Spring PGD versus Waiting List Control in the Treatment of Prolonged Grief Disorder: Protocol for a Randomised Controlled Trial

Background Prolonged Grief Disorder (PGD) is characterised by longing or persistent preoccupation with someone deceased, accompanied by intense emotional pain, which has persisted for six months or more and significantly impaired functioning. While Cognitive Behavioural Therapy (CBT) with a focus on grief is effective, access is limited due to high costs and therapist shortages. Guided digital therapy is a possible solution. Psychological therapy is delivered on an app/website with regular guidance from a health professional. Building on prior success with a guided digital intervention for post-traumatic stress disorder (PTSD), this study will evaluate an intervention for PGD based on similar principles in a UK-based randomised controlled trial (RCT). Methods We aim to ascertain proof of concept for Spring PGD, a co-produced guided digital therapy for PGD, in comparison to wait list, to establish whether it is acceptable, and to assess the feasibility of a future definitive RCT. The study will be an exploratory, randomised, parallel-group controlled trial. Forty-two participants will be allocated in a 1:1 ratio to either immediate Spring PGD or a waiting list control group. After a period of 11 weeks on the waiting list, participants in the control group will cross over to receive Spring PGD. The primary outcome measure is the Prolonged Grief 13 Revised (PG-13-R). We will include a nested process evaluation to explore fidelity, adherence, and programme theory. Interviews will be conducted with approximately ten purposively sampled participants and five therapists. Discussion If Spring PGD shows promise, it could provide a valuable option for the treatment of PGD. The scalability of guided digital therapy could make it more accessible to a wider population than traditional face-to-face therapy, particularly in areas with limited access to specialised mental health services. Trial registration In process of registering with ISRCTN