NCT02336581

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

2.5 years

First QC Date

January 8, 2015

Last Update Submit

September 18, 2017

Conditions

PsychosisSchizophrenia

Keywords

Acceptance and Commitment TherapyMindfulnessInpatientsPsychiatric Hospitalization

Outcome Measures

Primary Outcomes (1)

  • Brief Psychiatric Rating Scale

    Hospital Discharge (1 Week)

Secondary Outcomes (1)

  • Psychiatric Rehospitalization

    4 Months Post-Discharge

Other Outcomes (1)

  • Acceptance and Action Questionnaire-II

    Hospital Discharge (1 Week)

Study Arms (2)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

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)

Enhanced Treatment as Usual (eTAU)

ACTIVE COMPARATOR

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)

Interventions

Acceptance and Commitment Therapy (ACT)BEHAVIORAL

individual + group + follow-up phone contacts

Acceptance and Commitment Therapy (ACT)
Enhanced Treatment as Usual (eTAU)BEHAVIORAL

individual + group + follow-up phone contacts

Enhanced Treatment as Usual (eTAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older
  • ability to speak and read English.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

  • 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.

    PMID: 15893293BACKGROUND

  • 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.

    PMID: 37716204DERIVED

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Brandon Gaudiano, Ph.D.

    Butler Hospital/Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Psychologist/Associate Professor

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 20, 2017

Record last verified: 2017-09

Locations

US(1)