Cognitive Behavior Therapy for Patients With Psychoses.

NCT ID: NCT03501888

Last Updated: 2018-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-08-31

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.

Conditions

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Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Behavior Therapy (CBT)

CBT: individually, ca 18 weeks.

Group Type ACTIVE_COMPARATOR

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

18 sessions of individual treatment, no manual.

Acceptance and Commitment Therapy (ACT)

ACT: given in a group setting: ca 18 weeks.

Group Type ACTIVE_COMPARATOR

Acceptance and Commitment Therapy

Intervention Type BEHAVIORAL

18 sessions of group treatment, manual based.

Interventions

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Cognitive Behavior Therapy

18 sessions of individual treatment, no manual.

Intervention Type BEHAVIORAL

Acceptance and Commitment Therapy

18 sessions of group treatment, manual based.

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT ACT

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Helena Fatouros-Bergman

Pricipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helena Fatouros-Bergman, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Insitutet

Other Identifiers

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Karolinska Inst

Identifier Type: -

Identifier Source: org_study_id

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