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OpenTrials
Completed

NCT Number: NCT03501888

Cognitive Behavior Therapy for Patients With Psychoses.

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavior Therapy

Behavioral

18 sessions of individual treatment, no manual.

Other names: CBT

Acceptance and Commitment Therapy

Behavioral

18 sessions of group treatment, manual based.

Other names: ACT

Primary outcomes

  1. Symptoms of psychoses

    Time frame: Up to 11 months

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

A Single Blind Randomized Controlled Trial Comparing Cognitive Behavior Group Therapy and Individual Cognitive Behavioural Therapy for Patients With Psychoses

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 18, 2018
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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