Depressive SymptomsNCT04643964
Brief Video Interventions for Depression
A study testing Entrée: Cognitive skills, Entrée: Behavioral skills and Entrée: Interpersonal skills in people with Depressive Symptoms, run by Ohio State University at 1 site in United States.
Trial summary
In this study, we test brief video interventions for those with elevated depressive symptoms. We randomize participants to one of three conditions. (1) An entrée condition involving in-depth coverage a set of cognitive behavioral therapy (CBT) skills. (2) A sampler condition which introduces three sets of CBT skills. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Entrée: Cognitive skills, Entrée: Behavioral skills and Entrée: Interpersonal skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 655 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2020to 5 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Score above 10 on the Patient Health Questionnaire-9
- Are 18 years of age or older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Mental Health Resilience in the COVID-19 Pandemic.
In this study, we test brief video interventions for those with elevated depressive symptoms. We randomize participants to one of three conditions. (1) An entrée condition involving in-depth coverage a set of cognitive behavioral therapy (CBT) skills. (2) A sampler condition which introduces three sets of CBT skills. (3) A control condition involving no skills. Among those in the entrée condition, participants are further randomized to one of three CBT skills. We plan on two sets of primary comparisons. First, we will compare the effects of each form of video intervention (i.e., entrée and sampler) to the control condition. Second, we will compare the entrée and sampler conditions. We will recruit participants from Amazon's Mechanical Turk program (MTurk). In the intervention conditions, participants will be asked to watch several videos and practice skills using worksheets. They will also be asked to practice skills introduced in the videos in the week following the intervention. In the control condition, participants will not watch videos. One week after the intervention, all participants will respond to a follow-up assessment.
Read the detailed description
Access to the study will be provided via the MTurk website. Study measures and interventions will be provided via Qualtrics. To determine eligibility, participants will be asked to fill out a pre-screening measure of depressive symptoms, the Personal Health Questionnaire-9 (PHQ-9). Those who score 10 or higher will be eligible. After consenting to participate, participants will fill out baseline measures, be randomly assigned to a condition, participate in any condition related procedures, and then respond to a follow-up assessment one week later.
Each brief intervention consists of watching a series of videos. After each video, participants in the intervention conditions will be prompted to answer a series of questions to practice the skills explained in the videos. For the entrée and sampler conditions, watching all videos and filling out any worksheets that are part of the initial intervention is expected to take approximately 30 minutes.
Participants in the entrée and sampler conditions will be asked to work on a coping skills worksheet over the next seven days (estimated to involve about 10 minutes of work). Participants will receive an email seven days after participating in the brief intervention, asking them to take part in the following portion of the study. Before beginning the follow-up activity, participants in the intervention conditions will be asked to upload the coping skills worksheet they worked on. All participants will be asked to respond to follow-up assessment measures at this point.
- Conditions
- Depressive Symptoms
- Being tested
- Entrée: Cognitive skills, Entrée: Behavioral skills, Entrée: Interpersonal skills, Sampler skills
- Keywords
- Depression, Video intervention, Cognitive behavioral skills
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entrée: Cognitive skillsBehavioural
In this condition, participants view a video-based intervention covering cognitive emotion regulation skills. This intervention asks participants to respond to questions and practice identifying and evaluating their own thoughts using an intervention worksheet. One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills.
Entrée: Behavioral skillsBehavioural
In this condition, participants view a video-based intervention covering behavioral emotion regulation skills. This intervention asks participants to respond to questions and practice scheduling activities that might give them a sense of pleasure or accomplishment using an intervention worksheet. One week after the intervention, participants are asked to upload a worksheet showing their efforts to schedule and engage in behaviors in line with the intervention skills.
Entrée: Interpersonal skillsBehavioural
In this condition, participants view a video-based intervention covering interpersonal emotion regulation skills. This intervention asks participants to respond to questions and practice communicating effectively using an intervention worksheet. One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills.
Sampler skillsBehavioural
In this condition, participants view a video-based intervention covering three emotion regulation skills: cognitive, behavioral, and interpersonal skills. This intervention asks participants to respond to questions and practice using skills using intervention worksheets. One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills.
| Study group | Role | What they receive |
|---|---|---|
| Entrée: Cognitive Skills | Experimental | Not described Receives: Behavioral: Entrée: Cognitive skills |
| Entrée: Behavioral Skills | Experimental | Not described Receives: Behavioral: Entrée: Behavioral skills |
| Entrée: Interpersonal Skills | Experimental | Not described Receives: Behavioral: Entrée: Interpersonal skills |
| Sampler Skills | Experimental | Not described Receives: Behavioral: Sampler skills |
| Control | No intervention | Participants are not given videos to watch until their involvement in the study ends. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)
The Quick Inventory of Depressive Symptoms-Self Report is a 16-item self-report scale that measures depressive symptom severity. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.
