Clinical trial NCT02787135: Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: University of Hamburg-Eppendorf
name: Ruhr University of Bochum
First posted: 2016-06-01
Enrollment: 94
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Psychotic Rating Scale (PSYRATS) delusions scale
timeFrame: Change between pre-therapy and post-therapy assessment after six month
Secondary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Calgary Depression Rating Scale for Schizophrenia (CDSS(
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Role Functioning Scale (RFS)
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Peters et al. Delusions Inventory (PDI- R)
timeFrame: Change between pre-therapy and post-therapy assessment after six month
Other outcomes:
measure: Change in Emotion-regulation Questionnaire (ERQ)
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Emotion regulation inventory
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Paranoia assessed with Electronical mobile assessment
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Sleep quality as assessed with an Actiwatch
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Emotion regulation quality as assessed experimental using International Affect Picture System Paradigm for the Assessment of emotion regulation (IAPS)
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in heart rate variability
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Brief Core Schema Scale (BCSS)
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Self-Compassion Scale (SCS)
timeFrame: Change between pre-therapy and post-therapy assessment after six month
measure: Change in Self-perception of emotional competencies (SEK-27)
timeFrame: Change between pre-therapy and post-therapy assessment after six month
Locations:
city: Marburg
country: Germany
facility: University of Marburg, Faculty of Clinical Psychology and Psychotherapy
state: Hessen
city: Hamburg
country: Germany
facility: University of Hamburg, Faculty of Clinical Psychology and Psychotherapy
Study officials:
affiliation: Philipps University Marburg
name: Stephanie Mehl, Ph. D.
role: STUDY_CHAIR
affiliation: University of Hamburg-Eppendorf
name: Tania M Lincoln, Ph. D.
role: STUDY_CHAIR
affiliation: Ruhr University of Bochum
name: Tobias Teismann, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kammerer 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.
citation: Ludwig 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.