Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations

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.

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Key information

Conditions

Schizophrenia, Schizoaffective Disorder Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer CBT

Behavioral

Primary outcomes

Brief Psychiatric Rating Scale (BPRS)

Time frame: Baseline, Post-Treatment, 3-Month Follow-up

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

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: Jul 17, 2014
Registry last updated: Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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