- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07454200
Feasibility, Acceptability, and Effectiveness of a Hatha Yoga-in Patients Hospitalized for Schizophrenia
March 3, 2026 updated by: Abdallah Abu Khait, The Hashemite University
Feasibility, Acceptability, and Preliminary Effectiveness of a Hatha Yoga-on Reminiscence Functions and Mindfulness in Patients Hospitalized for Schizophrenia
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abdallah F Abu Khait, Ph.D, MSN
- Phone Number: +962792269831
- Email: abdallah.abukhait@hu.edu.jo
Study Contact Backup
- Name: Austin Menger, PhD
- Phone Number: 516-220-7313
- Email: austin@mengeranalytics.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Hatha Yoga-Based Group Intervention
|
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 lessons are held in a comfortable area with adjustable props and lighting.
Trainers employ trauma-sensitive language and retain privacy on all participants, including "Hesitant" and "Overwhelmed."
Each session includes grounding, pranayama, asana, and dhyana.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Five-Facet Mindfulness Questionnaire-15 (FFMQ-15)
Time Frame: 12 weeks
|
The Five-Facet Mindfulness Questionnaire-15 is a 15-item self-report measure assessing five domains: observing, describing, acting with awareness, nonjudging, and nonreactivity.
Each item is rated on a 5-point Likert scale from 1 to 5. Total scores range from 15 to 75.
Higher scores indicate higher levels of dispositional mindfulness, reflecting a better outcome.
|
12 weeks
|
|
Feasibility Indicators: Recruitment Retention Attrition Adherence Data completeness Adverse events.
Time Frame: 10 weeks
|
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The 18-item Tripartite Adjusted Arabic Reminiscence Functions Scale (AARFS-tri)
Time Frame: 12 weeks
|
The 18-item Tripartite Adjusted Arabic Reminiscence Functions Scale assesses three core reminiscence functions: positive reminiscence, negative reminiscence, and social reminiscence.
Each item is rated on a 6-point Likert scale from 1, never, to 6, very often.
Total scores range from 18 to 108, with higher total scores indicating greater overall use of reminiscence functions.
The scale includes three 6-item subscales.
The Positive Reminiscence Subscale measures adaptive functions such as identity consolidation, meaning making, problem solving, and positive emotion regulation, with scores ranging from 6 to 36, where higher scores reflect more frequent use of adaptive reminiscence strategies.
The Negative Reminiscence Subscale assesses maladaptive functions such as rumination, regret, bitterness revival, and mood worsening, with scores ranging from 6 to 36, where higher scores indicate more frequent maladaptive reminiscence patterns.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abdallah Abu Khait, Ph.D.,MSN, The Hashemite University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
February 27, 2026
First Submitted That Met QC Criteria
March 3, 2026
First Posted (Actual)
March 6, 2026
Study Record Updates
Last Update Posted (Actual)
March 6, 2026
Last Update Submitted That Met QC Criteria
March 3, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 17/4/2024/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on SCHIZOPHRENIA 1 (Disorder)
-
New York State Psychiatric InstituteBristol-Myers SquibbNot yet recruitingSchizoaffecitve Disorder | SCHIZOPHRENIA 1 (Disorder)United States
-
Tarsus UniversityCompleted
-
University of California, San DiegoNot yet recruitingSchizoaffecitve Disorder | SCHIZOPHRENIA 1 (Disorder)
-
Shanghai Mental Health CenterRecruiting
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.CompletedSCHIZOPHRENIA 1 (Disorder)China
-
Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre...Active, not recruitingSchizoaffective Disorder | SCHIZOPHRENIA 1 (Disorder)Italy
-
Vanderbilt University Medical CenterBeth Israel Deaconess Medical CenterCompletedSCHIZOPHRENIA 1 (Disorder) | Nicotine UseUnited States
-
University of Alabama at BirminghamNot yet recruitingPsychosis | Schizophrenia Prodromal | SCHIZOPHRENIA 1 (Disorder)United States
-
Nathan Kline Institute for Psychiatric ResearchNational Institute of Mental Health (NIMH); Columbia University; Research Foundation...RecruitingSchizo Affective Disorder | SCHIZOPHRENIA 1 (Disorder)United States
-
Nikolai AlbertRecruitingSchizotypal Disorder | SCHIZOPHRENIA 1 (Disorder) | Post Traumatic Stress SymptomsDenmark
Clinical Trials on Intervention Arm: Hatha Yoga
-
University of PittsburghNational Institutes of Health (NIH); National Center for Complementary and...CompletedObesity | Physical Activity | Weight Loss | Weight Change, BodyUnited States
-
University of MinnesotaThe John A. Hartford Foundation; St. Catherine University; Midwest Nursing Center...CompletedQuality of Life | Osteoarthritis, Knee | Poor Quality Sleep | Physical ImpairmentUnited States
-
University of MinnesotaCompleted
-
University of Texas at AustinCompleted
-
Universität Duisburg-EssenCompleted
-
Brown UniversityNational Center for Complementary and Integrative Health (NCCIH); Butler HospitalCompleted
-
Massachusetts General HospitalBrown UniversityCompletedDepression | Mood Disorders | Bipolar DisorderUnited States
-
Rob RutledgeNova Scotia Health Authority; Dalhousie University; IWK Health CentreCompleted
-
Southern Methodist UniversityCompletedDepression | Anxiety | Psychological Distress | Physiological StressUnited States