scholarly journals An Online Minimally Guided Intervention to Support Family and Other Unpaid Carers of People With Dementia: Protocol for a Randomized Controlled Trial

10.2196/14106 ◽  
2019 ◽  
Vol 8 (10) ◽  
pp. e14106 ◽  
Author(s):  
Ángel C Pinto-Bruno ◽  
Anne Margriet Pot ◽  
Annet Kleiboer ◽  
Rose-Marie Droes ◽  
Annemieke van Straten
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
The Netherlands ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Waiting List ◽  
Online Interventions ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
People With Dementia

Background About three-quarters of people with dementia live in their own homes, with help from family members and/or other unpaid carers, such as friends or neighbors. Often, unpaid carers themselves experience negative consequences, such as stress, burden, and symptoms of depression or anxiety. Research has shown that these consequences can be alleviated by psychosocial and psychological interventions. Moreover, there are indications that those interventions can be effective when offered online. Objective This paper describes the protocol of a randomized controlled trial (RCT) that will take place in the Netherlands to evaluate the effectiveness of iSupport, a minimally guided, internet-based intervention to improve carers’ mental health and coping resources. Methods A superiority two-arm RCT comparing the effects of the online support program with a waiting list control condition will be carried out in the Netherlands. The iSupport intervention was developed by the World Health Organization and is based on cognitive behavioral therapy principles. It has five main themes divided into 23 lessons. Carers can pick and choose which lessons they want to complete. We aim to recruit 200 unpaid carers. The experimental group (n=100) will be provided with access to the intervention for 3 months following randomization; those in the waiting list control group (n=100) will be granted access to the intervention after 3 months. Assessments will be conducted at baseline (T0), 3 months after baseline (post intervention, T1), and 6 months after baseline (follow-up, T2). The primary outcome is perceived stress, measured by the Perceived Stress Scale. Secondary outcomes are symptoms of depression and anxiety, caregiver burden, sense of competence, self-efficacy, mastery, and carers’ attitudes toward dementia and their person-centered approach (ie, to what extent carers tailor the provided care to the interest, needs, and history of the person with dementia). Results Recruitment for the trial started in January 2019. As of July 2019, we have enrolled 120 participants. Data collection is expected to be completed by March 2020. Once all the data have been collected, we will conduct the data analyses between April and May 2020. We aim to publish our results in a manuscript by June 2020. Conclusions Online interventions have shown promising results in improving the mental health of carers of people with dementia. Additionally, online interventions may overcome accessibility barriers. If successful, this intervention will have important potential for implementation as a public health intervention, since costs and support by trained staff are minimal. Trial Registration Netherlands Trial Register (NTL) NL6417; https://www.trialregister.nl/trial/6417 International Registered Report Identifier (IRRID) DERR1-10.2196/14106

scholarly journals An Online Minimally Guided Intervention to Support Family and Other Unpaid Carers of People With Dementia: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Ángel C Pinto-Bruno ◽  
Anne Margriet Pot ◽  
Annet Kleiboer ◽  
Rose-Marie Droes ◽  
Annemieke van Straten
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
The Netherlands ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Waiting List ◽  
Online Interventions ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
People With Dementia

BACKGROUND About three-quarters of people with dementia live in their own homes, with help from family members and/or other unpaid carers, such as friends or neighbors. Often, unpaid carers themselves experience negative consequences, such as stress, burden, and symptoms of depression or anxiety. Research has shown that these consequences can be alleviated by psychosocial and psychological interventions. Moreover, there are indications that those interventions can be effective when offered online. OBJECTIVE This paper describes the protocol of a randomized controlled trial (RCT) that will take place in the Netherlands to evaluate the effectiveness of iSupport, a minimally guided, internet-based intervention to improve carers’ mental health and coping resources. METHODS A superiority two-arm RCT comparing the effects of the online support program with a waiting list control condition will be carried out in the Netherlands. The iSupport intervention was developed by the World Health Organization and is based on cognitive behavioral therapy principles. It has five main themes divided into 23 lessons. Carers can pick and choose which lessons they want to complete. We aim to recruit 200 unpaid carers. The experimental group (n=100) will be provided with access to the intervention for 3 months following randomization; those in the waiting list control group (n=100) will be granted access to the intervention after 3 months. Assessments will be conducted at baseline (T0), 3 months after baseline (post intervention, T1), and 6 months after baseline (follow-up, T2). The primary outcome is perceived stress, measured by the Perceived Stress Scale. Secondary outcomes are symptoms of depression and anxiety, caregiver burden, sense of competence, self-efficacy, mastery, and carers’ attitudes toward dementia and their person-centered approach (ie, to what extent carers tailor the provided care to the interest, needs, and history of the person with dementia). RESULTS Recruitment for the trial started in January 2019. As of July 2019, we have enrolled 120 participants. Data collection is expected to be completed by March 2020. Once all the data have been collected, we will conduct the data analyses between April and May 2020. We aim to publish our results in a manuscript by June 2020. CONCLUSIONS Online interventions have shown promising results in improving the mental health of carers of people with dementia. Additionally, online interventions may overcome accessibility barriers. If successful, this intervention will have important potential for implementation as a public health intervention, since costs and support by trained staff are minimal. CLINICALTRIAL Netherlands Trial Register (NTL) NL6417; https://www.trialregister.nl/trial/6417 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/14106

