NCT03501888

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

January 30, 2017

Last Update Submit

April 10, 2018

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

Acceptance and Commitment TherapyACTCognitive Behavior TherapyCBTSchizophreniaPsychoses

Outcome Measures

Primary Outcomes (1)

  • Symptoms of psychoses

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

    Up to 11 months

Secondary Outcomes (9)

  • Quality of Life,

    Up to 11 months

  • Symptoms of depression

    Up to 11 months

  • Self Esteem

    Up to 11 months

  • Values,

    Up to 11 months

  • Psychological inflexibility and Experiential Avoidance.

    Up to 11 months

  • +4 more secondary outcomes

Study Arms (2)

Cognitive Behavior Therapy (CBT)

ACTIVE COMPARATOR

CBT: individually, ca 18 weeks.

Behavioral: Cognitive Behavior Therapy

Acceptance and Commitment Therapy (ACT)

ACTIVE COMPARATOR

ACT: given in a group setting: ca 18 weeks.

Behavioral: Acceptance and Commitment Therapy

Interventions

Cognitive Behavior TherapyBEHAVIORAL

18 sessions of individual treatment, no manual.

Also known as: CBT
Cognitive Behavior Therapy (CBT)
Acceptance and Commitment TherapyBEHAVIORAL

18 sessions of group treatment, manual based.

Also known as: ACT
Acceptance and Commitment Therapy (ACT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • schizophrenia spectrum disorders:
  • schizophrenia,
  • schizophreniform psychosis,
  • schizoaffective disorder)
  • delusional disorder,
  • brief psychotic disorder
  • psychosis not otherwise classified.

You may not qualify if:

  • Patients with drug abuse diagnosis
  • organic brain injury,
  • patients with grave somatic illness with secondary psychotic symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic DisordersSchizophreniaPsychotic Disorders

Interventions

Cognitive Behavioral TherapyAcceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Helena Fatouros-Bergman, PhD

    Karolinska Insitutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pricipal investigator

Study Record Dates

First Submitted

January 30, 2017

First Posted

April 18, 2018

Study Start

October 1, 2015

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

April 18, 2018

Record last verified: 2018-04