Feasibility, Acceptability, and Effectiveness of a Hatha Yoga-in Patients Hospitalized for Schizophrenia

Official title

Feasibility, Acceptability, and Preliminary Effectiveness of a Hatha Yoga-on Reminiscence Functions and Mindfulness in Patients Hospitalized for Schizophrenia

Overview

The current study aims to examine the feasibility, acceptability, and preliminary effectiveness of a Hatha yoga-based group intervention on reminiscence functions and mindfulness in a sample of patients hospitalized for schizophrenia.

Detailed description

This study employs a mixed-methods sequential explanatory design. Convenience sampling will be used to recruit 36 participants for a cross-culturally adapted Hatha yoga-based group intervention (16 one hour-long sessions over 8 weeks). Feasibility indicators will be monitored systematically. Acceptability will be assessed using semi-structured interviews. Preliminary effectiveness will be evaluated using a quasi-experimental one-group pre-post test design to test group-level (paired t-test) and individual-level (reliability change index) changes in mindfulness and reminiscence functions. Thematic analysis will be conducted to analyze qualitative data, with meta-inference used to integrate the qualitative and quantitative findings.

Interventions

• Behavioral Intervention Arm: Hatha Yoga
  Hatha Yoga balances the body's "sun" (ha) and "moon" (tha) energies to promote physical, mental, and emotional wellness. There will be eight two-hour Hatha yoga-based group therapy sessions over eight weeks. A professional yoga teacher and mental health nurse will lead these helpful sessions. Better memory and alertness are the major goals. To ensure participant safety and study validity, a multidisciplinary team assesses health, trauma triggers, and personal goals before the program begins. The

Primary outcome measures

• The Five-Facet Mindfulness Questionnaire-15 (FFMQ-15) [Time frame: 12 weeks]
• Feasibility Indicators: Recruitment Retention Attrition Adherence Data completeness Adverse events. [Time frame: 10 weeks]

Secondary outcome measures (1)

• The 18-item Tripartite Adjusted Arabic Reminiscence Functions Scale (AARFS-tri) [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• Patients are diagnosed with schizophrenia according to the DSM-5-TR or ICD-10 criteria
• Patients are aged between 18 and 65 years old
• Patients are clinically stabile, defined as being in the post-acute phase of care with no acute psychotic episode or psychiatric hospitalization within the 30 days preceding enrollment
• Patients have adequate cognitive functioning, as evidenced by passing the Mini-Mental State Examination (MMSE), with sufficient insight and capacity to respond meaningfully to study procedures
• Patients have the ability to attend group-based sessions and provide informed consent
• Patients have the willingness and physical ability to engage safely in light-to-moderate yoga practice.

Exclusion criteria

• Patients with severe cognitive impairment or intellectual disability that would disqualify meaningful participation
• Patients with acute psychiatric symptoms or active suicidal ideation
• Patients with physical limitations, such as a severe musculoskeletal condition, that would contraindicate safe participation in yoga practice.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07454200 · 17/4/2024/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