Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-09
Brief Title:
Adaptive Messaging to Support Depression Self-Management
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Adaptive Messaging to Support Depression Self-Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot randomized controlled trial of an adaptive 8-week text messaging intervention for depression self-management Among 100 individuals with elevated depression symptoms we will compare the effects of 8 weeks of the adaptive text messaging intervention n40 to 8 weeks of a non-adaptive text messaging intervention n40 and 8 weeks of a psychoeducation-only intervention n20 We will include a 6-month post-treatment follow-up to verify that treatment gains are maintained
Both messaging arms will receive 8 weeks of daily text messaging Messages will prompt learning and applying cognitive and behavioral self-management strategies Whereas the non-adaptive messaging system will randomly select daily messaging styles representing a variety of self-management strategies and message tones the adaptive messaging system will apply reinforcement learning to select daily messaging styles to maximize user engagement Text messages will also be used to solicit feedback such as message ratings to inform the reinforcement learning algorithm if applicable The psychoeducation control group will receive a few brief text messages per week providing weblinks to access psychoeducation information
We will recruit participants through digital methods eg advertising on social media platforms like Facebook and Instagram
Administration of study measures will occur at baseline weeks 4 and 8 and 3-month and 6-month follow-up The primary outcomes is depression symptom severity PHQ-9 Secondary outcomes are anxiety severity GAD-7 and suicidality DSI-SS Using an Intention to Treat paradigm we will test our hypothesis that
H1 Relative to the psychoeducation-only control messaging interventions will reduce depression H1a and anxiety and suicidal ideation H1b
H2 Relative to non-adaptive messaging adaptive messaging will reduce depression H1a and anxiety and suicidality H2b
H3 Adaptive messaging will reduce depression relative to non-adaptive messaging by producing greater objective and subjective engagement
Both messaging arms will receive 8 weeks of daily text messaging Messages will prompt learning and applying cognitive and behavioral self-management strategies Whereas the non-adaptive messaging system will randomly select daily messaging styles representing a variety of self-management strategies and message tones the adaptive messaging system will apply reinforcement learning to select daily messaging styles to maximize user engagement Text messages will also be used to solicit feedback such as message ratings to inform the reinforcement learning algorithm if applicable The psychoeducation control group will receive a few brief text messages per week providing weblinks to access psychoeducation information
We will recruit participants through digital methods eg advertising on social media platforms like Facebook and Instagram
Administration of study measures will occur at baseline weeks 4 and 8 and 3-month and 6-month follow-up The primary outcomes is depression symptom severity PHQ-9 Secondary outcomes are anxiety severity GAD-7 and suicidality DSI-SS Using an Intention to Treat paradigm we will test our hypothesis that
H1 Relative to the psychoeducation-only control messaging interventions will reduce depression H1a and anxiety and suicidal ideation H1b
H2 Relative to non-adaptive messaging adaptive messaging will reduce depression H1a and anxiety and suicidality H2b
H3 Adaptive messaging will reduce depression relative to non-adaptive messaging by producing greater objective and subjective engagement
Detailed Description:
The primary goal of this prospective randomized controlled trial is to pilot all trial procedures for a larger fully-powered trail We will enroll 100 participants out of consideration for feasibility
Among individuals with elevated depression symptoms we will compare the effects of 8 weeks of an adaptive text messaging intervention n40 8 weeks of a non-adaptive text messaging intervention n40 and a psychoeducation-only control group n20 We will include a 6-month post-treatment follow-up to verify that treatment gains are maintained
The study will enroll individuals who have at least moderate symptoms of depression as indicated by Patient Health Questionnaire-9 PHQ-9 scores greater than or equal to 10
We will recruit participants through digital methods eg advertising on social media platforms like Facebook and Instagram Recruitment advertisements will direct potential participants to a centralized recruitment website that provides additional information about the IRB-approved protocol Participants will represent likely users of a mobile-based depression intervention They will also reflect the racial and ethnic diversity of the United States Interested individuals will confirm eligibility by completing an online screening survey Participants will self-report their specific recruitment source as part of this survey and will provide contact information If eligible participants confirm interest study staff will obtain informed consent
