DepressionNCT05914025
The Effect of a Brief Online Behavioral Activation Intervention
A study testing Behavioral Activation in people with Depression, run by Palo Alto University at 1 site in United States.
Trial summary
Depression is a worldwide phenomena that has a severe personal, social and societal impact. One such impact is an over $200 billion worldwide economic cost. While many treatments exist for depression, many individuals may not receive the support that they need for reasons such as stigma, financial restraints, or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 18 Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- United States Resident
Who cannot join
- Non-US resident
- Younger than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Online Recruitment/Palo Alto University Campus
Palo Alto, California, 94304
About this study
Official title: The Effect of a Brief Online Behavioral Activation Intervention by Activity Type
Depression is a worldwide phenomena that has a severe personal, social and societal impact. One such impact is an over $200 billion worldwide economic cost. While many treatments exist for depression, many individuals may not receive the support that they need for reasons such as stigma, financial restraints, or limited access to therapists. As such, it is important to assess the efficacy of brief online treatments as an alternative to full length, in-person treatments. A series of studies looking at a brief behavioral activation for depression treatment has shown that participants have reported temporarily improved mood, confidence, motivation and reduced depressive symptoms. It is important to test this treatment in multiple groups of people to acquire additional information regarding brief online interventions. This study seeks to collect participants from online social media sources and compare results to historical data that were collected from a prior research study which used Amazon Mechanical Turk as a recruitment source.
- Conditions
- Depression
- Being tested
- Behavioral Activation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Individuals will be provided with information about maladaptive patterns of behavior and how to correct these cycles with activity scheduling to elicit more positive emotional experiences. Participants will be provided with categories/lists of activities and a downloadable calendar after receiving the psychoeducation.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation Intervention | Experimental | All individuals enrolled in the study will be assigned to this arm and will receive a brief behavioral activation psychoeducation module among other self-report assessments. Receives: Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression level
Changes in depression score as measured by the PROMIS scale. The PROMIS is scored on a 5-point Likert scale with responses 1 to 5 corresponding to Never, Rarely, Sometimes, Often, and Always respectively.
Measured: 3 days
Self-reported mood
Changes in mood as measured by a self-reported mood question. This measure is scored on a 9-point Likert scale (1 = Extremely Negative to 9 = Extremely Positive)
Measured: 3 days
Daily Enjoyment
Changes in enjoyment as measured by a self-reported question around daily enjoyment. This measure is scored on a 5-point Likert scale (1 = Not at all to 9 = Extremely)
Measured: At time of original survey
Secondary outcomes (1)
Confidence, Motivation, and Usefulness
Changes in confidence, motivation, and usefulness are measured with single self-reported measures for confidence, motivation, and usefulness of the intervention. They are rated on a 9 point Likert scale (1 = Extremely Negative to 9 = Extremely Positive)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start24 Jan 2022
- Primary completion20 Feb 2023
- Study completion18 Apr 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parker Benson, Palo Alto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914025
- Sponsor's protocol ID
- 2021-082
- Status last verified
- Jun 2023
- First submitted
- 2 Feb 2022
- Last updated
- 22 Jun 2023
- Results posted
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Brief Online Behavioral Activation Intervention by Activity Type
- ClinicalTrials.gov ID
- NCT05914025
- Acronym / sponsor ID
- 2021-082
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Palo Alto UniversityUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 22 Jun 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.
Depression is a worldwide phenomena that has a severe personal, social and societal impact. One such impact is an over $200 billion worldwide economic cost. While many treatments exist for depression, many individuals may not receive the support that they need for reasons such as stigma, financial restraints, or limited access to therapists. As such, it is important to assess the efficacy of brief online treatments as an alternative to full length, in-person treatments. A series of studies looking at a brief behavioral activation for depression treatment has shown that participants have reported temporarily improved mood, confidence, motivation and reduced depressive symptoms. It is important to test this treatment in multiple groups of people to acquire additional information regarding brief online interventions. This study seeks to collect participants from online social media sources and compare results to historical data that were collected from a prior research study which used Amazon Mechanical Turk as a recruitment source.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation Intervention | Experimental | Behavioral: Behavioral ActivationAll individuals enrolled in the study will be assigned to this arm and will receive a brief behavioral activation psychoeducation module among other self-report assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- United States Resident
Key exclusion criteria (2 listed)
- Non-US resident
- Younger than 18 years old
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 |
|---|---|---|
| Behavioral ActivationIndividuals will be provided with information about maladaptive patterns of behavior and how to correct these cycles with activity scheduling to elicit more positive emotional experiences. Participants will be provided with categories/lists of activities and a downloadable calendar after receiving the psychoeducation. | Behavioural | Behavioral Activation Intervention |
Primary outcome
Depression level
Time frame: 3 days
Changes in depression score as measured by the PROMIS scale. The PROMIS is scored on a 5-point Likert scale with responses 1 to 5 corresponding to Never, Rarely, Sometimes, Often, and Always respectively.
Self-reported mood
Time frame: 3 days
Changes in mood as measured by a self-reported mood question. This measure is scored on a 9-point Likert scale (1 = Extremely Negative to 9 = Extremely Positive)
Daily Enjoyment
Time frame: At time of original survey
Changes in enjoyment as measured by a self-reported question around daily enjoyment. This measure is scored on a 5-point Likert scale (1 = Not at all to 9 = Extremely)
1 secondary outcome
Confidence, Motivation, and Usefulness
Time frame: 3 days
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 22 Jun 2023.
- 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.
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 Behavioral Activation in people with Depression, run by Palo Alto 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 2 inclusion and 2 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 22 Jun 2023. 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?
Depression level (time frame: 3 days). The study lists 3 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 22 Jun 2023.