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

Primary Purpose

Psychosis, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy (ACT)
Enhanced Treatment as Usual (eTAU)
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Acceptance and Commitment Therapy, Mindfulness, Inpatients, Psychiatric Hospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acceptance and Commitment Therapy (ACT)

Enhanced Treatment as Usual (eTAU)

Arm Description

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) which includes other individual and group sessions during hospitalization and follow-up phone contacts the first month following hospital discharge.

Outcomes

Primary Outcome Measures

Brief Psychiatric Rating Scale

Secondary Outcome Measures

Psychiatric Rehospitalization

Full Information

First Posted
January 8, 2015
Last Updated
September 18, 2017
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02336581
Brief Title
Researching the Effectiveness of Acceptance-Based Coping During Hospitalization
Acronym
REACH
Official Title
Effectiveness of Psychosocial Treatment for Inpatients With Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Schizophrenia
Keywords
Acceptance and Commitment Therapy, Mindfulness, Inpatients, Psychiatric Hospitalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy (ACT)
Arm Type
Experimental
Arm Description
ACT which includes individual and group sessions during hospitalization and follow-up phone contacts the first month following hospital discharge.
Arm Title
Enhanced Treatment as Usual (eTAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy (ACT)
Intervention Description
individual + group + follow-up phone contacts
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment as Usual (eTAU)
Intervention Description
individual + group + follow-up phone contacts
Primary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale
Time Frame
Hospital Discharge (1 Week)
Secondary Outcome Measure Information:
Title
Psychiatric Rehospitalization
Time Frame
4 Months Post-Discharge
Other Pre-specified Outcome Measures:
Title
Acceptance and Action Questionnaire-II
Time Frame
Hospital Discharge (1 Week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Gaudiano, Ph.D.
Organizational Affiliation
Butler Hospital/Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15893293
Citation
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. Erratum In: Behav Res Ther. 2020 Jan;124:103534.
Results Reference
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Researching the Effectiveness of Acceptance-Based Coping During Hospitalization

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