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Researching the Effectiveness of Acceptance-Based Coping During Hospitalization (REACH)

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ClinicalTrials.gov Identifier: NCT02336581
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : September 20, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Brandon Gaudiano, Butler Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Psychosis Schizophrenia Behavioral: Acceptance and Commitment Therapy (ACT) Behavioral: Enhanced Treatment as Usual (eTAU) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Psychosocial Treatment for Inpatients With Psychosis
Study Start Date : March 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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.
Behavioral: Acceptance and Commitment Therapy (ACT)
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.
Behavioral: Enhanced Treatment as Usual (eTAU)
individual + group + follow-up phone contacts




Primary Outcome Measures :
  1. Brief Psychiatric Rating Scale [ Time Frame: Hospital Discharge (1 Week) ]

Secondary Outcome Measures :
  1. Psychiatric Rehospitalization [ Time Frame: 4 Months Post-Discharge ]

Other Outcome Measures:
  1. Acceptance and Action Questionnaire-II [ Time Frame: Hospital Discharge (1 Week) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. current psychiatric hospitalization
  2. 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
  3. 18 years or older
  4. ability to speak and read English.

Exclusion Criteria:

  1. psychosis severe enough to prevent participation in regular hospital groups
  2. psychotic disorder related to a general medical condition or substance-induced psychotic disorder
  3. significant cognitive impairment (mini-mental state exam score < 15).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336581


Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Brandon Gaudiano, Ph.D. Butler Hospital/Brown University

Publications:
Responsible Party: Brandon Gaudiano, Research Psychologist/Associate Professor, Butler Hospital
ClinicalTrials.gov Identifier: NCT02336581     History of Changes
Other Study ID Numbers: 1411-001
5R34MH097987-02 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Brandon Gaudiano, Butler Hospital:
Acceptance and Commitment Therapy
Mindfulness
Inpatients
Psychiatric Hospitalization

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders