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Psychological Treatment in Psychiatric Inpatient Care

Primary Purpose

Compulsory Psychiatric Care Act, Psychosis, Acceptance & Commitment Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ACT
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Compulsory Psychiatric Care Act

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18 years old or older. Treated according to the compulsory psychiatric care act. Meet the criterion of informed consent. Exclusion Criteria: Lack the cognitive ability to acquire the treatment intervention, such as impaired attention, memory, logic and reasoning, and also auditory and visual processing. This will be based on a clinical assessment by the ward team, including the attending psychiatrist and a clinical psychologist. Ongoing psychological treatment parallel to the admission.

Sites / Locations

  • Hospital of Västmanland, VästeråsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acceptance & Commitment Therapy (ACT)

Arm Description

Psyhotherapy based on principles of functional analysis, behavioral activation, and experiential avoidance.

Outcomes

Primary Outcome Measures

Change in Personal Questionnaire
Scores range from 1-4 per item (number of items might differ between patients as the measure is individually constructed. Higher scores correspond to worse outcome.
Change in Bull's Eye Values Survey
The score ranges from 0-28, higher scores corresponding to better outcome.
Change in PHQ-9
The score ranges from 0-27, higher scores corresponding to worse outcome.
Change in GAD-7
The score ranges from 0-21, higher scores corresponding to worse outcome.
Change in Psy-flex
The score ranges from 6-30, higher scores corresponding to better outcome.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2023
Last Updated
September 4, 2023
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT06012981
Brief Title
Psychological Treatment in Psychiatric Inpatient Care
Official Title
Psychological Treatment in Psychiatric Inpatient Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to investigate the effect of a brief psychotherapeutic treatment intervention based on ACT, aimed specifically at the vulnerable group of patients in psychiatric 24-hour care treated according to LPT. The study aims to investigate whether a brief number of therapeutic sessions according to ACT during inpatient care produce positive effects on personally relevant life areas for a diagnostically mixed group of patients in a psychiatric intensive care unit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compulsory Psychiatric Care Act, Psychosis, Acceptance & Commitment Therapy, Psychiatric Hospitalization, Psychiatric Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-case experimental design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acceptance & Commitment Therapy (ACT)
Arm Type
Experimental
Arm Description
Psyhotherapy based on principles of functional analysis, behavioral activation, and experiential avoidance.
Intervention Type
Behavioral
Intervention Name(s)
ACT
Intervention Description
The treatment is based on a variant of CBT, as briefly referred to before, ACT. In short, the treatment consists of identifying central and important areas of life, and how to approach these even though you are also struggling with persistent and challenging problems. In this study, the treatment intervention is flexibly constructed, focusing on several central principles based on ACT. These can be applied during one or numerous sessions. The intervention is a flexible application of clinical functional analysis, as well as a couple of selected interventions which, in terms of experience and in previous studies, have been shown to work well for the current group (24-hour psychiatric patients with complex problems) and which are individually adaptable to the nature of the problem and degree.
Primary Outcome Measure Information:
Title
Change in Personal Questionnaire
Description
Scores range from 1-4 per item (number of items might differ between patients as the measure is individually constructed. Higher scores correspond to worse outcome.
Time Frame
Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
Title
Change in Bull's Eye Values Survey
Description
The score ranges from 0-28, higher scores corresponding to better outcome.
Time Frame
Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
Title
Change in PHQ-9
Description
The score ranges from 0-27, higher scores corresponding to worse outcome.
Time Frame
Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
Title
Change in GAD-7
Description
The score ranges from 0-21, higher scores corresponding to worse outcome.
Time Frame
Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
Title
Change in Psy-flex
Description
The score ranges from 6-30, higher scores corresponding to better outcome.
Time Frame
Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years old or older. Treated according to the compulsory psychiatric care act. Meet the criterion of informed consent. Exclusion Criteria: Lack the cognitive ability to acquire the treatment intervention, such as impaired attention, memory, logic and reasoning, and also auditory and visual processing. This will be based on a clinical assessment by the ward team, including the attending psychiatrist and a clinical psychologist. Ongoing psychological treatment parallel to the admission.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mårten J Tyrberg, PhD
Phone
+4621174373
Email
marten.tyrberg@regionvastmanland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Nilsson, Professor
Organizational Affiliation
Uppsala University
Official's Role
Study Director
Facility Information:
Facility Name
Hospital of Västmanland, Västerås
City
Västerås
State/Province
Västmanland
ZIP/Postal Code
72189
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mårten Tyrberg, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Psychological Treatment in Psychiatric Inpatient Care

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