Mental DisordersNCT00134576
Automated Assessment of Mental Health in the Workplace
A study testing Computer Assisted Education for Behavioral Change in people with Mental Disorders, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to design, refine, and test for the effectiveness of a computer-based telephone system (Telephone-Linked Communications for Detection of Mental Health Disorders in the Workplace; TLC-Detect) that will screen workers for mental health distress; educate them about seeking treatment; and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Computer Assisted Education for Behavioral Change
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employment with benefits at Boston Medical Center, Boston University, or Florida Power and Light Company
- Ability to speak and understand conversational English
- > 18 years of age
- Access to a touch-tone telephone
- Screen positive for the World Health Organization (WHO)-5 Well-Being Index
Who cannot join
- Being under treatment (medication or therapy) for a mental health disorder
- Taking medication for a serious/major medical disorder that interferes with normal life
- Taking medication prescribed for mental health treatment on a daily basis
- Diagnosed with schizophrenia
- Planning to go on leave for over 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to design, refine, and test for the effectiveness of a computer-based telephone system (Telephone-Linked Communications for Detection of Mental Health Disorders in the Workplace; TLC-Detect) that will screen workers for mental health distress; educate them about seeking treatment; and follow up with them over a 6 month period.
- Conditions
- Mental Disorders
- Being tested
- Computer Assisted Education for Behavioral Change
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Assisted Education for Behavioral ChangeBehavioural
TLC-Detect will provide subjects in the intervention group with information about each diagnosed mental health disorder. TLC-Detect will then give the Treatment Module and will tell the intervention subjects that it will call back in one month for a follow-up or the next week if a subject is comorbid with other disorders.
What is being measured
The primary outcome is the main question the study is designed to answer.
Absenteeism and presentism (functionality at work), measured every three months for 6 months
Measured: 6 months
Secondary outcomes (2)
Treatment status, timing of measurement depends upon symptom severity
Measured: 6 months
Health status measured every three months for 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startMay 2007
- Primary completionSep 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Ramesh Farzanfar, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134576
- Sponsor's protocol ID
- R01DP000116
- Status last verified
- May 2010
- First submitted
- 23 Aug 2005
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Assessment of Mental Health in the Workplace
- ClinicalTrials.gov ID
- NCT00134576
- Acronym / sponsor ID
- R01DP000116
- Conditions
- Mental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- May 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 Aug 2005 (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.
The purpose of this study is to design, refine, and test for the effectiveness of a computer-based telephone system (Telephone-Linked Communications for Detection of Mental Health Disorders in the Workplace; TLC-Detect) that will screen workers for mental health distress; educate them about seeking treatment; and follow up with them over a 6 month period.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Employment with benefits at Boston Medical Center, Boston University, or Florida Power and Light Company
- Ability to speak and understand conversational English
- > 18 years of age
- Access to a touch-tone telephone
- Screen positive for the World Health Organization (WHO)-5 Well-Being Index
Key exclusion criteria (5 listed)
- Being under treatment (medication or therapy) for a mental health disorder
- Taking medication for a serious/major medical disorder that interferes with normal life
- Taking medication prescribed for mental health treatment on a daily basis
- Diagnosed with schizophrenia
- Planning to go on leave for over 6 months
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 Assisted Education for Behavioral ChangeTLC-Detect will provide subjects in the intervention group with information about each diagnosed mental health disorder. TLC-Detect will then give the Treatment Module and will tell the intervention subjects that it will call back in one month for a follow-up or the next week if a subject is comorbid with other disorders. | Behavioural | – |
Primary outcome
Absenteeism and presentism (functionality at work), measured every three months for 6 months
Time frame: 6 months
2 secondary outcomes
Treatment status, timing of measurement depends upon symptom severity
Time frame: 6 months
Health status measured every three months for 6 months
Time frame: 6 months
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 3 Jun 2010.
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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.
Ramesh Farzanfar, 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 Assisted Education for Behavioral Change in people with Mental Disorders, run by Boston Medical Center 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 5 inclusion and 5 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 3 Jun 2010. 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?
Absenteeism and presentism (functionality at work), measured every three months for 6 months (time frame: 6 months). 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 3 Jun 2010.