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

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").

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.

Study Overview

• Status: Completed
• Conditions: Emotional Distress; Delusions; Self Esteem; Early Psychosis
• Intervention / Treatment: Behavioral: Feel-Good- Group

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Marburg, Hessen, Germany, 35037
      • University of Marburg, Faculty of Clinical Psychology and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feel-Good-Group; Pre-post assessment of feasibility and putative efficacy of an emotion-oriented cognitive-behavioral group intervention over 8 sessions and four weeks.	Behavioral: Feel-Good- Group; Eight sessions of group intervention focussing on information on emotion regulation, training of emotion regulation techniques and mindfulness.; Other Names: Emotion-oriented version of Cognitive Behavior Therapy for psychosis in group format for inpatients with psychosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Change between start of therapy and end of therapy (approximately 8 weeks).
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.	Change between start of therapy and end of therapy (approximately 8 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change between start of therapy and end of therapy (approximately 8 weeks).
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.	Change between start of therapy and end of therapy (approximately 8 weeks).
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.	Change between start of therapy and end of therapy (approximately 8 weeks).
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.	Change between start of therapy and end of therapy (approximately 8 weeks).
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.	Change between start of therapy and end of therapy (approximately 8 weeks).
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.	Change between start of therapy and end of therapy (approximately 8 weeks).
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.	Change between start of therapy and end of therapy (approximately 8 weeks).
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.	Change between start of therapy and end of therapy (approximately 8 weeks).
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.	Change between start of therapy and end of therapy (approximately 8 weeks).
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.	Change between start of therapy and end of therapy (approximately 8 weeks).
Feasibility and acceptance of therapy (Lincoln et al., 2012)	Self-reported assessment of feasibility and acceptability of the intervention.	Change between start of therapy and end of therapy(approximately 8 weeks).

Collaborators and Investigators

• 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
• Investigators: Study Chair: Nikola M Stenzel, Ph. D., Psychologische Hochschule Berlin; Study Director: Andreas Bechdolf, MD, Vivantes Klinikum Am Urban, Berlin; Study Chair: Karolina Leopold, MD, Vivantes Klinikum Am Urban, Berlin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 1, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Psychosis; Cognitive behavioral therapy; targeted therapy; Group therapy; emotion regulation; emotional stability
• Additional Relevant MeSH Terms: Behavioral Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders; Delusions
• Other Study ID Numbers: Feel-Good-Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No