Measured: Baseline, 1-2 weeks after baseline
Secondary outcomes (3)
Change in the Ways of Responding Questionnaire (WOR)
The Ways of Responding Questionnaire is a measure of compensatory skills taught in CBT for depression. Participants respond to 6 hypothetical stressful situations in which their initial thoughts regarding the event are given. Quality scores range from 0 to 6, with higher scores indicating greater CBT skills.
Measured: Baseline, 1-2 weeks after baseline
Change in the Styles of Emotion Response Questionnaire (SERQ)
The Styles of Emotion Response Questionnaire is a 36-item self-report scale that measures the extent to which respondents endorse four different domains of coping skills: cognitive, behavioral, interpersonal, and mindfulness. For each item, participants are asked how often they use the strategy and how much feeling upset negatively impacts the use of this strategy. Scores from the first three skills are secondary outcomes. Scores range from 72-360, with higher scores indicating greater coping skill use.
For the purpose of this study, we used the Cognitive, Behavioral, and Interpersonal scales. Scores in each subscale range from 18-90, with higher scores indicating greater coping skill use in that domain.
Measured: Baseline, 1-2 weeks after baseline
Change in the University of California, Los Angeles (UCLA) Loneliness Scale, Version 3
The University of California, Los Angeles (UCLA) Loneliness Scale, Version 3 is a 20-item self-report scale that measures subjective feelings of loneliness and isolation. Scores range from 20-80, with higher scores indicating greater subjective experience of loneliness.
Measured: Baseline, 1-2 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start17 Nov 2020
- Primary completion5 Jun 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Model description
- Participants will be randomly assigned to one of three conditions: (1) a brief intervention focused on one domain of coping skills (the entrée condition), (2) a brief intervention focused on three domains of coping skills (the sampler condition), or (3) a no-intervention control condition. If participants are randomly assigned to the first condition, they will be further randomized into one of three brief interventions: (1) a focus on cognitive coping skills, (2) a focus on behavioral coping skills, or (3) a focus on interpersonal coping skills. The sampler condition will involve limited coverage of each of these same three types of skills.
- Masking
- None (open label)
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel R. Strunk, Ohio State University
- Investigators
- Daniel R Strunk, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643964
- Sponsor's protocol ID
- 2020B0326
- Status last verified
- May 2024
- First submitted
- 12 Nov 2020
- Last updated
- 20 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be posted to clinicaltrials.gov within one year after completion of the final participant's participation in the clinical trial. Following initial publication, deidentified individual participant data (IPD) that underlie results in the primary outcome data reported will be available on reasonable request for 5 years after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Mental Health Resilience in the COVID-19 Pandemic.
- ClinicalTrials.gov ID
- NCT04643964
- Acronym / sponsor ID
- 2020B0326
- Conditions
- Depressive Symptoms
- Keywords
- Depression, Video intervention, Cognitive behavioral skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Posted 20 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we test brief video interventions for those with elevated depressive symptoms. We randomize participants to one of three conditions. (1) An entrée condition involving in-depth coverage a set of cognitive behavioral therapy (CBT) skills. (2) A sampler condition which introduces three sets of CBT skills. (3) A control condition involving no skills. Among those in the entrée condition, participants are further randomized to one of three CBT skills. We plan on two sets of primary comparisons. First, we will compare the effects of each form of video intervention (i.e., entrée and sampler) to the control condition. Second, we will compare the entrée and sampler conditions. We will recruit participants from Amazon's Mechanical Turk program (MTurk). In the intervention conditions, participants will be asked to watch several videos and practice skills using worksheets. They will also be asked to practice skills introduced in the videos in the week following the intervention. In the control condition, participants will not watch videos. One week after the intervention, all participants will respond to a follow-up assessment.
Detailed description
Access to the study will be provided via the MTurk website. Study measures and interventions will be provided via Qualtrics. To determine eligibility, participants will be asked to fill out a pre-screening measure of depressive symptoms, the Personal Health Questionnaire-9 (PHQ-9). Those who score 10 or higher will be eligible. After consenting to participate, participants will fill out baseline measures, be randomly assigned to a condition, participate in any condition related procedures, and then respond to a follow-up assessment one week later.
