Internet Intervention for the Prevention of Depression - Approaches to Improving Mood (AIM)

June 29, 2012 updated by: David Mohr, Northwestern University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AIM + surveillance
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.
Behavioral: AIM Web based intervention + surveillance
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.
Experimental: AIM intervention
Participants will receive access to the AIM web based intervention and calls from a motivational coach for 12 weeks
Behavioral: AIM web based intervention
The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach.
Active Comparator: Educational website
Participants will be given access to a static website with depression prevention related materials and handouts.
Behavioral: Educational website
Participants will receive access to a static educational website for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
From baseline through 12 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: David C. Mohr, Ph.D., Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

July 3, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU IRB STU00020637

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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