Inpatient Alcohol Detox & Psychotherapy
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Detoxification & psychotherapeutic support
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
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
NCT ID
NCT03988478
First Posted
June 13, 2019
Last Updated
June 14, 2019
Sponsor
Tribhuvan University, Nepal
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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