purposes; any commercial or unauthorized use is strictly prohibited. Use of the data must align with an approved research proposal and comply with ethical research standards. Permitted analyses include secondary statistical analyses and meta-analyses that contribute to scientific knowledge. Applicants must submit a formal request including a methodologically sound research proposal, an official request letter, and a confidentiality agreement. All requests will be reviewed and approved by the principal investigator before data access is granted.

Where to obtain:
Requests for data or documents should be directed to the Principal Investigator. Email is the preferred method of contact. 
Contact information is as follows: Abdolazim Shahroie 
azim.shahroiee@yahoo.com

How to obtain:
Requests for data or documents follow a structured process as outlined below:
1. Submit a formal request via email to the Principal Investigator, including:
A methodologically sound research proposal; 
An official request letter; A signed confidentiality agreement.
2. Review of the request by the research team for scientific, ethical, and technical suitability (within 2 to 4 weeks).
3. Notification of decision and, if approved, preparation of a Data Access Agreement.
4. Transfer of approved data/documents via secure and encrypted platforms after signing the agreement. 
In total, depending on the completeness of the submitted documents, the process typically takes 3 to 6 weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abdolazim Shahroie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Ahvaz, Shahrak Bargh, Manazele Shahrdari, Street 10, appartment 11, Unit 1</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6137896473</zip>
        <telephone>‎+‎986132234716</telephone>
        <email>azim.shahroiee@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abdolazim Shahroie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Ahvaz, Bargh Town, Manazel Shahrdari, 10th Street, Block 11, Unit 1</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6137896473</zip>
        <telephone>+‎986132234716</telephone>
        <email>azim.shahroiee@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>
    </countries>
    <criteria>
      <inclusion_criteria>Having a history of at least one suicide attempt during the last four months
Age range between 20-40 years
Being literate (at least completed second grade of primary school and able to read and write)
Signing the informed consent form
No serious medical or psychiatric conditions requiring special treatment (NO current substance or alcohol dependence, No current schizophrenia or psychotic disorders)
No diagnosis of personality disorders</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a psychotic disorder
Having a serious personality disorder
Active drug/alcohol use or dependence disorders
Inability to understand and comprehend questionnaires (insufficient literacy or serious cognitive problems)
Language problem (inability to speak or understand Persian)
Undergoing other regular psychotherapy at the same time
Acute medical or psychiatric condition that prevents attendance at sessions
Failure to complete a consent form to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T14.91</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Suicide attempt</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1. Women experimental Group (ASSIP): Female suicide attempters who receive the ASSIP intervention. ASSIP (Attempted Suicide Short Intervention Program) is an ultra-brief psychotherapy consisting of 3 to 4 weekly face-to-face sessions, each lasting 60 to 90 minutes, conducted over the course of approximately one month. The intervention follows a narrative-based therapeutic approach and is delivered by a trained clinician. Session 1 involves video or audio recording of the participant’s personal narrative, focusing on the background, crisis experience, and suicidal behavior. In Session 2, the participant and therapist review the recorded material together, engaging in a collaborative reflection and dual processing of the narrative to gain insight. Session 3 focuses on the development of an individualized safety plan, identifying personal warning signs and adaptive coping strategies, with the guidance of the therapist. Session 4 includes a review of key insights, consolidation of safety strategies and coping mechanisms, and preparation for ongoing support through continued therapeutic contact.</i_keyword>
      <i_keyword>2. Men experimental Group (ASSIP): Male suicide attempters who receive the ASSIP intervention. ASSIP (Attempted Suicide Short Intervention Program) is an ultra-brief psychotherapy consisting of 3 to 4 weekly face-to-face sessions, each lasting 60 to 90 minutes, conducted over the course of approximately one month. The intervention follows a narrative-based therapeutic approach and is delivered by a trained clinician. Session 1 involves video or audio recording of the participant’s personal narrative, focusing on the background, crisis experience, and suicidal behavior. In Session 2, the participant and therapist review the recorded material together, engaging in a collaborative reflection and dual processing of the narrative to gain insight. Session 3 focuses on the development of an individualized safety plan, identifying personal warning signs and adaptive coping strategies, with the guidance of the therapist. Session 4 includes a review of key insights, consolidation of safety strategies and coping mechanisms, and preparation for ongoing support through continued therapeutic contact.</i_keyword>
