RESUMO
Background: The proposed research aims to test the effects and mechanisms of a six-month yoga-based intervention as an add-on to standard treatment in opioid use disorder (OUD) by conducting a randomized controlled study with the following primary outcome variables: 1) clinical: abstinence (opioid negative urine test), and reductions in pain and craving, and 2) mechanisms: reward circuit activation in response to opioid visual cue craving paradigm, activation in response to a cognitive control task, and resting state functional connectivity through fMRI, and plasma beta-endorphin levels. Secondary outcome variables are perceived stress, anxiety, sleep quality, cognitive performance, pain threshold, buprenorphine dosage and side effects, withdrawal symptoms, socio-occupational functioning, vedic personality traits, heart rate variability, serum cortisol, and brain GABA levels through magnetic resonance spectroscopy (MRS). Methods: In this single-blinded, randomized, controlled, parallel-group superiority trial with 1:1 allocation ratio, 164 patients with OUD availing the outpatient/ inpatient clinical services at a tertiary mental healthcare hospital in India will be enrolled after giving informed consent. Consecutive consenting patients will be randomly allotted to one of the two groups - yoga arm (standard treatment + yoga-based intervention), or waitlist group (standard treatment alone). Allocation concealment will be followed, the clinicians, outcome assessors and data analysts will remain blind to subject-group allocation. A validated and standardized yoga program for OUD will be used as an intervention. Participants in the yoga arm will receive 10 supervised in-person sessions of yoga in the initial two weeks followed by tele-yoga sessions thrice a week for the next 22 weeks. The wait-list control group will continue the standard treatment alone for 24 weeks. Assessments will be done at baseline, two weeks, 12 weeks, and 24 weeks. Data from all randomized subjects will be analysed using intent-to-treat analysis and mixed model multivariate analysis. Dissemination: Findings will be disseminated through peer-reviewed publication, conference presentations, and social media. Trial registration number: The trial has been registered under Clinical Trials Registry-India with registration number CTRI/2023/03/050737.
RESUMO
Background Twenty one (12 females) subjects, diagnosed with schizophrenia by a psychiatrist using ICD-10, in the ages 52.87 + 9.5âyears and suffering since 24.0 ± 3.05âyears were recruited into the study from a schizophrenia rehabilitation center in Bengaluru. Methods All subjects were taking anti-psychotic medications and were in stable state for more than a month. Psychiatric medications were kept constant during the study period. Assessments were done at three points of time: (1) baseline, (2) after one month of usual routine (pre) and (3) after five months of validated Integrated Yoga (IY) intervention (post). Validated 1âh Yoga module (consisting of asanas, pranayama, relaxation techniques and chantings) was practiced for 5âmonths, five sessions per week. Antipsychotic-induced side effects were assessed using Simpson Angus Scale (SAS) and Udvalg for Kliniske Undersogelser (UKU) side effect rating scale. Cognitive functions (using Trail making Test A and B), clinical symptoms and anthropometry were assessed as secondary variables. Comparisons between "pre" and "post" data was done using paired samples t-tests after subtracting baseline scores from them respectively. Results At the end of five months, significant reduction in drug-induced Parkinsonian symptoms (SAS score; p=0.001) and 38 items of UKU scale was observed along with significant improvement in processing speed, executive functions and negative symptoms of schizophrenia patients. No side effects of Yoga were reported. Conclusions The present study provides preliminary evidence for usefulness of Integrated Yoga intervention in managing anti-psychotic-induced side effects.