Effectiveness of Prompt Mental Health Care: Preliminary results from a randomized controlled trial

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Knapstad ◽  
L V Lervik ◽  
S M M Saether ◽  
L E Aaroe ◽  
O R F Smith
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Mental Health Care ◽  
Controlled Trial ◽  
Sensitivity Analyses ◽  
Depression And Anxiety ◽  
Symptoms Of Depression ◽  
Randomized Controlled

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.

scholarly journals Effectiveness of an 8-Week Web-Based Mindfulness Virtual Community Intervention for University Students on Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial

10.2196/18595 ◽  
2020 ◽  
Vol 7 (7) ◽  
pp. e18595 ◽  
Author(s):  
Christo El Morr ◽  
Paul Ritvo ◽  
Farah Ahmad ◽  
Rahim Moineddin ◽  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Undergraduate Students ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Virtual Community ◽  
Depression And Anxiety ◽  
Discussion Forums ◽  
Web Based ◽  
Randomized Controlled

Background A student mental health crisis is increasingly acknowledged and will only intensify with the COVID-19 crisis. Given accessibility of methods with demonstrated efficacy in reducing depression and anxiety (eg, mindfulness meditation and cognitive behavioral therapy [CBT]) and limitations imposed by geographic obstructions and localized expertise, web-based alternatives have become vehicles for scaled-up delivery of benefits at modest cost. Mindfulness Virtual Community (MVC), a web-based program informed by CBT constructs and featuring online videos, discussion forums, and videoconferencing, was developed to target depression, anxiety, and experiences of excess stress among university students. Objective The aim of this study was to assess the effectiveness of an 8-week web-based mindfulness and CBT program in reducing symptoms of depression, anxiety, and stress (primary outcomes) and increasing mindfulness (secondary outcome) within a randomized controlled trial (RCT) with undergraduate students at a large Canadian university. Methods An RCT was designed to assess undergraduate students (n=160) who were randomly allocated to a web-based guided mindfulness–CBT condition (n=80) or to a waitlist control (WLC) condition (n=80). The 8-week intervention consisted of a web-based platform comprising (1) 12 video-based modules with psychoeducation on students’ preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences. The outcomes (depression, anxiety, stress, and mindfulness) were measured via an online survey at baseline and at 8 weeks postintervention using the Patient Health Questionnaire-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible covariates (gender, age, country of birth, ethnicity, English as first language, paid work, unpaid work, relationship status, physical exercise, self-rated health, and access to private mental health counseling). Results Of the 159 students who provided T1 data, 32 were males and 125 were females with a mean age of 22.55 years. Participants in the MVC (n=79) and WLC (n=80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work. At postintervention follow-up, according to the adjusted comparisons, there were statistically significant between-group reductions in depression scores (β=–2.21, P=.01) and anxiety scores (β=–4.82, P=.006), and a significant increase in mindfulness scores (β=4.84, P=.02) compared with the WLC group. There were no statistically significant differences in perceived stress for MVC (β=.64, P=.48) compared with WLC. Conclusions With the MVC intervention, there were significantly reduced depression and anxiety symptoms but no significant effect on perceived stress. Online mindfulness interventions can be effective in addressing common mental health conditions among postsecondary populations on a large scale, simultaneously reducing the current burden on traditional counseling services. Trial Registration ISRCTN Registry ISRCTN12249616; http://www.isrctn.com/ISRCTN12249616

scholarly journals Corrigendum

2018 ◽  
Vol 25 (12) ◽  
pp. NP1-NP2
Keyword(s):  
Mental Health ◽  
Health Psychology ◽  
Randomized Controlled Trial ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Randomized Controlled

