Cognitive Behavior Therapy for Patients With Psychoses.

Schizophrenia Spectrum and Other Psychotic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501888
• Other study ID #: Karolinska Inst
• Status: Completed
• Phase: N/A
• First received: January 30, 2017
• Last updated: April 10, 2018
• Start date: October 2015
• Est. completion date: August 31, 2016

Study information

• Verified date: April 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders

Intervention

Behavioral:
• Cognitive Behavior Therapy
18 sessions of individual treatment, no manual.
• Acceptance and Commitment Therapy
18 sessions of group treatment, manual based.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of psychoses	measured with PANSS (subscales: positive and negative symptoms).	Up to 11 months
Secondary	Quality of Life,	Quality of life is measured by Brunnsviken Brief Quality of Life Inventory.	Up to 11 months
Secondary	Symptoms of depression	Symptoms of Depression; Becks Depression Inventory.	Up to 11 months
Secondary	Self Esteem	Self esteem is measured by Self Concept Questionaire	Up to 11 months
Secondary	Values,	Living in accordance with ones values is measured by Bull´s eye Values Survey.	Up to 11 months
Secondary	Psychological inflexibility and Experiential Avoidance.	Psychological inflexibility and experiential avoidance is measured with Acceptance and Action Questionaire II	Up to 11 months
Secondary	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
Secondary	Symptoms of anxiety	Becks Anxiety Inventory,	Up to 11 months
Secondary	Alcohol use	Alcohol Use Disorder Identification Test	Upt to 11 months
Secondary	Drug use	Drug Use Disorder Identification Test.	Up to 11 months