PsychosisREACHNCT02336581
Researching the Effectiveness of Acceptance-Based Coping During Hospitalization
A study testing Acceptance and Commitment Therapy (ACT) and Enhanced Treatment as Usual (eTAU) in people with Psychosis and Schizophrenia, run by Butler Hospital at 1 site in United States.
Trial summary
To test the effectiveness of Acceptance and Commitment Therapy (ACT) versus enhanced Treatment as Usual (eTAU) delivered by hospital staff for inpatients with psychotic-spectrum disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis, Schizophrenia
- What is being tested?
- Acceptance and Commitment Therapy (ACT) and Enhanced Treatment as Usual (eTAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Sep 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
- current psychiatric hospitalization
- diagnosis of schizophrenia, schizoaffective disorder, schizophreniform, brief psychotic disorder, delusional disorder, specified/unspecified other psychotic disorder, or a diagnosis of a mood disorder (major depressive disorder or bipolar disorder) with psychotic features, as determined by chart review and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-5
- 18 years or older
- ability to speak and read English.
Who cannot join
- psychosis severe enough to prevent participation in regular hospital groups
- psychotic disorder related to a general medical condition or substance-induced psychotic disorder
- significant cognitive impairment (mini-mental state exam score < 15).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Psychosocial Treatment for Inpatients With Psychosis
To test the effectiveness of Acceptance and Commitment Therapy (ACT) versus enhanced Treatment as Usual (eTAU) delivered by hospital staff for inpatients with psychotic-spectrum disorders.
Read the detailed description
Patients with psychotic disorders frequently require treatment at inpatient hospital settings during periods of acute illness for crisis management and stabilization. Although these patients often receive efficacious pharmacotherapy, there is a recognized lack of empirically-supported psychosocial interventions provided to patients in typical hospital settings. The provision of high quality psychosocial treatment during hospitalization is challenging due to short lengths of stay and a general lack of trained therapist employed on hospital units who can provide these evidence-based therapies. This unmet need for hospital psychosocial treatment represents a crucial missed opportunity to teach patients coping strategies that can speed time to recovery and impact post-discharge risk factors. Acceptance and Commitment Therapy (ACT) is a newer cognitive-behavioral approach that combines innovative mindfulness-based strategies for helping patients to cope more successfully with psychotic and other symptoms and implement values-consistent behavioral goals. However, adaptations to the original ACT approach are urgently needed to foster widespread implementation in community settings. The aim of the current study is to adapt the only promising acute-care psychosocial treatment for psychosis to be implementable in an inpatient setting and pilot test its effectiveness.
- Conditions
- Psychosis, Schizophrenia
- Being tested
- Acceptance and Commitment Therapy (ACT), Enhanced Treatment as Usual (eTAU)
- Keywords
- Acceptance and Commitment Therapy, Mindfulness, Inpatients, Psychiatric Hospitalization
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
individual + group + follow-up phone contacts
Enhanced Treatment as Usual (eTAU)Behavioural
individual + group + follow-up phone contacts
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | ACT which includes individual and group sessions during hospitalization and follow-up phone contacts the first month following hospital discharge. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
| Enhanced Treatment as Usual (eTAU) | Active comparator | Enhanced treatment as usual (eTAU) which includes other individual and group sessions during hospitalization and follow-up phone contacts the first month following hospital discharge. Receives: Behavioral: Enhanced Treatment as Usual (eTAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale
Measured: Hospital Discharge (1 Week)
Secondary outcomes (1)
Psychiatric Rehospitalization
Measured: 4 Months Post-Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Brandon Gaudiano, Butler Hospital
- Investigators
- Brandon Gaudiano, Ph.D., Principal investigator, Butler Hospital/Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336581
- Sponsor's protocol ID
- 1411-001
- Other IDs
- 5R34MH097987-02
- Acronym
- REACH
- Status last verified
- Sep 2017
- First submitted
- 8 Jan 2015
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaudiano BA, Herbert JD. Acute treatment of inpatients with psychotic symptoms using Acceptance and Commitment Therapy: pilot results. Behav Res Ther. 2006 Mar;44(3):415-37. doi: 10.1016/j.brat.2005.02.007.
PubMed 15893293Gaudiano BA, Ellenberg S, Johnson JE, Mueser KT, Miller IW. Effectiveness of acceptance and commitment therapy for inpatients with psychosis: Implementation feasibility and acceptability from a pilot randomized controlled trial. Schizophr Res. 2023 Nov;261:72-79. doi: 10.1016/j.schres.2023.09.017. Epub 2023 Sep 14.
