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)

IntroductionSelf-harm in prison is a major public health concern. Less than 5% of UK prisoners are women, but they carry out more than a fifth of prison self-harm. Scars resulting from self-harm can be traumatising and stigmatising, yet there has been little focus on recovery of women prisoners with self-harm scarring. Medical skin camouflage (MSC) clinics treat individuals with disfiguring skin conditions, with evidence of improved well-being, self-esteem and social interactions. Only one community study has piloted the use of MSC for self-harm scarring.Methods and analysisWe describe an acceptability and feasibility pilot randomised controlled trial; the first to examine MSC for women prisoners who self-harm. We aim to randomise 20–25 women prisoners to a 6-week MSC intervention and 20–25 to a waitlist control (to receive the MSC after the study period). We aim to train at least 6–10 long-term prisoners with personal experience of self-harm to deliver the intervention. Before and after intervention, we will pilot collection of women-centred outcomes, including quality of life, well-being and self-esteem. We will pilot collection of self-harm incidents during the intervention, resources used to manage/treat self-harm and follow-up of women at 12 weeks from baseline. Data on recruitment, retention and dropout will be recorded. We aim for the acceptability of the intervention to prison staff and women prisoners to be explored in qualitative interviews and focus groups.Ethics and disseminationEthical approval for COVER has been granted by the North East–York Research Ethics Committee (REC) for phases 1 and 2 (reference: 16/NE/0030) and West of Scotland REC 3 for phases 3 and 4 (reference: 16/WS/0155). Informed consent will be the primary consideration; it will be made clear that participation will have no effect on life in prison or eligibility for parole. Due to the nature of the study, disclosures of serious self-harm may need to be reported to prison officials. We aim for findings to be disseminated via events at the study prison, presentations at national/international conferences, journal publications, prison governor meetings and university/National Health Service trust communications.Trial registration numberNCT02638974; Pre-results.

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Effects of a novel positive psychological intervention on prenatal stress and well-being: A pilot randomised controlled trial

Women and Birth ◽

10.1016/j.wombi.2016.10.003 ◽

2017 ◽

Vol 30 (2) ◽

pp. e111-e118 ◽

Cited By ~ 28

Author(s):

Karen Matvienko-Sikar ◽

Samantha Dockray

Keyword(s):

Randomised Controlled Trial ◽

Prenatal Stress ◽

Psychological Intervention ◽

Controlled Trial ◽

Well Being ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled ◽

Positive Psychological Intervention

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Online single-session interventions for Kenyan adolescents: study protocol for a comparative effectiveness randomised controlled trial

General Psychiatry ◽

10.1136/gpsych-2020-100446 ◽

2021 ◽

Vol 34 (3) ◽

pp. e100446

Author(s):

Akash R Wasil ◽

Tom Lee Osborn ◽

John R Weisz ◽

Robert J DeRubeis

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Comparative Effectiveness ◽

Mental Health Problems ◽

Controlled Trial ◽

Well Being ◽

Single Session ◽

Post Intervention ◽

Digital Interventions ◽

Randomised Controlled

BackgroundMental health problems are the leading cause of disability among adolescents worldwide, yet access to treatment is limited. Brief digital interventions have been shown to improve youth mental health, but little is known about which digital interventions are most effective.AimsTo evaluate the effectiveness of two digital single-session interventions (Shamiri-Digital and Digital-CBT (cognitive-behavioural therapy)) among Kenyan adolescents.MethodsWe will perform a school-based comparative effectiveness randomised controlled trial. Approximately 926 Kenyan adolescents will be randomly assigned to one of three conditions: Shamiri-Digital (focused on gratitude, growth mindsets and values), Digital-CBT (focused on behavioural activation, cognitive restructuring and problem solving) or a study-skills control condition (focused on note-taking and essay writing skills). The primary outcomes include depressive symptoms (measured by the Patient Health Questionnaire-8), anxiety symptoms (Generalized Anxiety Disorder Screener-7) and subjective well-being (Short Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes include acceptability, appropriateness, primary control and secondary control. Acceptability and appropriateness will be measured immediately post-intervention; other outcomes will be measured 2 weeks, 4 weeks and 12 weeks post-intervention.ResultsWe hypothesise that adolescents assigned to Shamiri-Digital and adolescents assigned to Digital-CBT will experience greater improvements (assessed via hierarchical linear models) than those assigned to the control group. We will also compare Shamiri-Digital with Digital-CBT, although we do not have a preplanned hypothesis.ConclusionsOur findings will help us evaluate two digital single-session interventions with different theoretical foundations. If effective, such interventions could be disseminated to reduce the public health burden of common mental health problems.Trial registration numberPACTR202011691886690.

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Evaluating the impact of a common elements-based intervention to improve maternal psychological well-being and mother–infant interaction in rural Pakistan: study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-047609 ◽

2021 ◽

Vol 11 (7) ◽

pp. e047609

Author(s):

Zill-e- Huma ◽

Ayella Gillani ◽

Fakhira Shafique ◽

Alina Rashid ◽

Bushra Mahjabeen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Well Being ◽

Common Elements ◽

Psychological Well Being ◽

Low Resource Settings ◽

Low Resource ◽

Secondary Outcomes ◽

Randomised Controlled ◽

Self Reporting Questionnaire

IntroductionMillions of children in low resource settings are at high risk of poor development due to factors such as under nutrition, inadequate stimulation and maternal depression. Evidence-based interventions to address these risk factors exist, but often as a separate and overlapping package. The current study aims to evaluate the effectiveness of a common elements-based intervention to improve mother–infant interaction at 12 months post-partum.Method and analysisA two-arm, single-blinded, individual randomised controlled trial is being carried out in the community settings of the rural subdistrict of Gujar Khan in Rawalpindi, Pakistan. 250 pregnant women in third trimester with distress (Self-Reporting Questionnaire, cut-off score >9) have been randomised on 1:1 allocation ratio into intervention (n=125) and treatment-as-usual arms (n=125). The participants in the intervention arm will receive 15 individual sessions of intervention on a monthly basis by non-specialist facilitators. The intervention involves components of early stimulation, learning through play, responsive feeding, guided discovery using pictures, behavioural activation and problem solving. The primary outcome is caregiver–infant interaction at 12 months postpartum. The secondary outcomes include maternal psychological well-being, quality of life, social support and empowerment. Infant secondary outcomes include growth, nutrition and development. The data will be collected at baseline, 6 and 12 months postpartum. A qualitative process evaluation will be conducted to inform the feasibility of intervention delivery.EthicsEthics approval for the present study was obtained from the Human Development Research Foundation Institutional Review Board, Islamabad Pakistan.DisseminationIf proven effective, the study will contribute to scale-up care for maternal and child mental health in low resource settings, globally. The findings of the present study will be published in peer-reviewed journals and presented at conferences and community forums.Trial registration numberNCT04252807.

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