Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

A feasibility study for NOn-Traditional providers to support the management of Elderly People with Anxiety and Depression: The NOTEPAD study Protocol

Authors: Heather Burroughs, Bernadette Bartlam, Mo Ray, Tom Kingstone, Tom Shepherd, Reuben Ogollah, Janine Proctor, Waquas Waheed, Peter Bower, Peter Bullock, Karina Lovell, Simon Gilbody, Della Bailey, Stephanie Butler-Whalley, Carolyn Chew-Graham

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

Anxiety and depression are common among older people, with up to 20% reporting such symptoms, and the prevalence increases with co-morbid chronic physical health problems. Access to treatment for anxiety and depression in this population is poor due to a combination of factors at the level of patient, practitioner and healthcare system.
There is evidence to suggest that older people with anxiety and/or depression may benefit both from one-to-one interventions and group social or educational activities, which reduce loneliness, are participatory and offer some activity. Non-traditional providers (support workers) working within third-sector (voluntary) organisations are a valuable source of expertise within the community but are under-utilised by primary care practitioners. Such a resource could increase access to care, and be less stigmatising and more acceptable for older people.

Methods

The study is in three phases and this paper describes the protocol for phase III, which will evaluate the feasibility of recruiting general practices and patients into the study, and determine whether support workers can deliver the intervention to older people with sufficient fidelity and whether this approach is acceptable to patients, general practitioners and the third-sector providers.
Phase III of the NOTEPAD study is a randomised controlled trial (RCT) that is individually randomised. It recruited participants from approximately six general practices in the UK. In total, 100 participants aged 65 years and over who score 10 or more on PHQ9 or GAD7 for anxiety or depression will be recruited and randomised to the intervention or usual general practice care. A mixed methods approach will be used and follow-up will be conducted 12 weeks post-randomisation.

Discussion

This study will inform the design and methods of a future full-scale RCT.

Trial registration

ISRCTN, ID: ISRCTN16318986. Registered 10 November 2016. The ISRCTN registration is in line with the World Health Organization Trial Registration Data Set. The present paper represents the original version of the protocol. Any changes to the protocol will be communicated to ISRCTN.
Appendix
Available only for authorised users
Footnotes
1
The Adult Attitude to Loneliness is not yet a validated measure. It was adapted from the Adult Attitude for Grief and it will be used in this feasibility study to gather data on the acceptability of the scale to NOTEPAD participants and to the research nurse who administers it.
 
