Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Steglitz, State of Berlin, 1220, Germany
Location status: Recruiting
NCT Number: NCT04730518
A rater-blinded randomized controlled trial with a parallel-group design is utilized, comprised of yoga-based group intervention (YoGI) in the experimental condition, and treatment as usual (TAU) in the control condition. The participants in the experimental condition participate in YoGI 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 YoGI (T0), and after four weeks of taking part in intervention (T1).
Building on the results of the feasibility and acceptability trial, the study is now progressing to a full randomized controlled trial. The primary outcome for the full trial will be positive symptoms of schizophrenia spectrum disorders, assessed by a blinded rater using the Positive and Negative Syndrome Scale (PANSS). The target sample size has been adjusted to ensure sufficient statistical power, and the trial will evaluate secondary outcomes, including (body) mindfulness, negative symptoms, cognitive functioning, and quality of life, and stress. This study aims to provide robust evidence for the effectiveness of YoGI in comparison to treatment as usual (TAU).
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Steglitz, State of Berlin, 1220, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
see above
Time frame: 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)
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)
Time frame: 18 months
The number of eligible participants that are willing to participate in YoGI (recruitment)
Time frame: 18 months
Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)
Time frame: 18 months
Body Mindfulness Questionnaire (BMQ), 14 items on a scale from 1 (not at all) to (5) every day
Time frame: 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)
Time frame: 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. Different domains are rated on a scale from absent to highly severe.
Time frame: 18 months
Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always)
Time frame: 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.
Time frame: 18 months
CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia
Time frame: 18 months
Subjective Scale to Investigate Cognition (SSTICS), 21 items from a scale from 1 to 5.
Contact information is provided by the study sponsor or research team.
Eric Hahn, Dr.
CONTACT
Kerem Böge, Dr.
CONTACT
Charite University, Berlin, Germany
Other
Yoga-based Group Intervention for In-Patients With Schizophrenia Spectrum Disorder - a Rater-Blinded Randomized Controlled Trial
Acronym: YING
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05537376
Behavior, Behavioral Symptoms
San Diego, California, United States
View Trial DetailsNCT05962879
Anxiety Disorders, Depressive Disorder
Boston, Massachusetts, United States
View Trial DetailsNCT03525054
Diagnosis, Psychiatric, Mental Disorders
Brest, France
View Trial DetailsNCT05656469
Anxiety Disorders, Mental Disorders
Syracuse, New York, United States
View Trial Details