Depression
Conditions
Keywords
Depression, Web-based intervention, Aging, Geriatrics, Social network, Older adults
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.
Interventions
BEHAVIORALiCBT for late life depression
Sponsors
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module | 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. |
| Mean Number of Sessions Across the 8-week Trial | 8 weeks | — |
| System Usability Scale (SUS) | 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. |
| Average Coaching Time Per Participant by Group | 8 weeks | The average time spent on messages and calls and on group moderation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 23 |
| Waitlist Control (WLC) WLC participants received access to the III following the 8-week waiting period. | 12 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Symptoms dropped below threshold | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 0 |
Baseline characteristics
| Characteristic | Individual Internet Intervention (III) | Internet Intervention With Peer Support (II+PS) | Waitlist Control (WLC) | Total |
|---|---|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 3.4 | 69.5 years STANDARD_DEVIATION 4.3 | 70 years STANDARD_DEVIATION 4.7 | 69.6 years STANDARD_DEVIATION 4.1 |
| Annual gross household income (x1000) | 37.5 USD | 37 USD | 50 USD | 41 USD |
| Education 2-yr College (Associate's) | 0 Participants | 5 Participants | 2 Participants | 7 Participants |
| Education 4-yr College (Bachelor's) | 3 Participants | 6 Participants | 4 Participants | 13 Participants |
| Education Doctoral Degree (PhD, MD, JD) | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Education Master's Degree | 5 Participants | 5 Participants | 2 Participants | 12 Participants |
| Education Some College | 1 Participants | 5 Participants | 1 Participants | 7 Participants |
| Education Some High School | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Employed | 3 Participants | 4 Participants | 3 Participants | 10 Participants |
| Employment Status Retired | 9 Participants | 18 Participants | 7 Participants | 34 Participants |
| Employment Status Unemployed/Disability | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 22 Participants | 12 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Health Insurance Insured | 12 Participants | 22 Participants | 12 Participants | 46 Participants |
| Health Insurance Medicaid | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Health Insurance Medicare | 10 Participants | 19 Participants | 11 Participants | 40 Participants |
| Marital Status No Partner | 8 Participants | 16 Participants | 5 Participants | 29 Participants |
| Marital Status Partner | 4 Participants | 7 Participants | 7 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 19 Participants | 11 Participants | 41 Participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants | 32 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 4 Participants | 15 Participants |
| Taking antidepressant medication No | 7 Participants | 18 Participants | 7 Participants | 32 Participants |
| Taking antidepressant medication Yes | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 23 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 23 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 23 | 0 / 12 |
Outcome results
Primary
Average Coaching Time Per Participant by Group
The average time spent on messages and calls and on group moderation.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Internet Intervention (III) | Average Coaching Time Per Participant by Group | 134.33 Minutes | Standard Deviation 28.43 |
| Internet Intervention With Peer Support (II+PS) | Average Coaching Time Per Participant by Group | 92.43 Minutes | Standard Deviation 32.36 |
p-value: 0.003t-test, 2 sided
Primary
Mean Number of Sessions Across the 8-week Trial
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Internet Intervention (III) | Mean Number of Sessions Across the 8-week Trial | 45.6 number of sessions | Standard Deviation 24.9 |
| Internet Intervention With Peer Support (II+PS) | Mean Number of Sessions Across the 8-week Trial | 49.1 number of sessions | Standard Deviation 35.8 |
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.
Time frame: Baseline and Week 8 - Difference in PHQ-9 score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Internet Intervention (III) | Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module | -5.4 units on a scale | Standard Deviation 2.4 |
| Internet Intervention With Peer Support (II+PS) | Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module | -4.8 units on a scale | Standard Deviation 4.4 |
| Waitlist Control (WLC) | Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module | -1.1 units on a scale | Standard Deviation 4.7 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.44t-test, 2 sided
p-value: 0.03ANOVA
p-value: 0.68t-test, 2 sided
p-value: 0.02t-test, 2 sided
p-value: 0.03t-test, 2 sided
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.
Time frame: Week 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Internet Intervention (III) | System Usability Scale (SUS) | 68.75 units on a scale | Standard Deviation 16.09 |
| Internet Intervention With Peer Support (II+PS) | System Usability Scale (SUS) | 60.5 units on a scale | Standard Deviation 16.69 |