PubMed 37716204
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Psychosocial Treatment for Inpatients With Psychosis
- ClinicalTrials.gov ID
- NCT02336581
- Acronym / sponsor ID
- REACH / 1411-001
- Conditions
- Psychosis, Schizophrenia
- Keywords
- Acceptance and Commitment Therapy, Mindfulness, Inpatients, Psychiatric Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Jan 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.
To test the effectiveness of Acceptance and Commitment Therapy (ACT) versus enhanced Treatment as Usual (eTAU) delivered by hospital staff for inpatients with psychotic-spectrum disorders.
Detailed description
Patients with psychotic disorders frequently require treatment at inpatient hospital settings during periods of acute illness for crisis management and stabilization. Although these patients often receive efficacious pharmacotherapy, there is a recognized lack of empirically-supported psychosocial interventions provided to patients in typical hospital settings. The provision of high quality psychosocial treatment during hospitalization is challenging due to short lengths of stay and a general lack of trained therapist employed on hospital units who can provide these evidence-based therapies. This unmet need for hospital psychosocial treatment represents a crucial missed opportunity to teach patients coping strategies that can speed time to recovery and impact post-discharge risk factors. Acceptance and Commitment Therapy (ACT) is a newer cognitive-behavioral approach that combines innovative mindfulness-based strategies for helping patients to cope more successfully with psychotic and other symptoms and implement values-consistent behavioral goals. However, adaptations to the original ACT approach are urgently needed to foster widespread implementation in community settings. The aim of the current study is to adapt the only promising acute-care psychosocial treatment for psychosis to be implementable in an inpatient setting and pilot test its effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)ACT which includes individual and group sessions during hospitalization and follow-up phone contacts the first month following hospital discharge. |
| Enhanced Treatment as Usual (eTAU) | Active comparator | Behavioral: Enhanced Treatment as Usual (eTAU)Enhanced treatment as usual (eTAU) which includes other individual and group sessions during hospitalization and follow-up phone contacts the first month following hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- current psychiatric hospitalization
- diagnosis of schizophrenia, schizoaffective disorder, schizophreniform, brief psychotic disorder, delusional disorder, specified/unspecified other psychotic disorder, or a diagnosis of a mood disorder (major depressive disorder or bipolar disorder) with psychotic features, as determined by chart review and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-5
- 18 years or older
- ability to speak and read English.
Key exclusion criteria (3 listed)
- psychosis severe enough to prevent participation in regular hospital groups
- psychotic disorder related to a general medical condition or substance-induced psychotic disorder
- significant cognitive impairment (mini-mental state exam score < 15).
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 and Commitment Therapy (ACT)individual + group + follow-up phone contacts | Behavioural | Acceptance and Commitment Therapy (ACT) |
| Enhanced Treatment as Usual (eTAU)individual + group + follow-up phone contacts | Behavioural | Enhanced Treatment as Usual (eTAU) |
Primary outcome
Brief Psychiatric Rating Scale
Time frame: Hospital Discharge (1 Week)
1 secondary outcome
Psychiatric Rehospitalization
Time frame: 4 Months Post-Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Background: PubMed 15893293Gaudiano BA, Herbert JD. Acute treatment of inpatients with psychotic symptoms using Acceptance and Commitment Therapy: pilot results. Behav Res Ther. 2006 Mar;44(3):415-37. doi: 10.1016/j.brat.2005.02.007.
- Derived from this study: PubMed 37716204Gaudiano BA, Ellenberg S, Johnson JE, Mueser KT, Miller IW. Effectiveness of acceptance and commitment therapy for inpatients with psychosis: Implementation feasibility and acceptability from a pilot randomized controlled trial. Schizophr Res. 2023 Nov;261:72-79. doi: 10.1016/j.schres.2023.09.017. Epub 2023 Sep 14.
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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.
Brandon Gaudiano, Ph.D. principal investigator
Butler Hospital/Brown 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 Acceptance and Commitment Therapy (ACT) and Enhanced Treatment as Usual (eTAU) in people with Psychosis and Schizophrenia, run by Butler Hospital at 1 site in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 20 Sep 2017. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brief Psychiatric Rating Scale (time frame: Hospital Discharge (1 Week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02336581, which also lists 2 linked publications.
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 Sep 2017.