Text Based Digital Interventions Prompting Enjoyable and Healthy Behaviors
Intervention in Depression: Randomized Control Trial Examining a Fully Automated Mobile Behavioral Activation Intervention
1 other identifier
interventional
156
1 country
1
Brief Summary
The proposed project aims to examine the effectiveness of an automated digital (i.e., text message based) intervention prompting adults with at least moderate depressive symptoms to complete enjoyable daily activities (i.e., 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Nov 2022
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
July 9, 2024
CompletedAugust 29, 2024
August 1, 2024
3 months
July 1, 2024
August 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Change in depressive symptoms
Depression, Anxiety, and Stress Scale (DASS-21) creates a total score for depression based on 7 items. Scores range from 0-42, higher score indication more depression.
Collected at baseline and one month
Change in anhedonia
Personality Inventory for DSM-5 (PID 5), anhedonia subscale, creates a score of current anhedonic symptoms consisting of 8 items. Scores range from 0-24, higher scores indicating more symptoms of anhedonia.
Collected at baseline and one month
Study Arms (3)
Enjoyable Activities Condition
EXPERIMENTALWatched an introduction video that discussed the rationale for the enjoyable activities intervention. During the initial visit, enjoyable activities participants were asked to choose five enjoyable activities from a large list that they wanted to do more frequently over the next four weeks. Over the next four weeks, daily text message reminders were sent each morning. These text messages reminded participants of the five enjoyable activities that they wanted to do and encouraged them to complete at least two of the of the enjoyable activities that day. Additionally, participants received a link to complete a daily checklist where they reported if they had completed any of their five activities on the previous day. At the end of the four-week period, enjoyable activities participants completed a post-intervention online survey consisting of the same measures from the initial survey.
Healthy Activities Condition
ACTIVE COMPARATORParticipants in the healthy activities condition were promoted to complete the following five activities each day: drinking more water, going to bed early, brushing their teeth, showering or bathing that day, and eating well-balanced meals. Healthy activities condition participants also watched an introduction video that discussed the rationale for the healthy activities intervention. Daily text reminders were sent regarding these five healthy living activities each morning. Consistent with the enjoyable activities condition, healthy activities participants were asked to try to complete at least two of the five healthy activities each day but could do more if they desired. At the end of the month, they completed an online post-intervention survey consisting of the same measures from the pre-intervention assessment.
Passive Control
NO INTERVENTIONControl participants completed an initial online survey which also included an introduction video (approximately one and half minutes long) explaining the rationale for this specific condition and that researchers wanted to understand the naturalistic course of mood and behavior over the course of one month. However, passive control participants were not explicitly asked to complete any enjoyable activities or healthy living activities during the subsequent four weeks. Passive control participants were not sent daily text reminders or checklists to complete over the four-week period. They were asked to complete the same short weekly questionnaire asking about their mood for the preceding week. At the end of the month, they also completed a post online survey consisting of the same measures from the initial survey. Participants in this condition also had the option to complete the enjoyable activities digital intervention after completing the passive control condition if they desired.
Interventions
Participants 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.
They will 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. 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 documentation). At the end of the month, they will also complete a follow-up survey consisting of the same measures from the pre-intervention survey.
Eligibility Criteria
You may qualify if:
- PHQ-8 score greater than or equal to 10
- years or older
- Had access to a cell phone
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Florida State University
Tallahassee, Florida, 32304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Principal Investigator
Study Record Dates
First Submitted
July 1, 2024
First Posted
July 9, 2024
Study Start
November 1, 2022
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
August 29, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share