      <i_keyword>3- Women Control Group (TAU): Women in this group will receive the standard care typically provided for suicide attempters in the selected clinical setting. TAU may include psychiatric evaluation, pharmacotherapy, crisis intervention, or referral to outpatient mental health services, as deemed appropriate by clinical staff. No ASSIP sessions and other standard psychotherapies will be provided.</i_keyword>
      <i_keyword>4- Men Control Group (TAU): Men in this group will receive the standard care typically provided for suicide attempters in the selected clinical setting. TAU may include psychiatric evaluation, pharmacotherapy, crisis intervention, or referral to outpatient mental health services, as deemed appropriate by clinical staff. No ASSIP sessions and other standard psychotherapies will be provided.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Suicide ideation: Suicidal ideation or thoughts are defined as thinking about, considering, or planning to commit suicide (Klonsky et al., 2016). Timepoint: 1- Pre-test (before intervention/without intervention); 2- Post-test (after intervention and 1 month after pre-test); 3- First follow-up (1 week after post-test); 4- Second follow-up (2 weeks after post-test); 5- Third follow-up (4 weeks after post-test); 6- Fourth follow-up (8 weeks after post-test); 7- Fifth follow-up (12 weeks after post-test). Method of measurement: Beck Scale for Suicide Ideation (BSSI) - Beck.</prim_outcome>
      <prim_outcome>Reasons for living: Reasons for living (RFL) are beliefs or expectations that are thought to reduce the risk of suicide and include survival and coping beliefs, responsibility to family, concerns about children, fear of suicide, fear of social disapproval, and moral objections (Linehan et al., 1983). Timepoint: 1- Pre-test (before intervention/without intervention); 2- Post-test (after intervention and 1 month after pre-test); 3- First follow-up (1 week after post-test); 4- Second follow-up (2 weeks after post-test); 5- Third follow-up (4 weeks after post-test); 6- Fourth follow-up (8 weeks after post-test); 7- Fifth follow-up (12 weeks after post-test). Method of measurement: Reasons for Living Scale (RFL) - Linehan.</prim_outcome>
      <prim_outcome>Coping styles: A coping style or strategy is an action, set of actions, or thought process used to deal with a stressful or unpleasant situation or to modify a person's response to such a situation. Unlike defense mechanisms, coping strategies usually involve a conscious and direct approach to problems (Dictionary of the American Psychological Association 2023). Timepoint: 1- Pre-test (before intervention/without intervention); 2- Post-test (after intervention and 1 month after pre-test); 3- First follow-up (1 week after post-test); 4- Second follow-up (2 weeks after post-test); 5- Third follow-up (4 weeks after post-test); 6- Fourth follow-up (8 weeks after post-test); 7- Fifth follow-up (12 weeks after post-test). Method of measurement: Coping Inventory for Stressful Situation (CISS) - Endler &amp; Parker.</prim_outcome>
      <prim_outcome>Help seeking intention: Help-seeking intention is defined as an individual's subjective possibility of seeking help (Wei, 2017). Timepoint: 1- Pre-test (before intervention/without intervention); 2- Post-test (after intervention and 1 month after pre-test); 3- First follow-up (1 week after post-test); 4- Second follow-up (2 weeks after post-test); 5- Third follow-up (4 weeks after post-test); 6- Fourth follow-up (8 weeks after post-test); 7- Fifth follow-up (12 weeks after post-test). Method of measurement: General Help Seeking Questionnaire (GHSQ) - Wilson et al.</prim_outcome>
      <prim_outcome>Prevention of suicide attempt: Suicide prevention is a set of efforts to reduce the risk of suicide (Centers for Disease Control, 2019). Timepoint: 1- Pre-test (before intervention/without intervention); 2- Post-test (after intervention and 1 month after pre-test); 3- First follow-up (1 week after post-test); 4- Second follow-up (2 weeks after post-test); 5- Third follow-up (4 weeks after post-test); 6- Fourth follow-up (8 weeks after post-test); 7- Fifth follow-up (12 weeks after post-test). Method of measurement: Inperson/Telephone Interview; Suicide Status Form (SSF-3) - Jobes.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-14</approval_date>
        <contact_name>Ethics Committee of Faculty of Medicine-Shahed University</contact_name>
        <contact_address>Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran Tehran Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
