Cognitive Behavior Therapy for Patients With Psychoses.

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
• Intervention / Treatment: Behavioral: Cognitive Behavior Therapy; Behavioral: Acceptance and Commitment Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Helena Fatouros-Bergman, PhD, Karolinska Insitutet

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Schizophrenia; Acceptance and Commitment Therapy; CBT; ACT; Cognitive Behavior Therapy; Psychoses
• Additional Relevant MeSH Terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
• Other Study ID Numbers: Karolinska Inst