Acute PsychosisNCT02458105
Acceptance & Commitment Therapy for Psychotic Inpatients
A study testing Acceptance & Commitment Therapy and Attention in people with Acute Psychosis, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Psychosis
- What is being tested?
- Acceptance & Commitment Therapy and Attention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2015to Dec 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cognitive difficulties to an extent where informed consent cannot be given.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Västmanland Hospital, Västerås, Västmanland County Council
Västerås
About this study
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.
- Conditions
- Acute Psychosis
- Being tested
- Acceptance & Commitment Therapy, Attention
- Keywords
- Acceptance and commitment therapy, Cognitive behavior therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance & Commitment TherapyBehavioural
A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.
AttentionBehavioural
Supportive conversation at a frequency and length corresponding to the experimental condition.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance & Commitment Therapy | Experimental | A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms. Receives: Behavioral: Acceptance & Commitment Therapy |
| Attention | Active comparator | Supportive conversation at a frequency and length corresponding to the experimental condition. Receives: Behavioral: Attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization
Whether or not, and if so for how many days, a patient has ben readmitted to inpatient care during the follow-up period.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
EQ-5D
Health related quality of life instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Measured: 12 months
Clinical Global Impression Scale
Symptom severity instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Measured: 12 months
Acceptance & Action Questionnaire
Psychological flexibility instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Measured: 12 months
Psychotic Symptom Rating Scales
Symptom severity instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.
Measured: 12 months
Checklist of Unit Behaviors
Measure for degree of activity on the ward.
Measured: During inpatient care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Required resources not available at the moment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PsychosisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University
- Responsible party
- Sponsor
- Investigators
- Tobias Lundgren, PhD, Study director, Stockholm University; Karolinska Institutet, department of Clinical Neuroscience & Centre for Psychiatry Research and Education, Stockholm County Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458105
- Sponsor's protocol ID
- 2014/541
- Status last verified
- May 2018
- First submitted
- 27 May 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance & Commitment Therapy for Psychotic Inpatients
- ClinicalTrials.gov ID
- NCT02458105
- Acronym / sponsor ID
- 2014/541
- Conditions
- Acute Psychosis
- Keywords
- Acceptance and commitment therapy, Cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Required resources not available at the moment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Stockholm University
- Study start
- Apr 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 May 2015 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance & Commitment Therapy | Experimental | Behavioral: Acceptance & Commitment TherapyA variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms. |
| Attention | Active comparator | Behavioral: AttentionSupportive conversation at a frequency and length corresponding to the experimental condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Cognitive difficulties to an extent where informed consent cannot be given.
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 |
|---|---|---|
| Acceptance & Commitment TherapyA variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms. | Behavioural | Acceptance & Commitment Therapy |
| AttentionSupportive conversation at a frequency and length corresponding to the experimental condition. | Behavioural | Attention |
Primary outcome
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.
6 secondary outcomes
Bull's Eye Values Inventory
Time frame: 12 months
EQ-5D
Time frame: 12 months
Clinical Global Impression Scale
Time frame: 12 months
Acceptance & Action Questionnaire
Time frame: 12 months
Psychotic Symptom Rating Scales
Time frame: 12 months
Checklist of Unit Behaviors
Time frame: During inpatient care.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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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.
Tobias Lundgren, PhD study director
Stockholm University; Karolinska Institutet, department of Clinical Neuroscience & Centre for Psychiatry Research and Education, Stockholm County Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance & Commitment Therapy and Attention in people with Acute 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 11 May 2018. 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 withdrawn before enrolling participants, so there are no results.
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?
Rehospitalization (time frame: 12 months). 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 11 May 2018.