SchizophreniaCBTd-ENCT02787135
Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis
A study testing emotion-oriented Cognitive Behavior Therapy in people with Schizophrenia and Psychotic Disorders, run by Philipps University Marburg at 2 sites in Germany.
Trial summary
The aim of the present single-blind randomized-controlled therapy study is to assess the efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion regulation, improvement of self-esteem and sleep quality (CBTd-E). Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychotic Disorders, Delusions
- What is being tested?
- emotion-oriented Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 2 sitesGermany
- Study dates
- 1 May 2016to 31 Dec 2019
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder (DSM-5 diagnosis)
- Delusions present in the last three months (score of at least three in three out of six PSYRATS scores)
- problems in at least two out of three possible mediators: sleep problems (ISI sum score > 7), low self-esteem (score > 3in the BCSS negative self scale) and/or problems in emotion regulation (score in all items < 4)
- fluent in German language
- agree to participate
- estimated general intelligence of at least 70 in the German Mehrfachwahlwortschatztest (MWT-B)
- no present suicidality
Who cannot join
- acute suicidal tendency
- comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month
- taking 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: Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis (CBTp-E) in Reducing Delusions. A Randomized-controlled Treatment Study (CBTd-E)
The aim of the present single-blind randomized-controlled therapy study is to assess the efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion regulation, improvement of self-esteem and sleep quality (CBTd-E).
Read the detailed description
Numerous meta-analyses have found Cognitive Behaviour Therapy for psychosis (CBTp) to be effective. The effect sizes that are achieved for positive symptoms in addition to antipsychotic treatment vary between small to medium. However, the effect sizes for changes in delusions are somewhat lower. Thus, it could prove beneficial to tailor CBTp interventions more precisely to the processes that are relevant to delusions. Empirically derived models of the formation and maintenance of delusions postulate an important role of cognitive biases, emotional factors and self-esteem. Additional studies have demonstrated the relevance of impaired sleep to delusions. Nevertheless, CBTp interventions that aim to change delusions tend to focus mainly on reasoning bias.
The results of several uncontrolled pilot studies that focused primarily at improving emotional factors, quality of sleep and self-esteem in patients with delusions indicate that changes in these factors have the potential to reduce delusions. However, in these studies the singular interventions were short and were not implemented into a broader therapy rational. It can thus be assumed that a combination of CBT-interventions within a broader therapy rational might have an even greater impact on delusions.
The aim of the present single-blind randomized-controlled therapy study is to assess the efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion regulation, improvement of self-esteem and sleep quality (CBTd-E) that will be applied in 25 individual sessions. Moreover, the study aims to test whether the efficacy of CBTd-E is mediated by the postulated processes. The main hypotheses are:
- Baseline differences: in comparison to healthy controls, patients with schizophrenia show more pronounced problems in emotion regulation, a reduced sleep quality and a lower and less stable self-esteem.
- Efficacy of CBTd-E: patients with acute delusions who receive CBTd-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.
- Mediation: the effect of CBTd-E on change in delusions is mediated by a) improved emotional stability and ability to regulate one's own emotions, b) improved sleep quality, c) improved and more stable self-esteem.
In addition to questionnaires and interviews, behavioral paradigms, psychophysiological assessments and electronic diaries will be used to test the hypotheses. If we can demonstrate that CBTd-E reduces delusions, this would provide us with a more acceptable and feasible therapy for treating delusions.
- Conditions
- Schizophrenia, Psychotic Disorders, Delusions, Emotions, Self-esteem, Sleep
- Being tested
- emotion-oriented Cognitive Behavior Therapy
- Keywords
- Delusions, Schizophrenia, Cognitive Behavior Therapy, Emotion, Emotion regulation, self-esteem, sleep quality, Efficacy of change
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Delusions, Emotional Regulation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotion-oriented Cognitive Behavior TherapyBehavioural
Also called CBTd-E
Emotion-oriented Cognitive Behavior Therapy with a focus on delusions: Aim of the intervention is to change factors that are involved in the formation and maintenance of delusions: emotional stability and regulation of negative emotions, sleep quality and self-esteem.
