Cancer
Conditions
Keywords
Compassion, Self-criticism, App, Emotion Regulation, Intervention, EMA assessment, Self-compassion, Self-help
Brief summary
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.
Interventions
OTHERA digital self-help self-compassion app intervention
A 6 week self-help self-compassion app intervention providing psychoeducation and brief exercises via the app
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. aged 18 and older; 2. Diagnosed with cancer (stage I-III); 3. Completed medical treatment in the past 2 years; 4. Reporting a reduced well-being (Mental Health Inventory (MHI-5) = \<76 score (Kelly et al., 2008) \[lower scores indicate worse well-being\]); 5. Proficient in Dutch; 6. willing to try out the app for about 2 hours per week during 6 weeks and fill in the questionnaires for 8-10 weeks; 7. Participants should have a smartphone, computer or tablet with internet access for digital intervention and data-collection. *
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-compassion | 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. | 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"). |
| Self-criticims | 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. | 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"). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mindfulness | 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. | 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"). |
| Affect | 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. | 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"). |
| Emotion regulation | 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 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"). |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORErnst Bohlmeijer, Prof. dr.
Twente University Department of Psychology
Outcome results
None listed