Goldstein E, Topitzes J, Brown RL et al. (2018) Mediational pathways of meditation and exercise on mental health and perceived stress: A randomized controlled trial. Journal of Health Psychology. Epub ahead of print 7 May 2018. DOI: 10.1177/1359105318772608

scholarly journals Effectiveness of an 8-Week Web-Based Mindfulness Virtual Community Intervention for University Students on Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Christo El Morr ◽  
Paul Ritvo ◽  
Farah Ahmad ◽  
Rahim Moineddin ◽  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Undergraduate Students ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Virtual Community ◽  
Depression And Anxiety ◽  
Discussion Forums ◽  
Web Based ◽  
Randomized Controlled

BACKGROUND A student mental health crisis is increasingly acknowledged and will only intensify with the COVID-19 crisis. Given accessibility of methods with demonstrated efficacy in reducing depression and anxiety (eg, mindfulness meditation and cognitive behavioral therapy [CBT]) and limitations imposed by geographic obstructions and localized expertise, web-based alternatives have become vehicles for scaled-up delivery of benefits at modest cost. Mindfulness Virtual Community (MVC), a web-based program informed by CBT constructs and featuring online videos, discussion forums, and videoconferencing, was developed to target depression, anxiety, and experiences of excess stress among university students. OBJECTIVE The aim of this study was to assess the effectiveness of an 8-week web-based mindfulness and CBT program in reducing symptoms of depression, anxiety, and stress (primary outcomes) and increasing mindfulness (secondary outcome) within a randomized controlled trial (RCT) with undergraduate students at a large Canadian university. METHODS An RCT was designed to assess undergraduate students (n=160) who were randomly allocated to a web-based guided mindfulness–CBT condition (n=80) or to a waitlist control (WLC) condition (n=80). The 8-week intervention consisted of a web-based platform comprising (1) 12 video-based modules with psychoeducation on students’ preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences. The outcomes (depression, anxiety, stress, and mindfulness) were measured via an online survey at baseline and at 8 weeks postintervention using the Patient Health Questionnaire-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible covariates (gender, age, country of birth, ethnicity, English as first language, paid work, unpaid work, relationship status, physical exercise, self-rated health, and access to private mental health counseling). RESULTS Of the 159 students who provided T1 data, 32 were males and 125 were females with a mean age of 22.55 years. Participants in the MVC (n=79) and WLC (n=80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work. At postintervention follow-up, according to the adjusted comparisons, there were statistically significant between-group reductions in depression scores (β=–2.21, <i>P</i>=.01) and anxiety scores (β=–4.82, <i>P</i>=.006), and a significant increase in mindfulness scores (β=4.84, <i>P</i>=.02) compared with the WLC group. There were no statistically significant differences in perceived stress for MVC (β=.64, <i>P</i>=.48) compared with WLC. CONCLUSIONS With the MVC intervention, there were significantly reduced depression and anxiety symptoms but no significant effect on perceived stress. Online mindfulness interventions can be effective in addressing common mental health conditions among postsecondary populations on a large scale, simultaneously reducing the current burden on traditional counseling services. CLINICALTRIAL ISRCTN Registry ISRCTN12249616; http://www.isrctn.com/ISRCTN12249616

scholarly journals Mindfulness versus Physical Exercise: Effects of Two Recovery Strategies on Mental Health, Stress and Immunoglobulin A during Lunch Breaks. A Randomized Controlled Trial

2020 ◽  
Vol 17 (8) ◽  
pp. 2839
Author(s):  
Cintia Díaz-Silveira ◽  
Carlos-María Alcover ◽  
Francisco Burgos ◽  
Alberto Marcos ◽  
Miguel A. Santed
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Physical Exercise ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Time Factor ◽  
General Mental Health ◽  
Randomized Controlled ◽  
Interaction Factor ◽  
Recovery Strategies

This research analyses the effects of mindfulness meditation (MM) and physical exercise (PE), practised as daily recovery activities during lunch breaks, on perceived stress, general mental health, and immunoglobin A (IgA). A three-armed randomized controlled trial with 94 employees was conducted for five weeks including two follow-up sessions after one and six months. Daily practice lasted 30 min maximum. Perceived stress and general mental health questionnaires and saliva samples were used. There were significant differences in time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ) both for PE [Mdiff = 0.10, SE = 0.03, p = 0.03], and for MM [Mdiff = 0.09, SE = 0.03, p = 0.03]. Moreover, there were significant differences of interaction factor when comparing MM vs. PE in total score at pre-post [F = −2.62 (6, 168.84), p = 0.02, ω2 = 0.09], favoring PE with medium and high effect sizes. Regarding General Health Questionnaire (GHQ) variable, practicing MM showed significant effects in time factor compared to pre-Fup2. No significant differences were found for IgA. Thus, practicing both MM and PE as recovery strategies during lunch breaks could reduce perceived stress after five weeks of practice, with better results for PE. Moreover, practicing MM could improve mental health with effects for 6 months.

