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Cognitive Behavior Therapy for Patients With Psychoses.

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ClinicalTrials.gov Identifier: NCT03501888
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Region Stockholm
Information provided by (Responsible Party):
Helena Fatouros-Bergman, Karolinska Institutet

Study Description
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Brief Summary:
Patients with psychoses are randomized either to group treatment (ACT) or individual CBT for 18 sessions.

Condition or disease Intervention/treatment Phase
Schizophrenia Spectrum and Other Psychotic Disorders Behavioral: Cognitive Behavior Therapy Behavioral: Acceptance and Commitment Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Blind Randomized Controlled Trial Comparing Cognitive Behavior Group Therapy and Individual Cognitive Behavioural Therapy for Patients With Psychoses
Study Start Date : October 2015
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : August 31, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cognitive Behavior Therapy (CBT)
CBT: individually, ca 18 weeks.
 Behavioral: Cognitive Behavior Therapy
18 sessions of individual treatment, no manual.
Other Name: CBT
Active Comparator: Acceptance and Commitment Therapy (ACT)
ACT: given in a group setting: ca 18 weeks.
 Behavioral: Acceptance and Commitment Therapy
18 sessions of group treatment, manual based.
Other Name: ACT


Outcome Measures
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Primary Outcome Measures :
  1. Symptoms of psychoses [ Time Frame: Up to 11 months ]
    measured with PANSS (subscales: positive and negative symptoms).


Secondary Outcome Measures :
  1. Quality of Life, [ Time Frame: Up to 11 months ]
    Quality of life is measured by Brunnsviken Brief Quality of Life Inventory.

  2. Symptoms of depression [ Time Frame: Up to 11 months ]
    Symptoms of Depression; Becks Depression Inventory.

  3. Self Esteem [ Time Frame: Up to 11 months ]
    Self esteem is measured by Self Concept Questionaire

  4. Values, [ Time Frame: Up to 11 months ]
    Living in accordance with ones values is measured by Bull´s eye Values Survey.

  5. Psychological inflexibility and Experiential Avoidance. [ Time Frame: Up to 11 months ]
    Psychological inflexibility and experiential avoidance is measured with Acceptance and Action Questionaire II

  6. Treatment safety [ Time Frame: 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).

  7. Symptoms of anxiety [ Time Frame: Up to 11 months ]
    Becks Anxiety Inventory,

  8. Alcohol use [ Time Frame: Upt to 11 months ]
    Alcohol Use Disorder Identification Test

  9. Drug use [ Time Frame: Up to 11 months ]
    Drug Use Disorder Identification Test.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501888


Sponsors and Collaborators
Karolinska Institutet
Region Stockholm
Investigators
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Principal Investigator: Helena Fatouros-Bergman, PhD Karolinska Insitutet
More Information
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Responsible Party: Helena Fatouros-Bergman, Pricipal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03501888    
Other Study ID Numbers: Karolinska Inst
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Keywords provided by Helena Fatouros-Bergman, Karolinska Institutet:
Acceptance and Commitment Therapy
ACT
Cognitive Behavior Therapy
 CBT
Schizophrenia
Psychoses
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders