Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study

The demographic characteristics of patients with IBD who report clinical levels of anxiety (according to IMPARTS pre-determined cut-offs) during routine mental health screening.

时间窗: 18 months

Assessing clinical reach of routine screening and the COMPASS intervention. Anxiety is measured with the Generalised Anxiety Disorder Scale (GAD-7). Min score = 0, Max score = 21, with higher scores indicating greater anxiety.

The proportion of patients with IBD who report clinical levels of anxiety (according to IMPARTS pre-determined cut-offs) during routine mental health screening.

时间窗: 18 months

Assessing clinical reach of routine screening and the COMPASS intervention. Anxiety is measured with the Generalised Anxiety Disorder Scale (GAD-7). Min score = 0, Max score = 21, with higher scores indicating greater anxiety.

The demographic characteristics of patients with IBD who report clinical levels of depression (according to IMPARTS pre-determined cut-offs) during routine mental health screening.

时间窗: 18 months

Assessing clinical reach of routine screening and the COMPASS intervention. Depression is measured with the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 27, with higher scores indicating greater depression.

Descriptive statistics of functioning in IBD patients, using the Work and Social Adjustment Scale questionnaire measured as part of standard care / routine screening.

时间窗: 18 months

Assessing clinical reach of routine screening and the COMPASS intervention. The Work and Social Adjustment Scale (WSAS) measures impaired functioning. Min score = 0, max score = 40, with higher scores indicating greater impaired functioning.

The proportion of IBD patients who show evidence of acute suicidal risk at screening

时间窗: 18 months

Assessing clinical reach of routine screening and the COMPASS intervention

The number and demographics of people who agree to and complete routine screening for psychological distress (including e-IMPARTS).

时间窗: 18 months

Assessing clinical reach of routine screening and the COMPASS intervention

The proportion of patients with IBD who report clinical levels of depression (according to IMPARTS pre-determined cut-offs) during routine mental health screening.

时间窗: 18 months

Assessing clinical reach of routine screening and the COMPASS intervention. Depression is measured with the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 27, with higher scores indicating greater depression.

The demographics of IBD patients who report clinical levels of psychological distress in the mild to moderate (PHQ-ADS distress score 10-29) and severe (PHQ-ADS distress score ≥30, but no acute suicidal risk) range at screening

时间窗: 18 months

Assessing clinical reach of routine screening and the COMPASS intervention. Psychological Distress is measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). The PHQ-ADS is a composite measure of Generalised Anxiety Disorder questionnaire (GAD-7) and Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.

Change in the The UK Inflammatory Bowel Disease Questionnaire (IBDQ-UK)

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

IBD-related Quality of Life. Min score = 0, Max score = 96. Higher values indicate better quality of life.

Change in the Brief Illness Perception Questionnaire (BIPQ)

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Illness perceptions. Questionnaire adapted to use first 8 items: illness consequences and timeline, the controllability of the illness personally and through treatment, illness identity, concerns, coherence, and the emotional-impact of the illness. Each item on the BIPQ is assessed as a separate construct (for each construct, min = 0, max = 10). Higher scores relate to stronger/greater illness perceptions.

Change in smoking status

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Current smoking status, including amount of cigarettes consumed per day.

The proportion of IBD patients who report clinical levels of psychological distress in the mild to moderate (PHQ-ADS distress score 10-29) and severe (PHQ-ADS distress score ≥30, but no acute suicidal risk) range at screening

时间窗: 18 months

Assessing clinical reach of routine screening and the COMPASS intervention. Psychological Distress is measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). The PHQ-ADS is a composite measure of Generalised Anxiety Disorder questionnaire (GAD-7) and Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.

COMPASS engagement

时间窗: 18 months

Assessing clinical reach of the COMPASS intervention. Descriptive data regarding demographic and clinical characteristics of non-engagers, less-adherent users and adherent-users of COMPASS.

Change in Patient Health Questionnaire - (PHQ-9)

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression.

Change in Generalised Anxiety Disorder scale (GAD-7)

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety

Change in EQ-5D-3L

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Quality of life. Min score = 5, Max score = 15 , with higher scores more problems in the scale dimensions.

Change in the Patient Global Impression Scales of Severity (PGI-S)

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.

The Patient Global Impression Scales of Severity (PGI-S)

时间窗: Baseline, 12 weeks (post-therapy), 6 months (follow-up)

Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.

Number and duration of therapist calls attended.

时间窗: 12-weeks (post therapy)

Adherence defined as 3 calls/messages attended.

Descriptive statistics of control of IBD in IBD patients, using the IBD control questionnaire measured as part of standard care / routine screening.

时间窗: 18 months

Assessing clinical reach of routine screening and the COMPASS intervention. The IBD control measures the extent to which patients have control over their IBD. Min score = 0, max score = 16, with higher scores indicating poorer control.

The demographic and clinical characteristics, and proportion of IBD patients who meet inclusion criteria and are willing and able to engage in the COMPASS treatment.

时间窗: 18 months

Assessing clinical reach of the COMPASS intervention

The reasons for study ineligibility (descriptively).

