Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations

NCT ID: NCT02192593

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-02-28

Brief Summary

This is a randomized controlled trial, examining the effects of a computerized, internet-based Cognitive Behavioral Therapy (CBT) Intervention for persons with a schizophrenia spectrum disorder who experience distressing auditory hallucinations (voices). Participants are randomized to one of two conditions: either to receive the 10-session computer-based program on a weekly basis, or to their usual care at their mental health clinic. This study takes place at Cambridge Health Alliance in Cambridge Massachusetts. It is hypothesized that the participants who participate in the CBT program will have significant improvements in the severity of their auditory hallucinations, as well as their associated distress, compared to the participants receiving usual care.

Conditions

Schizophrenia, Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Computer CBT

A 10-session computerized cognitive-behavioral therapy intervention

Group Type: EXPERIMENTAL

Computer CBT

Intervention Type: BEHAVIORAL

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Computer CBT

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants will be on a stable dose of antipsychotic medication for the past 3 months.

• Schizophrenia-spectrum diagnosis, including schizophrenia, schizoaffective disorder, schizophreniform disorder, and psychosis, not otherwise specified.
• At least moderate severity on Brief Psychiatric Rating Scale (BPRS) hallucinations item.
• Naïve to CBTp for Auditory Hallucinations within the past 3 years.
• No current suicidal ideation or hospitalization within the past month.
• Reading level of at least 4th grade, as measured by the reading section of the Wide Range Achievement Test (WRAT)
• Current patient receiving care at Cambridge Health Alliance

Exclusion Criteria

• Terminal physical illness expected to result in the death of the study participant within one year.

• Primary diagnosis of dementia or a diagnosis of a psychiatric disorder secondary to a medical condition.
• Comorbid dementia (severe cognitive impairment) as indicated by a Mini-mental state examination score <24.
• Current active substance abuse or dependence with the need for specialized substance abuse services
• Does not speak English
• Does not achieve a 4th grade reading level as demonstrated on the Wide Range Achievement Test (WRAT)
• Has a legal guardian

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Gottlieb

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer D Gottlieb, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Cambridge Health Alliance

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

ComputerCBTPsychosis

Identifier Type: -

Identifier Source: org_study_id