scholarly journals Mixed methods pilot evaluation of interpersonal psychotherapy for body image for adolescents

2020 ◽  
pp. 135910452096337
Author(s):  
Fiona Duffy ◽  
Helen Sharpe ◽  
Emily Beveridge ◽  
Kate Osborne ◽  
Cathy Richards
Keyword(s):  
Body Image ◽  
Young People ◽  
Body Dissatisfaction ◽  
Clinical Outcomes ◽  
Group Intervention ◽  
Treatment Satisfaction ◽  
Controlled Trial ◽  
Interpersonal Psychotherapy ◽  
Post Intervention ◽  
Randomised Controlled

Body dissatisfaction is common in adolescence and associated with poor outcomes. The aim of this mixed method pilot evaluation was to determine acceptability, feasibility and preliminary efficacy of Interpersonal Psychotherapy for Body Image (IPT-BI), a school-based group intervention for young people with high levels of body dissatisfaction. Eighteen participants (11–13 years, 78% female) took part in two IPT-BI groups ( n = 10; n = 8). Feasibility was measured by recruitment and attrition rates; acceptability using a treatment satisfaction questionnaire and focus groups; and clinical outcomes at baseline, each session and post intervention. The majority of young people (72%, n = 18/25) who were referred or expressed interest went on to take part. Average session attendance was 100% and 89%. Participants expressed high levels of treatment satisfaction with 94% ( n = 16/17) rating IPT-BI as ‘quite helpful’ or ‘very helpful’ and 94% ( n = 16/17) stating they would recommend it to others. Preliminary exploration of efficacy showed significant improvements in body image and significant reductions in interpersonal difficulties and appearance-based conversations. Young people valued specific IPT-BI skills (role play, communication strategies), alongside generic therapeutic factors (therapeutic alliance, group cohesion). IPT-BI is feasible and acceptable with promising provisional clinical outcomes indicating the need for a fully powered randomised controlled trial.

scholarly journals Protocol for the RELATE trial: a feasibility and pilot randomised controlled trial of a low-intensity group intervention for young people in care with elevated posttraumatic stress symptoms

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Rachel M. Hiller ◽  
Rebecca S. Davis ◽  
John Devaney ◽  
Sarah L. Halligan ◽  
Richard Meiser-Stedman ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Young People ◽  
Posttraumatic Stress ◽  
Group Intervention ◽  
Social Care ◽  
Controlled Trial ◽  
Good Evidence ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Introduction Young people in out-of-home care have often experienced trauma, such as direct maltreatment or witnessing violence. There is good evidence that rates of mental health difficulties are high in this group, including posttraumatic stress disorder (PTSD), a trauma-specific mental health outcome. There remains less evidence to guide how to effectively address elevated PTSD symptoms (PTSS) in these young people, particularly in ways that are feasible and scalable for stretched social-care and mental health services. Methods and analysis This protocol describes a feasibility study comprising a pilot two-arm randomised controlled trial (RCT). Participants (N = 50) will be randomised to either (a) a group-based trauma-focused programme (Teaching Recovery Techniques), delivered by mental health practitioners both online and in-person, or (b) care-as-usual. Primarily, the trial aims to explore the key feasibility and protocol acceptability questions, including rates of recruitment and retention, as well as the acceptability of the intervention (particularly the online delivery format) to participants and services. In addition, outcomes including PTSS (primary clinical outcome), depression and functioning will be assessed at baseline (pre-randomisation), post-intervention and at a 3-month follow-up. Ethics and dissemination Ethical approval has been received from the Health Research Authority (Wales REC1 Ref 20/WA/0100) and University, with further approval from the host trust and social care site. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries. Trial registration ClinicalTrials.gov, NCT04467320. Registered on 13 July 2020.

scholarly journals Evaluating the effect of Brainfood groups for people with mild cognitive impairment and mild dementia: preliminary mixed-methodology study

