Clinical trial NCT04592042: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Early Psychosis
Delusions
Emotional Distress
Self Esteem
Keywords: Psychosis
Cognitive behavioral therapy
Group therapy
targeted therapy
emotion regulation
emotional stability
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Andreas Bechdolf (Chair of hospital), Vivantes Hospital Am Urban Berlin
name: Prof. Dr. Nikola Stenzel (Collaboration partner), Berlin Psychological University, Berlin
name: Dr. Karolina Leopold (Senior physician), Vivantes Hospital Am Urban Berlin
First posted: 2020-10-19
Enrollment: 36
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group of patients will be enrolled in the study.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Goal attainment scale (GAS, Kiresuk & Sherman, 1968)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Positive and Negative Scale Total score (Kay et al., 1992)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
Secondary outcomes:
measure: Psychotic Symptoms Rating Scale delusions subscale (PSYRATS, Haddock et al., 1999)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Calgary Depression Scale for Schizophrenia (CDSS; Mueller et al., 1999)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Peters et al, Delusions Inventory (PDI; Lincoln, Keller & Rief, 2009)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Role Functioning Scale (RFS; Goodman et al., 1999)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Paranoia checklist (Freeman et al., 2005)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Emotion Regulation Skills Questionnaire (ERSQ; Berking & Znoj, 2008)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Emotion Regulation Inventory (ERI; Koenig, 2011)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Rosenberg Self-Esteem Scale (RSE; Collani & Herzberg, 2003)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Beliefs About Stress Scale (BASS; Laferton et al., 2016)
timeFrame: Change between start of therapy and end of therapy (approximately 8 weeks).
measure: Feasibility and acceptance of therapy (Lincoln et al., 2012)
timeFrame: Change between start of therapy and end of therapy(approximately 8 weeks).
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: University of Marburg, Faculty of Clinical Psychology and Psychotherapy
state: Hessen
Study officials:
affiliation: Psychologische Hochschule Berlin
name: Nikola M Stenzel, Ph. D.
role: STUDY_CHAIR
affiliation: Vivantes Klinikum Am Urban, Berlin
name: Andreas Bechdolf, MD
role: STUDY_DIRECTOR
affiliation: Vivantes Klinikum Am Urban, Berlin
name: Karolina Leopold, MD
role: STUDY_CHAIR
References:
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.