Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Behavioral: Computer CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |