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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visitor Mindset | Behavioral | Single-session, self-guided intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 2-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 2-week follow-up |
| State emotional awareness, clarity, and acceptance following negative affect induction |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-compassion | Self-Compassion Scale (SCS). Total scores range from 0 to 48, with higher scores indicating greater self-compassion. | Baseline to 2-week follow-up |
| Repetitive negative thinking |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39233850 | Derived | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Relaxing with Nature |
| Behavioral |
Single-session, self-guided intervention |
|
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. |
| 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. | 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. | 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. | 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 | 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) | Baseline to 2-week follow-up |
Persistent and Intrusive Negative Thoughts Scale (PINTS). Total scores range from 0 to 20, with higher scores indicating greater repetitive negative thinking.
| Baseline to 2-week follow-up |
| Avoidance | Cognitive avoidance subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater avoidance. | Baseline to 2-week follow-up |
| Problem-solving | Problem-solving subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater problem-solving. | Baseline to 2-week follow-up |
| Positive Reappraisal | Positive reappraisal subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater positive reappraisal. | Baseline to 2-week follow-up |
| Pain intensity | Single item visual analogue scale (0 to 10) of pain intensity drawn from the Brief Pain Inventory (BPI) | Baseline to 2-week follow-up |
| Pain interference | Single item visual analogue scale (0 to 10) of pain interference ("To what extent has pain interfered with your ability to enjoy life") drawn from the Brief Pain Inventory (BPI) | Baseline to 2-week follow-up |
| Pain catastrophizing | Single item ("When I feel pain, it is terrible, and I feel it is never going to get any better") drawn from the Pain Catastrophizing Scale (PCS), rated on a scale from 0 to 4. | Baseline to 2-week follow-up |
| Alcohol use | Daily Drinking Questionnaire (DDQ). Minimum score is 0 and maximum score is not known and depends on how many drinks the participant reports. Higher scores indicate greater alcohol use. | Baseline to 2-week follow-up |
| Alcohol craving | Single item visual analogue scale (0 to 10) of craving severity | Baseline to 2-week follow-up |
| Affective self-compassion | Affective Self-Compassion Questionnaire (ASCQ). Total scores range from 0 to 40, with higher scores indicating greater affective self-compassion. | Baseline to 2-week follow-up |