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Inpatient Alcohol Detox & Psychotherapy

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Detoxification & psychotherapeutic support
Sponsored by
Tribhuvan University, Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed as ADS according to ICD 10

Exclusion Criteria:

  • Major Psychiatric or medical comorbidity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Behavioral, detoxificaiton & psychotherapy

    Arm Description

    Providing treatment as usual (detoxificaion) & psychotherapy

    Outcomes

    Primary Outcome Measures

    Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form
    The questionnaire is 19 item self-report questionnaire assessing client readiness for change. There are three sub scales: Recognition, Ambivalence, and Taking Steps. Higher scores indicate greater recognition, ambivalence and taking steps. Scores range from 7 to 35, 4 to 20, and 8-40, respectively.
    Percentage of participants staying abstinent
    Percentage of participants not taking single drink or staying complete abstinent

    Secondary Outcome Measures

    Full Information

    First Posted
    June 13, 2019
    Last Updated
    June 14, 2019
    Sponsor
    Tribhuvan University, Nepal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03988478
    Brief Title
    Inpatient Alcohol Detox & Psychotherapy
    Official Title
    Effectiveness of Inpatient Alcohol Detoxification and Psychotherapeutic Support Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    September 25, 2018 (Actual)
    Study Completion Date
    September 25, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tribhuvan University, Nepal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to evaluate effectiveness of inpatient detoxification and psycho-therapeutic support, measured in terms of readiness to change and abstinence maintenance. The study participants will be the patients admitted for alcohol use disorder (age: 18 years above) at a tertiary level hospital in Kathmandu. Baseline assessments on readiness to change will be done during admission, and compared prior to and after discharge. Percentage of participants maintaining abstinence in 3 months after discharge will be another outcome to be analysed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    109 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Behavioral, detoxificaiton & psychotherapy
    Arm Type
    Experimental
    Arm Description
    Providing treatment as usual (detoxificaion) & psychotherapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Detoxification & psychotherapeutic support
    Primary Outcome Measure Information:
    Title
    Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form
    Description
    The questionnaire is 19 item self-report questionnaire assessing client readiness for change. There are three sub scales: Recognition, Ambivalence, and Taking Steps. Higher scores indicate greater recognition, ambivalence and taking steps. Scores range from 7 to 35, 4 to 20, and 8-40, respectively.
    Time Frame
    Change from baseline at discharge, an average of 2 weeks
    Title
    Percentage of participants staying abstinent
    Description
    Percentage of participants not taking single drink or staying complete abstinent
    Time Frame
    Three month follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed as ADS according to ICD 10 Exclusion Criteria: Major Psychiatric or medical comorbidity

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    If required, it will be discussed among the team and will be decided on need basis

    Learn more about this trial

    Inpatient Alcohol Detox & Psychotherapy

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