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Cognitive Behavior Therapy for Patients With Psychoses.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03501888
Enrollment
16
Registered
2018-04-18
Start date
2015-10-31
Completion date
2016-08-31
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

Acceptance and Commitment Therapy, ACT, Cognitive Behavior Therapy, CBT, Schizophrenia, Psychoses

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.

Interventions

BEHAVIORALCognitive Behavior Therapy

18 sessions of individual treatment, no manual.

BEHAVIORALAcceptance and Commitment Therapy

18 sessions of group treatment, manual based.

Sponsors

Region Stockholm
CollaboratorOTHER_GOV
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Symptoms of psychosesUp to 11 monthsmeasured with PANSS (subscales: positive and negative symptoms).

Secondary

MeasureTime frameDescription
Values,Up to 11 monthsLiving in accordance with ones values is measured by Bull´s eye Values Survey.
Quality of Life,Up to 11 monthsQuality of life is measured by Brunnsviken Brief Quality of Life Inventory.
Symptoms of depressionUp to 11 monthsSymptoms of Depression; Becks Depression Inventory.
Psychological inflexibility and Experiential Avoidance.Up to 11 monthsPsychological inflexibility and experiential avoidance is measured with Acceptance and Action Questionaire II
Self EsteemUp to 11 monthsSelf esteem is measured by Self Concept Questionaire
Symptoms of anxietyUp to 11 monthsBecks Anxiety Inventory,
Alcohol useUpt to 11 monthsAlcohol Use Disorder Identification Test
Drug useUp to 11 monthsDrug Use Disorder Identification Test.
Treatment safetyUp to 11 monthsTreatment safety is evaluated through assessment of adverse effects or events by registering suicide, suicide attempts, re-hospitalization and severe depressive symptom exacerbation).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026