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Intervention to Improve Coping With Negative Emotions in Patients With Psychosis (Feel-Good-Study)

Primary Purpose

Early Psychosis, Delusions, Emotional Distress

Status
Completed
Phase
Early Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Feel-Good- Group
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Psychosis focused on measuring Psychosis, Cognitive behavioral therapy, Group therapy, targeted therapy, emotion regulation, emotional stability

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder, bipolar disorder with psychotic symptoms using the International Classification of Diseases-10 (ICD-10 (Codes: F 20.x, F21.x, F22.x, F 23.x, F 25, F30.x, F 31.x ) verified by the Structured Clinical Interview for Diagnostic and Statistical Manual for Mental Disorders 5-Clinical Version (SCID-5-CV) Beesdo-Baum et al., 2019) transformed to ICD-10.
  • first psychotic episode in the last five years
  • written informed consent provided by patient or legal guardian
  • estimated verbal intelligence of at least 80 IQ-scores estimated with the German Mehrfachwahlwortschatztest (MWT-B, Lehrl et al., 2005)

Exclusion Criteria:

  • acute suicidality
  • diagnosis of dementia (verified by the SCID-5-CV interview and patient documentation)

Sites / Locations

  • University of Marburg, Faculty of Clinical Psychology and Psychotherapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feel-Good-Group

Arm Description

Pre-post assessment of feasibility and putative efficacy of an emotion-oriented cognitive-behavioral group intervention over 8 sessions and four weeks.

Outcomes

Primary Outcome Measures

Goal attainment scale (GAS, Kiresuk & Sherman, 1968)
Patients select in an individual session with their therapist their most important therapy goal and mark on a scale from 0-100, whether it is reached at the present day. The mean score will be used (range between 0 and 100 with higher scores indicating higher values)
Positive and Negative Scale Total score (Kay et al., 1992)
Interview to assess positive symptoms, negative symptoms and general psychopathology in the last week. Range 30-210 with higher scores indicating more pronounced distress.

Secondary Outcome Measures

Psychotic Symptoms Rating Scale delusions subscale (PSYRATS, Haddock et al., 1999)
Interview to assess present delusions and hallucinations, the related distress, conviction rate, frequency and problems in daily life caused by the symptoms. Range 0 - 28 with higher scores indicating more pronounced delusions
Calgary Depression Scale for Schizophrenia (CDSS; Mueller et al., 1999)
Interview to assess depressive symptoms. Range between 0 and 44 with higher scores indicating more pronounced depressive symptoms.
Peters et al, Delusions Inventory (PDI; Lincoln, Keller & Rief, 2009)
Self-report questionnaire assessing endorsement of 21 delusions, frequency, distress and conviction rate in the last week. Grand total score, range between 0 and 312 with higher scores indicating more pronounced self-rated delusions.
Role Functioning Scale (RFS; Goodman et al., 1999)
Interview to assess role functioning, number of close relationship, community integration, work integration and community integration. Mean score of all four scores: range between 0 and 12 with higher scores indicating more pronounced functioning.
Paranoia checklist (Freeman et al., 2005)
Self-report assessment of persecutory delusions, frequency, distress and conviction. The total score will be used, range between 0 and 270 with higher scores indicating more pronounced paranoid symptoms.
Emotion Regulation Skills Questionnaire (ERSQ; Berking & Znoj, 2008)
Self-reported assessment of emotion regulation skills (e.g. mindfulness, suppression), Total score: range between 0 and 108 with higher scores indicating more elaborated emotion regulation skills.
Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
Self-reported assessment of emotion regulation skills (e.g. cognitive restructuring). The total score will be used (range 10-70) with higher scores indicating more pronounced emotion regulation skills.
Emotion Regulation Inventory (ERI; Koenig, 2011)
Self-reported assessment of emotion regulation skills (e.g. distraction). The total score will be used (range between 10 and 70 with higher scores indicating more pronounced emotion regulation skills.
Rosenberg Self-Esteem Scale (RSE; Collani & Herzberg, 2003)
Self-reported assessment of global self-worth and self-esteem. The total score will be used (range between 0-30) with higher scores indicating good self-esteem.
Beliefs About Stress Scale (BASS; Laferton et al., 2016)
Self-reported assessment of illness perception. The negative stress beliefs score will be used (range between 0 and 32) with higher scores indicating more pronounced negative beliefs about stress.
Feasibility and acceptance of therapy (Lincoln et al., 2012)
Self-reported assessment of feasibility and acceptability of the intervention.

