- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03988478
Inpatient Alcohol Detox & Psychotherapy
June 14, 2019 updated by: Jugu Maya Chaudhary, Tribhuvan University, Nepal
Effectiveness of Inpatient Alcohol Detoxification and Psychotherapeutic Support Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
109
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed as ADS according to ICD 10
Exclusion Criteria:
- Major Psychiatric or medical comorbidity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Behavioral, detoxificaiton & psychotherapy
Providing treatment as usual (detoxificaion) & psychotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form
Time Frame: Change from baseline at discharge, an average of 2 weeks
|
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.
|
Change from baseline at discharge, an average of 2 weeks
|
|
Percentage of participants staying abstinent
Time Frame: Three month follow up
|
Percentage of participants not taking single drink or staying complete abstinent
|
Three month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
September 25, 2018
Study Completion (ACTUAL)
September 25, 2018
Study Registration Dates
First Submitted
June 13, 2019
First Submitted That Met QC Criteria
June 14, 2019
First Posted (ACTUAL)
June 17, 2019
Study Record Updates
Last Update Posted (ACTUAL)
June 17, 2019
Last Update Submitted That Met QC Criteria
June 14, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOPMH-Inpt-detox-Psychotherapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
If required, it will be discussed among the team and will be decided on need basis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.