Yoga-based Group Therapy for In-patients With Schizophrenia Spectrum Disorders

Study Overview
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Brief Summary
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A rater-blinded randomized controlled trial with a parallel-group design is utilized, comprised of yoga-based group therapy (YBGT) in the experimental condition, and treatment as usual (TAU) in the control condition. The participants in the experimental condition participate in YBGT beside their regular psychiatric treatment (TAU). The intervention is designed for in-patients with schizophrenia spectrum disorders. With the aim of examining the feasibility, acceptability and effectiveness, self-report and blinded rater-based assessments are evaluated before the YBGT (T0), and after four weeks of taking part in intervention (T1).

Detailed Description
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Psychiatrists and psychologists at the ward for psychotic disorders identify eligible participants and invite them to participate in the study. An eligibility screening is held by the study assistant at baseline, introducing the study, providing informed electronic consent, as well as conducting the self-report measures and app-based assessments. A blinded psychologist who works independently of the (co-) psychologist conducts the remaining rater-questionnaires. Due to the psychotherapeutic nature of the study, information about the treatment allocation had to be shared with the co-psychologist and the participants. Saliva samples are also taken to examine stress-related biomarkers. Randomization was conducted by the Random Group Generator (pubmed, 2018). The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. The participants have the right to access their data, and the right to claim an annihilation. The data is being saved in an online database, only allowing researchers involved in the study to access the data.

Official Title
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Yoga-based Group Therapy for In-Patients With Schizophrenia Spectrum Disorder - Feasibility, Acceptability, and Preliminary Outcomes of a Rater-Blinded Randomized Controlled Trial

Conditions
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Psychotic Disorders

Intervention / Treatment
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* Behavioral: Yoga-based group therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female participants treated as psychiatric inpatients at the psychosis - or social-psychiatric day ward between 18 and 65 years of age diagnosis of a schizophrenia-spectrum disorder according to the Diagnostical and Statistical Manual 5th edition) and the International Statistical Classification of Diseases and Related Health Problems(ICD-10) code F2 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: a score ≥ 6, suggesting an acute psychotic episode with severe psychotic symptoms (Peralta& Cuesta, 1994) acute suicidality, assessed by item eight of the Calgary Depression Scale for Schizophrenia > 1 (Addington, Addington, Maticka-Tyndale, & Joyce, 1992) any neurological disorders that may affect cognitive functioning acute substance abuse other than nicotine and prescribed medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A rater-blinded randomized controlled trial with a parallel group design is used. The participants in the conditional group receive the usual treatment (TAU), while the experimental group receives yoga-based group therapy (YBGT) in addition to TAU.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga-based Group Therapy<br>The yoga-based group therapy (YBGT) involves a four-week intervention with weekly group therapy sessions in addition to TAU. The fifty-minute session takes place with a group size of max. 10 participants and was held once a week by a psychologist who is experienced in yoga-based therapy. A yoga session starts with breathing exercises (pranayama), followed by various exercises in standing, sitting and lying down (asanas), which are accompanied by mindful instructions from the psychologist. Every yoga session ends with a final relaxation (shavasana), which can take the form of a body scan, for example. | Behavioral: Yoga-based group therapy<br>* see above<br>|
| Active Comparator: Treatment as usual (TAU)<br>Treatment as usual (TAU) at the ward consists of a variety of daily activity groups the patients can choose from. Every patient at the ward receives a daily schedule depending on individual needs for therapy. The therapies offered at the ward include occupational therapy, physiotherapy, psychoeducative groups, and concentration practice of two levels, all not related to mindfulness interventions. In addition to the group activities at the ward, every patient receives individual psychotherapy sessions at least once a week, held by a certified psychiatrist or psychologist. Psychopharmacological treatment is provided by the physicians, and social workers are available in order to support patients in managing their everyday lives after the stationary treatment. Weekly group meetings at the ward, together with the treating physicians, psychotherapists, social workers and the respective patient, foster the exchange success and possible improvements of the treatment. | Behavioral: Yoga-based group therapy<br>* see above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of pp 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 pp willing to participate in YBGT (Operational Feasibility) | The number of eligible participants that are willing to participate in YBGT (recruitment) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SMQ Mindfulness | Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all) | 18 months | 
| BMQ Body Mindfulness | Body Mindfulness Questionnaire (BMQ), 14 items on a scale from 1 (not at all) to (5) every day | 18 months | 
| PANSS Symptomatology - Positive and Negative Symptoms | Positive and Negative Syndrome Scale (PANSS) to assess symptoms on a scale from 1 (non-existent) to 7 (extremely severe, 14 questions) | 18 months | 
| 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) | 18 months | 
| 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. Different domains are rated on a scale from absent to highly severe. | 18 months | 
| CFQ Cognitive Fusion | Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always) | 18 months | 
| 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. | 18 months | 
| CANTAB Broad Cognitive Functioning | CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia | 18 months | 
| SSTICS Subjective Cognitive Functioning | Subjective Scale to Investigate Cognition (SSTICS), 21 items from a scale from 1 to 5. | 18 months |