Back to resultsAcceptance & Commitment Therapy for Psychotic Inpatients
Primary Purpose
Acute Psychosis
Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Acceptance & Commitment Therapy
Attention
Sponsored by
About this trial
This is an interventional treatment trial for Acute Psychosis focused on measuring Acceptance and commitment therapy, Cognitive behavior therapy
Eligibility Criteria
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.
Sites / Locations
- Västmanland Hospital, Västerås, Västmanland County Council
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acceptance & Commitment Therapy
Attention
Arm Description
A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.
Supportive conversation at a frequency and length corresponding to the experimental condition.
Outcomes
Primary Outcome Measures
Rehospitalization
Whether or not, and if so for how many days, a patient has ben readmitted to inpatient care during the follow-up period.
Secondary Outcome Measures
Bull's Eye Values Inventory
Quality of life instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
EQ-5D
Health related quality of life instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Clinical Global Impression Scale
Symptom severity instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Acceptance & Action Questionnaire
Psychological flexibility instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Psychotic Symptom Rating Scales
Symptom severity instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Checklist of Unit Behaviors
Measure for degree of activity on the ward.
Full Information
NCT ID
NCT02458105
First Posted
May 27, 2015
Last Updated
May 4, 2018
Sponsor
Uppsala University
Collaborators
Stockholm University
1. Study Identification
Unique Protocol Identification Number
NCT02458105
Brief Title
Acceptance & Commitment Therapy for Psychotic Inpatients
Official Title
Acceptance & Commitment Therapy for Psychotic Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Required resources not available at the moment.
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Stockholm University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Psychosis
Keywords
Acceptance and commitment therapy, Cognitive behavior therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acceptance & Commitment Therapy
Arm Type
Experimental
Arm Description
A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.
Arm Title
Attention
Arm Type
Active Comparator
Arm Description
Supportive conversation at a frequency and length corresponding to the experimental condition.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance & Commitment Therapy
Intervention Description
A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Attention
Intervention Description
Supportive conversation at a frequency and length corresponding to the experimental condition.
Primary Outcome Measure Information:
Title
Rehospitalization
Description
Whether or not, and if so for how many days, a patient has ben readmitted to inpatient care during the follow-up period.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Bull's Eye Values Inventory
Description
Quality of life instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Time Frame
12 months
Title
EQ-5D
Description
Health related quality of life instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Time Frame
12 months
Title
Clinical Global Impression Scale
Description
Symptom severity instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Time Frame
12 months
Title
Acceptance & Action Questionnaire
Description
Psychological flexibility instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Time Frame
12 months
Title
Psychotic Symptom Rating Scales
Description
Symptom severity instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Time Frame
12 months
Title
Checklist of Unit Behaviors
Description
Measure for degree of activity on the ward.
Time Frame
During inpatient care.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Lundgren, PhD
Organizational Affiliation
Stockholm University; Karolinska Institutet, department of Clinical Neuroscience & Centre for Psychiatry Research and Education, Stockholm County Council
Official's Role
Study Director
Facility Information:
Facility Name
Västmanland Hospital, Västerås, Västmanland County Council
City
Västerås
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Acceptance & Commitment Therapy for Psychotic Inpatients
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