Clinical trial NCT06492824: Text Based Digital Interventions Prompting Enjoyable and Healthy Behaviors
Official title: Intervention in Depression: Randomized Control Trial Examining a Fully Automated Mobile Behavioral Activation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anhedonia
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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. 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.

Eligibility criteria: Inclusion Criteria:

* PHQ-8 score greater than or equal to 10
* 18 years or older
* Had access to a cell phone

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: Collected at baseline and one month
measure: Change in anhedonia
timeFrame: Collected at baseline and one month
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References: