Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis

Schizophrenia Clinical Trial

— CBTd-E  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787135
• Other study ID #: CBTd-E_MehlLincoln2016
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Treatment Group:

Inclusion Criteria:

• 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

Exclusion Criteria:

• acute suicidal tendency

• comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month

• taking of Benzodiazepines

Related Conditions & MeSH terms

• Delusions
• Emotions
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Self-esteem
• Sleep

Intervention

Behavioral:
• emotion-oriented Cognitive Behavior Therapy
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.

Locations

Country	Name	City	State
Germany	University of Hamburg, Faculty of Clinical Psychology and Psychotherapy	Hamburg
Germany	University of Marburg, Faculty of Clinical Psychology and Psychotherapy	Marburg	Hessen

Sponsors (3)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Ruhr University of Bochum, University of Hamburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Emotion-regulation Questionnaire (ERQ)	Questionnaire assesses the regular use of emotion regulation strategies	Change between pre-therapy and post-therapy assessment after six month
Other	Change in Emotion regulation inventory	Questionnaire assesses the regular use of emotion regulation strategies	Change between pre-therapy and post-therapy assessment after six month
Other	Change in Paranoia assessed with Electronical mobile assessment	Assessment of present emotions, emotion regulation strategies, present symptoms of psychosis, present delusions, self-esteem for six consecutive days (10 assessments per day) in daily life	Change between pre-therapy and post-therapy assessment after six month
Other	Change in Sleep quality as assessed with an Actiwatch	Assessment of sleep-quality using an electronic bracelet for six consecutive days, sleep quality is assessed with movement detectors and light sensors	Change between pre-therapy and post-therapy assessment after six month
Other	Change in Emotion regulation quality as assessed experimental using International Affect Picture System Paradigm for the Assessment of emotion regulation (IAPS)	Assessment of effectiveness of use of emotion regulation strategies after experimental induction of fear, assessment of heart rate and skin conduction	Change between pre-therapy and post-therapy assessment after six month
Other	Change in heart rate variability	Assessment of heart rate variability with sensors during stress induction (reaction experiment) and during rest	Change between pre-therapy and post-therapy assessment after six month
Other	Change in Brief Core Schema Scale (BCSS)	Assessment of positive and negative self-schemata and schemata on others	Change between pre-therapy and post-therapy assessment after six month
Other	Change in Insomnia Severity Index (ISI)	The ISI assesses present sleep problems	Change between pre-therapy and post-therapy assessment after six month
Other	Change in Self-Compassion Scale (SCS)	SCS assesses self-compassion and self-esteem	Change between pre-therapy and post-therapy assessment after six month
Other	Change in Self-perception of emotional competencies (SEK-27)	Questionnaire assesses the regular use of emotion regulation strategies	Change between pre-therapy and post-therapy assessment after six month
Primary	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	Change between pre-therapy and post-therapy assessment after six month
Secondary	Change in Positive and Negative Syndrome Scale (PANSS)	Assessment of positive, negative and general symptoms of schizophrenia	Change between pre-therapy and post-therapy assessment after six month
Secondary	Change in Calgary Depression Rating Scale for Schizophrenia (CDSS(	Assessment of depressive symptoms in patients with schizophrenia	Change between pre-therapy and post-therapy assessment after six month
Secondary	Change in Role Functioning Scale (RFS)	Assessment of social functioning	Change between pre-therapy and post-therapy assessment after six month
Secondary	Change in Peters et al. Delusions Inventory (PDI- R)	Assessment of self-rated delusion frequency, conviction and distress.	Change between pre-therapy and post-therapy assessment after six month