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Psychotic DisordersYOGIANCT07455929

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

A study testing Yoga-based Group Intervention (YoGI) and treatment as usual (TAU) and Strength and Flexibility Training (SFT) and TAU in people with Psychotic Disorders and Schizophrenia Spectrum Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A three-arm pilot rater-blinded randomized controlled trial is conducted, comprising Yoga-based Group Intervention (YoGI + TAU) as the experimental condition, a strength and flexibility training (SFT + TAU) group, and treatment as usual (TAU). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Yoga-based Group Intervention (YoGI) and treatment as usual (TAU) and Strength and Flexibility Training (SFT) and TAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGermany
Study dates
Mar 2026to Mar 2028
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Schizophrenia Spectrum Disorder by previous (medical) reports according to ICD-10/ DSM-V
  • Treated as psychiatric outpatients
  • Age between 18 and 65 years
  • Ability to give informed consent
  • Willingness and ability to engage in psychotherapeutic group therapy
  • Low to moderate psychotic state indicated with a score of ≤ 6 for each item at the Positive scale of the Positive and Negative Syndrome Scale (PANSS, Peralta \& Cuesta, 1994)

Who cannot join

  • Neurological disorders and history of severe traumatic brain injury in the past that may affect cognitive functioning
  • Acute substance dependence, excluding nicotine and prescribed medication
  • PANSS-P score on one item > 6 (= very severe)
  • Ineligibility for group participation
  • Acute suicidality, indicated by a score > 1 on item 8 of the Calgary Depression Scale for Schizophrenia (Addington, Addington, Maticka-Tyndale, \& Joyce, 1992)
  • Conflicting co-therapy such as electroconvulsive therapy or ketamine treatment as well as intensive psychotherapy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kerem Böge, Prof. Dr. Dr. contact

+4930450517319

kerem.boege@charite.de

Germany1 site, 1 recruiting
  • Charité - Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte

    Berlin, 10117

    Kerem Böge, Prof. Dr. Dr., +4930450517319, kerem.boege@charite.de

    Recruiting

Other trials in Germany

About this study

Official title: Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders (YOGIA Study) - a Three-arm, Single-blind Randomized Controlled Pilot Study

A three-arm pilot rater-blinded randomized controlled trial is conducted, comprising Yoga-based Group Intervention (YoGI + TAU) as the experimental condition, a strength and flexibility training (SFT + TAU) group, and treatment as usual (TAU). Participants in all conditions receive the respective intervention in addition to treatment as usual (TAU) in outpatient settings in Germany. The interventions are designed for patients with schizophrenia spectrum disorders. To examine feasibility, acceptability, and preliminary efficacy, self-report measures and blinded rater-based assessments are administered at baseline (T0), after 12 weeks of participation (T1), and at a 3-month follow-up (T2). Before each intervention session, acute stress (general stress and symptom-related distress) is measured using a visual analogue scale. After each intervention session, acute stress (general stress and symptom-related distress; visual analogue scale), perceived effort (BORG-RPE-Scale), and the occurrence of unpleasant experiences are recorded via self-report, while instructors rate exercise performance and overall participation quality. In addition, semi-structured interviews are conducted at T0 and T1 to assess subjective mechanisms of change and relevant processes.

The primary outcomes of this trial are the feasibility and acceptability of YoGI and the SFT, assessed through recruitment and retention rates, adherence, and participant feedback. Based on recommendations for pilot studies of 20-50 participants, a conservative target sample size of 60 patients was determined. Further, the trial will evaluate secondary outcomes, including (body) mindfulness (SMQ, BMQ), symptoms of depression, anxiety, and stress (DASS, CDSS), positive and negative symptomatology (PANSS), psychological flexibility (CFQ), psychological well-being (WHO-QoL-BREF), social functioning (PSP), subjectively perceived cognitive functioning (SSTICS), and physical activity (SIMPAQ). This study aims to provide preliminary evidence for the efficacy of YoGI in comparison to both SFT and a TAU, and to establish a foundation for a future fully powered randomized controlled trial.

Read the detailed description

Patients are recruited across Berlin through psychiatric outpatient departments, the outpatient clinics of Charité, and social media. Recruitment occurs either through direct approach by psychologists or psychotherapists in training, or via informational posters and flyers. At baseline, eligibility screening is conducted by a blinded psychologist who is independent of the intervention delivery. This psychologist introduces the study, obtains electronic informed consent, and administers the self-report and clinician-rated assessments.

