Table
1 displays primary and secondary outcome measures and time points. Primary measures are changes in: health-related quality of life as assessed by the AQoL-6D [
26], consisting of six separately scored dimensions of good health and a simple global ‘utility’ score and EQ-5D [
27]; and self-efficacy as measured by the General Self-Efficacy Scale (GSE) [
34], a general sense of perceived self-efficacy in regarding daily hassles as well as adaptation to stressful life events. Secondary measures are: the Diabetes Quality of Life (DQoL) [
35] measure, a screen for problem or risky substance use in adults as assessed by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) [
36] developed by the World Health Organization (WHO); coping strategies as measured by an abbreviated version of the COPE inventory [
37], the Brief COPE [
38]; treatment expectancy and rationale credibility in clinical studies as assessed by the Credibility/Expectancy Questionnaire (CEQ) [
39]; clinical indices such as body mass index (BMI) and glycated haemoglobin (HbA1c); diabetes-related psychosocial self-efficacy measured by the Diabetes Empowerment Scale (DES) [
40]; symptom severity and caseness (number meeting clinical disorder threshold) of anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [
41]; health care utilisation for economic evaluation purposes assessed by the Health Care Utilisation Questionnaire (HCUQ) [
32]; diabetes-related emotional distress measured by the Problem Areas in Diabetes Scale (PAID) [
42]; perceived acceptability of treatment assessed using the Treatment Evaluation Inventory-Short Form (TEI-SF) [
43]; a 10-item measure of the Big Five Inventory (BFI) personality dimensions [
44]; and impact of a person’s mental health difficulties on their ability to function via the Work and Social Adjustment Scale (WSAS) [
45].
Table 1
Primary and secondary outcome assessments and time points for MINDS
Primary outcomes |
AQoL-6D (20 items) | X | X | X | X |
GSE (10 items) | X | X | X | X |
Secondary outcomes |
DQoL (15 items) | X | X | X | X |
ASSIST (6 items) | X | X | X | X |
Brief COPE (28 items) | X | X | X | X |
CEQ (6 items) | X | | | |
Clinical Indices (e.g. BMI) | X | X | X | X |
DES (8 items) | X | X | X | X |
EQ-5D-3L (6 items) | X | X | X | X |
HADS (14 items) | X | X | X | X |
HCUQ (17 items) | X | X | X | X |
PAID (20 items) | X | X | X | X |
TEI-SF (9 Items) | | X | | |
BFI-10 (10 items) | X | | | |
WSAS (5 items) | X | X | X | X |
Due to variability of usual care across all participants, key aspects of usual care will be assessed via responses on the HCUQ [
32]. If possible, medical records will be reviewed to ascertain DM diagnostic information and clinical indicators such as HbA1c.