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Clinical Trials/NCT02841787
NCT02841787
Completed
Not Applicable

Technology Assisted Intervention for the Treatment and Prevention of Depression

Northwestern University1 site in 1 country47 target enrollmentDecember 2015
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Northwestern University
Enrollment
47
Locations
1
Primary Endpoint
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The goal of this field trial is to tailor and test a web-based intervention in adults 65 years of age or older. Two versions of the web-based intervention have been created and will be tested--one with an online social network and one without an online social network. The purpose of this study is to: pilot a novel intervention, examine methods to improve adherence to web-based interventions (e.g., peer network); collect data on feasibility, acceptability, and efficacy of an web-based intervention for late life depression; and ultimately, to overcome the numerous barriers to treating depression in later life.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
September 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Mohr

Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Has elevated depressive symptoms
  • Has a telephone, e-mail account, computer, and broadband access to the Internet.
  • Has basic internet skills and is able to access the internet independently
  • Is able to speak and read English.
  • Is at least 65 years of age.
  • Is able to give informed consent.

Exclusion Criteria

  • Has hearing or voice impairment that would prevent participation in psychotherapy
  • Has visual impairment that would prevent completion of assessment materials.
  • Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous.
  • Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 8-week treatment phase of the study
  • Is planning to be out of town or unavailable for an extended period of time during the study without access to the Internet
  • Exhibits severe suicidality, including ideation, plan, and intent.
  • Has initiated treatment with an antidepressant in past 14 days. Once patients have been on a stable dose for 14 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.

Outcomes

Primary Outcomes

Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module

Time Frame: Baseline and Week 8 - Difference in PHQ-9 score

The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe. The data table below shows PHQ-9 pre- and post- intervention score differences by group.

Mean Number of Sessions Across the 8-week Trial

Time Frame: 8 weeks

Average Coaching Time Per Participant by Group

Time Frame: 8 weeks

The average time spent on messages and calls and on group moderation.

System Usability Scale (SUS)

Time Frame: Week 8

The System Usability Scale (SUS) is a usability scale that can be used for global assessments of systems usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. A SUS score above a 68 would be considered above average and anything below 68 is below average.

Study Sites (1)

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