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

NCT01080105 | Withdrawn Phase 1

• 1 other identifier: NU IRB STU00020637
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Individuals at Risk for Depression

Keywords

Depression Prevention; Prevention; Major Depressive Disorder; Internet; Technology Assisted

Outcome Measures

Primary Outcomes (2)

• 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 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.

  From baseline through 12 month follow-up

Secondary Outcomes (1)

• Anxiety, impact on work, social support

  Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12

Study Arms (3)

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.

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

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.

Behavioral: Educational website

Interventions

AIM Web based intervention + surveillance BEHAVIORAL

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 + surveillance

AIM web based intervention BEHAVIORAL

The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach.

AIM intervention

Educational website BEHAVIORAL

Participants will receive access to a static educational website for 12 weeks.

Educational website

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• David C. Mohr, Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 3, 2012

Record last verified: 2012-06

Locations

US (1)