Back to resultsComputerized Cognitive-Behavioral Therapy for Auditory Hallucinations
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer CBT
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia, Schizoaffective Disorder
Eligibility Criteria
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
Sites / Locations
- Cambridge Health Alliance
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Computer CBT
Usual Care
Arm Description
A 10-session computerized cognitive-behavioral therapy intervention
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02192593
First Posted
September 13, 2013
Last Updated
March 3, 2017
Sponsor
Boston University Charles River Campus
1. Study Identification
Unique Protocol Identification Number
NCT02192593
Brief Title
Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations
Official Title
Randomized Controlled Trial of Computerized Cognitive Behavioral Therapy for Auditory Hallucinations in Persons With Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer CBT
Arm Type
Experimental
Arm Description
A 10-session computerized cognitive-behavioral therapy intervention
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Computer CBT
Primary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale (BPRS)
Description
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
Time Frame
Baseline, Post-Treatment, 3-Month Follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer D Gottlieb, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Health Alliance
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations
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