Skip to content

Self-help for those at risk of depression: The SHARD Trial

A multi-centred randomised controlled trial to determine whether a specifically designed guided self-help workbook, using behavioural activation principles in addition to GP usual care is more effective than GP usual care alone for older people with sub-threshold depression symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95270332
Enrollment
312
Registered
2014-02-21
Start date
2014-03-10
Completion date
Unknown
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sub-threshold depression in people 65 years and older Mental and Behavioural Disorders Depressive episode

Interventions

Eligible and consenting participants will be randomly allocated to one of two comparative arms. This sub-study forms part of a larger funded project supported by the Department of Heal

Sponsors

University of York (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants will be identified in primary care. Our target population will be older people (aged 65 and above) who screen-positive for depression on a two question brief depression screen (sometimes referred to as the 'Whooley' questions after their initial validation study), but who on further assessment do not fulfil criteria for DSM-IV Major Depressive Disorder (MDD), and therefore have sub-threshold depression. Inclusion criteria: Aged 65+ years and with a read code for any one of the following: 1. Depression 2. Anti-depressant medication 3. Ischemic heart disease (IHD) 4. Diabetes 5. Chronic obstructive pulmonary disease (COPD) 6. Arthritis 7. Carer

Exclusion criteria

Exclusion criteria: 1. Not currently experiencing psychotic symptoms 2. No known alcohol dependency (as recorded on GP records) 3. No known significant cognitive impairment; unable to give informed consent (as recorded on GP records) 4. No known recent bereavement (as recorded on GP records) 5. No known terminal malignancy (as recorded on GP records)

Design outcomes

Primary

MeasureTime frame
Patient-reported depression severity (Patient Health Questionnaire 9 - PHQ-9) at 4 months and again at 12 months to examine any sustained impact of the intervention.

Secondary

MeasureTime frame
1. Health-related quality of life (physical and mental component of the SF-12) at 4 months and 12 months 2. Health-state utility (EQ-5D) at 4 months and 12 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026