Each brief intervention consists of watching a series of videos. After each video, participants in the intervention conditions will be prompted to answer a series of questions to practice the skills explained in the videos. For the entrée and sampler conditions, watching all videos and filling out any worksheets that are part of the initial intervention is expected to take approximately 30 minutes.
Participants in the entrée and sampler conditions will be asked to work on a coping skills worksheet over the next seven days (estimated to involve about 10 minutes of work). Participants will receive an email seven days after participating in the brief intervention, asking them to take part in the following portion of the study. Before beginning the follow-up activity, participants in the intervention conditions will be asked to upload the coping skills worksheet they worked on. All participants will be asked to respond to follow-up assessment measures at this point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Participants will be randomly assigned to one of three conditions: (1) a brief intervention focused on one domain of coping skills (the entrée condition), (2) a brief intervention focused on three domains of coping skills (the sampler condition), or (3) a no-intervention control condition. If participants are randomly assigned to the first condition, they will be further randomized into one of three brief interventions: (1) a focus on cognitive coping skills, (2) a focus on behavioral coping skills, or (3) a focus on interpersonal coping skills. The sampler condition will involve limited coverage of each of these same three types of skills.
| Arm | Type | Receives |
|---|---|---|
| Entrée: Cognitive Skills | Experimental | Behavioral: Entrée: Cognitive skills |
| Entrée: Behavioral Skills | Experimental | Behavioral: Entrée: Behavioral skills |
| Entrée: Interpersonal Skills | Experimental | Behavioral: Entrée: Interpersonal skills |
| Sampler Skills | Experimental | Behavioral: Sampler skills |
| Control | No intervention | –Participants are not given videos to watch until their involvement in the study ends. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Score above 10 on the Patient Health Questionnaire-9
- Are 18 years of age or older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Entrée: Cognitive skillsIn this condition, participants view a video-based intervention covering cognitive emotion regulation skills. This intervention asks participants to respond to questions and practice identifying and evaluating their own thoughts using an intervention worksheet. One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills. | Behavioural | Entrée: Cognitive Skills |
| Entrée: Behavioral skillsIn this condition, participants view a video-based intervention covering behavioral emotion regulation skills. This intervention asks participants to respond to questions and practice scheduling activities that might give them a sense of pleasure or accomplishment using an intervention worksheet. One week after the intervention, participants are asked to upload a worksheet showing their efforts to schedule and engage in behaviors in line with the intervention skills. | Behavioural | Entrée: Behavioral Skills |
| Entrée: Interpersonal skillsIn this condition, participants view a video-based intervention covering interpersonal emotion regulation skills. This intervention asks participants to respond to questions and practice communicating effectively using an intervention worksheet. One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills. | Behavioural | Entrée: Interpersonal Skills |
| Sampler skillsIn this condition, participants view a video-based intervention covering three emotion regulation skills: cognitive, behavioral, and interpersonal skills. This intervention asks participants to respond to questions and practice using skills using intervention worksheets. One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills. | Behavioural | Sampler Skills |
Primary outcome
Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)
Time frame: Baseline, 1-2 weeks after baseline
The Quick Inventory of Depressive Symptoms-Self Report is a 16-item self-report scale that measures depressive symptom severity. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.
3 secondary outcomes
Change in the Ways of Responding Questionnaire (WOR)
Time frame: Baseline, 1-2 weeks after baseline
Change in the Styles of Emotion Response Questionnaire (SERQ)
Time frame: Baseline, 1-2 weeks after baseline
Change in the University of California, Los Angeles (UCLA) Loneliness Scale, Version 3
Time frame: Baseline, 1-2 weeks after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Results will be posted to clinicaltrials.gov within one year after completion of the final participant's participation in the clinical trial. Following initial publication, deidentified individual participant data (IPD) that underlie results in the primary outcome data reported will be available on reasonable request for 5 years after study completion.
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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.
Daniel R Strunk, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entrée: Cognitive skills, Entrée: Behavioral skills and Entrée: Interpersonal skills in people with Depressive Symptoms, run by Ohio 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 2 inclusion and 0 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 20 May 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?
Yes. Results are posted in the registry (first posted 20 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) (time frame: Baseline, 1-2 weeks after baseline). 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 20 May 2024.