Anxiety, Depression
Conditions
Brief 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
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.
Interventions
BEHAVIORALVisitor Mindset
Single-session, self-guided intervention
BEHAVIORALRelaxing with Nature
Single-session, self-guided intervention
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety and depression symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| State emotional awareness, clarity, and acceptance following negative affect induction | Immediate post-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. |
| State non-acceptance of emotions | Immediate post-intervention | 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. |
| Change over time in emotional awareness, clarity, and acceptance | Baseline to 2-week follow-up | 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. |
| Change over time in functional impairment | Baseline to 2-week follow-up | Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment. |
| Change over time in beliefs about the usefulness of negative emotions | Baseline to 2-week follow-up | Emotion Beliefs Questionnaire (EBQ). Total scores range from 0 to 16, with higher scores indicating greater beliefs that emotions are not useful or harmful |
| Change over time in beliefs about the duration of negative emotions | Baseline to 2-week follow-up | 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) |
| Change over time in non-acceptance of emotions | Baseline to 2-week follow-up | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Alcohol use | Baseline to 2-week follow-up | 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. |
| Change in self-compassion | Baseline to 2-week follow-up | Self-Compassion Scale (SCS). Total scores range from 0 to 48, with higher scores indicating greater self-compassion. |
| Affective self-compassion | Baseline to 2-week follow-up | Affective Self-Compassion Questionnaire (ASCQ). Total scores range from 0 to 40, with higher scores indicating greater affective self-compassion. |
| Alcohol craving | Baseline to 2-week follow-up | Single item visual analogue scale (0 to 10) of craving severity |
| Repetitive negative thinking | 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. |
| Avoidance | Baseline to 2-week follow-up | Cognitive avoidance subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater avoidance. |
| Problem-solving | Baseline to 2-week follow-up | Problem-solving subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater problem-solving. |
| Positive Reappraisal | Baseline to 2-week follow-up | Positive reappraisal subscale of the Coping Response Inventory (CRI). Total scores range from 0 to 20, with higher scores indicating greater positive reappraisal. |
| Pain intensity | Baseline to 2-week follow-up | Single item visual analogue scale (0 to 10) of pain intensity drawn from the Brief Pain Inventory (BPI) |
| Pain interference | Baseline to 2-week follow-up | 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) |
| Pain catastrophizing | Baseline to 2-week follow-up | 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. |
Countries
United States
Outcome results
None listed