Literature
1.
Djernes J. Prevalence and predictors of depression in populations of older: a review. Acta Psychiatr Scand. 2006;113:372–87.CrossRefPubMed
2.
Steffens D, Fisher G, Langa K, Potter G, Plassman B. Prevalence of depression among older Americans: the aging demographics and memory study. Int Psychogeriatr. 2009;21(5):879–88.CrossRefPubMedPubMedCentral
3.
Laidlaw K, Pachana N. Ageing, mental health and demographic change: challenges for psychotherapists. Prof Psychol: Res Pract. 2009;40(6):601–8.CrossRef
4.
5.
Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic disease and decrements in health. Results from the World Health Surveys. Lancet. 2007;370:851–8.CrossRefPubMed
6.
Zhang MWB, Ho RCM, Cheung MWL, Fu E, Mak A. Prevalence of depressive symptoms in patients with chronic obstructive pulmonary disease: a systematic review, meta-analysis and meta-regression. Gen Hosp Psychiatry. 2011;33:217–23.CrossRefPubMed
7.
Katon W, Ciechanowski P. Impact of major depression on chronic medical illness. J Psychosom Res. 2002;53(4):859–63.CrossRefPubMed
8.
Gallo JJ, Morales KH, Bogner H, Raue PJ, Zee J, Bruce M, et al. Long term effects of depression care management on mortality in older adults: follow-up of a cluster randomized clinical trial in primary care. BMJ. 2013;f2570:346.
9.
10.
Coventry P, Hays R, Dickens C, Bundy C, Garrett C, Cherrington A, et al. Talking about depression: barriers to managing depression in people with long term conditions in primary care. BMC Fam Pract. 2011;12:10.CrossRefPubMedPubMedCentral
11.
Chew-Graham C, Kovandžić M, Gask L, Burroughs H, Clarke P, Sanderson H, et al. Why may older people with depression not present to primary care? Messages from secondary analysis of qualitative data. Health Soc Care Commun. 2012;20(1):52–60.CrossRef
12.
Conner KO, Copeland VC, Grote NK, Koeske G, Rosen D, Reynolds CF, et al. Mental health treatment seeking among older adults with depression: the impact of stigma and race. Am J Geriatr Psychiatry. 2010;18(6):531.CrossRefPubMedPubMedCentral
13.
Gum AM, Arean PA, Hunkeler E, Tang L, Katon W, Hitchcock P, Steffans DC, Dickens J.
14.
Cattan M, White M, Bond J, Learmouth A. Preventing social isolation and loneliness among older people: a systematic review of health promotion interventions. Ageing Soc. 2005;25:41–67.CrossRef
15.
16.
Jetten J, Haslam SA, Iyer A, Haslam C. Turning to others in times of change: shared identity and coping with stress. In: Stürmer S, Snyder M, editors. New directions in the study of helping: group-level perspectives on motivations, consequences and interventions; 2009. p. 139–56.
17.
Uchino BN, Cacioppo JT, Kiecolt-Glaser JK. The relationship between social support and physiological processes: a review with emphasis on underlying mechanisms and implications for health. Psychol Bull. 1996;119:488–531.CrossRefPubMed
18.
19.
Heikkinen RL, Kauppinen M. Depressive symptoms in late life: a 10-year follow-up. Arch Geront Geriatr. 2004;38:239–50.CrossRef
20.
O’Luanaigh CO, Lawler BA. Loneliness and the health of older people. Int J Geriatr Psychiatry. 2008;23:1213–21.CrossRef
21.
Cacioppo JT, Hughes ME, Waite LJ, Hawkley LC, Thisted RA. Loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses. Psychol Aging. 2006;21(1):140–51.CrossRefPubMed
22.
Frost H, Haw S, Frank J. Promoting health and wellbeing in later life. Interventions in primary care and community settings. MRC Scottish Collaboration for Public Health Research and Policy; 2010.
23.
Wicke FS, Guthlin C, Margenthal K, Genshichen J, Loffler C, et al. Depressive mood mediates the influence of social support on health-related quality of life in elderly, multimorbid patients. BMC Fam Pract. 2014;15:62.CrossRefPubMedPubMedCentral
24.
Dickens AP, Richards SH, Greaves CJ, Campbell JL. Interventions targeting social isolation in older people: a systematic review. BMC Public Health. 2011;11:647.CrossRefPubMedPubMedCentral
25.
Tennstedt S, Howland J, Lachman M, Peterson E, Kasten L, Jette A. A randomized controlled trial of a group intervention to reduce fear of falling and associated activity restriction in older adults. J Gerontol B Psychol Sci Soc Sci. 1998;53:384–92.CrossRef
26.
Ciechanowski P, Wagner E, Schmaling K, Schwartz S, Williams B, Diehr P, et al. Community-integrated home-based depression treatment in adults. A randomized controlled trial. JAMA. 2004;291:1569–77.CrossRefPubMed
27.
McAuley E, Blissmer B, Marquez DX, Jerome GJ, Kramer AF, Katula J. Social relations, physical activity, and well-being in older adults. Prev Med. 2000;31:608–17.CrossRefPubMed
28.
