Development, Validation, and Feasibility of Yoga based Psychotherapy Program for Substance Use Disorders YPPS A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- NIMHANS
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Substance Craving – measured using the Substance Craving Scale
Study Overview
Brief Summary
The study aims to develop and validate a structured yoga based psychotherapy protocol for substance use disorders and assess its feasibility and efficacy through a pilot randomized controlled trial. Participants aged 18 to 60 with opioid use disorders will be recruited and randomly assigned to either the intervention group receiving yoga psychotherapy with conventional treatment or the control group receiving only conventional treatment with health education. The intervention will include weekly psychotherapy and thrice weekly yoga sessions for eight weeks. Various psychological and behavioral outcomes such as substance craving, abstinence days, anxiety, depression, stress, quality of life, and personality traits will be measured before and after the intervention. Data will be analyzed using statistical software to assess feasibility, acceptability, and preliminary effectiveness of the program.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Age Adults aged 18 to
- •2.Diagnosis Individuals who have a diagnosed substance use disorder as per the Diagnostic and Statistical Manual of Mental Disorders or DSM-
- •3.Substance Opioids 4.Willingness to Participate Participants who are willing to engage in Yogic Psychotherapy as a treatment modality for their substance use disorder.
- •5.Capacity to Provide Informed Consent Participants who have the cognitive and legal capacity to provide informed consent for participating in the study.
- •6.Mental Health Assess participants mental health to determine if they have any severe comorbid psychiatric disorders that may require specialized treatment or exclude them from the study.
- •7.Stability Individuals who are medically stable and not in immediate crisis or require acute medical intervention.
- •8.Language People who speak and understand English or Hindi.
Exclusion Criteria
- •Severe Physical Health Issues Individuals with severe physical health conditions that contraindicate participation in yoga practices
- •Severe Mental Health Issues Participants with severe comorbid psychiatric disorders that may interfere with the study objectives or require specialized treatment
- •Crisis or Acute Medical Need Individuals who are in crisis or require acute medical intervention as they may not be suitable for a research study
- •Those being treated with conventional structured psychotherapy
- •Those with a change in medications in the last 8 weeks or in whom the change would be required in the next 8 weeks.
Outcomes
Primary Outcomes
Substance Craving – measured using the Substance Craving Scale
Time Frame: outcome will be assessed/estimated at baseline and 8 weeks
Days of Abstinence – measured by counting the number of abstinent days
Time Frame: outcome will be assessed/estimated at baseline and 8 weeks
Secondary Outcomes
- Anxiety – assessed using the Hamilton Anxiety Rating Scale (HAM-A)(Depression – assessed using the Hamilton Depression Rating Scale (HAM-D))