Full Information

First Posted
October 13, 2020
Last Updated
May 1, 2022
Sponsor
Philipps University Marburg Medical Center
Collaborators
Prof. Dr. Andreas Bechdolf (Chair of hospital), Vivantes Hospital Am Urban Berlin, Prof. Dr. Nikola Stenzel (Collaboration partner), Berlin Psychological University, Berlin, Dr. Karolina Leopold (Senior physician), Vivantes Hospital Am Urban Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT04592042
Brief Title
Intervention to Improve Coping With Negative Emotions in Patients With Psychosis (Feel-Good-Study)
Official Title
Intervention to Improve Coping With Negative Emotions in Patients With Psychotic Disorders: Feasibility and Efficacy of an Emotion-oriented Cognitive-behavioural Group Intervention ("Feel-Good-Group").
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
Prof. Dr. Andreas Bechdolf (Chair of hospital), Vivantes Hospital Am Urban Berlin, Prof. Dr. Nikola Stenzel (Collaboration partner), Berlin Psychological University, Berlin, Dr. Karolina Leopold (Senior physician), Vivantes Hospital Am Urban Berlin

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
The aim of the present single-centered pre-post study is to assess the feasibility and to investigate the putative efficacy of an emotion-oriented group intervention for patients with psychosis. Patients with early psychosis in an inpatient unit receive a manualized group intervention focussing on emotional stability and emotion regulation (8 weekly sessions). Assessment will be performed at pre-therapy, post-therapy (after eight sessions and four weeks) and after a follow-up period of 12 weeks (8 weeks post therapy) and includes personal therapy goals and their realization, psychopathology, social functioning and emotion regulation skills as a putative mediator of change.
Detailed Description
The aim of the present single-centered pre-post study is to assess the feasibility and to investigate the putative efficacy of an emotion-oriented cognitive-behavioral group intervention for patients with psychosis. Patients with psychosis in an inpatient unit are informed on the study and written consent is obtained. At start of therapy, psychopathological interviews and self-report questionnaires are performed. Participants are reassessed after the intervention of 8 sessions (approximately 8 weeks) and after a follow-up period of 8 additional weeks). Patients are enrolled in a manualized group therapy over 8 sessions including 7 modules. In the first session, group rules are obtained and individual therapy goals are elaborated and developed for each patient. In the next seven sessions, in each session a new module is presented to the patient and the skills are trained in training sessions and role plays. Module 1 informs on emotions and their role in mental health, module 2 informs on techniques/skills in order to cope with negative emotions more generally. In module 3, mindfulness is presented as a technique to reduce the impact of negative emotions on the patients' life and practised. In module 4, patients learn skills on how to reduce their vulnerability for negative emotions in general. In Module 5, patients learn skills on how to cope with anger, Module 6 teaches skills on how to cope with guilt and shame, Module 7 is presented in the last session and includes skills on how to improve general emotional stability and to prevent relapse. Training: Therapists are psychologists or psychiatrists that are currently in postgraduate training of Cognitive Behavior Therapy and received 8 sessions of additional training by the study PI. Primary outcome variables are attainment of the individual therapy goals of the patient (Goal Attainment Scale) and reduced general psychopathology (PANSS total score) after 8 sessions therapy. Secondary outcomes are depressive symptoms (Calgary Depression Scale for Schizophrenia), social functioning (Role functioning scale), self-reported delusions (Peters et al. delusions inventory), self-reported persecutory delusions (Paranoia checklist), emotion regulation skills (Emotion Regulation Skills Questionnaire, Emotion regulation questionnaire, Emotion Regulation Inventory), self-esteem (Rosenberg Self-esteem Questionnaire) and the Beliefs About Stress Scale (BASS). Furthermore, patients are asked to assess feasibility and acceptance of the group intervention. Emotion regulation skills and self-esteem are also tested as putative mediators of change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Psychosis, Delusions, Emotional Distress, Self Esteem
Keywords
Psychosis, Cognitive behavioral therapy, Group therapy, targeted therapy, emotion regulation, emotional stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
A single group of patients will be enrolled in the study.
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feel-Good-Group
Arm Type
Experimental
Arm Description
Pre-post assessment of feasibility and putative efficacy of an emotion-oriented cognitive-behavioral group intervention over 8 sessions and four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Feel-Good- Group
Other Intervention Name(s)
Emotion-oriented version of Cognitive Behavior Therapy for psychosis in group format for inpatients with psychosis
Intervention Description
Eight sessions of group intervention focussing on information on emotion regulation, training of emotion regulation techniques and mindfulness.
Primary Outcome Measure Information:
Title
Goal attainment scale (GAS, Kiresuk & Sherman, 1968)
Description
Patients select in an individual session with their therapist their most important therapy goal and mark on a scale from 0-100, whether it is reached at the present day. The mean score will be used (range between 0 and 100 with higher scores indicating higher values)
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Positive and Negative Scale Total score (Kay et al., 1992)
Description