Greaves CJ, Farbus L. Effects of creative and social activity on the health and well-being of socially isolated older people: outcomes from a multi-method observational study. J R Soc Promot Heal. 2006;126(3):134–42.CrossRef
29.
30.
Johnson V, Stanley J. Capturing the contribution of community arts to health and well-being. Int J Ment Health Promot. 2007;9:28–35.CrossRef
31.
32.
Richards DA, et al. Cost and Outcome of behavioural activation versus cognitive behavioural therapy for depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016;388(10047):871–80.CrossRefPubMedPubMedCentral
33.
Ekers D, Richards DA, Gilbody S. A meta-analysis of randomized trials of behavioural treatment of depression. Psychol Med. 2008;38(5):611–23.CrossRefPubMed
34.
Veale D. Behavioural Activation for Depression. Adv Psychiatr Treat. 2008;14:29–36.CrossRef
35.
Samad Z, Brealey S, Gilbody S. The effectiveness of behavioural therapy for the treatment of depression in older adults: a meta-analysis. Int J Geriatr Psychiatr. 2011;26(12):1211–20.CrossRef
36.
37.
Richards D, Hill J, Gask L, Lovell K, Chew-Graham C, Bower P, Cape J, et al. Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial BMJ. 2013;347:f4913. https://​doi.​org/​10.​1136/​bmj.​f4913.
38.
Shih WJ, Ohman-Strickland PA, Lin Y. Analysis of pilot and early phase studies with small sample sizes. Stat Med. 2004;23(12):1827–42.CrossRefPubMed
39.
Kroenke K, Spitzer RL. The PHQ-9: a new depression and diagnostic severity measure. Psychiatr Ann. 2002;32:509–21.CrossRef
40.
Spitzer RL, Kroenka K, Williams J. A brief measure for assessing generalised anxiety disorder. The GAD −7. Arch Intern Med. 2006;166:1092–7.CrossRefPubMed
41.
Lovell K, Gask L, Bower P, Waheed W, Chew-Graham C, Aseem S, et al. Development and evaluation of culturally sensitive psychosocial interventions for under-served people in primary care. BMC Psychiatr. 2014;14:217.CrossRef
42.
Lewis G, Pelosi AJ, Araya R, Dunn G. Measuring psychiatric disorder in the community: a standardized assessment for use by lay interviewers. Psychol Med. 1992;22:465–86.CrossRefPubMed
43.
Lorig K, Stewart A, Ritter P, Gonzalez V, Laurent D, Lynch J. Outcome measures for health education and other health care interventions. Thousand Oaks: Sage Publications; 1996.
44.
Janssen MF, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013;22(7):1717–27.CrossRefPubMed
45.
Wiggins RD, Netuveli G, Hyde M, Higgs P, Blane D. The evaluation of a self-enumerated scale of quality of life (CASP-19) in the context of research on ageing: a combination of exploratory and confirmatory approaches. Soc Indic Res. 2008;89(1):61–77.CrossRef
46.
Jong Gierveld J, Kamphuis F. The development of a Rasch-type loneliness scale. Appl Psychol Meas. 1985;9:289–99.CrossRef
47.
48.
Machin L. Working with loss and grief: a new model for practitioners. 2nd ed. London: Sage; 2014.
49.
Densley K, Davidson S, Gunn J. Evaluation of the Social Participation Questionnaire in adult patients with depressive symptoms using Rasch analysis. Qual Life Res. 2013;22(8):1987–97.CrossRefPubMed
50.
Glaser BG. Emergence vs. forcing: basics of grounded theory analysis. Mill Valley: Sociology Press; 1992.
51.
Ritchie J, Spencer L. Qualitative data analysis for applied policy research. In: Bryman A, Burgess R, editors. Analysing qualitative data. London: Routledge; 1993. p. 173–94.
Metadata
Title
A feasibility study for NOn-Traditional providers to support the management of Elderly People with Anxiety and Depression: The NOTEPAD study Protocol
Authors
Heather Burroughs
Bernadette Bartlam
Mo Ray
Tom Kingstone
Tom Shepherd
Reuben Ogollah
Janine Proctor
Waquas Waheed
Peter Bower
Peter Bullock
Karina Lovell
Simon Gilbody
Della Bailey
Stephanie Butler-Whalley
Carolyn Chew-Graham
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2550-6

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Research

The effect of SODIS water treatment intervention at the household level in reducing diarrheal incidence among children under 5 years of age: a cluster randomized controlled trial in Dabat district, northwest Ethiopia

Study protocol

Daptomycin versus placebo as an adjunct to beta-lactam therapy in the treatment of Staphylococcus aureus bacteremia: study protocol for a randomized controlled trial

Study protocol

Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial

Study protocol

Shenmai injection for the treatment of cancer-related fatigue in advanced non-small cell lung cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial

Study protocol

Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants: a study protocol for a randomized controlled trial

Review

A checklist for clinical trials in rare disease: obstacles and anticipatory actions—lessons learned from the FOR-DMD trial