A clinical trial to study the effects of Mindfulness on relapsing factors like craving and emotion regulation, in patients with Alcohol Dependence Syndrome

Completed

• Conditions: Alcohol dependence,

• Registration Number: CTRI/2022/03/041523
• Lead Sponsor: Ms Riya

Brief Summary

This study is a randomized controlled comparative, Between-group design with pre-and post-treatment comparison with 12 sessions of psychotherapy. A total of 100 participants diagnosed with Alcohol dependence Syndrome will be obtained, 50 of them will be randomly assigned to the experimental group and 50 will be randomly assigned to the control group. The participants in the experimental group will initially receive four individual sessions of Motivational Enhancement Therapy held twice weekly for 1 hour and then they will be randomly assigned in the group sessions of Mindfulness-Based Relapse Prevention Therapy held weekly once for 2 hours each. The effect of psychotherapy will be assessed after 4 sessions, 8 sessions, and 12 sessions. The primary outcome measure is a significant difference in Mindfulness, Craving, Emotion Regulation, and Readiness for change after 12 sessions.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-15
• Study Completion: 2023-03-19
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Those who fulfill the ICD-10 criteria of Alcohol dependence.
• Those who score above the cutoff on AUDIT.
• Those who will give informed consent.
• Those educated up to Std 5th.

Exclusion Criteria

• Those who do not fulfill the ICD-10 criteria of Alcohol dependence 2.
• Those who score below the cutoff on AUDIT.
• Any other psychoactive substance (except for Caffeine and Nicotine).
• Currently having psychosis, organic condition, imminent suicide risk.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A significant change in Mindfulness, Craving, Emotion Regulation and Readiness for Change	after 12 session

Secondary Outcome Measures

Name	Time	Method
A significant change in Mindfulness, Craving, Emotion Regulation	after 8 session
A significant change in Readiness for Change	after 4 sessions

Trial Locations

Locations (1)

SGT University; 🇮🇳 Gurgaon, HARYANA, India

SGT University

🇮🇳Gurgaon, HARYANA, India

Ms Riya

Principal investigator

7739030309

riyamandal88@gmail.com