Table 2.
Outcome measures.
| No. of items | Scoring | Assessment time | ||
|---|---|---|---|---|
| Demographics | Age, sex, level of education, marital status, employment, language spoken at home, postcode, private insurance | 8 | N/A | Baseline |
| Health-related questions | IBD subtype (CD, UC, IC) | 1 | N/A | Baseline |
| When was your IBD diagnosed? | 1 | N/A | Baseline | |
| Do you currently have any of the following (click all that apply): Stoma (bag) Fistula Perianal disease Unsure |
1 | N/A | Baseline | |
| Do you suffer from other chronic illnesses? If yes, please list. | 1 | N/A | Baseline | |
| What treatment do you currently take for IBD? | 1 | N/A | Baseline | |
| Do you regularly use opioid medication such as oxycontin, codeine, tramadol, fentanyl or similar painkillers? If yes, please list. | 1 | N/A | Baseline | |
| Do you take antidepressants or anti-anxiety medication? | 1 | N/A | Baseline | |
| Smoking habits | 1 | N/A | Baseline | |
| Alcohol | 1 | N/A | Baseline | |
| BMI (weight and height) | 2 | N/A | Baseline | |
| COVID-19 questions | Were you in paid employment prior to the COVID-19 pandemic? Has your employment been negatively affected by COVID-19 (e.g. you were made redundant, received a pay cut or your hours were reduced? Has anyone in your household tested positive for COVID-19? How has COVID-19 affected your life? What strategies are helping you to stay calm in the current situation? Have you been impacted by any shortages related to COVID-19? No, toilet paper shortages, food shortages, medicine shortages, other – list To what extent do you experience the following when thinking about your ability to deal with COVID-19? Worry, fear, confidence hope, (not at all 1 – a great deal 4) What's your greatest fear regarding COVID-19 pandemic? |
8 | N/A | Baseline |
| IBD activity | IBD Control Scale [1] | 14 | A validated patient reported outcome measure (PROM), with two subscales: IBD-Control-8 (0–16, with 0 meaning worst control, with a cut-off of for remission ≥13 points) and IBD-Control-VAS (0–100, with 0 meaning worst control, with a cut-off for remission of ≥85). | Baseline & post-intervention, follow-up |
| Manitoba index [2] | 1 | A single item IBD activity measure, using a 6-point scale ranging from ‘Constantly active, giving me symptoms everyday’ to ‘I was well in the past 3 months, what I consider a remission or absence of symptoms’. | Baseline & post-intervention, follow-up | |
| Measure of mental health | Kessler Psychological Distress Scale (K10) [3] | 10 | A simple measure of psychological distress, using a 5-point Likert scale. The maximum score is 50 indicating severe distress, the minimum score is 10 indicating no distress. | Baseline & post-intervention, follow-up |
| DASS-21 (depression, anxiety, somatization symptoms) [4] | 21 | A brief measure of symptoms of depression, anxiety and stress. Standard cut-offs apply: Depression symptoms >10 Anxiety symptoms >7 Stress symptoms >14 |
Baseline & post-intervention, follow-up | |
| Distress VAS scale: On a scale from 0 to 10, how distressed do you feel right now? | 1 | An 11-point scale ranging from no distress to extremely severe distress. | Before and after each session, so 8 times during the intervention | |
| Multidimensional Scale of Perceived Social Support [5] | 12 | Three subscales of social support are measured: friends, family and significant other. Each scale ranges from 1 (very strongly disagree) to 7 (very strongly agree). A total average score is calculated, ranging from 0 to 7, with higher total scores indicating higher social support levels. | Baseline & post-intervention, follow-up | |
| AQOL8D [6] | 35 | The 35-item scale examines eight dimensions of physical and psychosocial QoL (eg. pain, senses, relationships, self-worth, coping), including 4–6 response levels for each item. Scores for each dimension and a total score, ranging from 0 to 100, with the higher score indicating better QoL. | Baseline & post-intervention, follow-up | |
| Brief Resilience Scale [7] | 6 | A brief measure of resilience, with a 5-point scale, ranging from strongly disagree to strongly agree. | Baseline & post-intervention, follow-up | |
| General Self-efficacy Scale [8] | 10 | A brief 10-item, 4-point measure of self-efficacy, ranging from not at all to exactly true. | Baseline & post-intervention, follow-up | |
| Satisfaction | VAS 0–10 satisfaction rating: On a scale from 0 to 10 how satisfied are you with the writing intervention you participated in? Open-ended questions: what was the best aspect of this intervention? What was the worst aspect of this intervention? How did the writing experience affect your mental health? |
4 | No cut-off, a continuous scale | Post-intervention |
References
1. Bodger K, Ormerod C, Shackcloth D, Harrison M. Development and validation of a rapid, generic measure of disease control from the patient’s perspective: the IBD-Control questionnaire. Gut. 2014;63:1092-102.
2. Clara I, Lix LM, Walker JR, Graff LA, Miller N, Rogala L, et al. The Manitoba IBD Index: evidence for a new and simple indicator of IBD activity. The American journal of gastroenterology. 2009;104(7):1754-63.
3. Andrews G, Slade T. Interpreting score on the Kessler Psychological Distress Scale (K10). Australia and New Zealand Journal of Public Health. 2001;25(6):494-7.
4. Osman A, Wong JL, Bagge CL, Freedenthal S, Gutierrez PM, Lozano G. The Depression Anxiety Stress Scales-21 (DASS-21): further examination of dimensions, scale reliability, and correlates. J Clin Psychol. 2012;68(12):1322-38.
5. Zimet GD, Dahlem NW, Zimet SG, Farley GK. The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment. 1988;52:30-41.
6. Richardson J, Iezzi A. Psychometric validity and the AQoL-8D multi attribute utility instrument. Centre for Health Economics, Monash University; 2011.
7. Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. International journal of behavioral medicine. 2008;15(3):194-200.
8. Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In: Weinman J, Wright S, Johnston M, editors. Measures in health psychology: A user’s portfolio Causal and control beliefs. Windsor, UK: NFER-NELSON; 1995. p. 35-7.