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

NCT07455929 | Recruiting

• 1 other identifier: YOGIA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Psychotic Disorders; Schizophrenia Spectrum Disorders

Outcome Measures

Primary Outcomes (2)

• 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)

  18 months

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

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

  18 months

Secondary Outcomes (11)

• PANSS Symptomatology - Positive and Negative Symptoms

  18 months

• SMQ Mindfulness

  18 months

• BMQ Body Mindfulness

  18 months

• DASS Symptoms - Depression and Anxiety

  18 months

• CDSS Calgary Depression Scale for Schizophrenia

  18 months

Study Arms (3)

Experimental: Yoga-based Group Intervention (YoGI)

EXPERIMENTAL

It 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.

Behavioral: Yoga-based Group Intervention (YoGI) and treatment as usual (TAU)

Active Comparator: Strength and Flexibility Training (SFT) and TAU

ACTIVE COMPARATOR

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.

Behavioral: Strength and Flexibility Training (SFT) and TAU

No Intervention: Treatment as usual

NO INTERVENTION

Participants 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.

Interventions

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

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.

Experimental: Yoga-based Group Intervention (YoGI)

Strength and Flexibility Training (SFT) and TAU BEHAVIORAL

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.

Active Comparator: Strength and Flexibility Training (SFT) and TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte

Berlin, 10117, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 36824673 BACKGROUND

• 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.

  PMID: 39550215 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Kerem Böge, Prof. Dr. Dr.

CONTACT

+4930450517319; kerem.boege@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments are conducted by a blinded psychologist or psychiatrist who is independent of the study therapists. Due to the psychotherapeutic nature of the interventions, treatment allocation cannot be concealed from participants or care providers. Randomization is performed using a block randomization procedure with a block size of four, generated in Microsoft Excel to ensure balanced group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)