CTRI/2025/09/094309 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On:
26/03/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Behavioral
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Efficacy of Group Mindfulness-Based Cognitive Therapy on Self-Esteem, Psychological Well-Being, and Happiness Index among Adults with Substance Use Disorder: A Randomized Controlled Trial (RCT)
Scientific Title of Study
Efficacy of Group Mindfulness-Based Cognitive Therapy on Self-Esteem, Psychological Well-Being, and Happiness Index among Adults with Substance Use Disorder: A Randomized Controlled Trial (RCT)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Puspanjali Borthakur
Designation
PhD Scholar
Affiliation
Christ (Deemed to be University), Bangalore
Address
Christ (Deemed to be University), Backgate no 5, Bhavani Nagar, Hosur Road, Department of Psychology, Research and Development block (R N D Block) Christ (Deemed to be University), Backgate no 5, Bhavani Nagar, Hosur Road, Department of Psychology, Research and Development block (R N D Block) Bangalore KARNATAKA 560029 India
Phone
8197978783
Fax
Email
puspanjali.borthakur@res.christuniversity.in
Details of Contact Person Scientific Query
Name
Dr. Thaddeus Alfonso
Designation
Assistant Professor
Affiliation
Christ (Deemed to be) University, Bangalore
Address
Christ (Deemed to be University), Central Campus, Bhavani Nagar, Hosur Road, School of Psychological Sciences Christ (Deemed to be University), Central Campus, Bhavani Nagar, Hosur Road, School of Psychological Sciences Bangalore KARNATAKA 560064 India
Phone
9952999141
Fax
Email
thaddeus.alfonso@christuniversity.in
Details of Contact Person Public Query
Name
Puspanjali Borthakur
Designation
PhD Scholar
Affiliation
Christ (Deemed to be) University, Bangalore
Address
Christ (Deemed to be University), Back gate no 5, Bhavani Nagar, Hosur Road, Department of Psychology, Research and Development block (R n D Block) Christ (Deemed to be University), Back gate no 5, Bhavani Nagar, Hosur Road, Department of Psychology, Research and Development block (R n D Block) Bangalore KARNATAKA 560029 India
Phone
8197978783
Fax
Email
puspanjali.borthakur@res.christuniversity.in
Source of Monetary or Material Support
Christ (Deemed to be University), Central Campus, Bhavani Nagar, Hosur Road, School of Psychological Sciences, Bangalore, 560029
Primary Sponsor
Name
Puspanjali Borthakur
Address
Christ (Deemed to be University), Back gate no 5, Bhavani Nagar, Hosur Road, Department of Psychology, Research and Development block (R n D Block)
Type of Sponsor
Other [Other (Self)]
Details of Secondary Sponsor
Name
Address
Thaddeus Alfonso
Christ University, Bangalore
Countries of Recruitment
India
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Ms Renuka Head Clinical Psychologist
Cadabams De-addiction rehabilitation center
De-addiction and Rehabilitation Department, Gulakamale Village, Near Kaggalipura 17th Mile, Kanakapura Road, Taralu, Post, Bengaluru, Karnataka 560082 Bangalore Rural KARNATAKA
9845778299
renuka@cadabams.org
Mr Ramesh Head Coordinator
Future Lights Trust
De-Addiction and Rehabilitation center, 85, 38th Cross Rd, 5th block near Radhika apartments, HBR extension, Prakruthi Layout, HBR Layout, Bengaluru, Karnataka 560043 Bangalore KARNATAKA
9886277141
futurelightsjoe@gmail.com
Details of Ethics Committee
No of Ethics Committees= 3
Name of Committee
Approval Status
Cadabams Group of Psychosocial Rehabilitation Centers
No Objection Certificate
Future Lights Trust Committee
No Objection Certificate
Research Conduct and Ethics Committee, Centre for Research
The intervention consisted of Group Mindfulness-Based Cognitive Therapy (MBCT) administered over a period of 8 weeks, with one session per week, totaling 8 sessions. Each session lasted approximately 90 to 120 minutes and focused on mindfulness training, cognitive restructuring, emotional regulation, self-awareness, self-esteem enhancement, and psychological well-being.
The sessions were delivered in a group format by the principal investigator (PhD scholar). Each session was monitored and supported by a multidisciplinary team, including the rehabilitation center head, a clinical psychologist, a counselor, a nurse, and a security personnel, to ensure ethical conduct, participant safety, and procedural integrity throughout the intervention period.
