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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01080105
• Date of registration: 02/03/2010
• Prospective Registration: Yes
• Primary sponsor: Northwestern University
• Public title: Internet Intervention for the Prevention of Depression - Approaches to Improving Mood AIM
• Scientific title: Technology Assisted Behavioral Intervention for the Prevention of Depression
• Date of first enrolment: June 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01080105
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: David C. Mohr, Ph.D.
• Affiliation: Northwestern University

Key inclusion & exclusion 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.



Age minimum: 19 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Individuals at Risk for Depression

Intervention(s)

Behavioral: AIM Web based intervention + surveillance

Behavioral: Educational website

Behavioral: AIM web based intervention

Primary Outcome(s)

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]

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(s)

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]

Secondary ID(s)

NU IRB STU00020637

Source(s) of Monetary Support

Please refer to primary and secondary sponsors