search
Back to results

Cognitive Behavior Therapy for Patients With Psychoses.

Primary Purpose

Schizophrenia Spectrum and Other Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Acceptance and Commitment Therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia Spectrum and Other Psychotic Disorders focused on measuring Acceptance and Commitment Therapy, ACT, Cognitive Behavior Therapy, CBT, Schizophrenia, Psychoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Cognitive Behavior Therapy (CBT)

    Acceptance and Commitment Therapy (ACT)

    Arm Description

    CBT: individually, ca 18 weeks.

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

    Outcomes

    Primary Outcome Measures

    Symptoms of psychoses
    measured with PANSS (subscales: positive and negative symptoms).

    Secondary Outcome Measures

    Quality of Life,
    Quality of life is measured by Brunnsviken Brief Quality of Life Inventory.
    Symptoms of depression
    Symptoms of Depression; Becks Depression Inventory.
    Self Esteem
    Self esteem is measured by Self Concept Questionaire
    Values,
    Living in accordance with ones values is measured by Bull´s eye Values Survey.
    Psychological inflexibility and Experiential Avoidance.
    Psychological inflexibility and experiential avoidance is measured with Acceptance and Action Questionaire II
    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).
    Symptoms of anxiety
    Becks Anxiety Inventory,
    Alcohol use
    Alcohol Use Disorder Identification Test
    Drug use
    Drug Use Disorder Identification Test.

    Full Information

    First Posted
    January 30, 2017
    Last Updated
    April 10, 2018
    Sponsor
    Karolinska Institutet
    Collaborators
    Region Stockholm
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03501888
    Brief Title
    Cognitive Behavior Therapy for Patients With Psychoses.
    Official Title
    A Single Blind Randomized Controlled Trial Comparing Cognitive Behavior Group Therapy and Individual Cognitive Behavioural Therapy for Patients With Psychoses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    August 31, 2016 (Actual)
    Study Completion Date
    August 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet
    Collaborators
    Region Stockholm

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia Spectrum and Other Psychotic Disorders
    Keywords
    Acceptance and Commitment Therapy, ACT, Cognitive Behavior Therapy, CBT, Schizophrenia, Psychoses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive Behavior Therapy (CBT)
    Arm Type
    Active Comparator
    Arm Description
    CBT: individually, ca 18 weeks.
    Arm Title
    Acceptance and Commitment Therapy (ACT)
    Arm Type
    Active Comparator
    Arm Description
    ACT: given in a group setting: ca 18 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavior Therapy
    Other Intervention Name(s)
    CBT
    Intervention Description
    18 sessions of individual treatment, no manual.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Acceptance and Commitment Therapy
    Other Intervention Name(s)
    ACT
    Intervention Description
    18 sessions of group treatment, manual based.
    Primary Outcome Measure Information:
    Title
    Symptoms of psychoses
    Description
    measured with PANSS (subscales: positive and negative symptoms).
    Time Frame
    Up to 11 months
    Secondary Outcome Measure Information:
    Title
    Quality of Life,
    Description
    Quality of life is measured by Brunnsviken Brief Quality of Life Inventory.
    Time Frame
    Up to 11 months
    Title
    Symptoms of depression
    Description
    Symptoms of Depression; Becks Depression Inventory.
    Time Frame
    Up to 11 months
    Title
    Self Esteem
    Description
    Self esteem is measured by Self Concept Questionaire
    Time Frame
    Up to 11 months
    Title
    Values,
    Description
    Living in accordance with ones values is measured by Bull´s eye Values Survey.
    Time Frame
    Up to 11 months
    Title
    Psychological inflexibility and Experiential Avoidance.
    Description
    Psychological inflexibility and experiential avoidance is measured with Acceptance and Action Questionaire II
    Time Frame
    Up to 11 months
    Title
    Treatment safety
    Description
    Treatment safety is evaluated through assessment of adverse effects or events by registering suicide, suicide attempts, re-hospitalization and severe depressive symptom exacerbation).
    Time Frame
    Up to 11 months
    Title
    Symptoms of anxiety
    Description
    Becks Anxiety Inventory,
    Time Frame
    Up to 11 months
    Title
    Alcohol use
    Description
    Alcohol Use Disorder Identification Test
    Time Frame
    Upt to 11 months
    Title
    Drug use
    Description
    Drug Use Disorder Identification Test.
    Time Frame
    Up to 11 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Helena Fatouros-Bergman, PhD
    Organizational Affiliation
    Karolinska Insitutet
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cognitive Behavior Therapy for Patients With Psychoses.

    We'll reach out to this number within 24 hrs