scholarly journals Evaluating the effectiveness of an E-Mental Health Intervention for People Living in Lebanon: study protocol for two randomised controlled trials (RCTs) (Preprint)

Author(s):  
Edith van 't Hof ◽  
Eva Heim ◽  
Jinane Abi Ramia ◽  
Sebastian Burchert ◽  
Ilja Cornelisz ◽  
...  
2020 ◽  
Author(s):  
Edith van 't Hof ◽  
Eva Heim ◽  
Jinane Abi Ramia ◽  
Sebastian Burchert ◽  
Ilja Cornelisz ◽  
...  

BACKGROUND The lack of availability of evidence-based services for people exposed to adversity globally has led to the development of psychological interventions with features that will likely make them more scalable. The evidence for the efficacy of e-mental health from high-income countries is compelling and the use of these interventions could be a way to increase the coverage of evidence--based psychological interventions in low- and middle-income countries. Step-by-Step, is a brief (5 session) intervention proposed by WHO as an innovative approach to reducing the suffering and disability associated with depression. OBJECTIVE This study aims to evaluate the effectiveness and cost-effectiveness of a locally adapted version of Step-by-Step with Syrian nationals (trial 1) and Lebanese nationals and other populations residing in Lebanon (trial 2). METHODS This Step-by-Step trial involves two parallel, two-armed randomized controlled trials (RCTs) comparing the e-intervention Step-by-Step to enhanced care as usual (ECAU) in participants with depressive symptoms and impaired functioning. The RCTs are designed and powered to detect effectiveness in two populations: Syrians in Lebanon (n=568) and other people residing in Lebanon (n=568) (Lebanese nationals and other populations resident in Lebanon). The primary outcomes are depressive symptomatology (measured by the Patient Health Questionnaire [PHQ-9]) and functioning (measured by the WHODAS 2.0). Secondary outcomes include anxiety symptoms, posttraumatic stress disorder (PTSD) symptoms, personalized measures of psychosocial problems, subjective wellbeing and economic effectiveness. Participants are mainly recruited through online advertising. Additional outreach methods will be used if required, for example through dissemination of information through partner agencies and organizations. They can access the intervention on a computer, tablet and mobile phone through a hybrid app. Step-by-Step has 5-sessions and users are guided by trained non-specialist “e-helpers” providing phone or message-based support for around 15 minutes a week. RESULTS The trials were funded in 2018. The study protocol was last verified 20.06.2019 (WHO ERC.0002797) and registered with ClinicalTrials.gov (NCT03720769). The trials started recruitment as of December 9th, 2019 and all data collection will likely be completed by November 2020. CONCLUSIONS The Step-by-Step trials will provide evidence about the effectiveness of an E-mental health intervention in Lebanon. If the intervention proves to be effective, this will inform future scale up of this and similar interventions in Lebanon and in other settings across the world. CLINICALTRIAL NCT03720769


2019 ◽  
Vol 215 (2) ◽  
pp. 485-493 ◽  
Author(s):  
Mark J. D. Jordans ◽  
Nagendra P. Luitel ◽  
Emily Garman ◽  
Brandon A. Kohrt ◽  
Sujit D. Rathod ◽  
...  

BackgroundEvidence shows benefits of psychological treatments in low-resource countries, yet few government health systems include psychological services.AimEvaluating the clinical value of adding psychological treatments, delivered by community-based counsellors, to primary care-based mental health services for depression and alcohol use disorder (AUD), as recommended by the Mental Health Gap Action Programme (mhGAP).MethodTwo randomised controlled trials, separately for depression and AUD, were carried out. Participants were randomly allocated (1:1) to mental healthcare delivered by mhGAP-trained primary care workers (psychoeducation and psychotropic medicines when indicated), or the same services plus individual psychological treatments (Healthy Activity Program for depression and Counselling for Alcohol Problems). Primary outcomes were symptom severity, measured using the Patient Health Questionnaire – 9 item (PHQ-9) for depression and the Alcohol Use Disorder Identification Test for AUD, and functional impairment, measured using the World Health Organization Disability Assessment Schedule (WHODAS), at 12 months post-enrolment.ResultsParticipants with depression in the intervention arm (n = 60) had greater reduction in PHQ-9 and WHODAS scores compared with participants in the control (n = 60) (PHQ-9: M = −5.90, 95% CI −7.55 to −4.25, β = −3.68, 95% CI −5.68 to −1.67, P < 0.001, Cohen's d = 0.66; WHODAS: M = −12.21, 95% CI −19.58 to −4.84, β = −10.74, 95% CI −19.96 to −1.53, P= 0.022, Cohen's d = 0.42). For the AUD trial, no significant effect was found when comparing control (n = 80) and intervention participants (n = 82).ConclusionAdding a psychological treatment delivered by community-based counsellors increases treatment effects for depression compared with only mhGAP-based services by primary health workers 12 months post-treatment.Declaration of interestNone.


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