- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02458105
Acceptance & Commitment Therapy for Psychotic Inpatients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Västerås, Sweden
- Västmanland Hospital, Västerås, Västmanland County Council
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Cognitive difficulties to an extent where informed consent cannot be given.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acceptance & Commitment Therapy
A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.
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A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.
|
Active Comparator: Attention
Supportive conversation at a frequency and length corresponding to the experimental condition.
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Supportive conversation at a frequency and length corresponding to the experimental condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rehospitalization
Time Frame: 12 months
|
Whether or not, and if so for how many days, a patient has ben readmitted to inpatient care during the follow-up period.
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bull's Eye Values Inventory
Time Frame: 12 months
|
Quality of life instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
|
12 months
|
EQ-5D
Time Frame: 12 months
|
Health related quality of life instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
|
12 months
|
Clinical Global Impression Scale
Time Frame: 12 months
|
Symptom severity instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
|
12 months
|
Acceptance & Action Questionnaire
Time Frame: 12 months
|
Psychological flexibility instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
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12 months
|
Psychotic Symptom Rating Scales
Time Frame: 12 months
|
Symptom severity instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
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12 months
|
Checklist of Unit Behaviors
Time Frame: During inpatient care.
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Measure for degree of activity on the ward.
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During inpatient care.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Tobias Lundgren, PhD, Stockholm University; Karolinska Institutet, department of Clinical Neuroscience & Centre for Psychiatry Research and Education, Stockholm County Council
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/541
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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