Feasibility and Acceptability of DemPower: A Couple Management App for Couples Where One Partner has a Dementia (Preprint)

2019 ◽  
Author(s):  
Reena Lasrado ◽  
Therese Bielsten ◽  
Mark Hann ◽  
James Schumm ◽  
Siobhan Reilly ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Self Management ◽  
Limited Attention ◽  
Post Intervention ◽  
Relational Networks ◽  
Health And Social Care ◽  
Diagnosis Of Dementia ◽  
Memory Clinics ◽  
Randomised Controlled ◽  
Study Participants

BACKGROUND The increasing rate of dementia and high health and social care costs call for effective measures to improve public health and enhance the wellbeing of people living with dementia and their relational networks. Most post diagnostic services focus on the condition and the person with dementia with limited attention to the spouse or partner caregiver. The key focus of the study is to develop a self-management guide for couples where one partner has a diagnosis of dementia. This couple self-management guide is delivered in the form of an app, DemPower. The contents of the app were organized into four main themes, ‘Home and Neighbourhood’, ‘Activities and Relationship’, ‘Meeting, Sharing and Caring’ ‘Communication and Emotions’. Each of these themes included a series of videos and activities for couples to do together. OBJECTIVE The study aimed to investigate the feasibility and acceptability of DemPower. METHODS The study used a non-randomized feasibility design. The study recruited 25 couples in the United Kingdom and 19 couples in Sweden. We aimed to complete the app within three months and collected usage data from the devices at the end of the study. Outcome measures were obtained at baseline and post intervention. RESULTS 21 couples completed the study (48%). Of these, 18 (86%) completed all parts of the app and each couple spent an average of 8hrs on the app during the study period. Among the four themes, ‘Home and Neighbourhood’ averaged 250 visits, ‘Activities and Relationship’ average 174 visits, ‘Meeting, Sharing and Caring’ average 160 and ‘Communication and Emotions’ received average 122 visits. Over the course of the study, participants visited suggested activities pages more frequently (average 95) than the core contents pages displaying section specific introductory videos (average 71) or videos of couples (average 69), for example taking pictures, physical exercise, talking to each other, walking, music and home adaptation checklist. CONCLUSIONS The findings suggest that the DemPower app is a useful resource for couples where one partner has a dementia and that its implementation requires the support of memory clinics to reach couples at early diagnosis. CLINICALTRIAL International Standard Randomised Controlled Trial Number (ISRCTN): 10122979; http://www.isrctn.com/ISRCTN10122979 (Archived by WebCite at http://www.webcitation.org/70rB1iWYI)

scholarly journals A Home-Based Couple Management Guide for Couples Affected by Dementia (DemPower): A Protocol (Preprint)

2017 ◽  
Author(s):  
Reena Lasrado ◽  
Therése Bielsten ◽  
Mark Hann ◽  
Linda Davies ◽  
James Schumm ◽  
...  
Keyword(s):  
Randomised Control Trial ◽  
Limited Attention ◽  
Post Intervention ◽  
Relational Networks ◽  
Home Based ◽  
Health And Social Care ◽  
Diagnosis Of Dementia ◽  
The Uk ◽  
Person With Dementia ◽  
Care Costs

BACKGROUND The increasing rate of dementia and high health and social care costs call for effective measures to improve public health and enhance the wellbeing of people living with dementia and their relational networks. Most post diagnostic services focus on the condition and the person with dementia with limited attention to the caring spouse/partner. The key focus of the study is to develop a guide for couples where one partner has a diagnosis of dementia. This couple-management guide is delivered in the form of an app, ‘DemPower’. OBJECTIVE The study aims to investigate the feasibility and acceptability of DemPower and assess the criteria for a full-integrated clinical and economic randomised control trial. METHODS DemPower couple-management app will be introduced to couples where one partner has dementia. The study will recruit 25 couples in the UK and 25 couples in Sweden. Couples will be given three months to engage with the app and the amount of time taken to complete the guide (it may be <3 months as well as >3) will be reviewed. A set of outcome measures will be obtained at baseline and post intervention stages. RESULTS The proposed study is at recruitment phase. The DemPower app is being introduced to couples from consultation groups at a pre-trial phase for identification of bugs and explore if any navigation challenges exist. The feasibility testing will begin in April 2018. CONCLUSIONS The study will determine how much support couples need to engage with DemPower and whether or not they make use of it in their everyday lives. If there is support for app use, a future study will assess whether it is superior to ‘usual care’. CLINICALTRIAL ISRCTN10122979

scholarly journals Lending an Ear: iPeer2Peer plus Teens Taking Charge online self-management to empower adolescents with arthritis in Ireland: protocol for a pilot randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e027952 ◽  
Author(s):  
Siobhan O'Higgins ◽  
Jennifer Stinson ◽  
Sara Ahola Kohut ◽  
Line Caes ◽  
Caroline Heary ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Support ◽  
Qualitative Content Analysis ◽  
Controlled Trial ◽  
Self Management ◽  
Advisory Panel ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Taking Charge ◽  
Randomised Controlled