Computer-generated randomization will be created prior to the start of the study to avoid allocation bias Random block sizes of 5 and 10 will be allocated in a 221 ratio to adaptive messaging non-adaptive messaging and the psychoeducation-only control group
Both messaging arms will receive 8 weeks of daily text messaging Messages will prompt learning and applying cognitive and behavioral self-management strategies Whereas the non-adaptive messaging system will randomly select daily messaging styles representing a variety of self-management strategies and message tones the adaptive messaging system will apply reinforcement learning to select daily messaging styles to maximize user engagement Text messages will also be used to solicit feedback such as message ratings to inform the reinforcement learning algorithm if applicable The psychoeducation control group will receive a few brief text messages per week providing weblinks to access psychoeducation information
Administration of study measures will occur as part of the research protocol via REDCap online at baseline weeks 4 and 8 and 3-month and 6-month follow-up The primary outcomes is depression symptom severity PHQ-9 Secondary outcomes are anxiety severity GAD-7 and suicidality DSI-SS We will additionally assess subjective and objective engagement with the intervention messaging arms only
We will collect qualitative data with a subset of 10 participants in each messaging arm via user interviews
Using an Intention to Treat paradigm we will use longitudinal linear mixed-effects models to test our hypothesis that
H1 Relative to the psychoeducation-only control messaging interventions will reduce depression H1a and anxiety and suicidal ideation H1b
H2 Relative to non-adaptive messaging adaptive messaging will reduce depression H1a and anxiety and suicidality H2b
H3 Adaptive messaging will reduce depression relative to non-adaptive messaging by producing greater objective and subjective engagement
Among individuals with elevated depression symptoms we will compare the effects of 8 weeks of an adaptive text messaging intervention n40 8 weeks of a non-adaptive text messaging intervention n40 and a psychoeducation-only control group n20 We will include a 6-month post-treatment follow-up to verify that treatment gains are maintained
The study will enroll individuals who have at least moderate symptoms of depression as indicated by Patient Health Questionnaire-9 PHQ-9 scores greater than or equal to 10
We will recruit participants through digital methods eg advertising on social media platforms like Facebook and Instagram Recruitment advertisements will direct potential participants to a centralized recruitment website that provides additional information about the IRB-approved protocol Participants will represent likely users of a mobile-based depression intervention They will also reflect the racial and ethnic diversity of the United States Interested individuals will confirm eligibility by completing an online screening survey Participants will self-report their specific recruitment source as part of this survey and will provide contact information If eligible participants confirm interest study staff will obtain informed consent
Computer-generated randomization will be created prior to the start of the study to avoid allocation bias Random block sizes of 5 and 10 will be allocated in a 221 ratio to adaptive messaging non-adaptive messaging and the psychoeducation-only control group
Both messaging arms will receive 8 weeks of daily text messaging Messages will prompt learning and applying cognitive and behavioral self-management strategies Whereas the non-adaptive messaging system will randomly select daily messaging styles representing a variety of self-management strategies and message tones the adaptive messaging system will apply reinforcement learning to select daily messaging styles to maximize user engagement Text messages will also be used to solicit feedback such as message ratings to inform the reinforcement learning algorithm if applicable The psychoeducation control group will receive a few brief text messages per week providing weblinks to access psychoeducation information
Administration of study measures will occur as part of the research protocol via REDCap online at baseline weeks 4 and 8 and 3-month and 6-month follow-up The primary outcomes is depression symptom severity PHQ-9 Secondary outcomes are anxiety severity GAD-7 and suicidality DSI-SS We will additionally assess subjective and objective engagement with the intervention messaging arms only
We will collect qualitative data with a subset of 10 participants in each messaging arm via user interviews
Using an Intention to Treat paradigm we will use longitudinal linear mixed-effects models to test our hypothesis that
H1 Relative to the psychoeducation-only control messaging interventions will reduce depression H1a and anxiety and suicidal ideation H1b
H2 Relative to non-adaptive messaging adaptive messaging will reduce depression H1a and anxiety and suicidality H2b
H3 Adaptive messaging will reduce depression relative to non-adaptive messaging by producing greater objective and subjective engagement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None