The intervention was designed to align with established MBCT protocols and was implemented within the residential rehabilitation setting for adults with substance use disorder.
Comparator Agent
Treatment as usual (TAU)
The control group received Treatment-As-Usual (TAU), which comprised the standard therapies and rehabilitation services routinely followed at the center. These included the centers own therapeutic programs, such as medical management, individual and group counseling, and other psychosocial interventions, as per their standard protocol. There was no additional contact or therapeutic input from the principal investigator during the intervention period. The TAU group participated only in the scheduled assessments conducted before the intervention, immediately after the intervention, and at the follow-up time points. This ensured that the control group remained unaffected by the experimental condition and served as a valid comparator for evaluating the efficacy of the MBCT intervention.
Inclusion Criteria
Age From
20.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
1. Participants within the age range of 20-40 years old, falling under the category of young and middle adulthood
2. Participants staying and getting in-patient treatment in rehabilitation centers in Bangalore: Karnataka.
3. Male and female adult participants diagnosed with Substance Use disorder.
4. Dual Diagnosis/Comorbidities with SUD will be included: SUD and major depressive disorder, Anxiety Disorder, Mood disorder and personality Disorder (National Institutes on Drug Abuse (US), 2020).
5. Only participants consenting for voluntary participation with signed approval from the respective rehabilitation centers will be included as the form of addiction puts them under a vulnerable population.
6. The study will include participants getting in-patient treatment for Alcohol, Cannabis, Cocaine (Stimulants) and Heroin (Opioids) as described and stated in DSM-V.
ExclusionCriteria
Details
1.Participants who are out-patients will be excluded.
2.Participants diagnosed with any other addictions or Substance use apart from Alcohol, Cannabis, Cocaine (Stimulants) and Heroin (Opioids) will be excluded.
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Self-esteem, Psychological well-being and Happiness
Baseline, immediately post-intervetion, one month follow-up, 3rd month follow-up
Secondary Outcome
Outcome
TimePoints
1. The mediation effect of self-esteem between psychological well-being and happiness.
Immediately post-intervention, one month follow-up, 3rd month follow-up
Maintenance of psychological gains that is sustained improvement in happiness, well-being, and self-esteem.
Immediately post-intervention, 1 month follow-up and 3rd month follow-up
Interrelationships among happiness, psychological well-being, and self-esteem.
immediately post-intervention, one month follow-up, 3rd month follow-up
Target Sample Size
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "60" Final Enrollment numbers achieved (India)="60"
Substance Use has been a really concerning problem for society for years now, and its impact can be seen in various forms and ways, within the individual as well as the outside surroundings of the people indulged in addiction or substance use. When it involves substance use, self-esteem, happiness, and psychological well-being are a few of the foremost important variables, concepts and concerns that have a varying influence on this problem. A study describes about the importance of increasing self-esteem to decrease their tendency towards addiction/substance use. Another study also describes that folks with chronic self-esteem issues may take on behaviors that reinforce their feelings of inadequacy, including drug misuse because they believe they need little to live up to. Whether or not individuals have relatively high self-esteem when they begin using alcohol or drugs, they will see this disappear as they fall further and further into addiction. Low self-esteem is one most common precursor to substance use and addiction (Gateway Foundation, 2021; UK rehab, 2019; Hamid Reza SADEGHI, 2017; Safe Landing Recovery, 2021). Both substance misuse and substance use disorders harm the health and well-being of people and communities. When a psychological state problem goes untreated, the substance use problem usually gets worse, when alcohol or drug use increases, psychological state problems, general psychological well-being, and behavior usually also increases (General, 2022; Melinda, 2022). An increase in the level of happiness, overall life satisfaction, and well-being has also been positively correlated in absence of substance use among adults and adolescents. Recent longitudinal evidence also indicates that a flourishing psychological state that may have been hindered as a result of anxiety, substance use, and more, can cause higher levels of happiness (hedonic, eudemonic), and mental well-being among adult individuals (Tuicomepee & Romano, 2017; Schotanus-Dijkstra et al., 2016). Overall, it can be seen how low self-esteem, psychological well-being, and happiness index may result in more relapses. Still, there are fewer studies that have tested the effect of MBCT on these variables. Hence the target of the current research is to see if MBCT can increase or enhance these factors so that the relapses can be prevented and improve the overall recovery process.