IntroductionJuvenile idiopathic arthritis (JIA) negatively affects adolescents’ everyday activities. To address the need for innovative, effective, convenient, low-cost psychosocial self-management programmes, we developed an Irish version of Canadian Teens Taking Charge (TTC) and integrated it with Skype-based peer support iPeer2Peer (iP2P).ObjectivesTo explore the feasibility and preliminary outcome impact (effectiveness) of an integrated iP2P and Irish TTC, via three-arm (treatment as usual, TTC and iP2P–TTC) pilot randomised controlled trial (RCT); and determine feasibility and sample size for a full RCT. To ensure active involvement of adolescents with JIA via a Young Person Advisory Panel and examine how participants experienced the study. Finally, to see if TTC and iP2P with TTC reduce costs for families.Methods and analysisRecruitment of 60 families will be ongoing until July 2019, via healthcare professionals and support groups. Analysis will consist of single-blinded (outcome assessment), three-arm pilot RCT, using online questionnaires, with assessments at baseline (T1), after intervention (T2) and 3 months post-intervention (T3). The primary outcomes on feasibility with comparisons of TTC and iP2P–TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring. The secondary outcomes will be self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs.Participants from the intervention groups will be invited to share their perspectives on the process in semistructured interviews. Quantitative data will be analysed using SPSS V.21 and the audio-taped and transcribed qualitative data will be analysed using qualitative content analysis.DisseminationVia journal articles, conference presentations, co-delivered by key stakeholders when possible, launch of accessible, effective and sustainable Internet self-management and peer support for Irish adolescents with JIA.Trial registration numberISRCTN13535901; Pre-results.

Brief digital interventions to support the psychological well-being of NHS staff during the COVID-19 pandemic: a three-arm pilot randomised controlled trial (Preprint)

2021 ◽  
Author(s):  
Johannes De Kock ◽  
Helen Ann Latham ◽  
Richard G. Cowden ◽  
Breda Cullen ◽  
Katia Narzisi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Well Being ◽  
Rate Of Change ◽  
Mental Toughness ◽  
Psychological Interventions ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Health And Social Care ◽  
Randomised Controlled ◽  
Mental Well Being

BACKGROUND Health and social care staff are at high risk of experiencing adverse mental health outcomes during the COVID-19 pandemic. Hence, there is a need to prioritize and identify ways to effectively support their psychological wellbeing. Compared to traditional psychological interventions, digital psychological interventions are cost effective treatment options that allow for large-scale dissemination and transcend social distancing, overcome rurality, and minimize clinician time. OBJECTIVE This study reports outcomes of a CONSORT-compliant parallel-arm pilot randomised controlled trial (RCT) examining the potential usefulness of an existing and a novel digital psychological intervention aimed at supporting psychological health among NHS staff working through the COVID-19 pandemic. METHODS NHS Highland (NHSH) frontline staff volunteers (N = 169) were randomly assigned to the newly developed NHSH Staff Wellbeing Project (NHSWBP), an established digital intervention (My Possible Self; MPS), or to a waitlist (WL) condition for four weeks. Attempts were made to blind participants to which digital intervention they were allocated. The interventions were fully automated, without any human input or guidance. We measured five self-reported psychological outcomes over three time points: before (baseline), middle (after 2 weeks) and after treatment (4 weeks). The primary outcomes were anxiety (GAD-7), depression (PHQ-9) and mental well-being (Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes included mental toughness (Mental Toughness Index) and gratitude (the Gratitude Questionnaire). RESULTS Retention rates at middle and post-intervention were 77% (n = 130) and 63.3% (n = 107), respectively. At post-intervention, small differences were noted between the WL condition and the two treatment conditions on anxiety (vs. MPS: d = .07, 95% CI: -.20, .33; vs. NHSWBP: d = .06, 95% CI: -.19, .31), depression (vs. MPS: d = .37, 95% CI: .07, .66; vs. NHSWBP: d = .18, 95% CI: -.11, .46), and mental well-being (vs. MPS: d = -.04, 95% CI: -.62, -.08; vs. NHSWBP: d = -.15, 95% CI: -.41, .10). A similar pattern of between-group differences was found for the secondary outcomes. The NHSWBP group generally had larger within group effects than the other groups and displayed a greater rate of change compared to the other conditions on all outcomes, except for gratitude, where the rate of change was greatest for the MPS group. CONCLUSIONS Conclusions: Our analyses provided encouraging results for the use of brief digital psychological interventions in improving psychological well-being among health and social care workers. Future multi-site RCTs, with power to reliably detect differences, are needed to determine the efficacy of contextualised interventions relative to existing digital treatments. CLINICALTRIAL Trial registration: ISRCTN18107122

