Cognitive Behavior Therapy for Patients With Psychoses.

Study Overview
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Brief Summary
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Patients with psychoses are randomized either to group treatment (ACT) or individual CBT for 18 sessions.

Detailed Description
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Since patients in the early stage of the illness seem to benefit more from CBT than patients with chronic conditions the present research will focus on patients with psychosis at the early stages of their illness. Patients with first episode psychosis from the Northern Stockholm Psychiatry (Midhagen) and the South West Stockholm Psychiatry (TIPS) will be included. Scores on Alcohol Use disorder identification Test (AUDIT) and Drug Use disorder Identification Test (DUDIT) will be used as a covariate in order to control for the patients' s drug and alcohol use habits. The study is single blind randomized controlled trials of manualized Cognitive Behavior Group Therapy (CBGT) versus an active treatment condition of individual CBT for patients with first episode psychosis. A total of 16 patients are enrolled and randomly allocated to either CBGT or to individual CBT treatment. Then 18 structured CBGT or individual CBT sessions approximately once a week will be offered. Three experienced CBT trained therapists will perform the therapies. Two therapists will be allocated to each group composed by approximately 5 patients. The group therapies are conducted according to the Acceptance and Commitment Therapy (ACT) for psychosis manual (an 18 Session Group Therapy Protocol by Pearson A. & Tingey R.). The individual therapies are conducted according to non-manualized ordinary clinical procedure. The ACT manual is originally constructed for patients with chronic schizophrenia and has therefore been adapted by the therapists to be appropriate for patients with first episode psychosis. The therapists have taken a course in ACT and they receive ACT-supervision during the trial. Assessments in both studies will be carried out at baseline, after therapy completion and 6 months later by an independent rater blind to group allocation and not involved in the treatment of the patients. The raters blindness will be measured.

Official Title
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A Single Blind Randomized Controlled Trial Comparing Cognitive Behavior Group Therapy and Individual Cognitive Behavioural Therapy for Patients With Psychoses

Conditions
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Schizophrenia Spectrum and Other Psychotic Disorders

Intervention / Treatment
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* Behavioral: Cognitive Behavior Therapy
* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnostic and Statistical Manual 5 (DSM-5): schizophrenia spectrum disorders: schizophrenia, schizophreniform psychosis, schizoaffective disorder) delusional disorder, brief psychotic disorder psychosis not otherwise classified. Exclusion Criteria: Patients with drug abuse diagnosis organic brain injury, patients with grave somatic illness with secondary psychotic symptoms.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Behavior Therapy (CBT)<br>CBT: individually, ca 18 weeks. | Behavioral: Cognitive Behavior Therapy<br>* 18 sessions of individual treatment, no manual.<br>* Other names: CBT;|
| Active Comparator: Acceptance and Commitment Therapy (ACT)<br>ACT: given in a group setting: ca 18 weeks. | Behavioral: Acceptance and Commitment Therapy<br>* 18 sessions of group treatment, manual based.<br>* Other names: ACT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of psychoses | measured with PANSS (subscales: positive and negative symptoms). | Up to 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life, | Quality of life is measured by Brunnsviken Brief Quality of Life Inventory. | Up to 11 months | 
| Symptoms of depression | Symptoms of Depression; Becks Depression Inventory. | Up to 11 months | 
| Self Esteem | Self esteem is measured by Self Concept Questionaire | Up to 11 months | 
| Values, | Living in accordance with ones values is measured by Bull´s eye Values Survey. | Up to 11 months | 
| Psychological inflexibility and Experiential Avoidance. | Psychological inflexibility and experiential avoidance is measured with Acceptance and Action Questionaire II | Up to 11 months | 
| Treatment safety | Treatment safety is evaluated through assessment of adverse effects or events by registering suicide, suicide attempts, re-hospitalization and severe depressive symptom exacerbation). | Up to 11 months | 
| Symptoms of anxiety | Becks Anxiety Inventory, | Up to 11 months | 
| Alcohol use | Alcohol Use Disorder Identification Test | Upt to 11 months | 
| Drug use | Drug Use Disorder Identification Test. | Up to 11 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance and Commitment Therapy, Cognitive Behavior Therapy, CBT, Schizophrenia, Psychoses, ACT