SchizophreniaCBT-ENCT02787122
Pilot-trial of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia
A study testing CBT-E and Treatment as Usual in people with Schizophrenia and Delusional Disorder, run by Philipps University Marburg at 2 sites in Germany.
Trial summary
The present study is a pilot single-blind randomized controlled therapy study. Its aim is to assess the efficacy of an emotion-focussed form of Cognitive behavior Therapy that focusses on emotional processes that are involved in the formation and maintenance of delusions such as emotional stability, emotion regulation… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Delusional Disorder, Schizoaffective Disorder
- What is being tested?
- CBT-E and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jan 2014to 31 Dec 2017
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or brief psychotic disorder
- Positive and Negative Syndrome Scale score in item P1 (delusions) of at least two
- fluent in German language
- agree to participate
- estimated general intelligence of at least 70 (assessed with the German Wortschatztest (MWT-B)
- no present suicidality
Who cannot join
- acute suicidality
- comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month
- intake of Benzodiazepines
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Hamburg, Faculty of Clinical Psychology and Psychotherapy
Hamburg, 20146
University of Marburg, Faculty of Clinical Psychology and Psychotherapy
Marburg, Hesse, 35037
About this study
Official title: Comparison of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia With Standard Treatment: Effects on Psychological Parameters and Rehospitalisation
The present study is a pilot single-blind randomized controlled therapy study. Its aim is to assess the efficacy of an emotion-focussed form of Cognitive behavior Therapy that focusses on emotional processes that are involved in the formation and maintenance of delusions such as emotional stability, emotion regulation and self-esteem.
Read the detailed description
Cognitive Behavior Therapy for psychosis (CBTp) is an effective treatment for patients with psychosis. Several meta-analyses showed an effect of CBTp in addition to antipsychotic treatment of small to medium effect size with regard to positive symptoms, general psychopathology and depression. Nevertheless, present research suggests that are especially emotional processes are closely related to positive symptoms and delusions, such as negative emotions, low self-esteem, depression and anxiety, whereas present interventions of CBTp focus often especially on cognitive interventions in order to change delusions as well as more cognitive risk factors for delusions such as reasoning biases and a dysfunctional causal attribution style.
Thus, the aim of the present single-blind randomized-controlled pilot therapy study was to assess the efficacy of a new form of emotion-focussed Cognitive behavior therapy for psychosis with regard to change in positive symptoms and delusions in comparison to standard treatment.
The main hypotheses are:
- Efficacy of CBT-E: patients with schizophrenia who receive CBT-E show a more pronounced reduction of delusions (primary outcome), as well as a more pronounced reduction of positive symptoms, depression and general psychopathology, a stronger improvement in general and social functioning and will receive lower doses of antipsychotic medication (secondary outcomes) at post-treatment.
- Conditions
- Schizophrenia, Delusional Disorder, Schizoaffective Disorder, Brief Psychotic Disorder, Schizophreniform Disorder
- Being tested
- CBT-E, Treatment as Usual
- Keywords
- Schizophrenia, psychotic disorders, Cognitive Behavior Therapy, emotion regulation, self-esteem, randomized-controlled trial
- Medical subject headings
- Schizophrenia, Schizophrenia, Paranoid, Psychotic Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-EBehavioural
Also called Emotion-focused Cognitive Behavior Therapy
Patients receive 25 sessions of individual emotion-focused Cognitive Behavior Therapy based on a manual. Interventions aim on patients' mood by implementing positive activities in their daily routine. Further, patients train to reduce worrying behavior. Social contacts are fostered as well. Later, patients are informed on emotions and train emotion regulation strategies. Finally, the focus of CBT-E is on self-acceptance.Patients receive psychoeducation on self-acceptance and learn strategies in order to reduce negative self-schema and foster positive self-schema.