BJPsych Open ◽  
2018 ◽  
Vol 4 (4) ◽  
pp. 208-214 ◽  
Author(s):  
Saba Hassan ◽  
Elisa Aguirre ◽  
Anna Betz ◽  
Sarah Robertson ◽  
Deepak Sankhla ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Group Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Post Intervention ◽  
Mild Dementia ◽  
Creative Commons ◽  
Mediterranean Diet Adherence ◽  
Randomised Controlled

BackgroundBrainfood is a 5-week group intervention for people with mild cognitive impairment and mild dementia, promoting cognitive health through a Mediterranean-style diet, exercise, mindfulness and health self-management.AimsTo evaluate Brainfood acceptability and the feasibility of conducting a randomised controlled trial; in a single group study in two National Health Service (NHS) memory services.MethodParticipants self-completed quantitative and semi-structured questionnaires. Recruitment, attendance and outcome completion were the primary outcomes.ResultsIn total, 30 of 59 people invited to Brainfood attended; of the 26 (87%) who completed baseline measures: 25 (96%) completed post-intervention quantitative measures, 16 (67%) qualitative questions and 21 (81%) attended ≥3/5 sessions. Compared with baseline, participants reported significantly higher quality of life, Mediterranean diet adherence and exercising more, up to 2 months after the groups. Participants valued the groups and felt enabled to improve their well-being.ConclusionsBrainfood was acceptable and feasible to implement in an NHS setting.Declaration of interestA.B. and C.C. developed Brainfood – they hold a creative commons license for the manual and make it available to use for free to all. The manual evolves iteratively, but the manual used in this research study is provided in an online supplement.

scholarly journals Treating sleep problems in young people at ultra-high-risk of psychosis: study protocol for a single-blind parallel group randomised controlled feasibility trial (SleepWell)

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e045235
Author(s):  
Felicity Waite ◽  
Thomas Kabir ◽  
Louise Johns ◽  
Jill Mollison ◽  
Apostolos Tsiachristas ◽  
...  
Keyword(s):  
Mental Health ◽  
High Risk ◽  
Young People ◽  
Sleep Problems ◽  
Qualitative Interviews ◽  
Feasibility Trial ◽  
Psychotic Experiences ◽  
Post Intervention ◽  
Ultra High Risk ◽  
Randomised Controlled

BackgroundEffective interventions, targeting key contributory causal factors, are needed to prevent the emergence of severe mental health problems in young people. Insomnia is a common clinical issue that is problematic in its own right but that also leads to the development and persistence of psychotic experiences. The implication is that treating sleep problems may prevent the onset of psychosis. We collected initial case series data with 12 young people at ultra-high-risk of psychosis. Post-intervention, there were improvements in sleep, depression and psychotic experiences. Now we test the feasibility of a randomised controlled trial, with a clinical aim to treat sleep problems and hence reduce depression, psychotic experiences, and prevent transition to psychosis.Methods and analysisA randomised controlled feasibility trial will be conducted. Forty patients aged 14 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 months (follow-up). The eight-session psychological intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants’ views on the acceptability of the intervention and study procedures, 16 participants (n=10 intervention, n=6 control) will take part in qualitative interviews. Analyses will focus on feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial CI estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention and trial procedures.Ethics and disseminationThe trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks.Trial registration numberISRCTN85601537.

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.

scholarly journals Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Williams ◽  
Charlotte L. Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Link Type ◽  
Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

scholarly journals DECRYPT trial: study protocol for a phase II randomised controlled trial of cognitive therapy for post-traumatic stress disorder (PTSD) in youth exposed to multiple traumatic stressors

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e047600
Author(s):  
Leila Allen ◽  
Polly-Anna Ashford ◽  
Ella Beeson ◽  
Sarah Byford ◽  
Jessica Chow ◽  
...  
Keyword(s):  
Young People ◽  
Cognitive Therapy ◽  
Multiple Trauma ◽  
Traumatic Stress ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Children And Young People ◽  
Post Traumatic ◽  
Randomised Controlled ◽  
Post Randomisation

BackgroundPost-traumatic stress disorder (PTSD) is a distressing and disabling condition that affects significant numbers of children and adolescents. Youth exposed to multiple traumas (eg, abuse, domestic violence) are at particular risk of developing PTSD. Cognitive therapy for PTSD (CT-PTSD), derived from adult work, is a theoretically informed, disorder-specific form of trauma-focused cognitive–behavioural therapy. While efficacious for child and adolescent single-event trauma samples, its effectiveness in routine settings with more complex, multiple trauma-exposed youth has not been established. The Delivery of Cognitive Therapy for Young People after Trauma randomised controlled trial (RCT) examines the effectiveness of CT-PTSD for treating PTSD following multiple trauma exposure in children and young people in comparison with treatment as usual (TAU).Methods/designThis protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) with TAU (n=60) in children and young people aged 8–17 years with a diagnosis of PTSD following multiple trauma exposure. The primary outcome is PTSD severity assessed using the Children’s Revised Impact of Event Scale (8-item version) at post-treatment (ie, approximately 5 months post-randomisation). Secondary outcomes include structured interview assessment for PTSD, complex PTSD symptoms, depression and anxiety, overall functioning and parent-rated mental health. Mid-treatment and 11-month and 29-month post-randomisation assessments will also be completed. Process–outcome evaluation will consider which mechanisms underpin or moderate recovery. Qualitative interviews with the young people, their families and their therapists will be undertaken. Cost-effectiveness of CT-PTSD relative to TAU will be also be assessed.Ethics and disseminationThis trial protocol has been approved by a UK Health Research Authority Research Ethics Committee (East of England–Cambridge South, 16/EE/0233). Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations and clinical workshops.Trial registrationISRCTN12077707. Registered 24 October 2016 (http://www.isrctn.com/ISRCTN12077707). Trial recruitment commenced on 1 February 2017. It is anticipated that recruitment will continue until June 2021, with 11-month assessments being concluded in May 2022.

Suicide Prevention in First Episode Psychosis: The Development of a Randomised Controlled Trial of Cognitive Therapy for Acutely Suicidal Patients With Early Psychosis

2003 ◽  
Vol 37 (4) ◽  
pp. 414-420 ◽  
Author(s):  
P.J.R. Power ◽  
R.J. Bell ◽  
R. Mills ◽  
T. Herrman-Doig ◽  
M. Davern ◽  
...  
Keyword(s):  
Early Intervention ◽  
Treatment Group ◽  
Young People ◽  
Controlled Trial ◽  
First Episode Psychosis ◽  
Early Psychosis ◽  
First Episode ◽  
Episode Psychosis ◽  
Randomised Controlled ◽  
Suicidal Patients

Background: Young people with early psychosis are at particularly high risk of suicide. However, there is evidence that early intervention can reduce this risk. Despite these advances, first episode psychosis patients attending these new services still remain at risk. To address this concern, a program called LifeSPAN was established within the Early Psychosis Prevention and Intervention Centre (EPPIC). The program developed and evaluated a number of suicide prevention strategies within EPPIC and included a cognitively oriented therapy (LifeSPAN therapy) for acutely suicidal patients with psychosis. We describe the development of these interventions in this paper. Method: Clinical audit and surveys provided an indication of the prevalence of suicidality among first episode psychosis patients attending EPPIC. Second, staff focus groups and surveys identified gaps in service provision for suicidal young people attending the service. Third, a suicide risk monitoring system was introduced to identify those at highest risk. Finally, patients so identified were referred to and offered LifeSPAN therapy whose effectiveness was evaluated in a randomised controlled trial. Results: Fifty-six suicidal patients with first episode psychosis were randomly assigned to standard clinical care or standard care plus LifeSPAN therapy. Forty-two patients completed the intervention. Clinical ratings and measures of suicidality and risk were assessed before, immediately after the intervention, and 6 months later. Benefits were noted in the treatment group on indirect measures of suicidality, e.g., hopelessness. The treatment group showed a greater average improvement (though not significant) on a measure of suicide ideation. Conclusions: Early intervention in psychosis for young people reduces the risk of suicide. Augmenting early intervention with a suicide preventative therapy may further reduce this risk.

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