The views of children and young people on the use of silk garments for the treatment of eczema: a nested qualitative study within the CLOTHing for the relief of Eczema Symptoms (CLOTHES) randomized controlled trial

UNSTRUCTURED In recent years, research into internet-based cognitive behavioral therapy (iCBT) has suggested that therapist-guided digital interventions have greater engagement, adherence, and effectiveness than self-directed digital therapies. While research has focused on the effectiveness of, and adherence to, these interventions, less attention has been paid to their implementation in practice and what aspects of the therapist role support success. An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized. In light of the coronavirus disease 2019 (COVID-19) pandemic, there is greater emphasis on allowing patients access to remote therapies. We report the experiences and reflections of 4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention in a randomized controlled trial for children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial). Themes discussed include the importance of training, supervision, creating support documents/manuals, and record keeping. Alongside this are communication strategies used by therapists to encourage patient adherence and treatment effectiveness. These include rapport building, treatment personalization, and suggestions for overcoming non-engagement. These reflections offer important considerations for the delivery of iCBTs as well as implications associated with the implementation of these interventions in existing services and future research studies. We share thoughts on where iCBTs may sit in a stepped care model, how services may deal with comorbid conditions, and the potential role of iCBTs in collecting clinical data.

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Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) randomized controlled trial for children and young people

Trials ◽

10.1186/s13063-019-3974-3 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 2

Author(s):

K. Khan ◽

C. Hollis ◽

C. L. Hall ◽

E. B. Davies ◽

D. Mataix-Cols ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Young People ◽

Process Evaluation ◽

Qualitative Data ◽

Controlled Trial ◽

Clinical Care ◽

Behavioural Intervention ◽

Main Trial ◽

Children And Young People ◽

Randomized Controlled

Abstract Background Process evaluations are an important component in the interpretation and understanding of outcomes in trials. The Online Remote Behavioural Intervention for Tics (ORBIT) study is a randomized controlled trial evaluating the effectiveness of an Internet-delivered behavioural intervention (called BIP TIC) compared to an Internet-delivered education programme aimed at children and young people with tics. A process evaluation will be undertaken alongside the main trial to determine precisely how the behavioural intervention works and ascertain whether, and if so, how, the intervention could be successfully implemented in standard clinical practice. This protocol paper describes the rationale, aims, and methodology of the ORBIT trial process evaluation. Methods The process evaluation will have a mixed-methods design following the UK Medical Research Council 2015 guidelines, comprising both quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arm; purposively sampled, semi-structured interviews of parents and children, therapists and supervisors, and referring clinicians of the ORBIT trial, as well as analysis of qualitative comments put into the online therapy platform by participants at the end of treatment. Qualitative data will be analysed thematically. Quantitative and qualitative data will be integrated in a triangulation approach, to provide an understanding of how the intervention works, and what resources are needed for effective implementation, uptake and use in routine clinical care. Discussion This process evaluation will explore the experiences of participants, therapists and supervisors and referring clinicians of a complex online intervention. By contextualising trial efficacy results, this will help understand how and if the intervention worked and what may be required to sustain the implementation of the treatment long term. The findings will also aid in our understanding of factors that can affect the success of complex interventions. This will enable future researchers developing online behavioural interventions for children and young people with mental health and neurological disorders to gain invaluable information from this process evaluation. Trial registration International Standard Randomised Controlled Trials Number, ISRCTN70758207. Registered on 20 March 2018. ClinicalTrials.gov, NCT03483493. Registered on 30 March 2018.

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Therapist-Supported Online Interventions for Children and Young People With Tic Disorders: Lessons Learned From a Randomized Controlled Trial and Considerations for Future Practice

JMIR Mental Health ◽

10.2196/19600 ◽

2020 ◽

Vol 7 (10) ◽

pp. e19600 ◽

Cited By ~ 1

Author(s):

Liam R Chamberlain ◽

Charlotte L Hall ◽

Per Andrén ◽

E Bethan Davies ◽

Joseph Kilgariff ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Young People ◽

