Individuals at Risk for DepressionPhase 1AIMNCT01080105
Internet Intervention for the Prevention of Depression - Approaches to Improving Mood
A Phase 1 study testing AIM Web based intervention + surveillance, AIM web based intervention and Educational website in people with Individuals at Risk for Depression, run by Northwestern University at 1 site in United States.
Trial summary
This study will develop and evaluate the effectiveness of a technology-assisted behavioral intervention, consisting of Internet-based cognitive behavioral therapy combined with telephone and email support, in preventing depressive symptoms and improving treatment adherence in individuals at risk of major depressive… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Individuals at Risk for Depression
- What is being tested?
- AIM Web based intervention + surveillance, AIM web based intervention and Educational website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2013
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PredictD Risk Score of .130
- Has a telephone, e-mail account, computer, and broadband access to the Internet.
- Is able to speak and read English.
- Is at least 19 years of age.
- Is able to give informed consent.
Who cannot join
- Has DSM-IV diagnosis of Major Depressive Episode assessed using the MINI
- Has hearing or voice impairment that would prevent participation in psychotherapy.
- Has visual impairment that would prevent use of the workbook and completion of assessment materials.
- Meets criteria for dementia by scoring < 25 on the Telephone Interview for Cognitive Status (TICS).
- Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current post-traumatic stress disorder (PTSD), current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous. Patients with substance abuse diagnoses who have been clean and sober for 3 months will be admitted if otherwise eligible.
- Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 12-week treatment phase of the study.
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- Is planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time.
- Exhibits severe suicidality, including ideation, plan, and intent.
- Has initiated treatment with an antidepressant in past 10 days. Once patients have been on a stable dose for 10 days and do not have an appointment with a physician or psychiatrist to change this dose, the patient will be eligible based on this criterion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology Assisted Behavioral Intervention for the Prevention of Depression
This study will develop and evaluate the effectiveness of a technology-assisted behavioral intervention, consisting of Internet-based cognitive behavioral therapy combined with telephone and email support, in preventing depressive symptoms and improving treatment adherence in individuals at risk of major depressive disorder.
Read the detailed description
Depression is common, with one-year prevalence rates of major depressive disorder (MDD) estimated to be between 6.6-10.3% in the general population. Depression imposes a very high societal burden in terms of cost, morbidity, suffering, and mortality. Yet only about 20% of all patients referred for psychotherapy ever enter treatment, and of those who initiate treatment, nearly half drop out before completion. Given the limitations of treatment and the significant burden of depression, research into the prevention of depression is needed. There is a dearth of research related to the effective prevention of depression.
Delivering an intervention through telecommunication technologies, such as the telephone and Internet, has the potential to overcome many of the barriers to existing depression prevention interventions. For example, telephone- and Web-based interventions can reduce cost, extend specialized treatment over broad geographic areas, and permit considerable flexibility in scheduling of treatment components. Approaches to Improving Mood (AIM) is a specific form of a telecommunication behavioral intervention that incorporates Web-based Internet, e-mail, and telephone intervention. Further study is needed to determine the effectiveness of AIM in preventing depressive symptoms and improving attrition from treatment rates in people at risk for MDD. The study will compare the effectiveness of the AIM program with a one year surveillance follow up with the effectiveness of the AIM program alone and a website offering information on depression prevention in preventing depressive symptoms and improving treatment adherence in individuals at risk of MDD.
Participation in the treatment phase of this study will last 12 weeks. All participants will first undergo initial assessments that will include a telephone interview and a series of questionnaires about mood. Eligible participants will then be assigned randomly to receive AIM + surveillance, AIM alone, or the education website. All participants will undergo 12 weeks of a Web-based Internet intervention consisting of modules to help them learn skills to manage their moods. Participants will be asked to access the Web site every day or two to complete the modules and to practice the learned techniques. Participants assigned to AIM + surveillance and AIM alone will also receive a weekly telephone-based motivational intervention from a coach and will be able to communicate with the coach via email throughout the first 12 weeks of treatment. Participants assigned to the education group will be given access to a website but no assistance from a coach. All participants will undergo repeat initial assessments at Weeks 6, 12 (end of treatment) and at 3 months, 6 months, 9 months and 12 months following the completion of treatment.
