Online Peer Networked Collaborative Learning for Managing Depressive Symptoms

NCT02841787 | Completed Results DMC

• 2 other identifiers: P20MH090318-FTP20MH090318
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Web-based intervention; Aging; Geriatrics; Social network; Older adults

Outcome Measures

Primary Outcomes (4)

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

  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.

  Baseline and Week 8 - Difference in PHQ-9 score

• Mean Number of Sessions Across the 8-week Trial

  8 weeks

• System Usability Scale (SUS)

  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.

  Week 8

• Average Coaching Time Per Participant by Group

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

  8 weeks

Study Arms (3)

Individual Internet Intervention (III)

EXPERIMENTAL

Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists. (iCBT for late life depression without social network included.)

Behavioral: iCBT for late life depression

Internet Intervention+Peer Supp.(II+PS)

EXPERIMENTAL

Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists. (iCBT for late life depression with social network included.)

Behavioral: iCBT for late life depression

Waitlist Control (WLC)

NO INTERVENTION

Waiting period, no intervention administered. WLC participants received access to the III following the 8-week waiting period.

Interventions

iCBT for late life depression BEHAVIORAL

Individual Internet Intervention (III); Internet Intervention+Peer Supp.(II+PS)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: David C. Mohr, PhD
• Organization: Northwestern University

d-mohr@northwestern.edu

312-503-1403

Study Officials

• David C Mohr, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 22, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-02

Locations

US (1)