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

Primary Purpose

Individuals at Risk for Depression

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AIM Web based intervention + surveillance
AIM web based intervention
Educational website
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Individuals at Risk for Depression focused on measuring Depression Prevention, Prevention, Major Depressive Disorder, Internet, Technology Assisted

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

AIM + surveillance

AIM intervention

Educational website

Arm Description

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.

Participants will receive access to the AIM web based intervention and calls from a motivational coach for 12 weeks

Participants will be given access to a static website with depression prevention related materials and handouts.

Outcomes

Primary Outcome Measures

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
Website utilization (e.g., number of logins, average visit length, total time spent on the site, number of exercises completed), Attrition and cost effectiveness.

Secondary Outcome Measures

Anxiety, impact on work, social support

Full Information

First Posted
March 2, 2010
Last Updated
June 29, 2012
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01080105
Brief Title
Internet Intervention for the Prevention of Depression - Approaches to Improving Mood
Acronym
AIM
Official Title
Technology Assisted Behavioral Intervention for the Prevention of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Withdrawn
Why Stopped
This is withdrawn because we started working on studies that are funded.
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Individuals at Risk for Depression
Keywords
Depression Prevention, Prevention, Major Depressive Disorder, Internet, Technology Assisted

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIM + surveillance
Arm Type
Experimental
Arm Description
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.
Arm Title
AIM intervention
Arm Type
Experimental
Arm Description
Participants will receive access to the AIM web based intervention and calls from a motivational coach for 12 weeks
Arm Title
Educational website
Arm Type
Active Comparator
Arm Description
Participants will be given access to a static website with depression prevention related materials and handouts.
Intervention Type
Behavioral
Intervention Name(s)
AIM Web based intervention + surveillance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
AIM web based intervention
Intervention Description
The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach.
Intervention Type
Behavioral
Intervention Name(s)
Educational website
Intervention Description
Participants will receive access to a static educational website for 12 weeks.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Mohr, Ph.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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

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