| Study group | Role | What they receive |
|---|---|---|
| CBTd-E | Active comparator | Experimental: emotion-oriented Cognitive Behavior Therapy focused on delusions for patients with schizophrenia-spectrum disorders and delusions. The therapeutical intervention follows a treatment-manual consisting of two modules. Patients work on two modules every week for 25 weeks in a row. Module I comprises psychoeducation on emotions, training radical acceptance of emotions and mindfulness, cognitive and behavioral strategies in order to change negative emotions and in order to foster positive emotions and suggestions for life-style changes (positive activities, sports, stress reduction). In the second module, the focus 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. Receives: Behavioral: emotion-oriented Cognitive Behavior Therapy |
| Treatment as Usual | Placebo comparator | Patients who are randomized and assigned to the Wait-list receive treatment as usual (regular visits to a physicist every third month and antipsychotic medication). After six month the waiting list patients receive the treatment specified above. Receives: Behavioral: emotion-oriented Cognitive Behavior Therapy |
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 due to the delusion
Measured: Change between pre-therapy and post-therapy assessment after six month
Secondary outcomes (4)
Change in Positive and Negative Syndrome Scale (PANSS)
Assessment of positive, negative and general symptoms of schizophrenia
Measured: Change between pre-therapy and post-therapy assessment after six month
Change in Calgary Depression Rating Scale for Schizophrenia (CDSS(
Assessment of depressive symptoms in patients with schizophrenia
Measured: Change between pre-therapy and post-therapy assessment after six month
Change in Role Functioning Scale (RFS)
Assessment of social functioning
Measured: Change between pre-therapy and post-therapy assessment after six month
Change in Peters et al. Delusions Inventory (PDI- R)
Assessment of self-rated delusion frequency, conviction and distress.
Measured: Change between pre-therapy and post-therapy assessment after six month
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 May 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hamburg-Eppendorf, Ruhr University of Bochum
- Responsible party
- Principal investigator, Prof. Dr. Stephanie Mehl, Philipps University Marburg
- Investigators
- Stephanie Mehl, Ph. D., Study chair, Philipps University MarburgTania M Lincoln, Ph. D., Study chair, University of Hamburg-EppendorfTobias Teismann, Ph. D., Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787135
- Sponsor's protocol ID
- CBTd-E_MehlLincoln2016
- Acronym
- CBTd-E
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2016
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mehl S, Hautmann C, Schlier B, Dorn LM, Ludwig L, Teismann T, Franz M, Rief W, Stark R, Lincoln TM. Efficacy of an emotion-oriented cognitive behavior therapy for delusions (CBTd-E) compared to waitlist in a single-blinded randomized-controlled trial. Schizophrenia (Heidelb). 2026 Feb 17;12(1):29. doi: 10.1038/s41537-026-00737-y.
PubMed 41702910Kammerer MK, Mehl S, Ludwig L, Lincoln TM. Sleep and circadian rhythm disruption predict persecutory symptom severity in day-to-day life: A combined actigraphy and experience sampling study. J Abnorm Psychol. 2021 Jan;130(1):78-88. doi: 10.1037/abn0000645. Epub 2020 Nov 19.
PubMed 33211503Ludwig L, Mehl S, Krkovic K, Lincoln TM. Effectiveness of emotion regulation in daily life in individuals with psychosis and nonclinical controls-An experience-sampling study. J Abnorm Psychol. 2020 May;129(4):408-421. doi: 10.1037/abn0000505. Epub 2020 Feb 27.
PubMed 32105124
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis (CBTp-E) in Reducing Delusions. A Randomized-controlled Treatment Study (CBTd-E)
- ClinicalTrials.gov ID
- NCT02787135
- Acronym / sponsor ID
- CBTd-E / CBTd-E_MehlLincoln2016
- Conditions
- Schizophrenia, Psychotic Disorders, Delusions, Emotions, Self-esteem, Sleep
- Keywords
- Delusions, Schizophrenia, Cognitive Behavior Therapy, Emotion, Emotion regulation, self-esteem, sleep quality, Efficacy of change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- University of Hamburg-Eppendorf, Ruhr University of Bochum
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (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 aim of the present single-blind randomized-controlled therapy study is to assess the efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion regulation, improvement of self-esteem and sleep quality (CBTd-E).
Detailed description
Numerous meta-analyses have found Cognitive Behaviour Therapy for psychosis (CBTp) to be effective. The effect sizes that are achieved for positive symptoms in addition to antipsychotic treatment vary between small to medium. However, the effect sizes for changes in delusions are somewhat lower. Thus, it could prove beneficial to tailor CBTp interventions more precisely to the processes that are relevant to delusions. Empirically derived models of the formation and maintenance of delusions postulate an important role of cognitive biases, emotional factors and self-esteem. Additional studies have demonstrated the relevance of impaired sleep to delusions. Nevertheless, CBTp interventions that aim to change delusions tend to focus mainly on reasoning bias.
The results of several uncontrolled pilot studies that focused primarily at improving emotional factors, quality of sleep and self-esteem in patients with delusions indicate that changes in these factors have the potential to reduce delusions. However, in these studies the singular interventions were short and were not implemented into a broader therapy rational. It can thus be assumed that a combination of CBT-interventions within a broader therapy rational might have an even greater impact on delusions.
