MBRP on Reducing Craving and Addictive Behaviour in Adults

NCT04034732 | Recruiting DMC

• 1 other identifier: MBRP protocol version 2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 9

Brief Summary

Mindfulness-base interventions are promising interventions as an adjunctive therapy to be integrated into current existing anti-drug services. The advantages of MBRP can include: 1) having very low stigma as mindfulness courses are already widely accepted and used among different populations including healthy populations. The running of mindfulness courses can be more acceptable by the community; 2) it could be more accessible and cost-effective as it can be provided in group and in community settings; 3) it is a skill that can be learned and be used after the 8 week course , e.g. when the drug user is triggered in unforeseen circumstances, they may apply the learnt mindfulness skills to help themselves overcome the difficulties when timely professional help is not available; 4) Drug Abuse Statistics from Narcotics Division, Security Bureau of the government of Hong Kong showed that the most common reasons for recurrent drug use were to avoid discomfort of its absence (62%) and relief of depression/stress/boredom (30%). The study objectives are as follow:

1. 1.To evaluate the feasibility of using mindfulness- based relapse prevention (MBRP) programme among adults with substance abuse in Hong Kong;
2. 2.To examine the changes of craving, substance use, mood symptoms, self-efficacy, acceptance, level of mindfulness and quality of life between those who have enrolled in the MBRP as compared to those in the usual care control group;
3. 3.To evaluate the correlations between changes in substance use and craving and changes in mood symptoms, self-efficacy, acceptance, level of mindfulness, and quality of life; and
4. 4.To study participants' characteristics related to adherence and benefits associated with MBRP.

Conditions

Substance Abuse; Substance Use Disorders

Keywords

Mindfulness-based intervention; Mindfulness; Relapse prevention

Outcome Measures

Primary Outcomes (2)

• Self report of any drug abuse and usage

  Self-reports of no substance use to confirm abstinence status

  Post intervention (after 8 weeks of intervnetion from baseline)

• Urine drug test (also known as Urine drug screen or UDS)

  Urine test for the presence of illegal drugs and prescription medications

  Post intervention (after 8 weeks of intervnetion from baseline)

Secondary Outcomes (11)

• The Penn Alcohol Craving Scale

  baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention

• the 9-item Patient Health Questionnaire (PHQ-9)

  baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention

• the 7-item Generalised Anxiety Disorder (GAD-7)

  baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention

• The Addiction Severity Index (ASI) - Lite Version

  baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention

• Drug Avoidance Self-Efficacy Scale

  baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention

Study Arms (2)

Mindfulness-based Relapses Prevention (MBRP)

EXPERIMENTAL

The MBRP program will be delivered by an instructor with training in MBSR/MBCT who has more than two years of teaching experience in MBSR/MBCT. The MBRP programme will consist of 2.5 hour weekly sessions for 8 weeks. The mindfulness curriculum will include training in mindfulness through (1) a body scan, (2) sitting meditation and (3) mindful stretching exercises.

Behavioral: Mindfulness-based Relapses Prevention (MBRP)

Usual Care Control Group (UCCG)

ACTIVE COMPARATOR

Participants in the UCCG condition will remain in their standard outpatient aftercare provided by the treatment agency with an aim to maintain their abstinence with the help from social workers or other healthcare professionals through different activities, such as topics on life training skills such as rational thinking skills, grief and loss, assertiveness, self esteem, goal setting, effects of drugs on interpersonal relationships and experience. Frequency of their visits to / contacts with healthcare professionals will be recorded.

Behavioral: Usual Care Control

Interventions

Mindfulness-based Relapses Prevention (MBRP) BEHAVIORAL

Manualized MBRP program is used with a central theme in each session, with meditation practices and relapse prevention exercises and discussions. Themes include the concept of "automatic pilot" and its relationship to addiction relapse, recognizing thoughts and emotions in relation to triggers of relapse, integrating mindfulness practices into daily activities, practicing mindfulness in high risk situations and the role of thoughts and emotions in relapse. Include daily homework exercises that consist of awareness exercises directed at increasing non-judgmental awareness of bodily sensations, thoughts and feelings, together with exercises designed to integrate awareness skills into daily life. Include training in mindfulness through body scan, sitting meditation, and mindful stretching exercises, to cultivate awareness during simple stretching movement.

Mindfulness-based Relapses Prevention (MBRP)

Usual Care Control BEHAVIORAL

Participants in the UCCG condition will remain in their standard outpatient aftercare provided by the treatment agency with an aim to maintain their abstinence with the help from social workers or other healthcare professionals through different activities, such as topics on life training skills such as rational thinking skills, grief and loss, assertiveness, self esteem, goal setting, effects of drugs on interpersonal relationships and experience. Frequency of their visits to / contacts with healthcare professionals will be recorded.

Usual Care Control Group (UCCG)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in Cantonese;
• Has ever fulfilled the Structured Clinical Interview for DSM-IV/DSM-5 (SCID) drug module criteria for substance use disorder diagnoses; and
• Has completed outpatient or inpatient treatment for substance abuse in the previous 6 months.

You may not qualify if:

• Inability to provide valid consent;
• Current or lifetime psychotic disorder assessed by the Structured Clinical interview for DSM-IV/DSM-5;
• Imminent suicidal risk; or
• Dementia.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (9)

Department of Psychiatry, AHNH, Hospital Authority

Hong Kong, Hong Kong

NOT YET RECRUITING

Department of Psychiatry, NDH, Hospital Authority

Hong Kong, Hong Kong

NOT YET RECRUITING

Evergreen Lutheran Centre, Hong Kong Lutheran Social Service

Hong Kong, Hong Kong

RECRUITING

Neo-Health Group

Hong Kong, Hong Kong

RECRUITING

PS33 - Shamshuipo Centre, Hong Kong Christian Service

Hong Kong, Hong Kong

RECRUITING

Rainbow Lutheran Centre, Hong Kong Lutheran Social Service

Hong Kong, Hong Kong

RECRUITING

Sane Centre

Hong Kong, Hong Kong

RECRUITING

The Society of Rehabilitation and Crime Prevention, Oasis

Hong Kong, Hong Kong

RECRUITING

TWGHs CROSS Centre

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Samuel YS Wong

  JCSPHPC, CUHK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daisy DX Zhang

CONTACT

(852) 2252-8452; zhangdxdaisy@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this open-label study, blinding of therapists and participants will not be possible. However, all data collection will be performed by a trained research assistant blinded to the allocation status of the participants. The research assistant will receive rigorous training in standardized data collection procedures. Data entry will be prepared so that the person can conduct the statistical analyses without referring to allocation information, thus ensuring blinding during data analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 26, 2019
• Study Start: August 15, 2019
• Primary Completion: January 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (9)