DepressionNCT05109507
Single-Session Intervention Targeting Emotional Awareness, Clarity, and Acceptance to Reduce Depression/Anxiety
A study testing Visitor Mindset and Relaxing with Nature in people with Depression and Anxiety, run by Yale University at 1 site in United States.
Trial summary
Two-arm, parallel group randomized clinical trial conducted via Mturk comparing a single-session web-based intervention called Visitor Mindset versus a control intervention (nature videos with relaxing music) for adults with depression and/or anxiety symptoms Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Visitor Mindset and Relaxing with Nature
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 1 Dec 2021
- 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
- Adults 18 years and older
- English-speaking
- At least mild anxiety and/or depression symptoms, as indicated by a score of 3 or greater on the 4-item Patient Health Questionnaire (PHQ-4)
Who cannot join
- fail to meet above-listed inclusion criteria
- exit the study prior to condition randomization
- obvious lack of English fluency in open response questions
- responding with random text in open response questions
- respond with either copy/pasted responses from text earlier in the intervention to any of free response questions
- participants with a completion time less than 180 seconds for the baseline survey assessment (taking about 1.5 seconds per question) OR who fail all three attention check questions in the baseline survey, indicating very careless, random, inattentive and/or hasty responding
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06511
About this study
Official title: Pilot Randomized Trial of Visitor Mindset: A Single-Session Self-Guided Digital Intervention Targeting Emotional Awareness, Clarity, and Acceptance Among Adults With Anxiety and/or Depression Symptoms
Two-arm, parallel group randomized clinical trial conducted via Mturk comparing a single-session web-based intervention called Visitor Mindset versus a control intervention (nature videos with relaxing music) for adults with depression and/or anxiety symptoms
Read the detailed description
Procedures include completing: (1) pre-intervention assessments; (2) one of two single-session web-based intervention (approximately 30 to 45 minutes each); (3) post-intervention assessments, including survey questions following a negative affect induction (brief film clip); and (4) a 2-week follow-up assessment.
- Conditions
- Depression, Anxiety
- Being tested
- Visitor Mindset, Relaxing with Nature
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visitor MindsetBehavioural
Single-session, self-guided intervention
Relaxing with NatureBehavioural
Single-session, self-guided intervention
| Study group | Role | What they receive |
|---|---|---|
| Visitor Mindset | Experimental | Single-session, self-guided web-based intervention (~30 to 45 minutes) hosted on Qualtrics with animated videos, audio-guided exercises, graphics, text-based material, and interactive questions. The intervention is designed to enhance emotional awareness, clarity, and acceptance, as well as modify beliefs about the duration and usefulness of negative emotions. Receives: Behavioral: Visitor Mindset |
| Relaxing with Nature | Active comparator | Single-session self-guided web-based intervention (~30 to 45 minutes) hosted on Qualtrics with videos (real-life images), text-based material, and questions. There are five videos showing different types of nature (e.g., forest scenes, beach scenes, etc.). Each video includes a sequence of pleasant nature photos (shown about 6 seconds each) with relaxing music in the background. Receives: Behavioral: Relaxing with Nature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety and depression symptoms
Patient Health Questionnaire-Anxiety Depression Scale (PHQ-ADS). Total scores range from 0 to 27, with higher scores indicating greater anxiety/depression symptoms.
Measured: Baseline to 2-week follow-up
Secondary outcomes (7)
Change over time in functional impairment
Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment.
Measured: Baseline to 2-week follow-up
State emotional awareness, clarity, and acceptance following negative affect induction
Adapted state version of Emotion Regulation Skills Questionnaire (ERSQ). Total scores for each subscale range from 0 to 12, with higher scores indicating greater state emotional awareness, clarity. or acceptance.
Measured: Immediate post-intervention
State non-acceptance of emotions
Non-acceptance subscale of the State Difficulties in Emotion Regulation Scale (S-DERS). Total scores range from 0 to 12, with higher scores indicating greater state emotional non-acceptance.
Measured: Immediate post-intervention
Change over time in emotional awareness, clarity, and acceptance
Emotion Regulation Skills Questionnaire (ERSQ). Total scores for each subscale range from 0 to 12, with higher scores indicating greater emotional awareness, clarity. or acceptance.
Measured: Baseline to 2-week follow-up
Change over time in non-acceptance of emotions
Non-acceptance subscale of the Difficulties in Emotion Regulation Scale (DERS). Total scores range from 0 to 12, with higher scores indicating greater state emotional non-acceptance.
