A pilot randomised controlled trial to compare changes in quality of life for participants with early diagnosis dementia who attend a ‘Living Well with Dementia’ group compared to waiting-list control

Abstract

Objectives: The aim of this paper is to report a pilot study in which participants who had recently received a diagnosis of dementia were randomised to either a 10-week group intervention or a waiting-list control.

Method: Memory clinic staff with limited previous experience of group therapy were trained to lead a 10-week group therapy intervention called ‘Living Well with Dementia’. Fifty-eight participants, all of whom had received a diagnosis of Alzheimer's disease, vascular or Lewy body dementia within the previous 18 months, were randomised to receive either the intervention or treatment as usual (waiting-list control). Data collection occurred at baseline, within two weeks after the intervention finished and at 10-week follow-up.

Results: The study met its recruitment targets, with a relatively low attrition rate for the intervention arm. The acceptability of the intervention and research methods was examined qualitatively and will be reported on elsewhere. For the primary outcome, measure of quality of life in Alzheimer's disease (QoL-AD), and secondary outcome, self-esteem, there was some evidence of improvement in the intervention group compared to the control group. There was, also, evidence of a reduction in cognitive functioning in the treatment group compared to the control. Such reported differences should be treated with caution because they are obtained from a pilot and not a definitive study.

Conclusion: This pilot study succeeded in collecting data to inform a future definitive cost effectiveness clinical trial of Living Well with Dementia group therapy.

Keywords:

• dementia
• Alzheimer's disease
• group psychotherapy
• recovery
• psychosocial support system

Acknowledgements

We would like to thank all of the participants and their families for participating in this research. The project team would also like to thank the group facilitators (Kathy Chapman-Hill, Jackie Shearing, Lorraine Conduit, Rachel Crane, Angela Lynch, Kate Wilson, Rebecca Burke, Heather Baldwin, Rachel Woodward, Alison Moren, Sue Ward, Helen Williams, Debbie Bolton, Susan Rynn, Emma Reed and Nicki Short). In addition, thanks are due to Rachel Summers, who contributed to the analysis of interviews, Zoe Hughes, who prepared the manual used in the intervention, and Lauren Gatting and Saskia Boisevin, who assisted in the analysis of recordings of sessions. Professor Clive Holmes and David Higgenbottom both contributed significantly to the project as members of the Trial Steering group. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

Notes

1. http://www.controlled-trials.com/ISRCTN25079950/

2. REC Number 11/SC/0363, approval dated 18 November 2011, protocol amendments accepted on 28 June 2012 and 23 August 2012.

3. Available on request from RC.

Additional information

Funding

This article presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme [grant number PB-PG-0610-22005].