Early PsychosisEarly Phase 1NCT04592042
Intervention to Improve Coping With Negative Emotions in Patients With Psychosis (Feel-Good-Study)
A Early Phase 1 study testing Feel-Good- Group in people with Early Psychosis and Delusions, run by Philipps University Marburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Early Psychosis, Delusions, Emotional Distress
- What is being tested?
- Feel-Good- Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jan 2021to 30 Jan 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- acute suicidality
- diagnosis of dementia (verified by the SCID-5-CV interview and patient documentation)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Marburg, Faculty of Clinical Psychology and Psychotherapy
Marburg, Hesse, 35037
About this 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").
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.
Read the 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
- Being tested
- Feel-Good- Group
- Keywords
- Psychosis, Cognitive behavioral therapy, Group therapy, targeted therapy, emotion regulation, emotional stability
- Medical subject headings
- Psychotic Disorders, Delusions, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feel-Good- GroupBehavioural
Also called Emotion-oriented version of Cognitive Behavior Therapy for psychosis in group format for inpatients with psychosis
Eight sessions of group intervention focussing on information on emotion regulation, training of emotion regulation techniques and mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| Feel-Good-Group | Experimental | Pre-post assessment of feasibility and putative efficacy of an emotion-oriented cognitive-behavioral group intervention over 8 sessions and four weeks. Receives: Behavioral: Feel-Good- Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Change between start of therapy and end of therapy (approximately 8 weeks).
Secondary outcomes (11)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change between start of therapy and end of therapy(approximately 8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start8 Jan 2021
- Primary completion1 Nov 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of patients will be enrolled in the study.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Vivantes Klinikum am Urban, Prof. Dr. Nikola Stenzel (Collaboration partner), Berlin Psychological University, Berlin
- Responsible party
- Principal investigator, Prof. Dr. Stephanie Mehl, Philipps University Marburg
- Investigators
- Nikola M Stenzel, Ph. D., Study chair, Psychologische Hochschule BerlinAndreas Bechdolf, MD, Study director, Vivantes Klinikum am UrbanKarolina Leopold, MD, Study chair, Vivantes Klinikum am Urban
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592042
- Sponsor's protocol ID
- Feel-Good-Study
- Status last verified
- May 2022
- First submitted
- 13 Oct 2020
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share anonymized data of the study on an online repository (Open Science Foundation)
Publications
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.
PubMed 39435124von 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.
PubMed 36186856
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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").
- ClinicalTrials.gov ID
- NCT04592042
- Acronym / sponsor ID
- Feel-Good-Study
- Conditions
- Early Psychosis, Delusions, Emotional Distress, Self Esteem
- Keywords
- Psychosis, Cognitive behavioral therapy, Group therapy, targeted therapy, emotion regulation, emotional stability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Vivantes Klinikum am Urban, Prof. Dr. Nikola Stenzel (Collaboration partner), Berlin Psychological University, Berlin
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of patients will be enrolled in the study.
| Arm | Type | Receives |
|---|---|---|
| Feel-Good-Group | Experimental | Behavioral: Feel-Good- GroupPre-post assessment of feasibility and putative efficacy of an emotion-oriented cognitive-behavioral group intervention over 8 sessions and four weeks. |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- acute suicidality
- diagnosis of dementia (verified by the SCID-5-CV interview and patient documentation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feel-Good- GroupAlso: Emotion-oriented version of Cognitive Behavior Therapy for psychosis in group format for inpatients with psychosisEight sessions of group intervention focussing on information on emotion regulation, training of emotion regulation techniques and mindfulness. | Behavioural | Feel-Good-Group |
Primary outcome
Goal attainment scale (GAS, Kiresuk & Sherman, 1968)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
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)
Positive and Negative Scale Total score (Kay et al., 1992)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Interview to assess positive symptoms, negative symptoms and general psychopathology in the last week. Range 30-210 with higher scores indicating more pronounced distress.
11 secondary outcomes
Psychotic Symptoms Rating Scale delusions subscale (PSYRATS, Haddock et al., 1999)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Calgary Depression Scale for Schizophrenia (CDSS; Mueller et al., 1999)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Peters et al, Delusions Inventory (PDI; Lincoln, Keller & Rief, 2009)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Role Functioning Scale (RFS; Goodman et al., 1999)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Paranoia checklist (Freeman et al., 2005)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Emotion Regulation Skills Questionnaire (ERSQ; Berking & Znoj, 2008)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Emotion Regulation Inventory (ERI; Koenig, 2011)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Rosenberg Self-Esteem Scale (RSE; Collani & Herzberg, 2003)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Beliefs About Stress Scale (BASS; Laferton et al., 2016)
Time frame: Change between start of therapy and end of therapy (approximately 8 weeks).
Feasibility and acceptance of therapy (Lincoln et al., 2012)
Time frame: Change between start of therapy and end of therapy(approximately 8 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 39435124von 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.
- Derived from this study: PubMed 36186856von 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.
- Individual participant dataSharing planned: Yes. We plan to share anonymized data of the study on an online repository (Open Science Foundation)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikola M Stenzel, Ph. D. study chair
Psychologische Hochschule Berlin
Andreas Bechdolf, MD study director
Vivantes Klinikum am Urban
Karolina Leopold, MD study chair
Vivantes Klinikum am Urban
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Feel-Good- Group in people with Early Psychosis and Delusions, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal attainment scale (GAS, Kiresuk & Sherman, 1968) (time frame: Change between start of therapy and end of therapy (approximately 8 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04592042, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.