时间窗: 18 months

Assessing clinical reach of the COMPASS intervention. Descriptive data, specifically frequencies documenting the number of individuals who are willing to use COMPASS, reasons documented for ineligibility/non-uptake and the sociodemographic and clinical profile of eligible vs non-eligible of COMPASS.

Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from pre- to post-treatment in IBD patients who receive COMPASS.

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

The PHQ-ADS will be used to establish the efficacy of treatment pathways for IBD patients. It is a composite measure of the Generalised Anxiety Disorder questionnaire (GAD-7) and the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.

Change in the Chronic Disease Self-efficacy Scale

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Disease self-efficacy. 9 sub-scales will be used: exercise regularly, get information about disease, obtain help from community, communicate with physician, manage disease in general, do chores, social/recreational activity, manage symptoms, control/manage depression. Min scores = 0, Max scores = 320. Higher scores indicate higher self-efficacy.

The Patient Global Impression Scales of Improvement (PGI-I)

时间窗: 12 weeks (post-therapy), 6 months (follow-up)

Perceived symptom improvement. 1 item. Min = 0, Max = 6, with higher scores indicating greater perceived symptom deterioration.

The clinical characteristics of IBD patients who receive COMPASS while on the IBD psychology wait-list, but are removed from the wait-list at the end of COMPASS.

时间窗: 18 months

These data will be used to establish the efficacy of treatment pathways for IBD patients.

Change in Body Mass Index (BMI)

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Weight (in kg) and Height (in m) will be combined to calculate BMI (weight in kg / (height in m)\^2

Change in the short Cognitive Behavioural Responses Questionnaire (CBRQ-short)

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Views and behaviours regarding symptoms. Only 3 subscales will be used: embarrassment avoidance (3 items), symptom focusing (3 items) and all-or-nothing behaviour (3 items) subscales. Min = 0, Max = 36. Higher scores indicate poorer cognitive and behavioural responses.

Change in the Acceptance of Chronic Health Conditions Scale

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Acceptance of illness. Min score = 0, Max = 40. Greater scores indicate higher levels of acceptance.

Change in Health Service Use Questionnaire

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

4 service use items (GP, psychologist, emergency care, secondary care service) from the client service receipt inventory (CSRI) will be used. Frequency and duration of particular services will be recorded, from which a total time will be calculated. There is no maximum value. Higher scores indicate more health service time used.

Change in alcohol consumption

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Number of units drunk in the past week.

Change in the International Physical Activity Questionnaire

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Physical activity. There are three subscales (vigorous activity, moderate activity and lower-level activity). Scores will be in minutes. Higher scores will indicate more physical activity performed.

Change in IBD activity

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

For Crohn's Disease patients: The Patient-Reported Outcomes for the Assessment of Crohn's Disease Activity (PRO-CD). The scale contains two sub-scales: 1) bowel signs and symptoms, 2) functional symptoms. Each scale is scored separately. There is no total score for the PRO-CD. The first sub-scale starts at 0 and has no maximum value, with greater scores indicating greater bowel signs/symptoms. The second subscale ranges from 0-21, with higher scores indicating greater functional symptoms. For Ulcerative Colitis / unclassified patients: The Patient-Reported Outcomes for Assessment of Ulcerative Colitis (PRO-UC). The scale has 9-items and includes two scales: 1) Bowel signs/symptoms and 2) functional symptoms. The first sub-scale starts at 0 and has no maximum value, with greater scores indicating greater bowel signs/symptoms. The second subscale ranges from 0-21, with higher scores indicating greater functional symptoms.

Change in IBD medication

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Current medication and dose.

Change in IBD flares

时间窗: At baseline, 12 weeks (post-therapy), 6 months (follow-up)

Frequency and severity (4-point scale) of IBD flares

The demographic characteristics of IBD patients who receive COMPASS while on the IBD psychology wait-list, but are removed from the wait-list at the end of COMPASS.

时间窗: 18 months

Descriptive data pertaining to demographics and frequencies. These data will be used to establish the efficacy of treatment pathways for IBD patients.

The number of patients who require digital support to use COMPASS.

时间窗: 18 months

Exploration of the adoption of COMPASS

The change in numbers on and duration of the wait-list to see clinical psychologist from pre- to post-COMPASS

时间窗: 18 months

Exploration of the adoption of COMPASS

Drop out rate of COMPASS

时间窗: 18 months

The number and proportion of patients that drop out of COMPASS will be recorded to assess the implementation of COMPASS into the service.

The adoption of routine screening and the COMPASS programme.

时间窗: For patients -12-weeks (post-therapy); For HCPs (over 18 months)

Qualitative exploration the perspectives of healthcare professionals (HCPs) and patients

Patient adherence to online sessions

时间窗: 12-weeks (post therapy)

Adherence defined as 5 online sessions completed. Will be used to assess the implementation of COMPASS into the service.

Scores in the NoMAD (tool for measuring implementation processes) as rated by healthcare professionals (HCPs)

时间窗: 18 months

23-item instrument for measuring implementation processes, organised by the Normalisation Process Theory framework.