Cognitive Stimulation Therapy in Menopause: Feasibility randomised controlled trial.

Aim: To evaluate the feasibility, acceptability, and potential effects of a novel, group-based online intervention for cognition in menopause transition; 'CST-Meno', through a feasibility randomised controlled trial. Method: 41 women were eligible to participate, with 33 randomised to CST-Meno (N=17) or treatment as usual (N=16). CST-Meno was delivered over six weeks within four, two-hour sessions. Feasibility and acceptability outcomes included recruitment, retention, attendance, and measure completion. Exploratory analysis examined changes in subjective and objective cognition, quality of life, vasomotor symptoms, anxiety and depression. Results: CST-Meno demonstrated acceptability as an intervention; with strong retention, good attendance and no adverse effects related to content or delivery. With recruitment and retention targets exceeded, willingness to be randomised high and outcome measures well tolerated; feasibility and acceptability of the trial design was demonstrated. Exploratory analysis showed small changes in all outcomes, some favouring CST-Meno and others favouring treatment as usual. However, the trial was not powered to detect changes, so these findings were interpreted with extreme caution. Conclusions: CST-Meno is both feasible to conduct as a randomised controlled trial and an acceptable intervention to participants. This warrants further research with a larger, diverse sample; exploring both effectiveness and cost-effectiveness. Lay summary: Cognitive changes ('brain fog') are highly prevalent during menopause transition. However, there are no treatments shown to help. We developed an online, group intervention called 'CST-Meno' (four, two-hour sessions), which provides information and management strategies. Thirty-three women were randomly assigned to receive either CST-Meno or usual care. Everyone was given the same tests (including cognition, mood, quality of life) at the beginning and end of the study. CST-Meno appeared acceptable to participants, with easy recruitment, good attendance, no adverse effects, few dropouts and most completing outcome measures. There were no notable changes in outcomes between those attending CST-Meno and usual care, however our sample was too small to detect clinical changes. We concluded that a larger trial with a more diverse sample is needed. This would help us understand whether CST-Meno improves cognition and other outcomes, and if it leads to any economic benefits; such as reduced time off work.