Telephone-supported Acceptance and Commitment Bibliotherapy for people with Multiple Sclerosis and psychological distress: a randomised controlled feasibility trial

Background: Telephone-supported self-help Acceptance and Commitment Therapy (ACT) may be a way of providing accessible and effective psychotherapy to people with Multiple Sclerosis (MS). The aim of this trial was to determine the feasibility of a randomised controlled trial (RCT) of telephone-supported ACT bibliotherapy compared to treatment-as-usual (TAU), and explore the effectiveness of the intervention. Methods: The study was a randomised control feasibility trial. The intervention was eight weekly support calls guiding participants through the ACT self-help text “Get Out Of Your Mind and Into Your Life†(Hayes, 2005). Participants were assessed at baseline and post-intervention using the Generalised Anxiety and Depression Measure (GAD) and the Patient Health Questionnaire (PHQ) as primary outcome measures. The EuroQol (EQ-5D-5L) and Multiple Sclerosis Impact Scale (MSIS-29) were secondary outcome measures, and the Acceptance and Action Questionnaire (AAQ-II) was a process measure. A sample of participants were interviewed to assess RCT feasibility. Results: 27 participants with MS with anxiety and/or depression were recruited from an outpatient MS clinic and an MS charity. The majority of participants found the different elements of the RCT acceptable. Overall attrition was 66%, and 64% in the intervention group. Linear mixed model analysis and effect size calculation found a significant effect (p=0.004) and large effect size (0.84 (95% confidence intervals 0.02-1.66)) at post-intervention in favour of the intervention on anxiety in intention-to-treat analysis. Smaller non-significant positive effects were found on other measures. Intervention completers had significantly lower scores on the MSIS and the AAQ-II at baseline. Discussion: Telephone-supported ACT bibliotherapy delivered in a RCT format may be a feasible research method for people with MS, and the intervention has the potential to be effective in reducing psychological distress. However, attrition rates must be addressed: practical changes to the method of delivery to increase participant retention are suggested.</p

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial

Objective: To determine the effectiveness of an exercise and functional activity therapy intervention in adults with early dementia or mild cognitive impairment compared with usual care. Design: Randomised controlled trial. Setting: Participants’ homes and communities at five sites in the United Kingdom. Participants: 365 adults with early dementia or mild cognitive impairment who were living at home, and family members or carers. Intervention: The intervention, Promoting activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED), was a specially designed, dementia specific, rehabilitation programme focusing on strength, balance, physical activity, and performance of activities of daily living, which was tailored and progressive and addressed risk and the psychological needs of people with dementia. Up to 50 therapy sessions were provided over 12 months. The control group received usual care plus a falls risk assessment. Procedures were adapted during the covid-19 pandemic. Main outcome measures: The primary outcome was score on the carer (informant) reported disability assessment for dementia scale 12 months after randomisation. Secondary outcomes were self-reported activities of daily living, physical activity, quality of life, balance, functional mobility, fear of falling, frailty, cognition, mood, carer strain, service use at 12 months, and falls between months 4 and 15. Results: 365 patient participants were randomised, 183 to intervention and 182 to control. The median age of participants was 80 years (range 65-95), median Montreal cognitive assessment score was 20 out of 30 (range 13-26), and 58% (n=210) were men. Intervention participants received a median of 31 therapy sessions (interquartile range 22-40) and reported completing a mean 121 minutes of PrAISED exercise each week. Primary outcome data were available for 149 intervention and 141 control participants. Scores on the disability assessment for dementia scale did not differ between groups: adjusted mean difference −1.3, 95% confidence interval −5.2 to 2.6; Cohen’s d effect size −0.06, 95% confidence interval −0.26 to 0.15; P=0.51). Upper 95% confidence intervals excluded small to moderate effects on any of the range of outcome measures. Between months 4 and 15 the intervention group experienced 79 falls and the control group 200 falls (adjusted incidence rate ratio 0.78, 95% confidence interval 0.5 to 1.3; P=0.3). Conclusion: The intensive PrAISED programme of exercise and functional activity training did not improve activities of daily living, physical activity, or quality of life; reduce falls; or improve any other secondary health status outcomes, despite good uptake. Future research should consider alternative approaches to maintaining ability and wellbeing in people with dementia. Trial registration: ISRCTN Registry ISRCTN15320670.</p