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Completed

NCT Number: NCT05109507

Single-Session Intervention Targeting Emotional Awareness, Clarity, and Acceptance to Reduce Depression/Anxiety

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

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visitor Mindset

Behavioral

Single-session, self-guided intervention

Relaxing with Nature

Behavioral

Single-session, self-guided intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change over time in functional impairment

    Time frame: 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.

  2. State emotional awareness, clarity, and acceptance following negative affect induction

    Time frame: 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.

  3. State non-acceptance of emotions

    Time frame: 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.

  4. Change over time in emotional awareness, clarity, and acceptance

    Time frame: 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.

  5. Change over time in non-acceptance of emotions

    Time frame: 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.

  6. Change over time in beliefs about the usefulness of negative emotions

    Time frame: 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

  7. Change over time in beliefs about the duration of negative emotions

    Time frame: 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)

Other outcomes

  1. Change in self-compassion

    Time frame: Baseline to 2-week follow-up

    Self-Compassion Scale (SCS). Total scores range from 0 to 48, with higher scores indicating greater self-compassion.

  2. Repetitive negative thinking

    Time frame: 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.

  3. Avoidance

    Time frame: 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.

  4. Problem-solving

    Time frame: 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.

  5. Positive Reappraisal

    Time frame: 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.

  6. Pain intensity

    Time frame: Baseline to 2-week follow-up

    Single item visual analogue scale (0 to 10) of pain intensity drawn from the Brief Pain Inventory (BPI)

  7. Pain interference

    Time frame: 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)

  8. Pain catastrophizing

    Time frame: 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.

  9. Alcohol use

    Time frame: 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.

  10. Alcohol craving

    Time frame: Baseline to 2-week follow-up

    Single item visual analogue scale (0 to 10) of craving severity

  11. Affective self-compassion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2021
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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