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

Emotional Distress Clinical Trial

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").

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592042
• Other study ID #: Feel-Good-Study
• Status: Completed
• Phase: Early Phase 1
• Start date: January 8, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: May 2022
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 30, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delusions
• Early Psychosis
• Emotional Distress
• Mental Disorders
• Psychotic Disorders
• Self Esteem

Intervention

Behavioral:
• Feel-Good- Group
Eight sessions of group intervention focussing on information on emotion regulation, training of emotion regulation techniques and mindfulness.

Locations

Country	Name	City	State
Germany	University of Marburg, Faculty of Clinical Psychology and Psychotherapy	Marburg	Hessen

Sponsors (4)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Dr. Karolina Leopold (Senior physician), Vivantes Hospital Am Urban Berlin, Prof. Dr. Andreas Bechdolf (Chair of hospital), Vivantes Hospital Am Urban Berlin, Prof. Dr. Nikola Stenzel (Collaboration partner), Berlin Psychological University, Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).