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Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)

Mark B Gabbay, Adele Ring, Richard Byng, Pippa Anderson, Rod S Taylor, Caryn Matthews, Tirril Harris, Vashti Berry, Paula Byrne, Elliot Carter, Pam Clarke, Laura Cocking, Suzanne Edwards Orcid Logo, Richard Emsley, Mauro Fornasiero, Lucy Frith, Shaun Harris, Peter Huxley, Siw Jones, Peter Kinderman, Michael King, Liv Kosnes, Daniel Marshall, Dave Mercer, Carl May, Debbie Nolan, Ceri Phillips, Tim Rawcliffe, Alexandra V Sardani, Elizabeth Shaw, Sam Thompson, Jane Vickery, Brian Wainman, Mark Warner

Health Technology Assessment, Volume: 21, Issue: 35, Pages: 1 - 164

Swansea University Authors: Pippa Anderson, Suzanne Edwards Orcid Logo, Ceri Phillips

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DOI (Published version): 10.3310/hta21350

Abstract

Background: Depression and debt are common in the UK. The DeCoDer trial aimed to assess the clinical and cost effectiveness of the addition of Primary Care debt counselling advice service to usual care, for patients with depression and debt. However, the study was terminated early during the interna...

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Published in: Health Technology Assessment
ISSN: 1366-5278 2046-4924
Published: 2017
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URI: https://cronfa.swan.ac.uk/Record/cronfa34298
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2017-07-26T14:50:22.2198193</datestamp><bib-version>v2</bib-version><id>34298</id><entry>2017-06-13</entry><title>Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)</title><swanseaauthors><author><sid>128cdedfba6e5e6374fdc85d5c78c428</sid><firstname>Pippa</firstname><surname>Anderson</surname><name>Pippa Anderson</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>0ef23e671a9056e0b45a659663991632</sid><ORCID>0000-0002-9334-6507</ORCID><firstname>Suzanne</firstname><surname>Edwards</surname><name>Suzanne Edwards</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>932c7a406ab4b6e4a881d422ca03c289</sid><firstname>Ceri</firstname><surname>Phillips</surname><name>Ceri Phillips</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2017-06-13</date><deptcode>HSOC</deptcode><abstract>Background: Depression and debt are common in the UK. The DeCoDer trial aimed to assess the clinical and cost effectiveness of the addition of Primary Care debt counselling advice service to usual care, for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research. Objectives: The overarching aim of the internal pilot was to identify and resolve problems, thereby assessing the feasibility of the main trial. Specific objectives were to: confirm methods for practice recruitment, ability to recruit patients via the proposed approaches, determine acceptability of the study interventions and outcome measures; assess contamination, confirm the randomisation method for main trial, the level of participant attrition; and check robustness of data collection systems. Design: Adaptive parallel two group multi-centre randomised controlled pilot trial with nested mixed methods process and economic evaluation. Both individual and cluster (General Practice) level allocation were used in the pilot phase to assign participants to intervention or control groups. Setting: General practices in England and Wales.Participants: Individuals age &#x2265;18 years, scoring &#x2265;14 on the Beck Depression Inventory and self-identifying as having debt worries were included. Main exclusion criteria were: actively suicidal or psychotic and/or severely depressed and unresponsive to treatment, severe addiction to alcohol/illicit drugs, unable/unwilling to give written informed consent, currently participating in other research including follow-up phases, received Citizen&#x2019;s Advice Bureau (CAB) debt advice in past year, and not wanting debt advice via GP practice. Interventions: Intervention: debt advice provided by CAB and shared biopsychosocial assessment in addition to treatment as usual (TAU) and two debt advice leaflets; Control: advice leaflets provided by GP and TAU only. Outcomes of pilot trial: Proportion of eligible patients who consented; number of participants recruited compared to target; assessment of contamination; assessment of patient satisfaction with intervention and outcome measures.Participant outcomes: Primary: Beck Depression Inventory II; Secondary: Psychological wellbeing, health and social care utilisation, service satisfaction, substance misuse, record of priority/non-priority debts, life events and difficulties and explanatory measures. Outcomes were assessed at baseline (pre-randomisation) and 4-months post randomisation. Other data sources: Qualitative interviews were conducted with participants, clinicians and CAB advisors.Results: Of the 238 expressions of interest screened, 61 participants (26%) were recruited and randomised (32 intervention and 29 control). All participants provided baseline outcomes and 52 provided primary outcome at four months follow up (14.7% drop out). 