The aim of the present single-blind randomized-controlled therapy study is to assess the efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion regulation, improvement of self-esteem and sleep quality (CBTd-E) that will be applied in 25 individual sessions. Moreover, the study aims to test whether the efficacy of CBTd-E is mediated by the postulated processes. The main hypotheses are:
- Baseline differences: in comparison to healthy controls, patients with schizophrenia show more pronounced problems in emotion regulation, a reduced sleep quality and a lower and less stable self-esteem.
- Efficacy of CBTd-E: patients with acute delusions who receive CBTd-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.
- Mediation: the effect of CBTd-E on change in delusions is mediated by a) improved emotional stability and ability to regulate one's own emotions, b) improved sleep quality, c) improved and more stable self-esteem.
In addition to questionnaires and interviews, behavioral paradigms, psychophysiological assessments and electronic diaries will be used to test the hypotheses. If we can demonstrate that CBTd-E reduces delusions, this would provide us with a more acceptable and feasible therapy for treating delusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBTd-E | Active comparator | Behavioral: emotion-oriented Cognitive Behavior TherapyExperimental: emotion-oriented Cognitive Behavior Therapy focused on delusions for patients with schizophrenia-spectrum disorders and delusions. The therapeutical intervention follows a treatment-manual consisting of two modules. Patients work on two modules every week for 25 weeks in a row. Module I comprises psychoeducation on emotions, training radical acceptance of emotions and mindfulness, cognitive and behavioral strategies in order to change negative emotions and in order to foster positive emotions and suggestions for life-style changes (positive activities, sports, stress reduction). In the second module, the focus 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 Usual | Placebo comparator | Behavioral: emotion-oriented Cognitive Behavior TherapyPatients who are randomized and assigned to the Wait-list receive treatment as usual (regular visits to a physicist every third month and antipsychotic medication). After six month the waiting list patients receive the treatment specified above. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder (DSM-5 diagnosis)
- Delusions present in the last three months (score of at least three in three out of six PSYRATS scores)
- problems in at least two out of three possible mediators: sleep problems (ISI sum score > 7), low self-esteem (score > 3in the BCSS negative self scale) and/or problems in emotion regulation (score in all items < 4)
- fluent in German language
- agree to participate
Key exclusion criteria (3 listed)
- acute suicidal tendency
- comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month
- taking 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 |
|---|---|---|
| emotion-oriented Cognitive Behavior TherapyAlso: CBTd-EEmotion-oriented Cognitive Behavior Therapy with a focus on delusions: Aim of the intervention is to change factors that are involved in the formation and maintenance of delusions: emotional stability and regulation of negative emotions, sleep quality and self-esteem. | Behavioural | CBTd-E, Treatment as Usual |
Primary outcome
Change in Psychotic Rating Scale (PSYRATS) delusions scale
Time frame: Change between pre-therapy and post-therapy assessment after six month
Assessment of delusion frequency, delusion distress, conviction and loss of quality of life due to the delusion
4 secondary outcomes
Change in Positive and Negative Syndrome Scale (PANSS)
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Calgary Depression Rating Scale for Schizophrenia (CDSS(
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Role Functioning Scale (RFS)
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Peters et al. Delusions Inventory (PDI- R)
Time frame: Change between pre-therapy and post-therapy assessment after six month
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 Mar 2020.
- Derived from this study: PubMed 41702910Mehl S, Hautmann C, Schlier B, Dorn LM, Ludwig L, Teismann T, Franz M, Rief W, Stark R, Lincoln TM. Efficacy of an emotion-oriented cognitive behavior therapy for delusions (CBTd-E) compared to waitlist in a single-blinded randomized-controlled trial. Schizophrenia (Heidelb). 2026 Feb 17;12(1):29. doi: 10.1038/s41537-026-00737-y.
- Derived from this study: PubMed 33211503Kammerer MK, Mehl S, Ludwig L, Lincoln TM. Sleep and circadian rhythm disruption predict persecutory symptom severity in day-to-day life: A combined actigraphy and experience sampling study. J Abnorm Psychol. 2021 Jan;130(1):78-88. doi: 10.1037/abn0000645. Epub 2020 Nov 19.
- Derived from this study: PubMed 32105124Ludwig L, Mehl S, Krkovic K, Lincoln TM. Effectiveness of emotion regulation in daily life in individuals with psychosis and nonclinical controls-An experience-sampling study. J Abnorm Psychol. 2020 May;129(4):408-421. doi: 10.1037/abn0000505. Epub 2020 Feb 27.
- Individual participant dataSharing planned: No
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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. study chair
Philipps University Marburg
Tania M Lincoln, Ph. D. study chair
University of Hamburg-Eppendorf
Tobias Teismann, Ph. D. principal investigator
Ruhr University of Bochum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotion-oriented Cognitive Behavior Therapy in people with Schizophrenia and Psychotic Disorders, 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 7 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 5 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 pre-therapy and post-therapy assessment after six month). 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 NCT02787135, which also lists 3 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 Mar 2020.