Given the behavioral nature of the interventions, participants and therapists are informed about group allocation after randomization. Randomization is performed using an Excel-generated list with block randomization (block size = 4).

Data management adheres to standard data protection procedures, including the use of anonymized identification codes and secure storage in an online database accessible only to authorized research team members. Participants retain the right to access their data and to request its deletion at any time. Upon completion of the study, each participant will receive compensation of 50 €.

Being tested
Yoga-based Group Intervention (YoGI) and treatment as usual (TAU), Strength and Flexibility Training (SFT) and TAU
Medical subject headings
Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga-based Group Intervention (YoGI) and treatment as usual (TAU)Behavioural

    YoGI combines breathing exercises (pranayama), sitting, standing and lying positions (asanas), as well as relaxation techniques (shavasana). Participation is also possible from a chair, thereby ensuring accessibility for all patients, irrespective of their physical condition. The 50-minute Yoga-based Group Intervention sessions are conducted once a week over a period of 12 weeks by psychologists or psychotherapists in training who have obtained supplementary certification in yoga therapy. Additionally, study participants receive the standard outpatient care (TAU) provided in Germany.

  • Strength and Flexibility Training (SFT) and TAUBehavioural

    The SFT intervention is delivered once weekly over a 12-week period. Each 50-minute group session comprises a brief warm-up with mobilization and preparatory exercises, a main phase focused on full-body strengthening and flexibility exercises, and a concluding stretching segment. Participation is also possible from a chair, thereby ensuring accessibility for all patients, irrespective of their physical condition. Sessions are conducted by qualified psychologists or psychotherapists in training in a designated sports facility. The SFT sessions are designed by a psychotherapist in training who has obtained supplementary certification in yoga therapy together with sport therapists.

Study groups in NCT07455929
Study groupRoleWhat they receive
Experimental: Yoga-based Group Intervention (YoGI)ExperimentalIt combines breathing exercises (pranayama), sitting, standing and lying positions (asanas), as well as relaxation techniques (shavasana). Participation is also possible from a chair, thereby ensuring accessibility for all patients, irrespective of their physical condition. The 50-minute Yoga-based Group Intervention sessions are conducted once a week over a period of 12 weeks by psychologists or psychotherapists in training who have obtained supplementary certification in yoga therapy. Additionally, study participants receive the standard outpatient care (TAU) provided in Germany.
Receives: Behavioral: Yoga-based Group Intervention (YoGI) and treatment as usual (TAU)
Active Comparator: Strength and Flexibility Training (SFT) and TAUActive comparatorThe SFT intervention is delivered once weekly over a 12-week period. Each 50-minute group session comprises a brief warm-up with mobilization and preparatory exercises, a main phase focused on full-body strengthening and flexibility exercises, and a concluding stretching segment. Participation is also possible from a chair, thereby ensuring accessibility for all patients, irrespective of their physical condition. Sessions are conducted by qualified psychologists or psychotherapists in training in a designated sports facility. The SFT sessions are designed by a psychotherapist in training who has obtained supplementary certification in yoga therapy together with sport therapists.
Receives: Behavioral: Strength and Flexibility Training (SFT) and TAU
No Intervention: Treatment as usualNo interventionParticipants assigned to this group receive treatment as usual (TAU) for 12 weeks. During this period, there is no contact, except for a follow-up at 8 weeks to inform them about the next steps for T1.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants receiving threshold dose (Acceptability)

    The proportions of participants receiving a threshold dose of the intervention (50% or more) and the proportion of participants with outcome measures at post-intervention and data completion. (Adherence and retention rate)

    Measured: 18 months

  2. Nr. of participants willing to participate in YoGI (Operational Feasibility)

    The number of eligible participants that are willing to participate in YoGI (recruitment)

    Measured: 18 months

Secondary outcomes (11)
  1. PANSS Symptomatology - Positive and Negative Symptoms

    Positive Symptoms as measure by the Positive and Negative Syndrome Scale (PANSS) to assess symptoms on a scale from 1 (non-existent) to 7 (extremely severe, 14 questions)

    Measured: 18 months

  2. SMQ Mindfulness

    Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)

    Measured: 18 months

  3. BMQ Body Mindfulness

    Body Mindfulness Questionnaire (BMQ), 14 items on a scale from 1 (not at all) to (5) every day.