scholarly journals A community-based nurse-led medication self-management intervention in the improvement of medication adherence in older patients with multimorbidity: protocol for a randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chen Yang ◽  
Zhaozhao Hui ◽  
Dejian Zeng ◽  
Song Zhu ◽  
Xiuhua Wang ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Usual Care ◽  
Older Patients ◽  
Controlled Trial ◽  
Healthcare Providers ◽  
Self Management ◽  
Management Support ◽  
Post Intervention ◽  
Management Intervention ◽  
Randomised Controlled

Abstract Background Older patients suffering from multimorbidity are at high risk of medication nonadherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. However, little is known about the effect of the medication self-management intervention in older patients with multimorbidity. This paper presents the protocol for a study that aims to evaluate the effectiveness of a nurse-led medication self-management intervention in improving medication adherence and health outcomes for community-dwelling older patients with multimorbidity. Methods The study protocol follows the recommendations of the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This study is a multicentre, single-blind, two-arm randomised controlled trial. Older patients with multimorbidity will be recruited from three community health centres in Changsha, China. A total of 136 participants will be randomly allocated to receive usual care or usual care plus the medication self-management intervention. The intervention will be delivered by community nurses. The 6-week intervention includes three face-to-face education sessions and two weekly follow-up phone calls. Participants in the control group continue to receive all respects of usual care offered by community healthcare providers, including chronic disease management, drug prescription, referral to hospital specialists, health education and consultations regarding patients’ diseases and treatments during centre visits. The primary outcome is medication adherence as measured by the 5-item Medication Adherence Report Scale. Secondary outcomes include medication self-management capacity (medication knowledge, medication beliefs, medication social support, medication skills, and medication self-efficacy), treatment experiences (medication treatment satisfaction and treatment burden), quality of life, and utilisation of healthcare services. All outcomes will be measured at baseline, immediately post-intervention, and at 3-month post-intervention. Discussion This study will provide evidence about the effectiveness of a medication self-management intervention, delivered by nurses, for older patients with multimorbidity and adherence problems. It is expected that the results of the study, if proven effective in improving patients’ adherence and health outcomes, will provide evidence-based self-management support strategies for healthcare providers in routine chronic disease management in community settings. Trial registration The trial is registered at ChiCTR.org.cn (ChiCTR2000030011; date February 19, 2020).

scholarly journals Theory-based self-management intervention to improve adolescents’ asthma control: a cluster randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e025867 ◽  
Author(s):  
Katherine Harris ◽  
Gioia Mosler ◽  
Jonathan Grigg
Keyword(s):  
Asthma Control ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Self Management ◽  
Post Intervention ◽  
Management Intervention ◽  
Cluster Randomised ◽  
Children With Asthma ◽  
Randomised Controlled ◽  
The Uk

IntroductionAsthma-related morbidity and mortality in the UK is higher than elsewhere in Europe. Although the reasons for this are largely unclear, one explanation could be a higher prevalence of poorly controlled asthma in the UK. Findings from our earlier study found that, in a sample of 766 children with asthma, 45.7% had poorly controlled asthma. Our earlier study also showed that adherence to inhaled corticosteroids was low. Subsequent focus groups identified concerns regarding embarrassment and bullying as barriers to adherence, as well as forgetfulness and incorrect medication beliefs. Following this, a school-based self-management intervention has been developed, aimed to improve asthma control and self-management behaviours.Methods and analysisThe theory-based cluster randomised controlled trial tests an intervention comprising two components: (1) a theatre workshop for all children in years 7 and 8, and (2) self-management workshops for children with asthma. The COM-B model was used to guide the development of the intervention. Questionnaire data will be collected in schools at baseline, immediately post intervention, and 3, 6 and 12 months post intervention. The data collected at 6 months will measure the effect of the intervention against the baseline data. The primary outcome will be asthma control, measured using the Asthma Control Test. All the data will be analysed quantitatively using generalised linear and non-linear mixed effects models.Ethics and disseminationEthical approval was obtained by the Queen Mary University of London Ethics Committee on 12 April 2018. Regular meetings will be held with key patient and public stakeholders to plan the key messages from this research. Key messages from the study will also be tweeted via the project twitter account (@SchoolsAsthma). The findings of the study will be submitted for presentation at conferences, as well as written into a manuscript.Trial registration numberMGU0400

