DepressionNCT00136240
Automated Telephone System to Improve Treatment Adherence in People With Depression
A study testing Computer Assisted Education for Behavior Change in people with Depression, run by Boston Medical Center at 1 site in United States.
Trial summary
This study will determine the efficacy of a computerized telephone system called Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in people with depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Computer Assisted Education for Behavior Change
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jan 2006
- 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
- A clinical diagnosis of major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or any combination of the three
- Prescribed at least one antidepressant medication
- Access to a telephone with touch-tone service
- Speak and understand conversational English
Who cannot join
- Current significant alcohol or drug abuse
- Clinical diagnosis of bipolar disorder, schizoaffective disorder, or significant personality disorder
- Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), or other neurodegenerative diseases
- Alzheimer's disease and other dementia
- Cancer, undergoing radiation therapy or chemotherapy
- Suffering from Renal disease or on dialysis
Show all 12Show fewer
- Immunologic disorder (rheumatoid arthritis, systemic lupus erythematosus [SLE], etc.)
- HIV
- Terminal illness
- Homeless
- Legally blind
- Planning to leave the geographic area during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telecom System to Improve Adherence to Antidepressants
This study will determine the efficacy of a computerized telephone system called Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in people with depression.
Read the detailed description
The purpose of this study is to test the efficacy of a computerized telephone system called TLC (Telephone-Linked Care) in helping subjects adhere to their antidepressant medication regimens.
- Conditions
- Depression
- Being tested
- Computer Assisted Education for Behavior Change
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Assisted Education for Behavior ChangeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Antidepressant medication adherence
Measured: Measured monthly for 4 months
Adherence to scheduled psychiatry clinic visits
Measured: Measured monthly for 4 months
Secondary outcomes (2)
Depression status, measured by self-administered depression inventory scale
Measured: Measured at baseline and at 4 month follow-up
General health status, measured by self-rating health survey
Measured: Measured at baseline and at 4 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 posted29 Aug 2005 (estimated)
- Study startApr 2003
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- 144 participants
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Ramesh Farzanfar, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136240
- Sponsor's protocol ID
- R21MH063937
- Other IDs
- R21MH063937, DAHBR HB-A
- Status last verified
- Aug 2008
- First submitted
- 25 Aug 2005
- Last updated
- 25 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telecom System to Improve Adherence to Antidepressants
- ClinicalTrials.gov ID
- NCT00136240
- Acronym / sponsor ID
- R21MH063937
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 29 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.
This study will determine the efficacy of a computerized telephone system called Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in people with depression.
Detailed description
The purpose of this study is to test the efficacy of a computerized telephone system called TLC (Telephone-Linked Care) in helping subjects adhere to their antidepressant medication regimens.
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 (4 listed)
- A clinical diagnosis of major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or any combination of the three
- Prescribed at least one antidepressant medication
- Access to a telephone with touch-tone service
- Speak and understand conversational English
Key exclusion criteria (12 listed)
- Current significant alcohol or drug abuse
- Clinical diagnosis of bipolar disorder, schizoaffective disorder, or significant personality disorder
- Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), or other neurodegenerative diseases
- Alzheimer's disease and other dementia
- Cancer, undergoing radiation therapy or chemotherapy
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 Behavior Change | Behavioural | – |
Primary outcome
Antidepressant medication adherence
Time frame: Measured monthly for 4 months
Adherence to scheduled psychiatry clinic visits
Time frame: Measured monthly for 4 months
2 secondary outcomes
Depression status, measured by self-administered depression inventory scale
Time frame: Measured at baseline and at 4 month follow-up
General health status, measured by self-rating health survey
Time frame: Measured at baseline and at 4 month follow-up
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 25 Jul 2013.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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 study director
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 Behavior Change in people with Depression, 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 4 inclusion and 12 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 25 Jul 2013. 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?
Antidepressant medication adherence (time frame: Measured monthly for 4 months). The study lists 2 primary outcomes in all. 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 25 Jul 2013.