Measured: Baseline to 2-week follow-up
Change over time in beliefs about the usefulness of negative emotions
Emotion Beliefs Questionnaire (EBQ). Total scores range from 0 to 16, with higher scores indicating greater beliefs that emotions are not useful or harmful
Measured: Baseline to 2-week follow-up
Change over time in beliefs about the duration of negative emotions
duration subscale (2 items) of the Leahy Emotion Schema Scale (LESS) and 2 items ("When I'm upset, I believe that I will remain that way for a long time" and "When I'm upset, I believe that I'll end up feeling very depressed") from the modification subscale of the Difficulties in Emotion Regulation Scale (DERS). Total scores range from 0 to 16, with higher scores indicating greater maladaptive beliefs about the duration of emotions (they last will last forever)
Measured: Baseline to 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start18 Oct 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Yale 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corey Roos, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109507
- Sponsor's protocol ID
- 2000030587
- Status last verified
- Dec 2021
- First submitted
- 18 Oct 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roos CR, Bricker J, Kiluk B, Trull TJ, Bowen S, Witkiewitz K, Kober H. A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial. Contemp Clin Trials Commun. 2024 Jul 26;41:101338. doi: 10.1016/j.conctc.2024.101338. eCollection 2024 Oct.
PubMed 39233850
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of Visitor Mindset: A Single-Session Self-Guided Digital Intervention Targeting Emotional Awareness, Clarity, and Acceptance Among Adults With Anxiety and/or Depression Symptoms
- ClinicalTrials.gov ID
- NCT05109507
- Acronym / sponsor ID
- 2000030587
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 5 Nov 2021 (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.
Two-arm, parallel group randomized clinical trial conducted via Mturk comparing a single-session web-based intervention called Visitor Mindset versus a control intervention (nature videos with relaxing music) for adults with depression and/or anxiety symptoms
Detailed description
Procedures include completing: (1) pre-intervention assessments; (2) one of two single-session web-based intervention (approximately 30 to 45 minutes each); (3) post-intervention assessments, including survey questions following a negative affect induction (brief film clip); and (4) a 2-week follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visitor Mindset | Experimental | Behavioral: Visitor MindsetSingle-session, self-guided web-based intervention (~30 to 45 minutes) hosted on Qualtrics with animated videos, audio-guided exercises, graphics, text-based material, and interactive questions. The intervention is designed to enhance emotional awareness, clarity, and acceptance, as well as modify beliefs about the duration and usefulness of negative emotions. |
| Relaxing with Nature | Active comparator | Behavioral: Relaxing with NatureSingle-session self-guided web-based intervention (~30 to 45 minutes) hosted on Qualtrics with videos (real-life images), text-based material, and questions. There are five videos showing different types of nature (e.g., forest scenes, beach scenes, etc.). Each video includes a sequence of pleasant nature photos (shown about 6 seconds each) with relaxing music in the background. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years and older
- English-speaking
- At least mild anxiety and/or depression symptoms, as indicated by a score of 3 or greater on the 4-item Patient Health Questionnaire (PHQ-4)
Key exclusion criteria (6 listed)
- fail to meet above-listed inclusion criteria
- exit the study prior to condition randomization
- obvious lack of English fluency in open response questions
- responding with random text in open response questions
- respond with either copy/pasted responses from text earlier in the intervention to any of free response questions
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 |
|---|---|---|
| Visitor MindsetSingle-session, self-guided intervention | Behavioural | Visitor Mindset |
| Relaxing with NatureSingle-session, self-guided intervention | Behavioural | Relaxing with Nature |
Primary outcome
Change in anxiety and depression symptoms
Time frame: Baseline to 2-week follow-up
Patient Health Questionnaire-Anxiety Depression Scale (PHQ-ADS). Total scores range from 0 to 27, with higher scores indicating greater anxiety/depression symptoms.
7 secondary outcomes
Change over time in functional impairment
Time frame: Baseline to 2-week follow-up
State emotional awareness, clarity, and acceptance following negative affect induction
Time frame: Immediate post-intervention
State non-acceptance of emotions
Time frame: Immediate post-intervention
Change over time in emotional awareness, clarity, and acceptance
Time frame: Baseline to 2-week follow-up
Change over time in non-acceptance of emotions
Time frame: Baseline to 2-week follow-up
Change over time in beliefs about the usefulness of negative emotions
Time frame: Baseline to 2-week follow-up
Change over time in beliefs about the duration of negative emotions
Time frame: Baseline to 2-week follow-up
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 Dec 2021.
- Derived from this study: PubMed 39233850Roos CR, Bricker J, Kiluk B, Trull TJ, Bowen S, Witkiewitz K, Kober H. A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial. Contemp Clin Trials Commun. 2024 Jul 26;41:101338. doi: 10.1016/j.conctc.2024.101338. eCollection 2024 Oct.
- Individual participant dataSharing planned: Undecided
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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 Visitor Mindset and Relaxing with Nature in people with Depression and Anxiety, run by Yale 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 6 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 Dec 2021. 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 anxiety and depression symptoms (time frame: Baseline to 2-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05109507, which also lists 1 linked publication.
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 Dec 2021.