Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations

Schizophrenia, Schizoaffective Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192593
• Other study ID #: ComputerCBTPsychosis
• Status: Completed
• Phase: N/A
• First received: September 13, 2013
• Last updated: March 3, 2017
• Start date: November 2011
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hallucinations
• Psychotic Disorders
• Schizophrenia
• Schizophrenia, Schizoaffective Disorder

Intervention

Behavioral:
• Computer CBT

Locations

Country	Name	City	State
United States	Cambridge Health Alliance	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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