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DepressionPhase 1NCT00719979

Effectiveness of a Technology Assisted Behavioral Intervention in Assisting People With Major Depressive Disorder

A Phase 1 study testing Behavioral intervention (iCBT + TeleCoach) and Internet-based cognitive behavioral therapy (I-CBT) in people with Depression, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 reducing depressive symptoms and improving treatment adherence in primary care patients with major depressive… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Depression
What is being tested?
Behavioral intervention (iCBT + TeleCoach) and Internet-based cognitive behavioral therapy (I-CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteUnited States
Study dates
Sep 2009to Jul 2012
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of MDD as assessed using the Mini Mental State Exam (MINI)
  • Has a telephone, email account, computer, and broadband access to the Internet
  • Able to navigate the Internet
  • Able to speak and read English

Who cannot join

  • Hearing or voice impairment
  • Visual impairment that would prevent use of the workbook and completion of assessment materials
  • Meets criteria for dementia
  • Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous
  • Currently receiving individual psychotherapy or planning to receive psychotherapy during the 12-week treatment phase of the study
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern University

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Integrated Telemental Health Intervention for Depression in Primary Care

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 reducing depressive symptoms and improving treatment adherence in primary care patients with major depressive disorder.

Read the detailed description

Major depressive disorder (MDD) is a common mental disorder, with up to 10.3% of the population experiencing the disorder in a given 12-month period. Symptoms of MDD include feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; excessive irritability and restlessness; inability to concentrate; and lack of enjoyment in previously enjoyed activities. Fortunately, MDD is treatable with forms of psychotherapy and/or antidepressant medications. Several studies have found that when given a choice, about two-thirds of depressed patients prefer psychotherapy treatment over antidepressant medication. Although psychotherapy treatments are both effective and desirable, a variety of barriers exist to initiating and sustaining psychotherapy. Only about 20% of all patients referred for psychotherapy treatments ever follow up. Of those who do initiate psychotherapy, nearly half drop out before completing treatment.

Delivering an intervention through telecommunication technologies, such as the telephone and Internet, has the potential to overcome many of the barriers to existing treatments for depression. 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. Technology-assisted Behavioral Intervention(TABI) 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 TABI in reducing depressive symptoms and attrition rates in people with MDD. This pilot study will first develop TABI, which will consist of Internet-based cognitive behavioral therapy (I-CBT) accompanied by telephone and e-mail support. The study will then compare the effectiveness of TABI with the effectiveness of I-CBT alone and treatment as usual (TAU) in reducing depressive symptoms and improving treatment adherence in primary care patients with 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 TABI, I-CBT alone, or TAU. Participants assigned to TABI and I-CBT will both undergo 12 weeks of a Web-based Internet intervention consisting of modules to help them learn skills to manage their moods. Participants assigned to TAU will receive standard treatment from their primary care physicians and will be able to choose between TABI and I-CBT treatment options after a 6-week wait-list period.

Conditions
Depression
Being tested
Behavioral intervention (iCBT + TeleCoach), Internet-based cognitive behavioral therapy (I-CBT), Treatment as usual / Wait-list control
Keywords
Major Depressive Disorder, Cognitive Behavior Therapy, Technology Assisted, Internet, Primary Care
Medical subject headings
Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral intervention (iCBT + TeleCoach)Behavioural

    TABI will include 12 weeks of Internet-based cognitive behavioral therapy (iCBT) combined with brief telephone and email support from a coach.

  • Internet-based cognitive behavioral therapy (I-CBT)Behavioural

    I-CBT will include access to an interactive Web-based intervention designed to teach and facilitate the use of cognitive behavioral skills. The intervention will last 12 weeks.

  • Treatment as usual / Wait-list controlBehavioural

    TAU will include standard treatment from participants' primary care physicians. Participants will be able to choose between TABI and I-CBT treatment options after a 6-week wait-list period.

Study groups in NCT00719979
Study groupRoleWhat they receive
iCBT and TeleCoachingExperimentalParticipants received the technology-assisted behavioral intervention (iCBT + TeleCoaching).
Receives: Behavioral: Behavioral intervention (iCBT + TeleCoach)
iCBT(MoodManager)ExperimentalParticipants received Internet-based cognitive behavioral therapy only.
Receives: Behavioral: Behavioral intervention (iCBT + TeleCoach); Behavioral: Internet-based cognitive behavioral therapy (I-CBT)
Treatment as usual / Wait-list controlActive comparatorParticipants received treatment as usual . For wait-list control, participants were not provided any intervention for 6 weeks, after which they were allowed to choose coached or self-directed moodManager.
Receives: Behavioral: Treatment as usual / Wait-list control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression

    PhQ-9 and diagnosis (using MINI)

    Measured: Measured at baseline and Weeks 6 & 12 (post treatment)

  2. Utilization and Attrition

    # logins

    Measured: Baseline-Week 12

Secondary outcomes (1)
  1. Patient Satisfaction (Satisfaction Index-Mental Health)

    Measured: Measured at baseline and Weeks 6 & 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2008 (estimated)
  2. Study startSep 2009
  3. Primary completionMay 2011
  4. Study completionJul 2012

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00719979
Sponsor's protocol ID
R34MH078922
Other IDs
DSIR 83-ATP, 5P20MH090318-02
Status last verified
Jan 2013
First submitted
18 Jul 2008
Last updated
19 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Mohr DC, Duffecy J, Ho J, Kwasny M, Cai X, Burns MN, Begale M. A randomized controlled trial evaluating a manualized TeleCoaching protocol for improving adherence to a web-based intervention for the treatment of depression. PLoS One. 2013 Aug 21;8(8):e70086. doi: 10.1371/journal.pone.0070086. eCollection 2013.

    PubMed 23990896

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Behavioral intervention (iCBT + TeleCoach) and Internet-based cognitive behavioral therapy (I-CBT) in people with 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 4 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 19 Mar 2014. 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 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?

Depression (time frame: Measured at baseline and Weeks 6 & 12 (post treatment)). 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?

On the ClinicalTrials.gov record for NCT00719979, which also lists 1 linked publication.

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 19 Mar 2014.

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