An interventional study of emotion-oriented Cognitive Behavior Therapy in Schizophrenia, Psychotic Disorders and Delusions, sponsored by Philipps University Marburg. Completed at 2 sites in Germany. Open to participants aged 16 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-05.
Sponsored by Philipps University Marburg · Not applicable, Interventional, and Treatment
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).
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:
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 94 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
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Treatment Group:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: emotion-oriented Cognitive Behavior Therapy
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.
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.
Also known as: CBTd-E
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
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Positive and Negative Syndrome Scale (PANSS)
Assessment of positive, negative and general symptoms of schizophrenia
Time frame: 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
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Role Functioning Scale (RFS)
Assessment of social functioning
Time frame: 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.
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Emotion-regulation Questionnaire (ERQ)
Questionnaire assesses the regular use of emotion regulation strategies
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Emotion regulation inventory
Questionnaire assesses the regular use of emotion regulation strategies
Time frame: Change between pre-therapy and post-therapy assessment after six month
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
Time frame: Change between pre-therapy and post-therapy assessment after six month
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
Time frame: Change between pre-therapy and post-therapy assessment after six month
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
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in heart rate variability
Assessment of heart rate variability with sensors during stress induction (reaction experiment) and during rest
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Brief Core Schema Scale (BCSS)
Assessment of positive and negative self-schemata and schemata on others
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Insomnia Severity Index (ISI)
The ISI assesses present sleep problems
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Self-Compassion Scale (SCS)
SCS assesses self-compassion and self-esteem
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Self-perception of emotional competencies (SEK-27)
Questionnaire assesses the regular use of emotion regulation strategies
Time frame: Change between pre-therapy and post-therapy assessment after six month
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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