| ID | Type | Description | Link |
|---|---|---|---|
| P20MH090318 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.) |
|
| 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.) |
|
| Waitlist Control (WLC) | No Intervention | Waiting period, no intervention administered. WLC participants received access to the III following the 8-week waiting period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCBT for late life depression | Behavioral |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C Mohr, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Individual Internet Intervention (III) | Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists. |
| FG001 | Internet Intervention With Peer Support (II+PS) | 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. |
| FG002 | Waitlist Control (WLC) | WLC participants received access to the III following the 8-week waiting period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Individual Internet Intervention (III) | Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists. |
| BG001 | Internet Intervention With Peer Support (II+PS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 - Difference in PHQ-9 score |
|
8 months (January 2016 through September 2016)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individual Internet Intervention (III) | Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David C. Mohr, PhD | Northwestern University | 312-503-1403 | d-mohr@northwestern.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Withdrawal by Subject |
|
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. |
| BG002 | Waitlist Control (WLC) | WLC participants received access to the III following the 8-week waiting period. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Annual gross household income (x1000) | Median | Inter-Quartile Range | USD |
|
| Marital Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| Health Insurance | Count of Participants | Participants |
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| Taking antidepressant medication | Count of Participants | Participants |
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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. |
| OG002 | Waitlist Control (WLC) | WLC participants received access to the III following the 8-week waiting period. |
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| Primary | Mean Number of Sessions Across the 8-week Trial | Out of the 12 participants who started Individual Internet Intervention, one participant was administratively dropped (no longer eligible for the study) before treatment started; only 11 participants were analyzed. | Posted | Mean | Standard Deviation | number of sessions | 8 weeks |
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| Primary | 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. | Participants were included in outcome analyses if they completed assessments at both baseline and week 8; for the Individual Internet Intervention (III) arm, 9 participants met this criterion, and for Internet Intervention with Peer Support (II+PS), 21 participants met this criterion. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
|
|
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| Primary | Average Coaching Time Per Participant by Group | The average time spent on messages and calls and on group moderation. | Participants were included in outcome analyses if they completed assessments at both baseline and week 8; for the Individual Internet Intervention (III) arm, 9 participants met this criterion, and for Internet Intervention with Peer Support (II+PS), 19 participants met this criterion. | Posted | Mean | Standard Deviation | Minutes | 8 weeks |
|
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|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Internet Intervention With Peer Support (II+PS) | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Waitlist Control (WLC) | WLC participants received access to the III following the 8-week waiting period. | 0 | 12 | 0 | 12 | 0 | 12 |
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