Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya.
Adult
Ambulatory Care
/ methods
Ambulatory Care Facilities
/ trends
Antidepressive Agents, Second-Generation
/ administration & dosage
Combined Modality Therapy
/ methods
Delivery of Health Care, Integrated
/ methods
Depressive Disorder, Major
/ epidemiology
Female
Fluoxetine
/ administration & dosage
Hospitals, County
/ trends
Humans
Kenya
/ epidemiology
Male
Mental Health Services
/ trends
Psychotherapy
/ methods
Public Sector
/ trends
Stress Disorders, Post-Traumatic
/ epidemiology
Treatment Outcome
Depression
Fluoxetine
Implementation science
Interpersonal psychotherapy (IPT)
Multiple assignment randomized trial
Post-traumatic stress disorder (PTSD)
Primary care
SSRI
Sequential
Sub-Saharan Africa
Trauma
Journal
BMC psychiatry
ISSN: 1471-244X
Titre abrégé: BMC Psychiatry
Pays: England
ID NLM: 100968559
Informations de publication
Date de publication:
28 12 2019
28 12 2019
Historique:
received:
13
11
2019
accepted:
05
12
2019
entrez:
30
12
2019
pubmed:
31
12
2019
medline:
17
6
2020
Statut:
epublish
Résumé
Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up. The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability. ClinicalTrials.gov NCT03466346, registered March 15, 2018.
Sections du résumé
BACKGROUND
Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.
METHODS/DESIGN
We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up.
DISCUSSION
The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03466346, registered March 15, 2018.
Identifiants
pubmed: 31883526
doi: 10.1186/s12888-019-2395-x
pii: 10.1186/s12888-019-2395-x
pmc: PMC6935499
doi:
Substances chimiques
Antidepressive Agents, Second-Generation
0
Fluoxetine
01K63SUP8D
Banques de données
ClinicalTrials.gov
['NCT03466346']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
424Subventions
Organisme : NIDA NIH HHS
ID : R01 DA039901
Pays : United States
Organisme : NIMH NIH HHS
ID : R01 MH113722
Pays : United States
Organisme : NIMH NIH HHS
ID : R01 MH115512
Pays : United States
Références
JAMA Psychiatry. 2013 Nov;70(11):1152-60
pubmed: 24005123
Arch Gen Psychiatry. 1961 Jun;4:561-71
pubmed: 13688369
J Nerv Ment Dis. 2001 Apr;189(4):238-42
pubmed: 11339319
Int J Environ Res Public Health. 2015 Oct 26;12(10):13494-509
pubmed: 26516877
J Eval Clin Pract. 2011 Apr;17(2):268-74
pubmed: 20874835
J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
pubmed: 9881538
Psychol Methods. 2013 Jun;18(2):137-50
pubmed: 23379553
Depress Anxiety. 2012 Oct;29(10):855-64
pubmed: 22815247
Acta Psychiatr Scand. 2010 Jun;121(6):415-23
pubmed: 19922522
Am J Psychiatry. 2012 Jan;169(1):80-8
pubmed: 21908494
Implement Sci. 2019 Jan 5;14(1):1
pubmed: 30611302
Lancet. 2016 Oct 8;388(10053):1603-1658
pubmed: 27733283
PLoS One. 2016 May 11;11(5):e0153132
pubmed: 27167852
Br J Psychiatry. 2003 Sep;183:184-6
pubmed: 12948986
Psychol Med. 2014 Aug;44(11):2363-74
pubmed: 24451993
J Affect Disord. 2015 Mar 15;174:619-26
pubmed: 25574781
PLoS Med. 2013 Nov;10(11):e1001547
pubmed: 24223526
PLoS Med. 2013;10(5):e1001448
pubmed: 23737736
Int J Ment Health Syst. 2013 Feb 04;7(1):6
pubmed: 23379737
World Psychiatry. 2004 Oct;3(3):136-9
