Music vs Relaxation Training in Craving Reduction in Alcohol Dependence Syndrome

Alcohol Dependence Syndrome Clinical Trial

Official title:

Comparison Between the Use of Music and Relaxation Training on Craving Alcohol in Patients With Alcohol Dependence Syndrome: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351217
• Other study ID #: IEC KMC MLR 01-19/14
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2020
• Source: Kasturba Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study was to compare the effectiveness of Music and Progressive Muscle Relaxation as interventions to reduce craving, increase coping, and understand the subjective experience of the interventions with patients diagnosed with Mental and Behavioral Disorders due to Alcohol, Dependence Syndrome, over a 5 day period.

Description:

Craving for alcohol produces an aversive, uncomfortable state, with autonomic arousal similar to that in anxiety disorders, and is the main factor leading to relapse. Music has been shown to reduce anxiety and stress levels. Progressive Muscle Relaxation (PMR) is the intervention of choice for treatment of anxiety and related syndromes. This study aimed to compare efficacy of PMR and music in reducing levels of alcohol craving and increasing perceived ability to cope with the craving. The intervention was conducted over 5 days with two randomised group of 10 patients each. The patients were assigned to either group based on randomizer sequencing. Initial motivation was assessed before beginning the study. Measures of craving level and coping were collected on Day 1, 3 and 5. Single question exit interview was conducted to understand subjective perception of the patients regarding the techniques. Significant difference was found in coping levels through use of PMR (p = 0.01), and subjective reduction in craving levels was reported by patients in the music group, though this was not statistically significant. Thus, PMR may be used as an adjunct to increase coping abilities in patients with alcohol dependence, while music may be a useful tool to reduce craving but cannot be conclusively commented upon without further research.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Diagnosed with Mental and Behavioral Disorders due to Use of Alcohol, Dependence Syndrome

• Abstinent for at least 1 week

Exclusion Criteria:

• Any other known psychiatric/physical condition

• Risk of Suicide or Relapse

• Less than 75% compliance

Related Conditions & MeSH terms

• Alcohol Dependence Syndrome
• Alcoholism
• Substance-Related Disorders
• Syndrome

Intervention

Behavioral:
• Music
Raga Ahir Bhairav and Bhairavi were used, played primarily on flute, without lyrics.
• Progressive Muscle Relaxation
The instructions were recorded in both English and the local language, Kannada

Locations

Country	Name	City	State
India	KMC Mangalore	Mangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Kasturba Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving	The level of craving for alcohol experienced by the patient, as measured through Alcohol Urge Questionnaire.	5 days
Primary	Coping	The patient's perceived ability to cope with their craving for alcohol, as assessed through a visual analogue scale for coping	5 days
Secondary	Single Question Exit Interview	Each patient was a asked a single question during the final debriefing on the last day of the study. The question was "Please describe your experience with the music/exercise". Their answers were recorded verbatim and were translated from Kannada as needed	5 days