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Completed

NCT Number: NCT02841787

Online Peer Networked Collaborative Learning for Managing Depressive Symptoms

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iCBT for late life depression

Behavioral

Primary outcomes

  1. 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.

  2. Mean Number of Sessions Across the 8-week Trial

    Time frame: 8 weeks

  3. 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.

  4. Average Coaching Time Per Participant by Group

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Technology Assisted Intervention for the Treatment and Prevention of Depression

Acronym: MoodTech

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2016
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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