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Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders

Primary Purpose

Psychotic Disorder

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mindfulness-based group therapy
Treatment as usual
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-based group therapy (MBGT)

treatment as usual (TAU)

Arm Description

The mindfulness-based group therapy (MBGT) involves a four-week manual with three group therapy sessions per week in addition to TAU. The therapy represents the first German group-based mindfulness manual for psychosis. One sixty-minute session was held by a certified psychotherapist who is experienced in mindfulness-based therapy. A trained co-therapist implements two 30-minute sessions. On a weekly basis, a new theme is discussed in the three sessions to ensure the internalization of different mindfulness concepts. Namely, the topics Mindfulness of the Breath (1), Mindfulness of the Senses in the Context of Nature (2), Mindfulness of Detachment (3), and Mindfulness in the Context of Bodily Awareness (4) are addressed during the group-sessions.

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.

Outcomes

Primary Outcome Measures

mindfulness
The Freiburg Mindfulness Inventory (FMI) to measure mindfulness, 14 items on a scale from 1 - 4 (1 = seldom, 4 = almost always)
mindfulness
Comprehensive Inventory of mindfulness experience (CHIME, 37 items on a scale from 1 (almost never) to 6 (almost always)
mindfulness
Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)

Secondary Outcome Measures

broad cognitive functioning
CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia
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.
Symptom - Depression
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
Positive and Negative Syndrome Scale (PANSS) to assess symptoms on a scale from 1 (non-existent) to 7 (extremely severe, 14 questions
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)
cognitive fusion
Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always)
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)
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.

Full Information

First Posted
September 7, 2018
Last Updated
February 7, 2023
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03671005
Brief Title
Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders
Official Title
Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to covid restrictions the recruitment for this study has been paused after the feasibility and acceptability data was published.
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
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).
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based group therapy (MBGT)
Arm Type
Experimental
Arm Description
The mindfulness-based group therapy (MBGT) involves a four-week manual with three group therapy sessions per week in addition to TAU. The therapy represents the first German group-based mindfulness manual for psychosis. One sixty-minute session was held by a certified psychotherapist who is experienced in mindfulness-based therapy. A trained co-therapist implements two 30-minute sessions. On a weekly basis, a new theme is discussed in the three sessions to ensure the internalization of different mindfulness concepts. Namely, the topics Mindfulness of the Breath (1), Mindfulness of the Senses in the Context of Nature (2), Mindfulness of Detachment (3), and Mindfulness in the Context of Bodily Awareness (4) are addressed during the group-sessions.
Arm Title
treatment as usual (TAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based group therapy
Intervention Description
see above
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
see above
Primary Outcome Measure Information:
Title
mindfulness
Description
The Freiburg Mindfulness Inventory (FMI) to measure mindfulness, 14 items on a scale from 1 - 4 (1 = seldom, 4 = almost always)
Time Frame
6 months
Title
mindfulness
Description
Comprehensive Inventory of mindfulness experience (CHIME, 37 items on a scale from 1 (almost never) to 6 (almost always)
Time Frame
6 months
Title
mindfulness
Description
Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
broad cognitive functioning
Description
CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia
Time Frame
6 months
Title
personal and social performance
Description
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
4 weeks
Title
Symptom - Depression
Description
Calgary Depression-Scale for Schizophrenia measures depressive symptoms based on 9 items rated on a scale from absent to severe.
Time Frame
6 months
Title
symptomatology - positive and negative symptoms
Description
Positive and Negative Syndrome Scale (PANSS) to assess symptoms on a scale from 1 (non-existent) to 7 (extremely severe, 14 questions
Time Frame
4 weeks
Title
Symptoms - Depression and Anxiety
Description
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
6 months
Title
cognitive fusion
Description
Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always)
Time Frame
6 months
Title
psychological flexibility
Description
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)
Time Frame
6 months
Title
Quality of Life - domains assessed include physical and psychological health, social relationships and environment
Description
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
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
1220
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33434727
Citation
Boge K, Hahne I, Bergmann N, Wingenfeld K, Zierhut M, Thomas N, Ta TMT, Bajbouj M, Hahn E. Mindfulness-based group therapy for in-patients with schizophrenia spectrum disorders - Feasibility, acceptability, and preliminary outcomes of a rater-blinded randomized controlled trial. Schizophr Res. 2021 Feb;228:134-144. doi: 10.1016/j.schres.2020.12.008. Epub 2021 Jan 9.
Results Reference
derived
Links:
URL
http://www.cambridgecognition.com/cantab/
Description
app-based assessment

Learn more about this trial

Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders

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