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

NCT ID: NCT04592042

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2022-01-30

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.

Conditions

Early Psychosis; Delusions; Emotional Distress; Self Esteem

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Feel-Good- Group

Intervention Type: BEHAVIORAL

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

Interventions

Feel-Good- Group

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Emotion-oriented version of Cognitive Behavior Therapy for psychosis in group format for inpatients with psychosis

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)

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Andreas Bechdolf (Chair of hospital), Vivantes Hospital Am Urban Berlin

UNKNOWN

Sponsor Role: collaborator

Prof. Dr. Nikola Stenzel (Collaboration partner), Berlin Psychological University, Berlin

UNKNOWN

Sponsor Role: collaborator

Dr. Karolina Leopold (Senior physician), Vivantes Hospital Am Urban Berlin

UNKNOWN

Sponsor Role: collaborator

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Stephanie Mehl

Principal Investigator, Managing Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikola M Stenzel, Ph. D.

Role: STUDY_CHAIR

Psychologische Hochschule Berlin

Andreas Bechdolf, MD

Role: STUDY_DIRECTOR

Vivantes Klinikum Am Urban, Berlin

Karolina Leopold, MD

Role: STUDY_CHAIR

Vivantes Klinikum Am Urban, Berlin

Locations

University of Marburg, Faculty of Clinical Psychology and Psychotherapy

Marburg, Hesse, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 39435124 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36186856 (View on PubMed)

Other Identifiers

Feel-Good-Study

Identifier Type: -

Identifier Source: org_study_id