    Measured: 18 months

  4. DASS Symptoms - Depression and Anxiety

    Depression Anxiety Stress Scales (DASS), 21 questions that can be answered on a scale from 0 (does not apply to me) to 3 (applies to me strongly/most of the time

    Measured: 18 months

  5. CDSS Calgary Depression Scale for Schizophrenia

    Calgary Depression Scale for Schizophrenia (CDSS), 9 items assessing depressive symptoms in schizophrenia, designed to minimize overlap with negative symptoms commonly observed in schizophrenia; each item rated on a scale from 0 (absent) to 3 (severe).

    Measured: 18 months

  6. PSP Personal and Social Performance

    Personal and Social Performance Scale (PSP), Interview measures personal and social functioning in the domains of: Socially useful activities (eg. work and study), Personal and social relationships, Self-care, Disturbing and aggressive behaviors. The scale compromises four domains/items rated on a scale from absent to highly severe.

    Measured: 18 months

  7. CFQ Cognitive Fusion

    Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always)

    Measured: 18 months

  8. WHO-QOL-Bref Quality of Life - domains assessed include physical and psychological health, social relationships and environment

    World Health Organisation Quality of Life (WHO-QOL-Bref) to assess quality of life measured on a scale from 1 (never) to 5 (always). Facets incorporated in the 4 domains: 1. Physical health - Activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility Pain and discomfort, Sleep and rest, Work Capacity; 2. Psychological - Bodily image and appearance, Negative feelings, Positive feelings, Self-esteem, Spirituality / Religion / Personal beliefs, Thinking, learning, memory and concentration; 3. Social relationships - Personal relationships Social support, Sexual activity; 4. Environment - Financial resources, Freedom, physical safety and security, Health and social care: accessibility and quality, Home environment, Opportunities for acquiring new information and skills, Participation in and opportunities for recreation / leisure activities, Physical environment (pollution / noise / traffic / climate), Transport

    Measured: 18 months

  9. SSTICS Subjective Scale to Investigate Cognition in Schizophrenia

    Simple Physical Activity Questionnaire (SIMPAQ), 5 items assessing physical activity and sedentary behavior in populations with severe mental illness. Covers time spent in bed, sedentary time, walking, structured exercise, and incidental activity. Responses are reported in minutes per day over the past seven days.

    Measured: 18 months

  10. Visual Analogue Scales ("Bubbles")

    Visual Analogue Scale with 'Bubbles', 4 self-report items represented by bubbles of increasing size, indicating different levels of general stress and symptom-related distress.

    Measured: During the intervention (12 weeks)

  11. BORG-RPE-Scale

    Self-report rating scale of perceived exertion that quantifies the subjective intensity of physical effort during activity. The scale ranges from 6 ("no exertion") to 20 ("maximal exertion").

    Measured: During the intervention (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A rater-blinded randomized controlled trial with a parallel-group design is conducted. Participants are allocated to one of three groups: one control group receives treatment as usual (TAU), a second control group receives strength and flexibility training (SFT) in addition to TAU, and the experimental group receives a yoga-based group intervention (YoGI) in addition to TAU.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07455929
Sponsor's protocol ID
YOGIA
Acronym
YOGIA
Status last verified
Mar 2026
First submitted
3 Mar 2026
Last updated
11 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tobelmann L, Hahne I, Schulze T, Bergmann N, Fuchs L, Zierhut M, Hahn E, Boge K. Mechanisms of action and processes of yoga-based group intervention for inpatients with schizophrenia spectrum disorders-A longitudinal qualitative study. Front Psychiatry. 2023 Feb 7;14:1086468. doi: 10.3389/fpsyt.2023.1086468. eCollection 2023.

    PubMed 36824673
  • Hahne I, Zierhut M, Bergmann N, Hahn E, Ta TMT, Calvano C, Bajbouj M, Boge K. Yoga-Based Group Intervention for Inpatients with Schizophrenia Spectrum Disorders-Feasibility, Acceptability, and Preliminary Outcomes of a Rater-Blinded Randomized Controlled Trial. Schizophr Bull. 2026 Jan 16;52(1):sbae198. doi: 10.1093/schbul/sbae198.

    PubMed 39550215

Questions about this trial

What is this clinical trial studying?

A study testing Yoga-based Group Intervention (YoGI) and treatment as usual (TAU) and Strength and Flexibility Training (SFT) and TAU in people with Psychotic Disorders and Schizophrenia Spectrum Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.

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 6 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Kerem Böge, Prof. Dr. Dr. (+4930450517319, kerem.boege@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants receiving threshold dose (Acceptability) (time frame: 18 months). 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?

On the ClinicalTrials.gov record for NCT07455929, which also lists 2 linked publications.

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 11 Mar 2026.

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