Debt counselling for depression in primary care
| ISRCTN | ISRCTN79705874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79705874 |
| Secondary identifying numbers | 16531; HTA 11/148/01 |
- Submission date
- 17/04/2014
- Registration date
- 17/04/2014
- Last edited
- 02/06/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Depression and associated anxiety are common among patients seen in general practices. Many such patients also have debt and prolonged absence from work. There is increasing evidence of a relationship between indebtedness, depression and risk of self-harm and suicide. It is suggested that anti-depressants and talking therapies are cost-effective in the treatment of depression in general practices. Whilst indebtedness and poverty are common in society, particularly in areas of deprivation and high unemployment, the economic recession has worsened these problems. Whilst debt advice services are widely available, there is no robust evidence of their impact on mental health outcomes or their cost-effectiveness. There is a long history of welfare advice provided in primary care, particularly in areas of greatest economic need. However, debt advice is different from general welfare advice, and in the model we propose testing (that provided by the Citizens Advice Bureau - CAB) different from many of the commercially available offers of debt consolidation. Instead it focuses on assessing the level and urgency of debts and arrears and triaging to specific detailed advice on debt, or money management. We propose to test the impact of a shared assessment and management plan between GPs and CAB staff, linked to sessions of individual debt advice.
Who can participate?
Patients with depression (with and without additional anxiety) who also are worried about debt
What does the study involve?
People wishing to participate in the study are first screened to see if they are eligible to take part. If they are, they complete an initial assessment visit with a researcher in the participant's own home or at a venue of their choosing. After this, the participant is randomly allocated to either receive debt advice from the Citizens Advice Bureau (CAB) and a shared comprehensive assessment between a general practitioner (GP) and the CAB advisor, or to receive treatment as usual and a debt advice leaflet. Participants take part in two further assessment visits with a researcher one at 3 months after allocation and one at 12 months. A number of participants are also invited to take part in two interviews with a second researcher to explore the participants' experience of debt, its impact on their life and their experience of the intervention. A number of staff (GPs and CAB advisors) also take part in interviews 6-12 months after the start of their participation. The purpose of these interviews is to look at the intervention in more detail from the professionals' point of view.
What are the possible benefits and risks of participating?
It is hoped that the debt advice will aid recovery from depression. The likely main risk is that people may become distressed when talking about their current difficulties. Researchers will follow protocol guidance in such circumstances.
Where is the study run from?
The study will recruit from sites in England and Wales and will be managed from three centres: Liverpool University (lead University), Plymouth University and Swansea University. Participants will be recruited from general practices in Liverpool, Plymouth and Bridgend.
When is the study starting and how long is it expected to run for?
June 2014 to May 2016
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Adele Ring
adeler@liverpool.ac.uk
Contact information
Scientific
Division of Public Health
Whelan Building
Quadrangle
Brownlow Hill
Liverpool
L69 3GB
United Kingdom
| adeler@liverpool.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Debt Counselling for Depression Randomised controlled trial |
| Study acronym | DeCoDeR |
| Study hypothesis | To what extent does debt advice from Citizens Advice Bureau counsellors for patients with debt and depression, accessed through general practices, make a difference to patients' recovery from depression. |
| Ethics approval(s) | 14/NW/0230 |
| Condition | Topic: Mental Health, Primary Care; Subtopic: Depression, Not Assigned; Disease: Depression, All Diseases |
| Intervention | Patients are randomised to two groups: 1. GP treatment as usual (TAU) supplemented by a debt management advice leaflet (control) 2. GP treatment as usual supplemented by debt advice leaflet and primary care based CAB debt advice, including a shared GP/CAB Advisor comprehensive assessment (intervention) Follow Up Length: 12 month(s) |
| Intervention type | Other |
| Primary outcome measure | Depression, measured using the BDI-II score; Timepoint(s): baseline, 4 and 12 months |
| Secondary outcome measures | 1. Explanatory measures; Timepoint(s): baseline and 4 months 2. Health and social care utilisation and employment factors; Timepoint(s): baseline, 4 and 12 months 3. Health-related QoL; Timepoint(s): baseline, 4 and 12 months 4. Life events; Timepoint(s): baseline and 4 months 5. Psychological wellbeing; Timepoint(s): baseline, 4 and 12 months 6. Service satisfaction; Timepoint(s): 4 months 7. Substance misuse; Timepoint(s): baseline, 4 and 12 months |
| Overall study start date | 30/06/2014 |
| Overall study end date | 16/05/2016 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 470; UK Sample Size: 470; Description: 390 if individual randomisation; 470 if cluster randomised |
| Participant inclusion criteria | 1. Aged 18 or above 2. Scoring 14 or above on the BDI 3. Self-identifying as having worries about debt Target Gender: Male & Female ; Lower Age Limit 18 years |
| Participant exclusion criteria | 1. Housebound and/or unable to get to CAB advice sessions 2. Actively suicidal or psychotic and/or severely depressed and unresponsive to treatment 3. Unlikely to comply with the intervention or follow-up e.g. experiencing severe problems with addiction to alcohol or illicit drugs 4. Unable or unwilling to give written informed consent to participate in study 5. Currently participating in another research study including follow-up data collection phase 6. Has received CAB debt advice in the past 12 months |
| Recruitment start date | 30/06/2014 |
| Recruitment end date | 16/05/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
L69 3GB
United Kingdom
Sponsor information
University/education
Head of Division of Primary Care
Whelan Building
Quadrangle
Brownlow Hill
Liverpool
L69 3BX
England
United Kingdom
"ROR" |
https://ror.org/04xs57h96 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 09/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The report will be published in the Health Technology Assessment Journal. |
| IPD sharing plan | Electronic records will be stored in a Structured Query Language (SQL) Server database, stored on a restricted access, secure server maintained by Plymouth University. The website will be encrypted using Secure Sockets Layer. Direct access to the trial data will be restricted to members of the research team and the CTU, with access granted to others on request. Access to the database will be overseen by the CTU data manager and trial manager. Those interested in accessing the data should contact the corresponding author Dr Adele Ring (adeler@liverpool.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
30/05/2017: The trial was stopped due to a participant recruitment issue.
