Clinical trial NCT02841787: Online Peer Networked Collaborative Learning for Managing Depressive Symptoms
Official title: Technology Assisted Intervention for the Treatment and Prevention of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Web-based intervention
Aging
Geriatrics
Social network
Older adults
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 47
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
timeFrame: Baseline and Week 8 - Difference in PHQ-9 score
measure: Mean Number of Sessions Across the 8-week Trial
timeFrame: 8 weeks
measure: System Usability Scale (SUS)
timeFrame: Week 8
measure: Average Coaching Time Per Participant by Group
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: David C Mohr, PhD
role: PRINCIPAL_INVESTIGATOR
References: