Computerized Cognitive-Behavioral Therapy for Auditory Ha... | NCT02192593

Studies
Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations

NCT02192593

Sponsor

Boston University Charles River Campus

Status

Completed

Last Update Posted

Mar 6, 2017Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Schizophrenia, Schizoaffective Disorder

Interventions

Computer CBT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jan 2014Actual

Completion Date

Feb 2015Actual

First Submitted Date

Sep 13, 2013

First Submission Date that Met QC Criteria

Jul 15, 2014

First Posted Date

Jul 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2017

Last Update Posted Date

Mar 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Label	Type	Description	Intervention Names
Computer CBT	Experimental	A 10-session computerized cognitive-behavioral therapy intervention	Behavioral: Computer CBT
Usual Care	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
Computer CBT	Behavioral		Computer CBT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders