DepressionMoodTechNCT02841787
Online Peer Networked Collaborative Learning for Managing Depressive Symptoms
A study testing iCBT for late life depression in people with Depression, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression
- What is being tested?
- iCBT for late life depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology Assisted Intervention for the Treatment and Prevention of Depression
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
- Being tested
- iCBT for late life depression
- Keywords
- Depression, Web-based intervention, Aging, Geriatrics, Social network, Older adults
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBT for late life depressionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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.) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 8 - Difference in PHQ-9 score
Mean Number of Sessions Across the 8-week Trial
Measured: 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.
Measured: Week 8
Average Coaching Time Per Participant by Group
The average time spent on messages and calls and on group moderation.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mohr, Northwestern University
- Investigators
- David C Mohr, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841787
- Sponsor's protocol ID
- P20MH090318-FT
- Other IDs
- P20MH090318
- Acronym
- MoodTech
- Status last verified
- Feb 2018
- First submitted
- 20 Jul 2016
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Intervention for the Treatment and Prevention of Depression
- ClinicalTrials.gov ID
- NCT02841787
- Acronym / sponsor ID
- MoodTech / P20MH090318-FT
- Conditions
- Depression
- Keywords
- Depression, Web-based intervention, Aging, Geriatrics, Social network, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual Internet Intervention (III) | Experimental | Behavioral: iCBT for late life depressionCoached 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 | Behavioral: iCBT for late life depressionCoached 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCBT for late life depression | Behavioural | Individual Internet Intervention (III), Internet Intervention+Peer Supp.(II+PS) |
Primary outcome
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.
Mean Number of Sessions Across the 8-week Trial
Time frame: 8 weeks
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.
Average Coaching Time Per Participant by Group
Time frame: 8 weeks
The average time spent on messages and calls and on group moderation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Mohr, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT for late life depression in people with Depression, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module (time frame: Baseline and Week 8 - Difference in PHQ-9 score). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.