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

NCT04592042 | Completed Early Phase 1

• 1 other identifier: Feel-Good-Study
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Psychosis; Delusions; Emotional Distress; Self Esteem

Keywords

Psychosis; Cognitive behavioral therapy; Group therapy; targeted therapy; emotion regulation; emotional stability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Psychotic Symptoms Rating Scale delusions subscale (PSYRATS, Haddock et al., 1999)

  Change between start of therapy and end of therapy (approximately 8 weeks).

• Calgary Depression Scale for Schizophrenia (CDSS; Mueller et al., 1999)

  Change between start of therapy and end of therapy (approximately 8 weeks).

• Peters et al, Delusions Inventory (PDI; Lincoln, Keller & Rief, 2009)

  Change between start of therapy and end of therapy (approximately 8 weeks).

• Role Functioning Scale (RFS; Goodman et al., 1999)

  Change between start of therapy and end of therapy (approximately 8 weeks).

• Paranoia checklist (Freeman et al., 2005)

  Change between start of therapy and end of therapy (approximately 8 weeks).

Study Arms (1)

Feel-Good-Group

EXPERIMENTAL

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

Interventions

Feel-Good- Group BEHAVIORAL

Eight sessions of group intervention focussing on information on emotion regulation, training of emotion regulation techniques and mindfulness.

Also known as: Emotion-oriented version of Cognitive Behavior Therapy for psychosis in group format for inpatients with psychosis

Feel-Good-Group

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Philipps University Marburg: lead
• Prof. Dr. Andreas Bechdolf (Chair of hospital), Vivantes Hospital Am Urban Berlin: collaborator
• Prof. Dr. Nikola Stenzel (Collaboration partner), Berlin Psychological University, Berlin: collaborator
• Dr. Karolina Leopold (Senior physician), Vivantes Hospital Am Urban Berlin: collaborator

Study Sites (1)

University of Marburg, Faculty of Clinical Psychology and Psychotherapy

Marburg, Hesse, 35037, Germany

Location

Related Publications (2)

• von Hardenberg L, Leopold K, Pfennig A, Kuhn C, Kallenbach M, Aliakbari N, Mehl S, Bechdolf A. Subjective experiences of an acceptance and mindfulness-based group intervention (Feel-Good-Group) in young people with early psychosis. Front Psychiatry. 2024 Oct 7;15:1369629. doi: 10.3389/fpsyt.2024.1369629. eCollection 2024.

  PMID: 39435124 DERIVED

• 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.

  PMID: 36186856 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Delusions; Emotional Regulation

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Nikola M Stenzel, Ph. D.

  Psychologische Hochschule Berlin

  STUDY CHAIR

• Andreas Bechdolf, MD

  Vivantes Klinikum Am Urban, Berlin

  STUDY DIRECTOR

• Karolina Leopold, MD

  Vivantes Klinikum Am Urban, Berlin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Managing Psychologist

Model Details: A single group of patients will be enrolled in the study.

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: January 8, 2021
• Primary Completion: November 1, 2021
• Study Completion: January 30, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will be available 6 month after the end of the study (September 2023)
• Access Criteria: no criteria

Locations

DE (1)