17 participants allocated to intervention saw CAB. Descriptive statistics are reported for participants with complete outcomes at baseline and 4-months&#x2019; follow up. Our qualitative findings suggest that the relationship between debt and depression is complex and the impact of each on the other is compounded by other psychological, social and contextual influences. Conclusions, Study Limitations and Future work: Due to low recruitment this trial was terminated at the internal pilot phase, and too small for inferential statistical analysis. We provide implications for conducting future research in this area.</abstract><type>Journal Article</type><journal>Health Technology Assessment</journal><volume>21</volume><journalNumber>35</journalNumber><paginationStart>1</paginationStart><paginationEnd>164</paginationEnd><publisher/><issnPrint>1366-5278</issnPrint><issnElectronic>2046-4924</issnElectronic><keywords/><publishedDay>7</publishedDay><publishedMonth>6</publishedMonth><publishedYear>2017</publishedYear><publishedDate>2017-06-07</publishedDate><doi>10.3310/hta21350</doi><url/><notes/><college>COLLEGE NANME</college><department>Health and Social Care School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HSOC</DepartmentCode><institution>Swansea University</institution><apcterm/><lastEdited>2017-07-26T14:50:22.2198193</lastEdited><Created>2017-06-13T16:39:05.5465066</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Mark B</firstname><surname>Gabbay</surname><order>1</order></author><author><firstname>Adele</firstname><surname>Ring</surname><order>2</order></author><author><firstname>Richard</firstname><surname>Byng</surname><order>3</order></author><author><firstname>Pippa</firstname><surname>Anderson</surname><order>4</order></author><author><firstname>Rod S</firstname><surname>Taylor</surname><order>5</order></author><author><firstname>Caryn</firstname><surname>Matthews</surname><order>6</order></author><author><firstname>Tirril</firstname><surname>Harris</surname><order>7</order></author><author><firstname>Vashti</firstname><surname>Berry</surname><order>8</order></author><author><firstname>Paula</firstname><surname>Byrne</surname><order>9</order></author><author><firstname>Elliot</firstname><surname>Carter</surname><order>10</order></author><author><firstname>Pam</firstname><surname>Clarke</surname><order>11</order></author><author><firstname>Laura</firstname><surname>Cocking</surname><order>12</order></author><author><firstname>Suzanne</firstname><surname>Edwards</surname><orcid>0000-0002-9334-6507</orcid><order>13</order></author><author><firstname>Richard</firstname><surname>Emsley</surname><order>14</order></author><author><firstname>Mauro</firstname><surname>Fornasiero</surname><order>15</order></author><author><firstname>Lucy</firstname><surname>Frith</surname><order>16</order></author><author><firstname>Shaun</firstname><surname>Harris</surname><order>17</order></author><author><firstname>Peter</firstname><surname>Huxley</surname><order>18</order></author><author><firstname>Siw</firstname><surname>Jones</surname><order>19</order></author><author><firstname>Peter</firstname><surname>Kinderman</surname><order>20</order></author><author><firstname>Michael</firstname><surname>King</surname><order>21</order></author><author><firstname>Liv</firstname><surname>Kosnes</surname><order>22</order></author><author><firstname>Daniel</firstname><surname>Marshall</surname><order>23</order></author><author><firstname>Dave</firstname><surname>Mercer</surname><order>24</order></author><author><firstname>Carl</firstname><surname>May</surname><order>25</order></author><author><firstname>Debbie</firstname><surname>Nolan</surname><order>26</order></author><author><firstname>Ceri</firstname><surname>Phillips</surname><order>27</order></author><author><firstname>Tim</firstname><surname>Rawcliffe</surname><order>28</order></author><author><firstname>Alexandra V</firstname><surname>Sardani</surname><order>29</order></author><author><firstname>Elizabeth</firstname><surname>Shaw</surname><order>30</order></author><author><firstname>Sam</firstname><surname>Thompson</surname><order>31</order></author><author><firstname>Jane</firstname><surname>Vickery</surname><order>32</order></author><author><firstname>Brian</firstname><surname>Wainman</surname><order>33</order></author><author><firstname>Mark</firstname><surname>Warner</surname><order>34</order></author></authors><documents><document><filename>0034298-26072017144928.pdf</filename><originalFilename>34298.pdf</originalFilename><uploaded>2017-07-26T14:49:28.1500000</uploaded><type>Output</type><contentLength>25782670</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><embargoDate>2017-07-26T00:00:00.0000000</embargoDate><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