scholarly journals Assessing the Efficacy and Acceptability of a Web-Based Intervention for Resilience Among College Students: Pilot Randomized Controlled Trial

10.2196/20167 ◽  
2020 ◽  
Vol 4 (11) ◽  
pp. e20167
Author(s):  
Angel Enrique Roig ◽  
Olwyn Mooney ◽  
Alicia Salamanca-Sanabria ◽  
Chi Tak Lee ◽  
Simon Farrell ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Waiting List ◽  
Web Based ◽  
Randomized Controlled ◽  
Automated Support ◽  
Pilot Randomized Controlled Trial

Background College students are at elevated risk for developing mental health problems and face specific barriers around accessing evidence-based treatment. Web-based interventions that focus on mental health promotion and strengthening resilience represent one possible solution. Providing support to users has shown to reduce dropout in these interventions. Further research is needed to assess the efficacy and acceptability of these interventions and explore the viability of automating support. Objective This study investigated the feasibility of a new web-based resilience program based on positive psychology, provided with human or automated support, in a sample of college students. Methods A 3-armed closed pilot randomized controlled trial design was used. Participants were randomized to the intervention with human support (n=29), intervention with automated support (n=26), or waiting list (n=28) group. Primary outcomes were resilience and well-being, respectively measured by the Connor–Davidson Resilience Scale and Pemberton Happiness Index. Secondary outcomes included measures of depression and anxiety, self-esteem, and stress. Outcomes were self-assessed through online questionnaires. Intention-to-treat and per-protocol analyses were conducted. Results All participants demonstrated significant improvements in resilience and related outcomes, including an unexpected improvement in the waiting list group. Within- and between-group effect sizes ranged from small to moderate and within-group effects were typically larger for the human than automated support group. A total of 36 participants began the program and completed 46.46% of it on average. Participants were generally satisfied with the program and found it easy to use. Conclusions Findings support the feasibility of the intervention. Preliminary evidence for the equal benefit of human and automated support needs to be supported by further research with a larger sample. Results of this study will inform the development of a full-scale trial, from which stronger conclusions may be drawn. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 11866034; http://www.isrctn.com/ISRCTN11866034 International Registered Report Identifier (IRRID) RR2-10.1016/j.invent.2019.100254

scholarly journals Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Luisa Weiner ◽  
Fabrice Berna ◽  
Nathalie Nourry ◽  
François Severac ◽  
Pierre Vidailhet ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Perceived Stress ◽  
Healthcare Workers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Healthcare Systems ◽  
Randomized Controlled

Abstract Background The acknowledgment of the mental health toll of the COVID-19 epidemic in healthcare workers has increased considerably as the disease evolved into a pandemic status. Indeed, high prevalence rates of depression, sleep disorders, and post-traumatic stress disorder (PTSD) have been reported in Chinese healthcare workers during the epidemic peak. Symptoms of psychological distress are expected to be long-lasting and have a systemic impact on healthcare systems, warranting the need for evidence-based psychological treatments aiming at relieving immediate stress and preventing the onset of psychological disorders in this population. In the current COVID-19 context, internet-based interventions have the potential to circumvent the pitfalls of face-to-face formats and provide the flexibility required to facilitate accessibility to healthcare workers. Online cognitive behavioral therapy (CBT) in particular has proved to be effective in treating and preventing a number of stress-related disorders in populations other than healthcare workers. The aim of our randomized controlled trial study protocol is to evaluate the efficacy of the ‘My Health too’ CBT program—a program we have developed for healthcare workers facing the pandemic—on immediate perceived stress and on the emergence of psychiatric disorders at 3- and 6-month follow-up compared to an active control group (i.e., bibliotherapy). Methods Powered for superiority testing, this six-site open trial involves the random assignment of 120 healthcare workers with stress levels > 16 on the Perceived Stress Scale (PSS-10) to either the 7-session online CBT program or bibliotherapy. The primary outcome is the decrease of PSS-10 scores at 8 weeks. Secondary outcomes include depression, insomnia, and PTSD symptoms; self-reported resilience and rumination; and credibility and satisfaction. Assessments are scheduled at pretreatment, mid-treatment (at 4 weeks), end of active treatment (at 8 weeks), and at 3-month and 6-month follow-up. Discussion This is the first study assessing the efficacy and the acceptability of a brief online CBT program specifically developed for healthcare workers. Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers’ mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis. Trial registration ClinicalTrials.gov NCT04362358, registered on April 24, 2020.

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