- Conditions
- Individuals at Risk for Depression
- Being tested
- AIM Web based intervention + surveillance, AIM web based intervention, Educational website
- Keywords
- Depression Prevention, Prevention, Major Depressive Disorder, Internet, Technology Assisted
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIM Web based intervention + surveillanceBehavioural
The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach. Surveillance will consist of monthly screening of depression symptoms and outreach from the coach should there be an increase in symptoms.
AIM web based interventionBehavioural
The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach.
Educational websiteBehavioural
Participants will receive access to a static educational website for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AIM + surveillance | Experimental | Participants will receive access to the AIM website and calls from a motivational coach for 12 weeks plus an additional year of surveillance and optional coach support. Receives: Behavioral: AIM Web based intervention + surveillance |
| AIM intervention | Experimental | Participants will receive access to the AIM web based intervention and calls from a motivational coach for 12 weeks Receives: Behavioral: AIM web based intervention |
| Educational website | Active comparator | Participants will be given access to a static website with depression prevention related materials and handouts. Receives: Behavioral: Educational website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, as assessed by Quick Inventory of Depressive Symptoms (QIDS), the Patient Health Questionnaire-9 (PHQ-9), and the Mini International Neuropsychiatric Interview (MINI) Disorders-Major Depressive Disorders Module
Measured: Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12
Website utilization (e.g., number of logins, average visit length, total time spent on the site, number of exercises completed), Attrition and cost effectiveness.
Measured: From baseline through 12 month follow-up
Secondary outcomes (1)
Anxiety, impact on work, social support
Measured: Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startJun 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: This is withdrawn because we started working on studies that are funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individuals at Risk for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mohr, Northwestern University
- Investigators
- David C. Mohr, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080105
- Sponsor's protocol ID
- NU IRB STU00020637
- Acronym
- AIM
- Status last verified
- Jun 2012
- First submitted
- 2 Mar 2010
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Behavioral Intervention for the Prevention of Depression
- ClinicalTrials.gov ID
- NCT01080105
- Acronym / sponsor ID
- AIM / NU IRB STU00020637
- Conditions
- Individuals at Risk for Depression
- Keywords
- Depression Prevention, Prevention, Major Depressive Disorder, Internet, Technology Assisted
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This is withdrawn because we started working on studies that are funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 3 Mar 2010 (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 develop and evaluate the effectiveness of a technology-assisted behavioral intervention, consisting of Internet-based cognitive behavioral therapy combined with telephone and email support, in preventing depressive symptoms and improving treatment adherence in individuals at risk of major depressive disorder.
Detailed description
Depression is common, with one-year prevalence rates of major depressive disorder (MDD) estimated to be between 6.6-10.3% in the general population. Depression imposes a very high societal burden in terms of cost, morbidity, suffering, and mortality. Yet only about 20% of all patients referred for psychotherapy ever enter treatment, and of those who initiate treatment, nearly half drop out before completion. Given the limitations of treatment and the significant burden of depression, research into the prevention of depression is needed. There is a dearth of research related to the effective prevention of depression.
Delivering an intervention through telecommunication technologies, such as the telephone and Internet, has the potential to overcome many of the barriers to existing depression prevention interventions. For example, telephone- and Web-based interventions can reduce cost, extend specialized treatment over broad geographic areas, and permit considerable flexibility in scheduling of treatment components. Approaches to Improving Mood (AIM) is a specific form of a telecommunication behavioral intervention that incorporates Web-based Internet, e-mail, and telephone intervention. Further study is needed to determine the effectiveness of AIM in preventing depressive symptoms and improving attrition from treatment rates in people at risk for MDD. The study will compare the effectiveness of the AIM program with a one year surveillance follow up with the effectiveness of the AIM program alone and a website offering information on depression prevention in preventing depressive symptoms and improving treatment adherence in individuals at risk of MDD.
Participation in the treatment phase of this study will last 12 weeks. All participants will first undergo initial assessments that will include a telephone interview and a series of questionnaires about mood. Eligible participants will then be assigned randomly to receive AIM + surveillance, AIM alone, or the education website. All participants will undergo 12 weeks of a Web-based Internet intervention consisting of modules to help them learn skills to manage their moods. Participants will be asked to access the Web site every day or two to complete the modules and to practice the learned techniques. Participants assigned to AIM + surveillance and AIM alone will also receive a weekly telephone-based motivational intervention from a coach and will be able to communicate with the coach via email throughout the first 12 weeks of treatment. Participants assigned to the education group will be given access to a website but no assistance from a coach. All participants will undergo repeat initial assessments at Weeks 6, 12 (end of treatment) and at 3 months, 6 months, 9 months and 12 months following the completion of treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AIM + surveillance | Experimental | Behavioral: AIM Web based intervention + surveillanceParticipants will receive access to the AIM website and calls from a motivational coach for 12 weeks plus an additional year of surveillance and optional coach support. |
| AIM intervention | Experimental | Behavioral: AIM web based interventionParticipants will receive access to the AIM web based intervention and calls from a motivational coach for 12 weeks |
| Educational website | Active comparator | Behavioral: Educational websiteParticipants will be given access to a static website with depression prevention related materials and handouts. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PredictD Risk Score of .130
- Has a telephone, e-mail account, computer, and broadband access to the Internet.
- Is able to speak and read English.
- Is at least 19 years of age.
- Is able to give informed consent.
Key exclusion criteria (9 listed)
- Has DSM-IV diagnosis of Major Depressive Episode assessed using the MINI
- Has hearing or voice impairment that would prevent participation in psychotherapy.
- Has visual impairment that would prevent use of the workbook and completion of assessment materials.
- Meets criteria for dementia by scoring < 25 on the Telephone Interview for Cognitive Status (TICS).
- Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current post-traumatic stress disorder (PTSD), current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous. Patients with substance abuse diagnoses who have been clean and sober for 3 months will be admitted if otherwise eligible.
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 |
|---|---|---|
| AIM Web based intervention + surveillanceThe web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach. Surveillance will consist of monthly screening of depression symptoms and outreach from the coach should there be an increase in symptoms. | Behavioural | AIM + surveillance |
| AIM web based interventionThe web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach. | Behavioural | AIM intervention |
| Educational websiteParticipants will receive access to a static educational website for 12 weeks. | Behavioural | Educational website |
Primary outcome
Depression, as assessed by Quick Inventory of Depressive Symptoms (QIDS), the Patient Health Questionnaire-9 (PHQ-9), and the Mini International Neuropsychiatric Interview (MINI) Disorders-Major Depressive Disorders Module
Time frame: Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12
Website utilization (e.g., number of logins, average visit length, total time spent on the site, number of exercises completed), Attrition and cost effectiveness.
Time frame: From baseline through 12 month follow-up
1 secondary outcome
Anxiety, impact on work, social support
Time frame: Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
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.
David C. Mohr, Ph.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AIM Web based intervention + surveillance, AIM web based intervention and Educational website in people with Individuals at Risk for Depression, run by Northwestern University 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 9 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: withdrawn, as of the sponsor's last update on 3 Jul 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Depression, as assessed by Quick Inventory of Depressive Symptoms (QIDS), the Patient Health Questionnaire-9 (PHQ-9), and the Mini International Neuropsychiatric Interview (MINI) Disorders-Major Depressive Disorders Module (time frame: Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12). 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 3 Jul 2012.