NCT06367023

Brief Summary

Drug addiction is a public health problem, mainly youths are involved in the addiction and the major reason were due to peer pressure. Spiritual meditation is thought to foster a deeper sense of meaning, which creates new sources of positive reinforcement, increasing motivation for alternative behavior patterns, such as entering treatment or maintaining abstinence. Cluster Randomized Control Trial will be performed for 1-year period where mixed method study design will be performed. The major variables will be Anxiety and depression score, Happiness index, Quality of life, Rate of Relapse, Age, Gender, Occupation, Education, Income, Family Size, Family Income, Family support, Social status- High/Middle/Low, History of drug use self, Types of drugs, Duration of usage: Reason of drug use, how they have started, Amount of drugs, Frequency of use, Family history of drug use, Money spent on drugs per month. A modified validated Questionnaire will be used. CRCT will be done by CONSORT Guidelines. A total of 160 samples will be taken, (40 from each center, two were given Meditation intervention and 80 were given standard treatment as a control group) and 16 qualitative interviews will be taken (4 from each center). The intervention will be given for 3 months, for 6 days one hour per day Rajyoga meditation basic course will be provided, followed by a 1-hour daily spiritual lesson, Positive thinking and motivation classes will be provided to the intervention group, and in the control group standard treatment will be given. Follow-up will be done after 1 month of discharge from the rehabilitation centers. Ethical clearance will be taken from the Ethical Review Board (ERB) of the Nepal Health Research Council (NHRC). This study will be useful for developing policy and practice in rehabilitation centers to apply the technique of Rajyoga Meditation in relapse prevention.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

March 29, 2024

Last Update Submit

April 14, 2024

Conditions

Keywords

Anxietymeditationdrug addiction

Outcome Measures

Primary Outcomes (3)

  • Anxiety score

    Anxiety score before and after, lower score means healthy

    6 month

  • Depression score

    Depression score before and after lower score means healthy

    6 month

  • quality of life score

    Quality of life before and after higher score means healthy

    6 month

Secondary Outcomes (1)

  • Rate of Relapse

    1 year

Study Arms (2)

Rajyoga Meditation Practice

EXPERIMENTAL

Rajyoga Meditation Intervention: 3 months, For 6 days one hour per day Rajyoga meditation basic course will be provided, followed by 1 hour daily spiritual lesson, Positive thinking and motivation classes will be provided to the intervention group where 1. Initiation - In this stage, thoughts in the mind, come in randomly, 2. Concentration - He now, converts all negative thoughts with positive thoughts of peace, happiness, love, bliss, purity, knowledge, and power 3. Realization - This final stage involves feeling the emotions of these positive thoughts and in the control group standard treatment will be given. Follow-up: Follow up will be done after 1 month of discharge from the rehabilitation centers.

Behavioral: Rajyoga Meditation Practice

Standard of care

NO INTERVENTION

The usual therapy of the rehabilitation center will be given for 3 months. Baseline, 3 month and follow up after 1 month will be taken

Interventions

The intervention will be given for 3 months, For 6 days one hour per day Rajyoga meditation basic course will be provided, followed by 1 hour daily spiritual lesson, Positive thinking and motivation classes will be provided to the intervention group and in control group standard treatment will be given.

Rajyoga Meditation Practice

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those youth more than 18 years old
  • Who had used drugs and residing in the rehabilitation center of Biratnagar and
  • Gave consent will be involved in the study.

You may not qualify if:

  • Those having other illnesses and unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation center

Biratnagar, Koshi, 56613, Nepal

Location

Related Publications (5)

  • Berking M, von Kanel M. [Mindfulness training as a psychotherapeutic tool. Clarification of concept, clinical application and current state of empirical research]. Psychother Psychosom Med Psychol. 2007 Mar-Apr;57(3-4):170-7. doi: 10.1055/s-2006-951956. German.

    PMID: 17427100BACKGROUND
  • Bizzarri J, Rucci P, Vallotta A, Girelli M, Scandolari A, Zerbetto E, Sbrana A, Iagher C, Dellantonio E. Dual diagnosis and quality of life in patients in treatment for opioid dependence. Subst Use Misuse. 2005;40(12):1765-76. doi: 10.1080/10826080500260800.

    PMID: 16419555BACKGROUND
  • Chapagain K, Rai D, Koirala B, Rauniyar GP. Exploring the Prevalence and Correlates of Substance Abuse Amongst the Adolescents of Dharan, Eastern Nepal. J Nepal Health Res Counc. 2020 Sep 8;18(2):263-267. doi: 10.33314/jnhrc.v18i2.2484.

    PMID: 32969390BACKGROUND
  • GBD 2016 Alcohol Collaborators. Alcohol use and burden for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2018 Sep 22;392(10152):1015-1035. doi: 10.1016/S0140-6736(18)31310-2. Epub 2018 Aug 23.

    PMID: 30146330BACKGROUND
  • Hayes, S. C. (2015). The Act in Context: The Canonical Papers of Steven C. Hayes. Routledge.

    BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 16, 2024

Study Start

May 1, 2024

Primary Completion

October 30, 2024

Study Completion

March 30, 2025

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

As per the request data will be shared

Locations