Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations

Randomized Controlled Trial of Computerized Cognitive Behavioral Therapy for Auditory Hallucinations in Persons With Psychosis

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia, Schizoaffective Disorder
• Intervention / Treatment: Behavioral: Computer CBT

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Cambridge Health Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Computer CBT; A 10-session computerized cognitive-behavioral therapy intervention	Behavioral: Computer CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Investigators: Principal Investigator: Jennifer D Gottlieb, PhD, Boston University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 13, 2013
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: March 3, 2017
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Schizophrenia; Psychotic Disorders; Hallucinations
• Other Study ID Numbers: ComputerCBTPsychosis