NCT07454200

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

February 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 6, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 27, 2026

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Five-Facet Mindfulness Questionnaire-15 (FFMQ-15)

    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.

    1. Recruitment rate: Percentage of eligible participants enrolled during the 10-week recruitment period, calculated as the number who provide written consent divided by the total eligible participants approached, multiplied by 100. 2. Retention rate: Percentage of enrolled participants who complete the week 10 assessment, calculated as completers divided by total enrolled at baseline, multiplied by 100. 3. Attrition rate: Percentage of participants who withdraw before week 10, calculated as discontinuations divided by total enrolled, multiplied by 100. 4. Adherence: Attendance rate across scheduled sessions, calculated as sessions attended divided by total sessions, multiplied by 100. 5. Data completeness: Percentage of completed outcome assessment items at baseline and week 10, calculated as completed items divided by total expected items, multiplied by 100. 6. Adverse events: Number and proportion of participants experiencing adverse events during the intervention period.

    10 weeks

Secondary Outcomes (1)

  • The 18-item Tripartite Adjusted Arabic Reminiscence Functions Scale (AARFS-tri)

    12 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Hatha Yoga-Based Group Intervention

Behavioral: Intervention Arm: Hatha Yoga

Interventions

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.

Experimental

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Abdallah Abu Khait, Ph.D.,MSN

    The Hashemite University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdallah F Abu Khait, Ph.D, MSN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 6, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

March 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share