spelling 2017-07-26T14:50:22.2198193 v2 34298 2017-06-13 Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study) 128cdedfba6e5e6374fdc85d5c78c428 Pippa Anderson Pippa Anderson true false 0ef23e671a9056e0b45a659663991632 0000-0002-9334-6507 Suzanne Edwards Suzanne Edwards true false 932c7a406ab4b6e4a881d422ca03c289 Ceri Phillips Ceri Phillips true false 2017-06-13 HSOC Background: Depression and debt are common in the UK. The DeCoDer trial aimed to assess the clinical and cost effectiveness of the addition of Primary Care debt counselling advice service to usual care, for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research. Objectives: The overarching aim of the internal pilot was to identify and resolve problems, thereby assessing the feasibility of the main trial. Specific objectives were to: confirm methods for practice recruitment, ability to recruit patients via the proposed approaches, determine acceptability of the study interventions and outcome measures; assess contamination, confirm the randomisation method for main trial, the level of participant attrition; and check robustness of data collection systems. Design: Adaptive parallel two group multi-centre randomised controlled pilot trial with nested mixed methods process and economic evaluation. Both individual and cluster (General Practice) level allocation were used in the pilot phase to assign participants to intervention or control groups. Setting: General practices in England and Wales.Participants: Individuals age ≥18 years, scoring ≥14 on the Beck Depression Inventory and self-identifying as having debt worries were included. Main exclusion criteria were: actively suicidal or psychotic and/or severely depressed and unresponsive to treatment, severe addiction to alcohol/illicit drugs, unable/unwilling to give written informed consent, currently participating in other research including follow-up phases, received Citizen’s Advice Bureau (CAB) debt advice in past year, and not wanting debt advice via GP practice. Interventions: Intervention: debt advice provided by CAB and shared biopsychosocial assessment in addition to treatment as usual (TAU) and two debt advice leaflets; Control: advice leaflets provided by GP and TAU only. Outcomes of pilot trial: Proportion of eligible patients who consented; number of participants recruited compared to target; assessment of contamination; assessment of patient satisfaction with intervention and outcome measures.Participant outcomes: Primary: Beck Depression Inventory II; Secondary: Psychological wellbeing, health and social care utilisation, service satisfaction, substance misuse, record of priority/non-priority debts, life events and difficulties and explanatory measures. Outcomes were assessed at baseline (pre-randomisation) and 4-months post randomisation. Other data sources: Qualitative interviews were conducted with participants, clinicians and CAB advisors.Results: Of the 238 expressions of interest screened, 61 participants (26%) were recruited and randomised (32 intervention and 29 control). All participants provided baseline outcomes and 52 provided primary outcome at four months follow up (14.7% drop out). 17 participants allocated to intervention saw CAB. Descriptive statistics are reported for participants with complete outcomes at baseline and 4-months’ follow up. Our qualitative findings suggest that the relationship between debt and depression is complex and the impact of each on the other is compounded by other psychological, social and contextual influences. Conclusions, Study Limitations and Future work: Due to low recruitment this trial was terminated at the internal pilot phase, and too small for inferential statistical analysis. We provide implications for conducting future research in this area. Journal Article Health Technology Assessment 21 35 1 164 1366-5278 2046-4924 7 6 2017 2017-06-07 10.3310/hta21350 COLLEGE NANME Health and Social Care School COLLEGE CODE HSOC Swansea University 2017-07-26T14:50:22.2198193 2017-06-13T16:39:05.5465066 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Mark B Gabbay 1 Adele Ring 2 Richard Byng 3 Pippa Anderson 4 Rod S Taylor 5 Caryn Matthews 6 Tirril Harris 7 Vashti Berry 8 Paula Byrne 9 Elliot Carter 10 Pam Clarke 11 Laura Cocking 12 Suzanne Edwards 0000-0002-9334-6507 13 Richard Emsley 14 Mauro Fornasiero 15 Lucy Frith 16 Shaun Harris 17 Peter Huxley 18 Siw Jones 19 Peter Kinderman 20 Michael King 21 Liv Kosnes 22 Daniel Marshall 23 Dave Mercer 24 Carl May 25 Debbie Nolan 26 Ceri Phillips 27 Tim Rawcliffe 28 Alexandra V Sardani 29 Elizabeth Shaw 30 Sam Thompson 31 Jane Vickery 32 Brian Wainman 33 Mark Warner 34 0034298-26072017144928.pdf 34298.pdf 2017-07-26T14:49:28.1500000 Output 25782670 application/pdf Version of Record true 2017-07-26T00:00:00.0000000 true eng
title Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)
spellingShingle Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)
Pippa Anderson
Suzanne Edwards
Ceri Phillips
title_short Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)
