Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04592042
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2020-10-13
Brief Title:
Intervention to Improve Coping With Negative Emotions in Patients With Psychosis Feel-Good-Study
Sponsor:
Philipps University Marburg Medical Center
Organization:
Philipps University Marburg Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 techniquesskills 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
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 techniquesskills 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None