Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders

Psychotic Disorder Clinical Trial

Official title:

Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03671005
• Other study ID #: APS2018
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorder
• Psychotic Disorders
• Schizophrenia

Intervention

Behavioral:
• Mindfulness-based group therapy
see above

Other:
• Treatment as usual
see above

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mindfulness	The Freiburg Mindfulness Inventory (FMI) to measure mindfulness, 14 items on a scale from 1 - 4 (1 = seldom, 4 = almost always)	6 months
Primary	mindfulness	Comprehensive Inventory of mindfulness experience (CHIME, 37 items on a scale from 1 (almost never) to 6 (almost always)	6 months
Primary	mindfulness	Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)	6 months
Secondary	broad cognitive functioning	CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia	6 months
Secondary	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.	4 weeks
Secondary	Symptom - Depression	Calgary Depression-Scale for Schizophrenia measures depressive symptoms based on 9 items rated on a scale from absent to severe.	6 months
Secondary	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	4 weeks
Secondary	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)	6 months
Secondary	cognitive fusion	Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always)	6 months
Secondary	psychological flexibility	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)	6 months
Secondary	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.	6 months

External Links

•   app-based assessment