Clinical trial NCT02336581: Researching the Effectiveness of Acceptance-Based Coping During Hospitalization
Official title: Effectiveness of Psychosocial Treatment for Inpatients With Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Schizophrenia
Keywords: Acceptance and Commitment Therapy
Mindfulness
Inpatients
Psychiatric Hospitalization
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-01-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Brief Psychiatric Rating Scale
timeFrame: Hospital Discharge (1 Week)
Secondary outcomes:
measure: Psychiatric Rehospitalization
timeFrame: 4 Months Post-Discharge
Other outcomes:
measure: Acceptance and Action Questionnaire-II
timeFrame: Hospital Discharge (1 Week)
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital/Brown University
name: Brandon Gaudiano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.