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
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
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
NCT ID
NCT03501888
First Posted
January 30, 2017
Last Updated
April 10, 2018
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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.
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