An Early Phase 1 interventional study of Feel-Good- Group in Early Psychosis, Delusions and Emotional Distress, sponsored by Philipps University Marburg. Completed at 1 site in Germany. Open to participants aged 17 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Philipps University Marburg · Early Phase 1, Interventional, and Treatment
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.
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.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's enrollment of 36 is below the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Philipps University Marburg is the lead sponsor of 116 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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)
Time frame: 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.
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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.
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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.
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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.
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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.
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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.
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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.
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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.
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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.
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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.
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Feasibility and acceptance of therapy (Lincoln et al., 2012)
Self-reported assessment of feasibility and acceptability of the intervention.
Time frame: Change between start of therapy and end of therapy(approximately 8 weeks).
Plan to share: Yes — We plan to share anonymized data of the study on an online repository (Open Science Foundation)
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: Data will be available 6 month after the end of the study (September 2023)
Access criteria: no criteria
Data sharing details ↗ · www.osf.io
Ran from Jan 2021 to primary completion in Nov 2021, 9 months.
Of 28 phase 1 interventional studies under Psychotic Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 55. This study's 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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