Individuals at Risk for Depression Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention