Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492824
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Text Based Digital Interventions Prompting Enjoyable and Healthy Behaviors
Sponsor:
Florida State University
Organization:
Florida State University
Study Overview
Official Title:
Intervention in Depression Randomized Control Trial Examining a Fully Automated Mobile Behavioral Activation Intervention
Status:
COMPLETED
Status Verified Date:
2024-08
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:
The proposed project aims to examine the effectiveness of an automated digital ie text message based intervention prompting adults with at least moderate depressive symptoms to complete enjoyable daily activities ie Behavioral Activation BA over the course of one month compared to adults with moderate or more depressive symptoms that complete an active and a passive control condition broadly prompting a healthier lifestyle or no prompts at all More specifically we aim to examine if the BA intervention will improve mental health and overall well-being among adults experiencing moderate or more symptoms of depression over and beyond the active and passive control conditions We will measure symptoms such as current depression anxiety and stress pre- and post- interventions to determine their effectiveness
Detailed Description:
Participants in the experimental BA condition will complete an introduction video about the intervention They will then take a pre-intervention survey after which they will choose five enjoyable activities from a large list Daily text message reminders will be sent to BA participants in the morning to remind them to do their enjoyable activities for the day as well as a link to a checklist where they will report how frequently they have completed any of their five activities from the previous day example text message in documentation At the end of the month they will complete a follow-up survey consisting of the same measures from the pre-intervention survey
Participants in the active control condition will complete mostly the same tasks as those in the experimental BA condition They will then take a pre-intervention survey and choose five enjoyable activities from the same list however active control participants will not explicitly be asked to complete these activities for the intervention Instead participants in the active control condition will be promoted to complete tasks such as drinking more water going to bed early brushing their teeth showering or bathing for that day and eating well balanced meals Daily text reminders will be sent about these healthy living activities in the morning In that same message they will receive a link to a checklist where they will report about their completed healthy living activities for the previous day example text message in documentationAt the end of the month they will also complete a follow-up survey consisting of the same measures from the pre-intervention survey Importantly participants in this condition will have the option to complete the BA digital intervention after completing the active control condition if they desire however these participants would not be paid for their time upon completing the BA intervention
Finally participants in the passive control condition will complete mostly the same tasks as those in the experimental BA and active control conditions They will take a pre-intervention survey and choose five enjoyable activities from the same list however passive control participants will not explicitly be asked to complete these enjoyable activities or any of the healthy living activities during the month To further clarify passive control participants will not be enrolled in SlickText and will therefore not be sent daily text reminders or checklists At the end of the month they will also complete a follow-up survey consisting of the same measures from the pre-intervention survey Importantly participants in this condition will also have the option to complete the BA digital intervention after completing the passive control condition if they desire however these participants would not be paid for their time upon completing the BA intervention
Participants in the active control condition will complete mostly the same tasks as those in the experimental BA condition They will then take a pre-intervention survey and choose five enjoyable activities from the same list however active control participants will not explicitly be asked to complete these activities for the intervention Instead participants in the active control condition will be promoted to complete tasks such as drinking more water going to bed early brushing their teeth showering or bathing for that day and eating well balanced meals Daily text reminders will be sent about these healthy living activities in the morning In that same message they will receive a link to a checklist where they will report about their completed healthy living activities for the previous day example text message in documentationAt the end of the month they will also complete a follow-up survey consisting of the same measures from the pre-intervention survey Importantly participants in this condition will have the option to complete the BA digital intervention after completing the active control condition if they desire however these participants would not be paid for their time upon completing the BA intervention
Finally participants in the passive control condition will complete mostly the same tasks as those in the experimental BA and active control conditions They will take a pre-intervention survey and choose five enjoyable activities from the same list however passive control participants will not explicitly be asked to complete these enjoyable activities or any of the healthy living activities during the month To further clarify passive control participants will not be enrolled in SlickText and will therefore not be sent daily text reminders or checklists At the end of the month they will also complete a follow-up survey consisting of the same measures from the pre-intervention survey Importantly participants in this condition will also have the option to complete the BA digital intervention after completing the passive control condition if they desire however these participants would not be paid for their time upon completing the BA intervention
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