Online Peer Networked Collaborative Learning for Managing Depressive Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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Technology Assisted Intervention for the Treatment and Prevention of Depression

Conditions
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Depression

Intervention / Treatment
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* Behavioral: iCBT for late life depression


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual Internet Intervention (III)<br>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<br> <br> |
| Experimental: Internet Intervention+Peer Supp.(II+PS)<br>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<br> <br> |
| No Intervention: Waitlist Control (WLC)<br>Waiting period, no intervention administered. WLC participants received access to the III following the 8-week waiting period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Web-based intervention, Aging, Geriatrics, Social network, Older adults