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

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:

  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).

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

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

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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