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Researching the Effectiveness of Acceptance-Based Coping During Hospitalization

NCT ID: NCT02336581

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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

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Psychosis Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy (ACT)

Intervention Type BEHAVIORAL

individual + group + follow-up phone contacts

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.

Group Type ACTIVE_COMPARATOR

Enhanced Treatment as Usual (eTAU)

Intervention Type BEHAVIORAL

individual + group + follow-up phone contacts

Interventions

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Acceptance and Commitment Therapy (ACT)

individual + group + follow-up phone contacts

Intervention Type BEHAVIORAL

Enhanced Treatment as Usual (eTAU)

individual + group + follow-up phone contacts

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brandon Gaudiano

Research Psychologist/Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brandon Gaudiano, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital/Brown University

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15893293 (View on PubMed)

Gaudiano 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.

Reference Type DERIVED
PMID: 37716204 (View on PubMed)

Other Identifiers

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5R34MH097987-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1411-001

Identifier Type: -

Identifier Source: org_study_id