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

Individuals at Risk for Depression Clinical Trial

— AIM  

Official title:

Technology Assisted Behavioral Intervention for the Prevention of Depression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01080105
• Other study ID #: NU IRB STU00020637
• Status: Withdrawn
• Phase: Phase 1
• First received: March 2, 2010
• Last updated: June 29, 2012
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 preventing depressive symptoms and improving treatment adherence in individuals at risk of major depressive disorder.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Individuals at Risk for Depression

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Anxiety, impact on work, social support		Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12	No