Treatment as UsualBehavioural
Patients receive standardized treatment. After a waiting period of six month, patients receive CBT-E
| Study group | Role | What they receive |
|---|---|---|
| CBT-E | Active comparator | Emotion-focussed Cognitive behavior therapy:
Patients receive 25 sessions of individual emotion-focused Cognitive Behavior Therapy. Interventions are behavioral activation, training of emotion regulation strategies, improvement of self-esteem and relapse prevention. Receives: Behavioral: CBT-E |
| Treatment as Usual | Placebo comparator | Patients who are randomized and assigned to the Wait list are required to wait for half a year, while they receive standardized care (antipsychotic medication). After half a year, they receive CBT-E, as well. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychotic Rating Scale (PSYRATS) delusions scale
Assessment of delusion frequency, delusion distress, conviction and loss of quality of life
Measured: Change between assessment pre-therapy and assessment after six month of therapy
Secondary outcomes (6)
Change in Positive and Negative Syndrome Scale (PANSS)
Assessment of positive, negative and general symptoms of schizophrenia
Measured: Change between assessment pre-therapy and assessment after six month of therapy
Change in Calgary Depression Rating Scale for Schizophrenia (CDSS)
Assessment of depressive symptoms in patients with schizophrenia
Measured: Change between assessment pre-therapy and assessment after six month of therapy
Change in Role Functioning Scale (RFS)
Assessment of social functioning
Measured: Change between assessment pre-therapy and assessment after six month of therapy
Change in Paranoia Checklist (PCL)
Assessment of self-reported paranoid delusion frequency, distress and conviction
Measured: Change between assessment pre-therapy and assessment after six month of therapy
Change in Beck Depression Inventory-II
Assessment of self-reported depressive symptoms
Measured: Change between assessment pre-therapy and assessment after six month of therapy
Change in Peters et al. Delusions Inventory
Assessment of self-rated delusion frequency, delusional distress and delusional
Measured: Change between assessment pre-therapy and assessment after six month of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The CBT-E group receives 15-25 sessions of cognitive behavior therapy with a special focus on emotion regulation (CBT-E), the wait list group receives CBT-E after six month waiting time
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hamburg-Eppendorf
- Responsible party
- Principal investigator, Prof. Dr. Stephanie Mehl, Philipps University Marburg
- Investigators
- Stephanie Mehl, Ph. D., Principal investigator, Philipps University MarburgTania M. Lincoln, Principal investigator, University of Hamburg-EppendorfWinfried Rief, Study director, Philipps University MarburgTilo Kircher, Study director, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787122
- Sponsor's protocol ID
- CBT-E_MehlLincoln
- Acronym
- CBT-E
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Mehl S, Hautmann C, Nittel CM, Rief W, Kircher T, Lincoln TM. Feasibility and Efficacy Estimate of an Emotion-Focused Version of Cognitive Behavior Therapy for Delusions in Comparison to Wait List in a Single-Blinded Randomized-Controlled Pilot Trial. Schizophr Bull Open. 2021 Oct 27;2(1):sgab035. doi: 10.1093/schizbullopen/sgab035. eCollection 2021 Jan.
PubMed 42936165
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia With Standard Treatment: Effects on Psychological Parameters and Rehospitalisation
- ClinicalTrials.gov ID
- NCT02787122
- Acronym / sponsor ID
- CBT-E / CBT-E_MehlLincoln
- Conditions
- Schizophrenia, Delusional Disorder, Schizoaffective Disorder, Brief Psychotic Disorder, Schizophreniform Disorder
- Keywords
- Schizophrenia, psychotic disorders, Cognitive Behavior Therapy, emotion regulation, self-esteem, randomized-controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- University of Hamburg-Eppendorf
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 1 Jun 2016 (estimated)
- 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 present study is a pilot single-blind randomized controlled therapy study. Its aim is to assess the efficacy of an emotion-focussed form of Cognitive behavior Therapy that focusses on emotional processes that are involved in the formation and maintenance of delusions such as emotional stability, emotion regulation and self-esteem.
Detailed description
Cognitive Behavior Therapy for psychosis (CBTp) is an effective treatment for patients with psychosis. Several meta-analyses showed an effect of CBTp in addition to antipsychotic treatment of small to medium effect size with regard to positive symptoms, general psychopathology and depression. Nevertheless, present research suggests that are especially emotional processes are closely related to positive symptoms and delusions, such as negative emotions, low self-esteem, depression and anxiety, whereas present interventions of CBTp focus often especially on cognitive interventions in order to change delusions as well as more cognitive risk factors for delusions such as reasoning biases and a dysfunctional causal attribution style.
Thus, the aim of the present single-blind randomized-controlled pilot therapy study was to assess the efficacy of a new form of emotion-focussed Cognitive behavior therapy for psychosis with regard to change in positive symptoms and delusions in comparison to standard treatment.
