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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02336581
Other study ID # 1411-001
Secondary ID 5R34MH097987-02
Status Completed
Phase N/A
First received January 8, 2015
Last updated September 18, 2017
Start date March 2015
Est. completion date September 2017

Study information

Verified date September 2017
Source Butler Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Butler Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Butler Hospital National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Acceptance and Action Questionnaire-II Hospital Discharge (1 Week)
Primary Brief Psychiatric Rating Scale Hospital Discharge (1 Week)
Secondary Psychiatric Rehospitalization 4 Months Post-Discharge
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