NCT02458105

Brief Summary

The overarching aim of the research project is to investigate whether Acceptance \& Commitment Therapy (ACT) is an efficacious psychotherapeutic method of treatment for inpatients suffering from acute psychosis. The method will be applied in two ways. Firstly, as an individual treatment for patients. Secondly, as an integrated part of the daily work on an inpatient ward, administered by nurses and assistant nurses trained in the method.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2.7 years

First QC Date

May 27, 2015

Last Update Submit

May 4, 2018

Conditions

Acute Psychosis

Keywords

Acceptance and commitment therapyCognitive behavior therapy

Outcome Measures

Primary Outcomes (1)

  • Rehospitalization

    Whether or not, and if so for how many days, a patient has ben readmitted to inpatient care during the follow-up period.

    12 months

Secondary Outcomes (6)

  • Bull's Eye Values Inventory

    12 months

  • EQ-5D

    12 months

  • Clinical Global Impression Scale

    12 months

  • Acceptance & Action Questionnaire

    12 months

  • Psychotic Symptom Rating Scales

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Acceptance & Commitment Therapy

EXPERIMENTAL

A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.

Behavioral: Acceptance & Commitment Therapy

Attention

ACTIVE COMPARATOR

Supportive conversation at a frequency and length corresponding to the experimental condition.

Behavioral: Attention

Interventions

Acceptance & Commitment TherapyBEHAVIORAL

A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.

Acceptance & Commitment Therapy
AttentionBEHAVIORAL

Supportive conversation at a frequency and length corresponding to the experimental condition.

Attention

Eligibility Criteria

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

You may qualify if:

  • Admitted to a specified psychiatric inpatient ward during the time-period of the study; psychotic spectrum diagnosis as specified in patient charts; assessed by contact person on the ward as having delusions or hallucinations.

You may not qualify if:

  • Cognitive difficulties to an extent where informed consent cannot be given.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Västmanland Hospital, Västerås, Västmanland County Council

Västerås, Sweden

Location

MeSH Terms

Interventions

Acceptance and Commitment TherapyNeuropsychological Tests

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPsychological Tests

Study Officials

  • Tobias Lundgren, PhD

    Stockholm University; Karolinska Institutet, department of Clinical Neuroscience & Centre for Psychiatry Research and Education, Stockholm County Council

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2015

First Posted

May 29, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

SE(1)