Interview to assess positive symptoms, negative symptoms and general psychopathology in the last week. Range 30-210 with higher scores indicating more pronounced distress.
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Secondary Outcome Measure Information:
Title
Psychotic Symptoms Rating Scale delusions subscale (PSYRATS, Haddock et al., 1999)
Description
Interview to assess present delusions and hallucinations, the related distress, conviction rate, frequency and problems in daily life caused by the symptoms. Range 0 - 28 with higher scores indicating more pronounced delusions
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Calgary Depression Scale for Schizophrenia (CDSS; Mueller et al., 1999)
Description
Interview to assess depressive symptoms. Range between 0 and 44 with higher scores indicating more pronounced depressive symptoms.
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Peters et al, Delusions Inventory (PDI; Lincoln, Keller & Rief, 2009)
Description
Self-report questionnaire assessing endorsement of 21 delusions, frequency, distress and conviction rate in the last week. Grand total score, range between 0 and 312 with higher scores indicating more pronounced self-rated delusions.
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Role Functioning Scale (RFS; Goodman et al., 1999)
Description
Interview to assess role functioning, number of close relationship, community integration, work integration and community integration. Mean score of all four scores: range between 0 and 12 with higher scores indicating more pronounced functioning.
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Paranoia checklist (Freeman et al., 2005)
Description
Self-report assessment of persecutory delusions, frequency, distress and conviction. The total score will be used, range between 0 and 270 with higher scores indicating more pronounced paranoid symptoms.
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Emotion Regulation Skills Questionnaire (ERSQ; Berking & Znoj, 2008)
Description
Self-reported assessment of emotion regulation skills (e.g. mindfulness, suppression), Total score: range between 0 and 108 with higher scores indicating more elaborated emotion regulation skills.
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
Description
Self-reported assessment of emotion regulation skills (e.g. cognitive restructuring). The total score will be used (range 10-70) with higher scores indicating more pronounced emotion regulation skills.
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Emotion Regulation Inventory (ERI; Koenig, 2011)
Description
Self-reported assessment of emotion regulation skills (e.g. distraction). The total score will be used (range between 10 and 70 with higher scores indicating more pronounced emotion regulation skills.
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Rosenberg Self-Esteem Scale (RSE; Collani & Herzberg, 2003)
Description
Self-reported assessment of global self-worth and self-esteem. The total score will be used (range between 0-30) with higher scores indicating good self-esteem.
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Beliefs About Stress Scale (BASS; Laferton et al., 2016)
Description
Self-reported assessment of illness perception. The negative stress beliefs score will be used (range between 0 and 32) with higher scores indicating more pronounced negative beliefs about stress.
Time Frame
Change between start of therapy and end of therapy (approximately 8 weeks).
Title
Feasibility and acceptance of therapy (Lincoln et al., 2012)
Description
Self-reported assessment of feasibility and acceptability of the intervention.
Time Frame
Change between start of therapy and end of therapy(approximately 8 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder, bipolar disorder with psychotic symptoms using the International Classification of Diseases-10 (ICD-10 (Codes: F 20.x, F21.x, F22.x, F 23.x, F 25, F30.x, F 31.x ) verified by the Structured Clinical Interview for Diagnostic and Statistical Manual for Mental Disorders 5-Clinical Version (SCID-5-CV) Beesdo-Baum et al., 2019) transformed to ICD-10. first psychotic episode in the last five years written informed consent provided by patient or legal guardian estimated verbal intelligence of at least 80 IQ-scores estimated with the German Mehrfachwahlwortschatztest (MWT-B, Lehrl et al., 2005) Exclusion Criteria: acute suicidality diagnosis of dementia (verified by the SCID-5-CV interview and patient documentation)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikola M Stenzel, Ph. D.
Organizational Affiliation
Psychologische Hochschule Berlin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andreas Bechdolf, MD
Organizational Affiliation
Vivantes Klinikum Am Urban, Berlin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karolina Leopold, MD
Organizational Affiliation
Vivantes Klinikum Am Urban, Berlin
Official's Role
Study Chair
Facility Information:
Facility Name
University of Marburg, Faculty of Clinical Psychology and Psychotherapy
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share anonymized data of the study on an online repository (Open Science Foundation)
IPD Sharing Time Frame
Data will be available 6 month after the end of the study (September 2023)
IPD Sharing Access Criteria
no criteria
IPD Sharing URL
http://www.osf.io
Citations:
PubMed Identifier
36186856
Citation
von Hardenberg L, Leopold K, Stenzel N, Kallenbach M, Aliakbari N, Bechdolf A, Mehl S. Feasibility and efficacy of an acceptance and mindfulness-based group intervention for young people with early psychosis (Feel-Good group). Front Psychiatry. 2022 Sep 16;13:943488. doi: 10.3389/fpsyt.2022.943488. eCollection 2022.
Results Reference
derived

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Intervention to Improve Coping With Negative Emotions in Patients With Psychosis (Feel-Good-Study)

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