Psychotic Disorders, Schizophrenia Spectrum Disorders
Conditions
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 €.
Interventions
BEHAVIORALYoga-based Group Intervention (YoGI) and treatment as usual (TAU)
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.
BEHAVIORALStrength 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.
Sponsors
Charite University, Berlin, Germany
Study design
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants receiving threshold dose (Acceptability) | 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) | 18 months | The number of eligible participants that are willing to participate in YoGI (recruitment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PANSS Symptomatology - Positive and Negative Symptoms | 18 months | 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) |
| SMQ Mindfulness | 18 months | Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all) |
| BMQ Body Mindfulness | 18 months | Body Mindfulness Questionnaire (BMQ), 14 items on a scale from 1 (not at all) to (5) every day. |
| DASS Symptoms - Depression and Anxiety | 18 months | 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 |
| CDSS Calgary Depression Scale for Schizophrenia | 18 months | 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). |
| PSP Personal and Social Performance | 18 months | 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. |
| CFQ Cognitive Fusion | 18 months | Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always) |
| WHO-QOL-Bref Quality of Life - domains assessed include physical and psychological health, social relationships and environment | 18 months | 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 |
| SSTICS Subjective Scale to Investigate Cognition in Schizophrenia | 18 months | 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. |
| Visual Analogue Scales ("Bubbles") | During the intervention (12 weeks) | 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. |
| BORG-RPE-Scale | During the intervention (12 weeks) | 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"). |
Countries
Germany
Contacts
CONTACTKerem Böge, Prof. Dr. Dr.
Outcome results
None listed