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| ID | Type | Description | Link |
|---|---|---|---|
| 4R37CA248434-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused on reducing symptoms of mental disorders. This is problematic given the range of psychosocial needs among breast cancer survivors, including those who may not have active mental health symptoms, yet could benefit from learning effective coping skills. Moreover, all of these interventions follow a "one size fits all" approach, lacking precision in terms of when, where, and to whom they should be given. The overarching goals of this project are to develop and pilot a variety of digital micro-interventions (DMIs) for breast cancer survivors - highly focused, technology-enabled interventions that can be delivered in the context of a person's daily life with little burden on the individual.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Savoring | Experimental | Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice. |
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| Gratitude | Experimental | Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it. |
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| Challenging UnhelpfulThoughts | Experimental | Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step. |
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| Psychoeducation | Experimental | Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from. |
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| Behavioral Activation | Experimental | Participants are led through an automated process of identifying tasks they can accomplish in their daily lives. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Micro-Interventions | Behavioral | Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Digital Micro-Intervention | 12 item scale measuring satisfaction and acceptability. Each question is scored on a 0-4 scale with a total raw summed score range of 0-48. Higher scores indicate greater satisfaction and acceptability. | Post 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS-29 Profile | 28 items that measure aspects of physical and mental health. Each question is scored on a 1-5 scale with a total raw score range of 28-140. Higher scores indicate worse overall health. A 29th item that assesses pain from 1-10 was omitted to limit redundancy with another pain measure. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Interview | Remote interview to assess for participant feedback on usability, obstacles to use, and suggestions for improvement. | Post 1 week |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Pilot study to test early stage digital micro-interventions (n=20 per micro-intervention)
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| Acceptance | Experimental | Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts. |
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| PROMIS-29 Profile |
28 items that measure aspects of physical and mental health. Each question is scored on a 1-5 scale with a total raw score range of 28-140. Higher scores indicate worse overall health. A 29th item that assesses pain from 1-10 was omitted to limit redundancy with another pain measure. |
| Post 1 week |
| Pain, Enjoyment of Life and General Activity (PEG) Scale | Assesses chronic pain based on 3 items, each one ranging from 0-10. Scores range from 0-30, with higher scores indicating more pain severity and interference. | Baseline |
| Pain, Enjoyment of Life and General Activity (PEG) Scale | Assesses chronic pain based on 3 items, each one ranging from 0-10. Scores range from 0-30, with higher scores indicating more pain severity and interference. | Post 1 week |
| Emotion Regulation Questionnaire | A 10 item scale to reassess for two emotion regulation strategies: cognitive reappraisal and expressive suppression. Participants rate each item on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Scores for each subscale range from 1-7 (after dividing by the number of items), with higher scores indicating a greater tendency to use that particular emotion regulation strategy. | Baseline |
| Emotion Regulation Questionnaire | A 10 item scale to reassess for two emotion regulation strategies: cognitive reappraisal and expressive suppression. Participants rate each item on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Scores for each subscale range from 1-7 (after dividing by the number of items), with higher scores indicating a greater tendency to use that particular emotion regulation strategy. | Post 1 week |
| Insomnia Severity Index | A 7-item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms. | Baseline |
| Insomnia Severity Index | A 7-item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms. | Post 1 week |
| Patient Health Questionnaire-8 | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. | Baseline |
| Patient Health Questionnaire-8 | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. | Post 1 week |
| Generalized Anxiety Disorder-7 | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. | Baseline |
| Generalized Anxiety Disorder-7 | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. | Post 1 week |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |