Cognitive Behavior Therapy for Patients With Psychoses.

Not Applicable

Completed

• Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
• Interventions: Behavioral: Cognitive Behavior Therapy; Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT03501888
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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 Timeline

• Study Start: 2015-10
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Study First Submitted: 2017-01-30
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-10
• Last Update Submitted: 2018-04-10
• Study First Posted: 2018-04-18
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

• Patients with drug abuse diagnosis
• organic brain injury,
• patients with grave somatic illness with secondary psychotic symptoms.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavior Therapy (CBT)	Cognitive Behavior Therapy	CBT: individually, ca 18 weeks.
Acceptance and Commitment Therapy (ACT)	Acceptance and Commitment Therapy	ACT: given in a group setting: ca 18 weeks.

Primary Outcome Measures

Name	Time	Method
Symptoms of psychoses	Up to 11 months	measured with PANSS (subscales: positive and negative symptoms).

Secondary Outcome Measures

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