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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Proportion of participants receiving threshold dose (Acceptability)
Overview
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.
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 €.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
Experimental: Yoga-based Group Intervention (YoGI)
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.
Intervention: Yoga-based Group Intervention (YoGI) and treatment as usual (TAU) (Behavioral)
Active Comparator: Strength and Flexibility Training (SFT) and TAU
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.
Intervention: Strength and Flexibility Training (SFT) and TAU (Behavioral)
No Intervention: Treatment as usual
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.
Outcomes
Primary Outcomes
Proportion of participants receiving threshold dose (Acceptability)
Time Frame: 18 months
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)
Nr. of participants willing to participate in YoGI (Operational Feasibility)
Time Frame: 18 months
The number of eligible participants that are willing to participate in YoGI (recruitment)
Secondary Outcomes
- 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)
- PSP Personal and Social Performance(18 months)
- CFQ Cognitive Fusion(18 months)
- WHO-QOL-Bref Quality of Life - domains assessed include physical and psychological health, social relationships and environment(18 months)
- SSTICS Subjective Scale to Investigate Cognition in Schizophrenia(18 months)
- Visual Analogue Scales ("Bubbles")(During the intervention (12 weeks))
- BORG-RPE-Scale(During the intervention (12 weeks))
Investigators
Kerem Böge
Prof. Dr. Dr.
Charite University, Berlin, Germany