- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02336581
Researching the Effectiveness of Acceptance-Based Coping During Hospitalization (REACH)
September 18, 2017 updated by: Brandon Gaudiano, Butler Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Butler Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
|
individual + group + follow-up phone contacts
|
|
ACTIVE_COMPARATOR: 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.
|
individual + group + follow-up phone contacts
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Brief Psychiatric Rating Scale
Time Frame: Hospital Discharge (1 Week)
|
Hospital Discharge (1 Week)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Psychiatric Rehospitalization
Time Frame: 4 Months Post-Discharge
|
4 Months Post-Discharge
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Acceptance and Action Questionnaire-II
Time Frame: Hospital Discharge (1 Week)
|
Hospital Discharge (1 Week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brandon Gaudiano, Ph.D., Butler Hospital/Brown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (ACTUAL)
September 1, 2017
Study Completion (ACTUAL)
September 1, 2017
Study Registration Dates
First Submitted
January 8, 2015
First Submitted That Met QC Criteria
January 8, 2015
First Posted (ESTIMATE)
January 13, 2015
Study Record Updates
Last Update Posted (ACTUAL)
September 20, 2017
Last Update Submitted That Met QC Criteria
September 18, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1411-001
- 5R34MH097987-02 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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