scholarly journals A pragmatic randomised controlled trial referring to a Personalised Self-management SUPport Programme (P-SUP) for persons enrolled in a disease management programme for type 2 diabetes mellitus and/or for coronary heart disease

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Uwe Konerding ◽  
Marcus Redaèlli ◽  
Karolin Ackermann ◽  
Sibel Altin ◽  
Sebastian Appelbaum ◽  
...  
Keyword(s):  
Disease Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Patient Activation ◽  
Self Management ◽  
Control Group ◽  
Randomised Controlled ◽  
Study Participants ◽  
Pragmatic Randomised Controlled Trial

Abstract Background Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: Meetings of peer support groups Personalised telephone-based health coaching for patients with low literacy and/or low patient activation Personalised patient feedback A browser-based web portal Methods Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention. Discussion If the intervention proves effective, it may be included into the DMPs for T2DM and CHD. Trial registration The study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network (https://www.drks.de/drks_web/setLocale_EN.do) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

scholarly journals EXPRESS: Telehealth coaching to improve self-management for secondary prevention after stroke: A randomized controlled trial of Stroke Coach

2021 ◽  
pp. 174749302110176
Author(s):  
Brodie M Sakakibara ◽  
Scott A Lear ◽  
Susan I Barr ◽  
Charles Goldsmith ◽  
Amy Schneeberg ◽  
...  
Keyword(s):  
Risk Factors ◽  
Controlled Trial ◽  
Cognitive Status ◽  
Self Management ◽  
Community Living ◽  
Memory Training ◽  
Stroke Survivors ◽  
Post Intervention ◽  
Lifestyle Behaviour ◽  
Mild Stroke

Background: Stroke Coach is a lifestyle coaching telehealth program to improve self-management of stroke risk factors. Aims: To examine the efficacy of Stroke Coach on lifestyle behaviour and risk factor control among community-living stroke survivors within one-year post stroke. Methods: Participants were randomized to Stroke Coach or an attention control Memory Training group. Lifestyle behaviour was measured using the Health Promoting Lifestyle Profile II. Secondary outcomes included specific behavioural and cardiometabolic risk factors, health-related quality of life (HRQoL), cognitive status, and depressive symptoms. Measurements were taken at baseline, post-intervention (6 months), and retention (12 month). Linear mixed-effects models were used to test the study hypotheses (p<0.05). All analyses were intention-to-treat. Results: The mean age of the Stroke Coach (n=64) and Memory Training (n=62) groups was 67.2 and 69.1 years, respectively. The majority of participants (n = 100) had mild stroke (modified Rankin Scale = 1 or 2), were active, with controlled blood pressure (mean = 129/79 mmHg) at baseline. At post-intervention, there were no significant differences in lifestyle (b = -2.87; 95%CI -8.03 to 2.29; p=0.28). Glucose control, as measured by HbA1c (b = 0.17; 95%CI 0.17 to 0.32; p=0.03), and HRQoL, measured using SF-36 Physical Component Summary (b = -3.05; 95%CI -5.88 to -0.21; p=0.04), were significantly improved in Stroke Coach compared to Memory Training, and the improvements were maintained at retention. Conclusion: Stroke Coach did not improve lifestyle behaviour, however, there were improvements to HbA1c and HRQoL among community-living stroke survivors with mild stroke-related disability. (ClinicalTrials.gov identifier: NCT02207023)

scholarly journals Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness–implementation randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e048350
Author(s):  
Monika Kastner ◽  
Julie Makarski ◽  
Leigh Hayden ◽  
Jemila S Hamid ◽  
Jayna Holroyd-Leduc ◽  
...  
Keyword(s):  
Older Adults ◽  
Chronic Disease ◽  
Randomised Controlled Trial ◽  
Disease Management ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Management Tool ◽  
Self Management ◽  
Plain Language ◽  
Randomised Controlled

IntroductionIn response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called ‘KeepWell’ that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.Methods and analysisWe will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness–implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.Ethics and disseminationEthics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.Trial registration numberNCT04437238.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

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