Other Clinical Trial - Cognitive Behavior Therapy for Patients With

Status Completed

Clinical Trial Summary

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

Clinical Trial 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

Related Conditions & MeSH terms

Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders

Clinical Trial Details

NCT number	NCT03501888
Study type	Interventional
Source	Karolinska Institutet
Contact
Status	Completed
Phase	N/A
Start date	October 2015
Completion date	August 31, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05321602` - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder	Phase 1
Recruiting	`NCT04298450` - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention	N/A
Enrolling by invitation	`NCT03090490` - 10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals	N/A
Completed	`NCT03323437` - Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia	Phase 4
Completed	`NCT06040944` - Antipsychotic Induced Hyperprolactinemaia as Risk Factor for Periodontitis in Schizophrenic Patients
Recruiting	`NCT04452175` - Cigarette Consumption After switchinG to High or Low Nicotine strENght E-cigaretteS In Smokers With Schizophrenia	N/A
Completed	`NCT05601063` - Ascertaining Diagnosis Classification With Elicited Speech
Recruiting	`NCT05877716` - EPI-MINN: Targeting Cognition and Motivation - National	N/A
Completed	`NCT03955549` - Insight Enhancement Program vs. Metacognitive Training for Psychosis in Patients With Schizophrenia: A Three-Armed Comparative Randomized Controlled Trial	Phase 3
Completed	`NCT03235908` - Copeptin in Outcome Prediction of an Acute Psychotic Episode
Recruiting	`NCT05622201` - A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults	Phase 2
Recruiting	`NCT05491486` - Mindfulness, Empathy and the Oxytocinergic System in Persons With Schizophrenia	N/A
Recruiting	`NCT04916496` - Acceptance and Commitment Therapy-based Lifestyle Counselling Programme for Early Psychosis on Physical Activity	N/A
Recruiting	`NCT04104347` - Metacognitive Training and Insight in Schizophrenia	N/A
Recruiting	`NCT05664594` - State Representation in Early Psychosis - Project 4	N/A
Recruiting	`NCT05538832` - Remote State Representation in Early Psychosis	Early Phase 1
Completed	`NCT02220504` - 3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals	N/A
Completed	`NCT04665401` - Personalizing Interventions Using Real-World Interactions	N/A
Recruiting	`NCT03919760` - Early Psychosis Intervention - Spreading Evidence-based Treatment
Completed	`NCT03449407` - Multi-dimensional Investigations of Negative Emotions and Drug-resistant Auditory Verbal Hallucinations in Psychosis

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cognitive Behavior Therapy for Patients With Psychoses.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms