Schizophrenia, Schizoaffective DisorderNCT02192593
Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations
A study testing Computer CBT in people with Schizophrenia, Schizoaffective Disorder, run by Boston University Charles River Campus at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Computer CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
About this study
Official title: Randomized Controlled Trial of Computerized Cognitive Behavioral Therapy for Auditory Hallucinations in Persons With Psychosis
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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Computer CBT
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer CBTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Computer CBT | Experimental | A 10-session computerized cognitive-behavioral therapy intervention Receives: Behavioral: Computer CBT |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Post-Treatment, 3-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startNov 2011
- Primary completionJan 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia, Schizoaffective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Gottlieb, Boston University
- Investigators
- Jennifer D Gottlieb, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192593
- Sponsor's protocol ID
- ComputerCBTPsychosis
- Status last verified
- Jul 2015
- First submitted
- 13 Sep 2013
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Computerized Cognitive Behavioral Therapy for Auditory Hallucinations in Persons With Psychosis
- ClinicalTrials.gov ID
- NCT02192593
- Acronym / sponsor ID
- ComputerCBTPsychosis
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer CBT | Experimental | Behavioral: Computer CBTA 10-session computerized cognitive-behavioral therapy intervention |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants will be on a stable dose of antipsychotic medication for the past 3 months.
Key exclusion criteria (7 listed)
- Terminal physical illness expected to result in the death of the study participant within one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer CBT | Behavioural | Computer CBT |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer D Gottlieb, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer CBT in people with Schizophrenia, Schizoaffective Disorder, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Psychiatric Rating Scale (BPRS) (time frame: Baseline, Post-Treatment, 3-Month Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.