A randomised controlled trial to assess the feasibility and acceptability of remote psychosocial and exercise interventions for people with lupus: The ADAPT feasibility trial.

Limited psychosocial support is available for people with lupus despite the highly reduced quality of life. This study assessed the acceptability, feasibility, and effectiveness estimations, of three (two psychosocial, one exercise) interventions. Lupus patients (N = 124) were randomised to a control arm or one of three interventions delivered remotely over 8-12 weeks: (1) listening support (The Wren project), (2) online Pilates classes, and (3) a text message and video support programme. Online follow up surveys post-intervention and six-months post-baseline included validated instruments for depression (PHQ-8), fatigue (FACIT-F), resilience (CD-RISC), acceptability measures and our co-designed "ADAPT" measure. A subsample of participants completed qualitative interviews. Hedge's g and linear regression were used to estimate effectiveness. All interventions were feasible in terms of recruitment, time, and costs, and met the pre-defined acceptability criteria of > 75% rating the intervention as acceptable/highly acceptable. Helpfulness ratings were highest for listening support with 89% rating it as often/always helpful (62% for Pilates and 52% for Text/videos). Proportions of participants reporting that the intervention had made them feel better mentally often/always was 71% for The Wren, 57% for Pilates and 48% for the text/video group. Qualitatively, the listening support participants valued the "safe space" to talk, and several of the exercise class participants reported improvements to physical and mental health. Although the text message and video programme was acceptable, feasible, and very low cost, 41% of participants would rather have received a different intervention. Suggested text/video adaptations included greater tailoring, particularly to stage of disease journey. Attendance was low for Pilates (only 55% attended > 50% of classes). Estimates of effectiveness favoured all interventions compared to control, although most improvements reduced with time. The interventions were feasible to deliver and acceptable to patients, with indications of potential effectiveness. Further studies are needed to determine effectiveness.Trial registration: ISRCTN72406488.