The main hypotheses are:
- Efficacy of CBT-E: patients with schizophrenia who receive CBT-E show a more pronounced reduction of delusions (primary outcome), as well as a more pronounced reduction of positive symptoms, depression and general psychopathology, a stronger improvement in general and social functioning and will receive lower doses of antipsychotic medication (secondary outcomes) at post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The CBT-E group receives 15-25 sessions of cognitive behavior therapy with a special focus on emotion regulation (CBT-E), the wait list group receives CBT-E after six month waiting time
| Arm | Type | Receives |
|---|---|---|
| CBT-E | Active comparator | Behavioral: CBT-EEmotion-focussed Cognitive behavior therapy: Patients receive 25 sessions of individual emotion-focused Cognitive Behavior Therapy. Interventions are behavioral activation, training of emotion regulation strategies, improvement of self-esteem and relapse prevention. |
| Treatment as Usual | Placebo comparator | Behavioral: Treatment as UsualPatients who are randomized and assigned to the Wait list are required to wait for half a year, while they receive standardized care (antipsychotic medication). After half a year, they receive CBT-E, as well. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or brief psychotic disorder
- Positive and Negative Syndrome Scale score in item P1 (delusions) of at least two
- fluent in German language
- agree to participate
- estimated general intelligence of at least 70 (assessed with the German Wortschatztest (MWT-B)
Key exclusion criteria (3 listed)
- acute suicidality
- comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month
- intake of Benzodiazepines
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 |
|---|---|---|
| CBT-EAlso: Emotion-focused Cognitive Behavior TherapyPatients receive 25 sessions of individual emotion-focused Cognitive Behavior Therapy based on a manual. Interventions aim on patients' mood by implementing positive activities in their daily routine. Further, patients train to reduce worrying behavior. Social contacts are fostered as well. Later, patients are informed on emotions and train emotion regulation strategies. Finally, the focus of CBT-E is on self-acceptance.Patients receive psychoeducation on self-acceptance and learn strategies in order to reduce negative self-schema and foster positive self-schema. | Behavioural | CBT-E |
| Treatment as UsualPatients receive standardized treatment. After a waiting period of six month, patients receive CBT-E | Behavioural | Treatment as Usual |
Primary outcome
Change in Psychotic Rating Scale (PSYRATS) delusions scale
Time frame: Change between assessment pre-therapy and assessment after six month of therapy
Assessment of delusion frequency, delusion distress, conviction and loss of quality of life
6 secondary outcomes
Change in Positive and Negative Syndrome Scale (PANSS)
Time frame: Change between assessment pre-therapy and assessment after six month of therapy
Change in Calgary Depression Rating Scale for Schizophrenia (CDSS)
Time frame: Change between assessment pre-therapy and assessment after six month of therapy
Change in Role Functioning Scale (RFS)
Time frame: Change between assessment pre-therapy and assessment after six month of therapy
Change in Paranoia Checklist (PCL)
Time frame: Change between assessment pre-therapy and assessment after six month of therapy
Change in Beck Depression Inventory-II
Time frame: Change between assessment pre-therapy and assessment after six month of therapy
Change in Peters et al. Delusions Inventory
Time frame: Change between assessment pre-therapy and assessment after six month of therapy
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 4 Mar 2020.
- Derived from this study: PubMed 42936165Mehl S, Hautmann C, Nittel CM, Rief W, Kircher T, Lincoln TM. Feasibility and Efficacy Estimate of an Emotion-Focused Version of Cognitive Behavior Therapy for Delusions in Comparison to Wait List in a Single-Blinded Randomized-Controlled Pilot Trial. Schizophr Bull Open. 2021 Oct 27;2(1):sgab035. doi: 10.1093/schizbullopen/sgab035. eCollection 2021 Jan.
- Individual participant dataSharing planned: Undecided
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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.
Stephanie Mehl, Ph. D. principal investigator
Philipps University Marburg
Tania M. Lincoln principal investigator
University of Hamburg-Eppendorf
Winfried Rief study director
Philipps University Marburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-E and Treatment as Usual in people with Schizophrenia and Delusional Disorder, run by Philipps University Marburg at 2 sites 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 6 inclusion and 3 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 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in Psychotic Rating Scale (PSYRATS) delusions scale (time frame: Change between assessment pre-therapy and assessment after six month of therapy). 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 NCT02787122, which also lists 1 linked publication.
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 4 Mar 2020.