title_full Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)
title_fullStr Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)
title_full_unstemmed Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)
title_sort Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)
author_id_str_mv 128cdedfba6e5e6374fdc85d5c78c428
0ef23e671a9056e0b45a659663991632
932c7a406ab4b6e4a881d422ca03c289
author_id_fullname_str_mv 128cdedfba6e5e6374fdc85d5c78c428_***_Pippa Anderson
0ef23e671a9056e0b45a659663991632_***_Suzanne Edwards
932c7a406ab4b6e4a881d422ca03c289_***_Ceri Phillips
author Pippa Anderson
Suzanne Edwards
Ceri Phillips
author2 Mark B Gabbay
Adele Ring
Richard Byng
Pippa Anderson
Rod S Taylor
Caryn Matthews
Tirril Harris
Vashti Berry
Paula Byrne
Elliot Carter
Pam Clarke
Laura Cocking
Suzanne Edwards
Richard Emsley
Mauro Fornasiero
Lucy Frith
Shaun Harris
Peter Huxley
Siw Jones
Peter Kinderman
Michael King
Liv Kosnes
Daniel Marshall
Dave Mercer
Carl May
Debbie Nolan
Ceri Phillips
Tim Rawcliffe
Alexandra V Sardani
Elizabeth Shaw
Sam Thompson
Jane Vickery
Brian Wainman
Mark Warner
format Journal article
container_title Health Technology Assessment
container_volume 21
container_issue 35
container_start_page 1
publishDate 2017
institution Swansea University
issn 1366-5278
2046-4924
doi_str_mv 10.3310/hta21350
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
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description Background: Depression and debt are common in the UK. The DeCoDer trial aimed to assess the clinical and cost effectiveness of the addition of Primary Care debt counselling advice service to usual care, for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research. Objectives: The overarching aim of the internal pilot was to identify and resolve problems, thereby assessing the feasibility of the main trial. Specific objectives were to: confirm methods for practice recruitment, ability to recruit patients via the proposed approaches, determine acceptability of the study interventions and outcome measures; assess contamination, confirm the randomisation method for main trial, the level of participant attrition; and check robustness of data collection systems. Design: Adaptive parallel two group multi-centre randomised controlled pilot trial with nested mixed methods process and economic evaluation. Both individual and cluster (General Practice) level allocation were used in the pilot phase to assign participants to intervention or control groups. Setting: General practices in England and Wales.Participants: Individuals age ≥18 years, scoring ≥14 on the Beck Depression Inventory and self-identifying as having debt worries were included. Main exclusion criteria were: actively suicidal or psychotic and/or severely depressed and unresponsive to treatment, severe addiction to alcohol/illicit drugs, unable/unwilling to give written informed consent, currently participating in other research including follow-up phases, received Citizen’s Advice Bureau (CAB) debt advice in past year, and not wanting debt advice via GP practice. Interventions: Intervention: debt advice provided by CAB and shared biopsychosocial assessment in addition to treatment as usual (TAU) and two debt advice leaflets; Control: advice leaflets provided by GP and TAU only. Outcomes of pilot trial: Proportion of eligible patients who consented; number of participants recruited compared to target; assessment of contamination; assessment of patient satisfaction with intervention and outcome measures.Participant outcomes: Primary: Beck Depression Inventory II; Secondary: Psychological wellbeing, health and social care utilisation, service satisfaction, substance misuse, record of priority/non-priority debts, life events and difficulties and explanatory measures. Outcomes were assessed at baseline (pre-randomisation) and 4-months post randomisation. Other data sources: Qualitative interviews were conducted with participants, clinicians and CAB advisors.Results: Of the 238 expressions of interest screened, 61 participants (26%) were recruited and randomised (32 intervention and 29 control). All participants provided baseline outcomes and 52 provided primary outcome at four months follow up (14.7% drop out). 17 participants allocated to intervention saw CAB. Descriptive statistics are reported for participants with complete outcomes at baseline and 4-months’ follow up. Our qualitative findings suggest that the relationship between debt and depression is complex and the impact of each on the other is compounded by other psychological, social and contextual influences. Conclusions, Study Limitations and Future work: Due to low recruitment this trial was terminated at the internal pilot phase, and too small for inferential statistical analysis. We provide implications for conducting future research in this area.
published_date 2017-06-07T01:21:27Z
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