DepressionNCT06492824
Text Based Digital Interventions Prompting Enjoyable and Healthy Behaviors
A study testing Enjoyable Activities Condition and Healthy Activities Condition in people with Depression and Anhedonia, run by Florida State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anhedonia
- What is being tested?
- Enjoyable Activities Condition and Healthy Activities Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PHQ-8 score greater than or equal to 10
- 18 years or older
- Had access to a cell phone
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
Official title: Intervention in Depression: Randomized Control Trial Examining a Fully Automated Mobile Behavioral Activation Intervention
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.
Read the 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.
- Conditions
- Depression, Anhedonia
- Being tested
- Enjoyable Activities Condition, Healthy Activities Condition
- Medical subject headings
- Depression, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enjoyable Activities ConditionBehavioural
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.
Healthy Activities ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enjoyable Activities Condition | Experimental | Watched 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. Receives: Behavioral: Enjoyable Activities Condition |
| Healthy Activities Condition | Active comparator | Participants 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. Receives: Behavioral: Healthy Activities Condition |
| Passive Control | No intervention | Control 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Collected at baseline and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Nov 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nick Santopetro, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492824
- Sponsor's protocol ID
- STUDY00003514
- Status last verified
- Aug 2024
- First submitted
- 1 Jul 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention in Depression: Randomized Control Trial Examining a Fully Automated Mobile Behavioral Activation Intervention
- ClinicalTrials.gov ID
- NCT06492824
- Acronym / sponsor ID
- STUDY00003514
- Conditions
- Depression, Anhedonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enjoyable Activities Condition | Experimental | Behavioral: Enjoyable Activities ConditionWatched 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 comparator | Behavioral: Healthy Activities ConditionParticipants 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 intervention | –Control 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PHQ-8 score greater than or equal to 10
- 18 years or older
- Had access to a cell phone
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Enjoyable Activities ConditionParticipants 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. | Behavioural | Enjoyable Activities Condition |
| Healthy Activities ConditionThey 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. | Behavioural | Healthy Activities Condition |
Primary outcome
Change in depressive symptoms
Time frame: Collected at baseline and one month
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.
Change in anhedonia
Time frame: Collected at baseline and one month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Depression
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enjoyable Activities Condition and Healthy Activities Condition in people with Depression and Anhedonia, run by Florida State 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 3 inclusion and 1 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 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in depressive symptoms (time frame: Collected at baseline and one month). The study lists 2 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 Aug 2024.