Psychotic Disorder
Conditions
Brief summary
A single-centered randomized controlled trial with a parallel-groups design is utilized, comprised of mindfulness-based group therapy (MBGT) in the experimental condition, and treatment as usual (TAU) in the control condition. Participants in the experimental condition continued their regular psychiatric treatment (TAU) next to the participation in the MBGT. In order to evaluate possible psychotherapeutic effects, self-report and other clinical questionnaires including interviews and app-based assessments are evaluated before (T0), and after the four-week intervention (T1). Ward psychiatrists 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 consent in written form, as well as conducting the self-report measures and app-based assessments. A blinded psychiatrist who works independently of the (co-) therapist 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-therapist and the participants. 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 stored in locked cupboards, only allowing researchers involved in the study to access the data.
Interventions
BEHAVIORALMindfulness-based group therapy
see above
OTHERTreatment as usual
see above
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A blinded psychiatrist who works independently of the (co-) therapist conducts the rater-questionnaires. Due to the psychotherapeutic nature of the study, information about the treatment allocation has to be shared with the co-therapist and the participants. Randomization is conducted by the Random Group Generator (pubmed, 2018).
Intervention model description
A single-centered randomized controlled trial with a parallel-groups design is utilized, comprising of mindfulness-based group therapy (MBGT) in addition to treatment as usual (TAU) in the experimental condition, and TAU in the control condition
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mindfulness | 6 months | The Freiburg Mindfulness Inventory (FMI) to measure mindfulness, 14 items on a scale from 1 - 4 (1 = seldom, 4 = almost always) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| personal and social performance | 4 weeks | 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. |
| Symptom - Depression | 6 months | Calgary Depression-Scale for Schizophrenia measures depressive symptoms based on 9 items rated on a scale from absent to severe. |
| symptomatology - positive and negative symptoms | 4 weeks | Positive and Negative Syndrome Scale (PANSS) to assess symptoms on a scale from 1 (non-existent) to 7 (extremely severe, 14 questions |
| broad cognitive functioning | 6 months | CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia |
| cognitive fusion | 6 months | Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always) |
| psychological flexibility | 6 months | Acceptance and Action Questionnaire (AAQ-II) measures psychological flexibility. 7 questions that can be measured on a scale from 1 (never true) to 7 (always true) |
| Quality of Life - domains assessed include physical and psychological health, social relationships and environment | 6 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. |
| Symptoms - Depression and Anxiety | 6 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) |
Countries
Germany
Outcome results
None listed