NCT06492824

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

July 1, 2024

Last Update Submit

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

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.

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.

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.

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.

Enjoyable Activities Condition

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.

Healthy Activities Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

DepressionAnhedonia

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations