DepressionNCT05767554
Depression, Experiential Diversity, and Behavioral Novelty
A study testing Brief modified behavioral activation in people with Depression, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of the study is to test whether changes in behavioral patterns are related to changes in depression. Depression is a psychological condition that involves persistent sad mood and/or an inability to enjoy pleasurable activities. Very stable behavioral patterns may be related to symptoms of depression. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Brief modified behavioral activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2023to 31 Mar 2024
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-25
- Possession and daily use of a smart phone
- Able to speak and read English
- Patient Health Questionnaire -8 (PHQ-8) > 10
- Behavioral Activation for Depression (BADS) Activation Subscale < 16
- Ability to complete all study procedures
Who cannot join
- Self-reported lifetime diagnosis of agoraphobia or bipolar disorder
- Severe neurodevelopmental disorder
- Major travel plans within study period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin Institute of Mental Health Research
Austin, Texas, 78712
About this study
Official title: Depression, Experiential Diversity, and Behavioral Novelty: A Mobile Sensing Experimental Paradigm
The purpose of the study is to test whether changes in behavioral patterns are related to changes in depression. Depression is a psychological condition that involves persistent sad mood and/or an inability to enjoy pleasurable activities. Very stable behavioral patterns may be related to symptoms of depression. The aim of this study is to learn more about the relationship between symptoms of depression and behavioral patterns that are collected via global positioning system location data from a smart phone.
- Conditions
- Depression
- Being tested
- Brief modified behavioral activation
- Keywords
- Behavioral activation, Mobile sensing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief modified behavioral activationBehavioural
The clinician will deliver psychoeducation about the nature of depression and the rationale behind the behavioral activation model (i.e. increasing level of activation can begin a positive feedback cycle of reward and improvements in mood state). Participants will be encouraged to add new, enjoyable activities to their daily schedules. Clinicians will emphasize the importance of novelty and increased engagement with the surrounding environment in the psychoeducational portion and in activity scheduling.
| Study group | Role | What they receive |
|---|---|---|
| Brief modified behavioral activation | Experimental | Participants randomized to the behavioral activation condition will meet with a graduate level clinician for one hour. Receives: Behavioral: Brief modified behavioral activation |
| Measurement-only control | No intervention | Participants who are not randomized to the active condition will take part in a measurement-only control condition. They will participate in all portions of the study except for the in-person behavioral activation session. They will complete a baseline and fill out daily surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-8 Total Score over 5 Weeks
Level of depression symptoms assessed weekly by the Patient Health Questionnaire - 8 via smart phone survey. The PHQ-8 ranges from 0-24 with higher scores indicating more severe symptoms of depression.
Measured: Baseline and 5 weeks
Secondary outcomes (1)
Change in Behavioral Activation for Depression Scale over 5 Weeks
Level of behavioral activation as measured by the Behavioral Activation for Depression Scale (BADS). The BADS ranges from 0-150 with higher scores indicating better functioning.
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start21 Apr 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
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.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher G. Beevers, University of Texas at Austin
- Investigators
- Christopher G Beevers, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767554
- Sponsor's protocol ID
- STUDY00003773
- Status last verified
- Aug 2024
- First submitted
- 2 Mar 2023
- Last updated
- 12 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression, Experiential Diversity, and Behavioral Novelty: A Mobile Sensing Experimental Paradigm
- ClinicalTrials.gov ID
- NCT05767554
- Acronym / sponsor ID
- STUDY00003773
- Conditions
- Depression
- Keywords
- Behavioral activation, Mobile sensing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 14 Mar 2023 (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 purpose of the study is to test whether changes in behavioral patterns are related to changes in depression. Depression is a psychological condition that involves persistent sad mood and/or an inability to enjoy pleasurable activities. Very stable behavioral patterns may be related to symptoms of depression. The aim of this study is to learn more about the relationship between symptoms of depression and behavioral patterns that are collected via global positioning system location data from a smart phone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief modified behavioral activation | Experimental | Behavioral: Brief modified behavioral activationParticipants randomized to the behavioral activation condition will meet with a graduate level clinician for one hour. |
| Measurement-only control | No intervention | –Participants who are not randomized to the active condition will take part in a measurement-only control condition. They will participate in all portions of the study except for the in-person behavioral activation session. They will complete a baseline and fill out daily surveys. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-25
- Possession and daily use of a smart phone
- Able to speak and read English
- Patient Health Questionnaire -8 (PHQ-8) > 10
- Behavioral Activation for Depression (BADS) Activation Subscale < 16
Key exclusion criteria (3 listed)
- Self-reported lifetime diagnosis of agoraphobia or bipolar disorder
- Severe neurodevelopmental disorder
- Major travel plans within study period
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 |
|---|---|---|
| Brief modified behavioral activationThe clinician will deliver psychoeducation about the nature of depression and the rationale behind the behavioral activation model (i.e. increasing level of activation can begin a positive feedback cycle of reward and improvements in mood state). Participants will be encouraged to add new, enjoyable activities to their daily schedules. Clinicians will emphasize the importance of novelty and increased engagement with the surrounding environment in the psychoeducational portion and in activity scheduling. | Behavioural | Brief modified behavioral activation |
Primary outcome
Change in Patient Health Questionnaire-8 Total Score over 5 Weeks
Time frame: Baseline and 5 weeks
Level of depression symptoms assessed weekly by the Patient Health Questionnaire - 8 via smart phone survey. The PHQ-8 ranges from 0-24 with higher scores indicating more severe symptoms of depression.
1 secondary outcome
Change in Behavioral Activation for Depression Scale over 5 Weeks
Time frame: Baseline and 5 weeks
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 12 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Christopher G Beevers, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief modified behavioral activation in people with Depression, run by University of Texas at Austin 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 6 inclusion and 3 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 12 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 Patient Health Questionnaire-8 Total Score over 5 Weeks (time frame: Baseline and 5 weeks). 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 12 Aug 2024.