Controlled Trial ◽

Clinical Care ◽

Lessons Learned ◽

Tic Disorders ◽

Stepped Care ◽

Behavioural Intervention ◽

Children And Young People ◽

Randomized Controlled

In recent years, research into internet-based cognitive behavioral therapy (iCBT) has suggested that therapist-guided digital interventions have greater engagement, adherence, and effectiveness than self-directed digital therapies. While research has focused on the effectiveness of, and adherence to, these interventions, less attention has been paid to their implementation in practice and what aspects of the therapist role support success. An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized. In light of the coronavirus disease 2019 (COVID-19) pandemic, there is greater emphasis on allowing patients access to remote therapies. We report the experiences and reflections of 4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention in a randomized controlled trial for children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial). Themes discussed include the importance of training, supervision, creating support documents/manuals, and record keeping. Alongside this are communication strategies used by therapists to encourage patient adherence and treatment effectiveness. These include rapport building, treatment personalization, and suggestions for overcoming non-engagement. These reflections offer important considerations for the delivery of iCBTs as well as implications associated with the implementation of these interventions in existing services and future research studies. We share thoughts on where iCBTs may sit in a stepped care model, how services may deal with comorbid conditions, and the potential role of iCBTs in collecting clinical data.

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IVF, acupuncture and mental health: a qualitative study of perceptions and experiences of women participating in a randomized controlled trial of acupuncture during IVF treatment

Reproductive Biomedicine & Society Online ◽

10.1016/j.rbms.2020.08.004 ◽

2021 ◽

Vol 12 ◽

pp. 22-31

Author(s):

Sheryl de Lacey ◽

Elizabeth Sanderman ◽

Caroline A. Smith

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Qualitative Study ◽

Controlled Trial ◽

Randomized Controlled ◽

Experiences Of Women

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A Randomized Controlled Trial of a Specialist Liaison Worker Model for Young People with Intellectual Disabilities with Challenging Behaviour and Mental Health Needs

Journal of Applied Research in Intellectual Disabilities ◽

10.1111/j.1468-3148.2008.00457.x ◽

2009 ◽

Vol 22 (3) ◽

pp. 256-263 ◽

Cited By ~ 11

Author(s):

R. Raghavan ◽

R. Newell ◽

F. Waseem ◽

N. Small

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Young People ◽

Intellectual Disabilities ◽

Controlled Trial ◽

Health Needs ◽

Challenging Behaviour ◽

Mental Health Needs ◽

Randomized Controlled ◽

People With Intellectual Disabilities

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Patient and therapist experiences of using affordable feedback-based technology in rehabilitation: a qualitative study nested in a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215518771820 ◽

2018 ◽

Vol 32 (9) ◽

pp. 1258-1270 ◽

Cited By ~ 7

Author(s):

Caitlin Hamilton ◽

Annie McCluskey ◽

Leanne Hassett ◽

Maggie Killington ◽

Meryl Lovarini

Keyword(s):

Randomized Controlled Trial ◽

Qualitative Study ◽

Patient Engagement ◽

Controlled Trial ◽

Aged Care ◽

Theory Approach ◽

Post Discharge ◽

Randomized Controlled ◽

The Right ◽

Two Stages

Objective: To explore how technologies are used and experienced in rehabilitation. Design: A qualitative study using a grounded theory approach within a randomized controlled trial investigating the effectiveness of tailored, affordable technologies to improve mobility and physical activity. Settings: Aged care and neurological rehabilitation wards with community follow-up. Participants: Twenty patients undergoing rehabilitation and randomized to the experimental arm of a trial (mean age 64 years (SD 23)) were recruited for interviews, plus 11 physiotherapists involved in technology prescription as part of the trial. Method: Two interviews per patient (one in hospital, one post-discharge) and four focus groups with physiotherapists were conducted. Transcribed data were coded and synthesized. Memo-writing and constant comparison methods guided data analysis. Results: A process of patient engagement with technology involving two stages: (1) initial patient engagement and (2) maintaining patient engagement was identified. Therapists used a series of steps and strategies to gain and maintain patient engagement. A positive first experience and continued input into patient programmes was needed. The level of patient engagement was not consistent across the duration of the trial, increasing or decreasing due to changes in the technologies prescribed or setting of use. Two conditions were key to optimizing patient engagement: sufficient support and perceived benefit from using technology. Conclusions: Patients can engage with technology during rehabilitation when prescription is tailored by a therapist. Perceiving benefit from using technology, in addition to receiving the right support to enable use appears to influence the level of patient engagement.

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