Health Condition 1: F139- Sedative, hypnotic or anxiolytic-related use, unspecified
Conditions
Interventions
Intervention1: Yoga Therapy: Treatment A is a specific pranayama-based yoga module of approximately 30 minutes duration, along with Pathya Apathya dietary advice and external Ayurveda oil application,
Sponsors
Department of Integrative Medicine NIMHANS
Collaborative Centre for Mind Body interventions through Yoga CCMBIY by CCRYN
Eligibility
Inclusion criteria
Inclusion criteria: Patients clinically diagnosed with BZD Use Disorder by psychiatrists based on DSM 5 criteria. Patients who are using class Z drugs will also be included in the study. Patients with a history of BZD and/or class Z drugs use for at least 3 months and currently exhibiting signs of dependence. Age limit criteria is between 18 to 60 years, both genders. Those willing to undergo reduction in BZD and/or class Z drugs dosage at study entry point. Willingness to provide written informed consent and undergo study interventions (Yoga, Ayurveda, Acupuncture).
Exclusion criteria
Exclusion criteria: Presence of cognitive impairment or any mental illness other than depression, anxiety or insomnia. Nasal abnormalities that do not allow the practice of pranayama. Very severe withdrawal symptoms where CIWA B is more than 60. Current dependence on substance other than BZDs and/or class Z drugs except nicotine. Participation in structured psychotherapy or any detoxification program within the last month. Contraindications for MRS. Pregnant or breastfeeding mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility outcomes for the SMART Trial: Recruitment Rate Retention Rate Adherence to Tapering Adherence to Interventions Acceptability of Adaptive Design/ Randomization Data CompletenessTimepoint: Baseline, 4 weeks and 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure changes in CIWA B scores.Timepoint: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks and 24 weeks.;To measure changes in PROMIS scores.Timepoint: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks and 24 weeks.;To measure changes in PSQI score.Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks.;To measure changes in HAM A/ HAM D scores.Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks.;To measure changes in salivary cortisol levels.Timepoint: Baseline and 6 weeks.;To measure changes in GABA levels.Timepoint: Baseline and 6 weeks.;To measure brief prakriti inventory scores.Timepoint: Baseline.;To assess BZD/Z drug dosage.Timepoint: Baseline, 6 weeks, 12 weeks and 24 weeks. | — |
Countries
India
Contacts
Public ContactSejal Sood
National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru
Outcome results
None listed