Compulsory Psychiatric Care ActNCT06012981
Psychological Treatment in Psychiatric Inpatient Care
A study testing ACT in people with Compulsory Psychiatric Care Act and Psychosis, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Compulsory Psychiatric Care Act, Psychosis, Acceptance & Commitment Therapy
- What is being tested?
- ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2023to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older.
- Treated according to the compulsory psychiatric care act.
- Meet the criterion of informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Hospital of Västmanland, Västerås
Västerås, Västmanland County, 72189
About this study
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.
- Conditions
- Compulsory Psychiatric Care Act, Psychosis, Acceptance & Commitment Therapy, Psychiatric Hospitalization, Psychiatric Disorder
- Being tested
- ACT
- Medical subject headings
- Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance & Commitment Therapy (ACT) | Experimental | Psyhotherapy based on principles of functional analysis, behavioral activation, and experiential avoidance. Receives: Behavioral: ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change in Bull's Eye Values Survey
The score ranges from 0-28, higher scores corresponding to better outcome.
Measured: 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
Change in PHQ-9
The score ranges from 0-27, higher scores corresponding to worse outcome.
Measured: 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
Change in GAD-7
The score ranges from 0-21, higher scores corresponding to worse outcome.
Measured: 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
Change in Psy-flex
The score ranges from 6-30, higher scores corresponding to better outcome.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Sep 2023
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Why it stopped: Unforeseen difficulties in recruiting participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compulsory Psychiatric Care ActStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-case experimental design.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marten Tyrberg, Uppsala University
- Investigators
- Kent Nilsson, Professor, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012981
- Sponsor's protocol ID
- 280468
- Status last verified
- Dec 2023
- First submitted
- 28 Apr 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Treatment in Psychiatric Inpatient Care
- ClinicalTrials.gov ID
- NCT06012981
- Acronym / sponsor ID
- 280468
- Conditions
- Compulsory Psychiatric Care Act, Psychosis, Acceptance & Commitment Therapy, Psychiatric Hospitalization, Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unforeseen difficulties in recruiting participants.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-case experimental design.
| Arm | Type | Receives |
|---|---|---|
| Acceptance & Commitment Therapy (ACT) | Experimental | Behavioral: ACTPsyhotherapy based on principles of functional analysis, behavioral activation, and experiential avoidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older.
- Treated according to the compulsory psychiatric care act.
- Meet the criterion of informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTThe 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. | Behavioural | Acceptance & Commitment Therapy (ACT) |
Primary outcome
Change in Personal Questionnaire
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
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
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
The score ranges from 0-28, higher scores corresponding to better outcome.
Change in PHQ-9
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
The score ranges from 0-27, higher scores corresponding to worse outcome.
Change in GAD-7
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
The score ranges from 0-21, higher scores corresponding to worse outcome.
Change in Psy-flex
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
The score ranges from 6-30, higher scores corresponding to better outcome.
Results and safety
The study was stopped early (reason given: Unforeseen difficulties in recruiting participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent Nilsson, Professor study director
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT in people with Compulsory Psychiatric Care Act and Psychosis, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unforeseen difficulties in recruiting participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Personal Questionnaire (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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.