Pilot-trial of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia (CBT-E)

Philipps University

Status: Completed

Conditions: Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder; Brief Psychotic Disorder; Delusional Disorder

Treatments: Behavioral: CBT-E; Behavioral: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT02787122

CBT-E_MehlLincoln

Details and patient eligibility

About

The present study is a pilot single-blind randomized controlled therapy study. Its aim is to assess the efficacy of an emotion-focussed form of Cognitive behavior Therapy that focusses on emotional processes that are involved in the formation and maintenance of delusions such as emotional stability, emotion regulation and self-esteem.

Full description

Cognitive Behavior Therapy for psychosis (CBTp) is an effective treatment for patients with psychosis. Several meta-analyses showed an effect of CBTp in addition to antipsychotic treatment of small to medium effect size with regard to positive symptoms, general psychopathology and depression. Nevertheless, present research suggests that are especially emotional processes are closely related to positive symptoms and delusions, such as negative emotions, low self-esteem, depression and anxiety, whereas present interventions of CBTp focus often especially on cognitive interventions in order to change delusions as well as more cognitive risk factors for delusions such as reasoning biases and a dysfunctional causal attribution style.

Thus, the aim of the present single-blind randomized-controlled pilot therapy study was to assess the efficacy of a new form of emotion-focussed Cognitive behavior therapy for psychosis with regard to change in positive symptoms and delusions in comparison to standard treatment.

The main hypotheses are:

• Efficacy of CBT-E: patients with schizophrenia who receive CBT-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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or brief psychotic disorder
• Positive and Negative Syndrome Scale score in item P1 (delusions) of at least two
• fluent in German language
• agree to participate
• estimated general intelligence of at least 70 (assessed with the German Wortschatztest (MWT-B)
• no present suicidality

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups, including a placebo group

CBT-E

Active Comparator group

Description:

Emotion-focussed Cognitive behavior therapy: Patients receive 25 sessions of individual emotion-focused Cognitive Behavior Therapy. Interventions are behavioral activation, training of emotion regulation strategies, improvement of self-esteem and relapse prevention.

Treatment:

Behavioral: CBT-E

Treatment as Usual

Placebo Comparator group

Description:

Patients who are randomized and assigned to the Wait list are required to wait for half a year, while they receive standardized care (antipsychotic medication). After half a year, they receive CBT-E, as well.

Treatment:

Behavioral: Treatment as Usual