Cognitive Behavior Therapy
Behavioral18 sessions of individual treatment, no manual.
Other names: CBT
NCT Number: NCT03501888
Patients with psychoses are randomized either to group treatment (ACT) or individual CBT for 18 sessions.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Diagnostic and Statistical Manual 5 (DSM-5):
Exclusion criteria
18 sessions of individual treatment, no manual.
Other names: CBT
18 sessions of group treatment, manual based.
Other names: ACT
Time frame: Up to 11 months
measured with PANSS (subscales: positive and negative symptoms).
Time frame: Up to 11 months
Quality of life is measured by Brunnsviken Brief Quality of Life Inventory.
Time frame: Up to 11 months
Symptoms of Depression; Becks Depression Inventory.
Time frame: Up to 11 months
Self esteem is measured by Self Concept Questionaire
Time frame: Up to 11 months
Living in accordance with ones values is measured by Bull´s eye Values Survey.
Time frame: Up to 11 months
Psychological inflexibility and experiential avoidance is measured with Acceptance and Action Questionaire II
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).
Time frame: Up to 11 months
Becks Anxiety Inventory,
Time frame: Upt to 11 months
Alcohol Use Disorder Identification Test
Time frame: Up to 11 months
Drug Use Disorder Identification Test.
Karolinska Institutet
Other
A Single Blind Randomized Controlled Trial Comparing Cognitive Behavior Group Therapy and Individual Cognitive Behavioural Therapy for Patients With Psychoses
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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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