Conducting a Randomized Controlled Trial in Spiritually Integrated Mental Health Care

2020 ◽  
Author(s):  
J. Irene Harris ◽  
Timothy Usset
2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Knapstad ◽  
L V Lervik ◽  
S M M Saether ◽  
L E Aaroe ◽  
O R F Smith

Abstract Background Prompt Mental Health Care (PMHC) service is a Norwegian initiative, adapted from the English ‘Improved Access to Psychological Therapy’ (IAPT), aimed at improving access to primary care treatment for anxiety and depression. Thus far, both PMHC and IAPT have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled. This study investigates the effectiveness of PMHC compared to treatment as usual (TAU) at six months follow-up. Methods Randomized controlled trial with parallel assignment in two PMHC sites from November 2015 to March 2018. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression. These were randomly assigned on a 70:30 ratio. Main outcomes were recovery rates and changes in symptoms of depression and anxiety between baseline and follow-up. Primary outcome data were available for 73%/67% in the PMHC/TAU group. Sensitivity analyses based on observed patterns of missingness were conducted. Results A reliable recovery rate of 58.5% was observed in the PMHC group and 31.9% in the TAU group, yielding a between-group effect size (ES) of 0.61 [95% CI 0.37-0.85, p<.001]. The differences in degree of improvement between PMHC and TAU yielded an ES of -0.88 [95% CI -1.23-0.43, p < 0.001] for symptoms of depression and -0.60 [95% CI -0.90-0.30, p < 0.001] for symptoms of anxiety in favour of PMHC. All sensitivity analyses pointed in the same direction with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. Conclusions The PMHC treatment was substantially more effective than TAU in alleviating symptoms of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access of effective treatment for adults who suffer from anxiety and mild to moderate depression. Key messages This study is the first to evaluate the effectiveness of an IAPT-like treatment model in terms of a randomized controlled trial. Prompt Mental Health Care was substantially more effective than TAU in alleviating symptoms of depression and anxiety at 6-months follow-up.


2019 ◽  
Vol 89 (2) ◽  
pp. 90-105 ◽  
Author(s):  
Marit Knapstad ◽  
Linn Vathne Lervik ◽  
Solbjørg Makalani Myrtveit Sæther ◽  
Leif Edvard Aarø ◽  
Otto Robert F. Smith

2018 ◽  
Author(s):  
Jennifer Hensel ◽  
James Shaw ◽  
Noah Ivers ◽  
Laura Desveaux ◽  
Simone Vigod ◽  
...  

BACKGROUND Web-based self-directed mental health applications are rapidly emerging as a solution to health service gaps and unmet needs for information and support. OBJECTIVE The aim of this study was to determine if a multi-component web-based moderated mental health application could benefit individuals with mental health symptoms severe enough to warrant specialized mental health care. METHODS A multi-centre, pragmatic randomized controlled trial was conducted across several outpatient mental health programs affiliated with 3 hospital programs in Ontario, Canada. Individuals referred to or receiving treatment, 16 years of age or older, with access to the internet and an email address, and having the ability to navigate a web-based mental health application were eligible. 812 participants were randomized 2:1 to receive immediate (ITG) or delayed (DTG) access for 3 months to the Big White WallTM, a web-based multi-component mental health intervention based in the United Kingdom and New Zealand. The primary outcome was total score on the Recovery Assessment Scale, revised (RAS-r) measuring mental health recovery. Secondary outcomes were total scores on the Patient Health Questionnaire-9 item (PHQ-9), the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7), the EQ-5D-5L, and the Community Integration Questionnaire (CIQ). An exploratory analysis examined the association between actual BWW use (categorized into quartiles) and outcomes among study completers. RESULTS Intervention participants achieved small, statistically significant increases in adjusted RAS-r score (4.97 points, 95% CI 2.90 to 7.05), and decreases in PHQ-9 score (-1.83 points, 95% CI -2.85 to -0.82) and GAD-7 score (-1.55 points, 95% CI -2.42 to -0.70). Follow-up was achieved for 446 (55%) at 3 months; 48% of ITG participants, and 69% of DTG participants. Only 58% of ITG participants logged on more than once. Some higher BWW user groups had significantly greater improvements in PHQ-9 and GAD-7 relative to the lowest use group. CONCLUSIONS The web-based application may be beneficial, however, many participants did not engage in an ongoing way. This has implications for patient selection and engagement as well as delivery and funding structures for similar web-based interventions. CLINICALTRIAL Clinicaltrials.gov NCT02896894. Registered on 31 August 2016 (retrospectively registered). https://clinicaltrials.gov/ct2/show/NCT02896894


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