<?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>IRCT20230909059381N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-23</date_registration>
      <primary_sponsor>University of Sahiwal</primary_sponsor>
      <public_title>Effectiveness of CBT and Twelve steps program on alcohol</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of cognitive behavior therapy (CBT) and Twelve steps program on alcohol consumption</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72560</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: quasi experiment design, Randomization description: Participants randomly divide into two groups through the www.random org. com website in which 10 Adults will be in the experimental group and 10 Adults will be in the control group for this study. The control group may receive standard care, other group will waiting the intervention of experimental group. There will be 20 participants in the groups, Blinding description: The data analysts responsible for conducting statistical analyses and interpreting study outcomes will be kept unaware of the group assignments of participants. other hand outcome assessors, responsible for conducting interviews, assessments, and collecting data related to study outcomes, will also be blinded to participant group assignments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Alcohol.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group name: Experimental group, In the starting conduct pre-assessment: scale (ADS) administered that measure the severity of alcohol consumption to gather baseline data on alcohol consumption.after that the conduct cognitive behavior therapy (CBT). These sessions of CBT will focus on helping them recognize and challenge cognitive distortions related to alcohol use, manage triggers and cravings, Along with restructuring their thinking. CBT sessions will be conduct 8 weeks, The frequency of sessions will be once a week. and each session will be approximately 40 to 60 minutes. It will be typically conducted through one-on-one session. Purpose of CBT intervention to reduce the alcohol consumption. .Participants in the experimental group will engage in the Twelve Steps program as part of their intervention. This will involve attending Twelve Steps meetings.participants will be attend two meetings per week. post-assessment (ADS) scale after the intervention to evaluate changes in severity of alcohol consumption. Intervention 2: Control group: Participants in the control group will undergo the same baseline assessment as the experimental group. This assessment will include the measurement of the severity of alcohol consumption using the Alcohol Dependence Scale (ADS).control group will not receiving the specific CBT and Twelve Steps program interventions, Just conduct Support Group Meetings  related to alcohol abuse, recovery, and coping. related topics will include triggers, cravings, stress management, and personal goals for reducing alcohol consumption. these meeting will be held 8 weeks, each meeting time will be 30 to 50 minutes.The frequency of sessions will be once a week. than conduct a post-intervention assessment for the control group. This assessment will be include the same measures and assessments used at the baseline to track changes in alcohol consumption. After the intervention comparison of both group to check the effective in reducing alcohol consumption among participants in the experimental group as compared to those in the control group.</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:
Study on Alcohol Abusers

When:
This process time will be 15-09-2023 to 15-10-2023

To whom:
Data and documents related to research participants will be handled with strict confidentiality and privacy protections. Access to these data/documents should be limited to individuals who have been authorized and trained to handle sensitive information in accordance with ethical and legal guidelines.

Conditions:
Intervention plan will be provided

Where to obtain:
amirhayatkallu02@gamil.com

How to obtain:
in the starting baseline assessment of both group than treatment will give to the experimental group and control group will be waiting than the check severity level after the intervention, 
the hypothesis present study is, CBT and Twelve steps program effectively reduce alcohol consumption of experimental group as compare to control group.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aamir Hayat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shakkar wala Tehsil Mankera Distt Bhakkar</address>
        <city>Bhakkar</city>
        <country1>Pakistan</country1>
        <zip>30001</zip>
        <telephone>+92 341 1363863</telephone>
        <email>amirhayatkallu02@gmail.com</email>
        <affiliation>University of Sahiwar</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aamir Hayat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shakkar wala Tehsil Mankkera Distt Bhakkar</address>
        <city>Bhakkar</city>
        <country1>Pakistan</country1>
        <zip>Punjab</zip>
        <telephone>+92 341 1363863</telephone>
        <email>amirhayatkallu02@gmail.com</email>
        <affiliation>University of Sahiwar</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male gender will become the part of present study,
The age range will be chose 18 years and above
Each individual in the sample will exhibits a moderate level of alcohol abuse or dependence, as assessed by the Alcohol Dependence Scale (ADS) during the baseline assessment.
The individuals are using the alcohol less than 5 years, they have included in our study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Females will not include in our study
Individuals with a current diagnosis of severe alcohol dependence, as their treatment needs may require a different level of care. they will not included in present study.
The individuals are using the alcohol more than 5 years they have not include in our study.
Individuals who are currently enrolled in another formal alcohol treatment program or receiving concurrent medicine for alcohol-related issues. They will be not participate of present study.
Individuals with a history of severe mental health disorders (e.g., schizophrenia, bipolar disorder, Major depression) that may significantly impact their ability to participate in the interventions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F10.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alcohol abuse</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group name: Experimental group, In the starting conduct pre-assessment: scale (ADS) administered that measure the severity of alcohol consumption to gather baseline data on alcohol consumption.after that the conduct cognitive behavior therapy (CBT). These sessions of CBT will focus on helping them recognize and challenge cognitive distortions related to alcohol use, manage triggers and cravings, Along with restructuring their thinking. CBT sessions will be conduct 8 weeks, The frequency of sessions will be once a week. and each session will be approximately 40 to 60 minutes. It will be typically conducted through one-on-one session. Purpose of CBT intervention to reduce the alcohol consumption. .Participants in the experimental group will engage in the Twelve Steps program as part of their intervention. This will involve attending Twelve Steps meetings.participants will be attend two meetings per week. post-assessment (ADS) scale after the intervention to evaluate changes in severity of alcohol consumption.</i_keyword>
      <i_keyword>Control group: Participants in the control group will undergo the same baseline assessment as the experimental group. This assessment will include the measurement of the severity of alcohol consumption using the Alcohol Dependence Scale (ADS).control group will not receiving the specific CBT and Twelve Steps program interventions, Just conduct Support Group Meetings  related to alcohol abuse, recovery, and coping. related topics will include triggers, cravings, stress management, and personal goals for reducing alcohol consumption. these meeting will be held 8 weeks, each meeting time will be 30 to 50 minutes.The frequency of sessions will be once a week. than conduct a post-intervention assessment for the control group. This assessment will be include the same measures and assessments used at the baseline to track changes in alcohol consumption. After the intervention comparison of both group to check the effective in reducing alcohol consumption among participants in the experimental group as compared to those in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of Alcohol consumption. Timepoint: The primary outcome will be measured after 8 weeks of intervention. Method of measurement: Alcohol dependence scale (ADS) to measure severity of alcohol.</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>university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-22</approval_date>
        <contact_name>University of Sahiwal</contact_name>
        <contact_address>Fareed town sahiwal Sahiwal Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
