SCHIZOPHRENIA 1 (Disorder)NCT07454200
Feasibility, Acceptability, and Effectiveness of a Hatha Yoga-in Patients Hospitalized for Schizophrenia
A study testing Intervention Arm: Hatha Yoga in people with SCHIZOPHRENIA 1 (Disorder) and Hospitalized Adult Patients, run by The Hashemite University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder), Hospitalized Adult Patients
- What is being tested?
- Intervention Arm: Hatha Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Intervention Arm: Hatha Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Arm: Hatha YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Hatha Yoga-Based Group Intervention Receives: Behavioral: Intervention Arm: Hatha Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Feasibility Indicators: Recruitment Retention Attrition Adherence Data completeness Adverse events.
- 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.
- Retention rate: Percentage of enrolled participants who complete the week 10 assessment, calculated as completers divided by total enrolled at baseline, multiplied by 100.
- Attrition rate: Percentage of participants who withdraw before week 10, calculated as discontinuations divided by total enrolled, multiplied by 100.
- Adherence: Attendance rate across scheduled sessions, calculated as sessions attended divided by total sessions, multiplied by 100.
- 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.
- Adverse events: Number and proportion of participants experiencing adverse events during the intervention period.
Measured: 10 weeks
Secondary outcomes (1)
The 18-item Tripartite Adjusted Arabic Reminiscence Functions Scale (AARFS-tri)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hashemite University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Abu Khait, The Hashemite University
- Investigators
- Abdallah Abu Khait, Ph.D.,MSN, Principal investigator, The Hashemite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454200
- Sponsor's protocol ID
- 17/4/2024/2025
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Effectiveness of a Hatha Yoga-on Reminiscence Functions and Mindfulness in Patients Hospitalized for Schizophrenia
- ClinicalTrials.gov ID
- NCT07454200
- Acronym / sponsor ID
- 17/4/2024/2025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Hashemite UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Intervention Arm: Hatha YogaHatha Yoga-Based Group Intervention |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Arm: Hatha YogaHatha 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. | Behavioural | Experimental |
Primary outcome
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.
Feasibility Indicators: Recruitment Retention Attrition Adherence Data completeness Adverse events.
Time frame: 10 weeks
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.
1 secondary outcome
The 18-item Tripartite Adjusted Arabic Reminiscence Functions Scale (AARFS-tri)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abdallah Abu Khait, Ph.D.,MSN principal investigator
The Hashemite University
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm: Hatha Yoga in people with SCHIZOPHRENIA 1 (Disorder) and Hospitalized Adult Patients, run by The Hashemite University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdallah F Abu Khait, Ph.D, MSN (+962792269831, abdallah.abukhait@hu.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Five-Facet Mindfulness Questionnaire-15 (FFMQ-15) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.