Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations

NCT02192593 | Completed

• 1 other identifier: ComputerCBTPsychosis
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Brief Psychiatric Rating Scale (BPRS)

  Primary outcome is change in BPRS hallucinations item from baseline to post-treatment to 3 month follow-up. This measure assesses severity of auditory hallucinations as well as overall psychiatric symptoms

  Baseline, Post-Treatment, 3-Month Follow-up

Study Arms (2)

Computer CBT

EXPERIMENTAL

A 10-session computerized cognitive-behavioral therapy intervention

Behavioral: Computer CBT

Usual Care

NO INTERVENTION

Interventions

Computer CBT BEHAVIORAL

Computer CBT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jennifer D Gottlieb, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: July 17, 2014
• Study Start: November 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 6, 2017

Record last verified: 2015-07

Locations

US (1)