pubmed: 16633477
Ann Gen Psychiatry. 2009 Jan 14;8:1
pubmed: 19144164
Addiction. 2017 May;112(5):901-909
pubmed: 28029718
Sci Transl Med. 2014 Sep 10;6(253):253cm9
pubmed: 25210058
J Trauma Stress. 2013 Jun;26(3):299-309
pubmed: 23696449
Afr Health Sci. 2006 Dec;6(4):215-22
pubmed: 17604510
Cochrane Database Syst Rev. 2013 Jul 17;(7):CD004185
pubmed: 24353997
Bull World Health Organ. 2010 Nov 1;88(11):815-23
pubmed: 21076562
Int J Ment Health Syst. 2016 Mar 08;10:19
pubmed: 26958075
J Consult Clin Psychol. 2008 Dec;76(6):909-22
pubmed: 19045960
Adm Policy Ment Health. 2011 Jan;38(1):4-23
pubmed: 21197565
Eur Psychiatry. 2007 Jan;22(1):1-8
pubmed: 17194571
Behav Res Ther. 1996 Aug;34(8):669-73
pubmed: 8870294
J Affect Disord. 2018 Jan 1;225:413-421
pubmed: 28850856
Br J Psychiatry. 2012 Feb;200(2):97-106
pubmed: 22297588
Am J Psychiatry. 2000 Apr;157(4 Suppl):1-45
pubmed: 10767867
Am J Psychiatry. 2015 May;172(5):430-40
pubmed: 25677355
Br J Psychiatry. 2006 Jun;188:567-73
pubmed: 16738348
Trials. 2016 Feb 03;17:64
pubmed: 26841875
Psychother Res. 2008 Sep;18(5):497-507
pubmed: 18816001
Am J Psychiatry. 1995 Oct;152(10):1504-9
pubmed: 7573591
PLoS One. 2015 Feb 06;10(2):e0116820
pubmed: 25658103
J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59
pubmed: 7962581
Lancet Psychiatry. 2016 May;3(5):415-24
pubmed: 27083119
Am J Psychiatry. 2006 Jan;163(1):28-40
pubmed: 16390886
Br J Psychiatry. 1999 Jul;175:17-22
pubmed: 10621763
Lancet. 2010 Dec 18;376(9758):2086-95
pubmed: 21159375
Psychol Methods. 2012 Dec;17(4):478-94
pubmed: 23025434
Cochrane Database Syst Rev. 2013 Nov 19;(11):CD009149
pubmed: 24249541
Psychol Assess. 2011 Jun;23(2):463-77
pubmed: 21517189
Annu Rev Neurosci. 2009;32:57-74
pubmed: 19400725
Eur Arch Psychiatry Clin Neurosci. 2005 Apr;255(2):75-82
pubmed: 15812600
J Consult Clin Psychol. 2015 Apr;83(2):359-69
pubmed: 25622199
Addict Behav. 1982;7(4):363-71
pubmed: 7183189
Int J Ment Health Syst. 2013 Jan 23;7(1):5
pubmed: 23343127
J Clin Psychiatry. 2009 Sep;70(9):1219-29
pubmed: 19818243
PLoS Med. 2014 Nov 11;11(11):e1001757
pubmed: 25386945
Arch Intern Med. 2006 Nov 27;166(21):2314-21
pubmed: 17130383
Int J Ment Health Syst. 2015 Dec 30;9:40
pubmed: 26719762
J Behav Ther Exp Psychiatry. 2015 Sep;48:17-26
pubmed: 25677254
Br J Psychiatry. 2000 May;176:421-8
pubmed: 10912216
Annu Rev Public Health. 2004;25:99-117
pubmed: 15015914
J Gen Intern Med. 2007 Jun;22(6):711-8
pubmed: 17503104
Am J Psychiatry. 2005 Jan;162(1):181-3
pubmed: 15625219
J Pers Assess. 1990 Winter;55(3-4):610-7
pubmed: 2280326
Trials. 2014 Jun 25;15:248
pubmed: 24962086
Res Adv Psychiatry. 2016 Jan-Apr;3(1):12-21
pubmed: 32661505
Int J Group Psychother. 2010 Jan;60(1):131-40
pubmed: 20059298
Soc Psychiatry Psychiatr Epidemiol. 2014 Aug;49(8):1257-68
pubmed: 23959589
Clin Trials. 2014 Jun 5;11(4):426-434
pubmed: 24902922
Clin Trials. 2004 Feb;1(1):9-20
pubmed: 16281458
J Clin Psychol. 2006 Jul;62(7):815-35
pubmed: 16703602
Depress Anxiety. 2010;27(1):72-7
pubmed: 20013958
Nat Rev Neurosci. 2008 Oct;9(10):788-96
pubmed: 18784657
Stat Med. 2005 May 30;24(10):1455-81
pubmed: 15586395
Depress Anxiety. 2016 Sep;33(9):792-806
pubmed: 27126398