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To support patients with cancer with managing psychological distress due to their illness and treatment, a self-help digital Compassionate Mind Training (i.e., Compas-Y App) was developed in co-creation with people with cancer and nurses in oncology.
This study will examine : What is the feasibility, acceptability, and effectiveness of Compas-Y app in distressed cancer patients? The reseachers use a multiple baseline design, with a 2-3 week baseline phase and a 6-week intervention phase.
Adult patients (>= 18 years) will be approached for the study, who finished their medical treatment and who experience a reduced well-being.
To examine the effects of Compas-Y, the researchers will examine changes in self-compassion and self-criticism (primary outcomes) and mindfulness, emotion regulation strategies, and positive and negative affect (secondary outcomes). We will use EMA items to assess momentary levels of these primary and secondary outcomes.
These assessments will be 3 times per week at 7:00 PM, both during the 2-3 week baseline phase ( 6-9 assessments in total) and the 6-week intervention phase (18 times assessments in total).
The expectation is increases in self-compassion, reductions in self-criticism, and improved affect as well as improved mindfulness and emotion regulation. In addition, the expectation is more improvement in outcomes in those patients with greater usage of the app.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital self-help self-compassion app (Compas-Y) | Experimental | 6-week self-help app intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A digital self-help self-compassion app intervention | Other | A 6 week self-help self-compassion app intervention providing psychoeducation and brief exercises via the app |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-compassion | Momentary self-compassion is assessed using ecological momentary assessment (EMA) items. We use five items based on the Sussex-Oxford Compassion for the Self Scale (SOCS-S), with each of the five facets of self-compassion covered by one EMA item: (1) "I'm quick to notice early signs of distress in myself.", (2) "I understand that feeling upset at times is part of human nature.", (3) "I feel kindly towards myself.", (4) "I connect with my own suffering without judging myself.", (5) "I try to look after myself." Items are rated on a 0-100 visual analogue scale with verbal anchors (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much"). | During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week. |
| Self-criticims | Momentary self-criticism is assessed with a single item derived from the Self-Compassion Scale: "I am a bit cold-hearted towards myself when I'm experiencing suffering", rated on a 0-100 visual analogue scale with verbal anchors (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much"). | During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week. |
| Measure | Description | Time Frame |
|---|---|---|
| Mindfulness | Mindfulness is assessed with two validated momentary assessments items from the platform HowNutsAreTheDutch: (1) "I did activities automatically, without being aware of what I was doing"; (2) "I was easily distracted". Both items are rated on 0-100 scale (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much"). | During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week. |
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Inclusion criteria:
aged 18 and older;
Diagnosed with cancer (stage I-III);
Completed medical treatment in the past 2 years;
Reporting a reduced well-being (Mental Health Inventory (MHI-5) = <76 score (Kelly et al., 2008) [lower scores indicate worse well-being]);
Proficient in Dutch;
willing to try out the app for about 2 hours per week during 6 weeks and fill in the questionnaires for 8-10 weeks;
Participants should have a smartphone, computer or tablet with internet access for digital intervention and data-collection.
1. Participants have a current psychological or psychiatric treatment outside this study. 2. Insufficient Dutch language skills to follow the group sessions or complete homework exercises
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| Name | Affiliation | Role |
|---|---|---|
| Ernst Bohlmeijer, Prof. dr. | Twente University Department of Psychology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Health Sciences, Health Psychology Section, University Medical Center Groningen | Groningen | 9713 AV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32116052 | Background | Austin J, Drossaert CHC, Schroevers MJ, Sanderman R, Kirby JN, Bohlmeijer ET. Compassion-based interventions for people with long-term physical conditions: a mixed methods systematic review. Psychol Health. 2021 Jan;36(1):16-42. doi: 10.1080/08870446.2019.1699090. Epub 2020 Mar 2. | |
| 35916691 | Background | Austin J, Drossaert CHC, van Dijk J, Sanderman R, Borosund E, Mirkovic J, Schotanus-Dijkstra M, Peeters NJ, Van 't Klooster JJR, Schroevers MJ, Bohlmeijer ET. Integrating Top-down and Bottom-up Requirements in eHealth Development: The Case of a Mobile Self-compassion Intervention for People With Newly Diagnosed Cancer. JMIR Cancer. 2022 Aug 1;8(3):e37502. doi: 10.2196/37502. |
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Meta data will be put on the official Groningen University Data Repository to inform researchers about the data and support open science
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Meta data accessible via the University Research Portal
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000544 | Alzheimer Disease |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Affect | Affect is assessed with eight items from the platform HowNutsAreTheDutch. Four items for Positive affect: "I feel excited/relaxed/satisfied/energetic". Four items for Negative affect: "I feel anxious/down/irritable/tired". All items are rated on 0-100 scale (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much"). | During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week. |
| Emotion regulation | Emotion Regulation is assessed by four items from existing validated questionnaires adapted for momentary assessment. For all four items the stem is: "Today when unpleasant thoughts came to me .... The items are: "I think that I have to accept the situation (Cognitive Emotion Regulation Questionnaire (CERQ), acceptance subscale), "I think I can learn something from the situation" (CERQ, positive reappraisal subscale), "I am preoccupied with what I think and feel about what I have experienced" (CERQ, rumination subscale), "I try to put them out of my mind" (Multidimensional Experiential Avoidance Questionnaire, avoidance subscale). The four items are rated on 0-100 scale (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much"). | During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week. |
| 37868157 | Background | Austin J, Schroevers MJ, Van Dijk J, Sanderman R, Borosund E, Wymenga AMN, Bohlmeijer ET, Drossaert CHC. Compas-Y: A mixed methods pilot evaluation of a mobile self-compassion training for people with newly diagnosed cancer. Digit Health. 2023 Oct 19;9:20552076231205272. doi: 10.1177/20552076231205272. eCollection 2023 Jan-Dec. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |