Skip to content

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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02787135
Acronym
CBTd-E
Enrollment
94
Registered
2016-06-01
Start date
2016-05-01
Completion date
2019-12-31
Last updated
2020-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delusions, Emotions, Psychotic Disorders, Schizophrenia, Self-esteem, Sleep

Keywords

Delusions, Schizophrenia, Cognitive Behavior Therapy, Emotion, Emotion regulation, self-esteem, sleep quality, Efficacy of change

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.

Interventions

BEHAVIORALemotion-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.

Sponsors

University of Hamburg-Eppendorf
CollaboratorOTHER
Ruhr University of Bochum
CollaboratorOTHER
Philipps University Marburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Psychotic Rating Scale (PSYRATS) delusions scaleChange between pre-therapy and post-therapy assessment after six monthAssessment of delusion frequency, delusion distress, conviction and loss of quality of life due to the delusion

Secondary

MeasureTime frameDescription
Change in Positive and Negative Syndrome Scale (PANSS)Change between pre-therapy and post-therapy assessment after six monthAssessment of positive, negative and general symptoms of schizophrenia
Change in Calgary Depression Rating Scale for Schizophrenia (CDSS(Change between pre-therapy and post-therapy assessment after six monthAssessment of depressive symptoms in patients with schizophrenia
Change in Role Functioning Scale (RFS)Change between pre-therapy and post-therapy assessment after six monthAssessment of social functioning
Change in Peters et al. Delusions Inventory (PDI- R)Change between pre-therapy and post-therapy assessment after six monthAssessment of self-rated delusion frequency, conviction and distress.

Other

MeasureTime frameDescription
Change in heart rate variabilityChange between pre-therapy and post-therapy assessment after six monthAssessment of heart rate variability with sensors during stress induction (reaction experiment) and during rest
Change in Brief Core Schema Scale (BCSS)Change between pre-therapy and post-therapy assessment after six monthAssessment of positive and negative self-schemata and schemata on others
Change in Emotion-regulation Questionnaire (ERQ)Change between pre-therapy and post-therapy assessment after six monthQuestionnaire assesses the regular use of emotion regulation strategies
Change in Self-Compassion Scale (SCS)Change between pre-therapy and post-therapy assessment after six monthSCS assesses self-compassion and self-esteem
Change in Self-perception of emotional competencies (SEK-27)Change between pre-therapy and post-therapy assessment after six monthQuestionnaire assesses the regular use of emotion regulation strategies
Change in Insomnia Severity Index (ISI)Change between pre-therapy and post-therapy assessment after six monthThe ISI assesses present sleep problems
Change in Emotion regulation inventoryChange between pre-therapy and post-therapy assessment after six monthQuestionnaire assesses the regular use of emotion regulation strategies
Change in Paranoia assessed with Electronical mobile assessmentChange between pre-therapy and post-therapy assessment after six monthAssessment 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 in Sleep quality as assessed with an ActiwatchChange between pre-therapy and post-therapy assessment after six monthAssessment of sleep-quality using an electronic bracelet for six consecutive days, sleep quality is assessed with movement detectors and light sensors
Change in Emotion regulation quality as assessed experimental using International Affect Picture System Paradigm for the Assessment of emotion regulation (IAPS)Change between pre-therapy and post-therapy assessment after six monthAssessment of effectiveness of use of emotion regulation strategies after experimental induction of fear, assessment of heart rate and skin conduction

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026