scholarly journals Protocol For a Randomised Controlled Feasibility Study Examining the Efficacy of Brief Cognitive Therapy For the Treatment of Panic Disorder in Adolescents (PANDA)

2021 ◽  
Author(s):  
Polly Waite
Keyword(s):  
Young People ◽  
Panic Disorder ◽  
Anxiety Disorders ◽  
Cognitive Therapy ◽  
Controlled Trial ◽  
Randomised Control Trial ◽  
Definitive Trial ◽  
Co Morbidity ◽  
Randomised Controlled ◽  
Feasibility Rct

Abstract Background: Panic disorder occurs in between 1-3% of adolescents, is associated with high levels of co-morbidity, and without treatment, appears to have a chronic course. To improve access to effective psychological interventions, briefer versions of CBT have been developed and evaluated for pre-adolescent children with anxiety disorders. However, there are currently no brief evidence-based CBT interventions for adolescents with anxiety disorders that can be delivered in less than eight sessions. Given that a brief version of cognitive therapy has been shown to be effective in adults with panic disorder, with a large effect size, it is possible that an adapted version could be effective for adolescents with panic disorder.Methods: The study will examine whether a definitive trial can be conducted, based on a feasibility RCT using several well-defined criteria. The feasibility RCT is a single centre, randomised control trial. Between 30-48 young people (age 11-18 years) who meet diagnostic criteria for panic disorder, attending a routine clinical service, will be randomly allocated to receive either (i) brief cognitive therapy, or (ii) a general form of CBT treatment that is more commonly used for adolescents with anxiety disorders. Both will be delivered 1:1 by a therapist and involve five treatment sessions and two booster sessions. Young people’s outcomes will be assessed at the end of treatment and at 3 month follow up, and qualitative interviews will be conducted to examine acceptability. We will also explore outcomes 1-year after the completion of treatment. Discussion: This study will test the feasibility of a randomised controlled trial to compare brief cognitive therapy to a general form of CBT for adolescents with panic disorder in the UK. The outputs from the study will provide a clear indication of the feasibility of a future definitive trial and, if indicated, the critical resources that will be required and key information to inform the design and maximise the successful completion of the trial. This has the potential to bring direct benefits to young people and their families, as well as services and society more broadly.Trial Registration: This trial is registered on the ISRCTN Registry, registration number ISRCTN14884288, registered retrospectively on 05/12/2019.

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.

scholarly journals The 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.

2021 ◽  
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

Background: Post-traumatic stress disorder (PTSD) is a distressing and disabling condition that affects significant numbers of children and adolescents. Youth exposed to multiple traumas (e.g. 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 (TF-CBT). 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 (DECRYPT) randomised controlled trial (RCT) examines the effectiveness of CT-PTSD for treating PTSD following multiple trauma exposure in children and young people in comparison to treatment as usual (TAU). Methods/Design: This protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) to 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 (i.e. approximately five 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- 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 dissemination: This trial protocol has been approved by a UK Health Research Authority (HRA) 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 registration: ISRCTN, ISRCTN12077707. Registered 24th October 2016, http://www.isrctn.com/ISRCTN12077707

scholarly journals Impact of cognitive therapy on internalised stigma in people with at-risk mental states

2013 ◽  
Vol 203 (2) ◽  
pp. 140-145 ◽  
Author(s):  
Anthony P. Morrison ◽  
Max Birchwood ◽  
Melissa Pyle ◽  
Clare Flach ◽  
Suzanne L. K. Stewart ◽  
...  
Keyword(s):  
At Risk ◽  
Young People ◽  
Cognitive Therapy ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Mental States ◽  
Psychotic Experiences ◽  
Randomised Controlled ◽  
Negative Appraisals ◽  
At Risk Mental States

BackgroundInternalised stigma in young people meeting criteria for at-risk mental states (ARMS) has been highlighted as an important issue, and it has been suggested that provision of cognitive therapy may increase such stigma.AimsTo investigate the effects of cognitive therapy on internalised stigma using a secondary analysis of data from the EDIE-2 trial.MethodParticipants meeting criteria for ARMS were recruited as part of a multisite randomised controlled trial of cognitive therapy for prevention and amelioration of psychosis. Participants were assessed at baseline and at 6, 12, 18 and 24 months using measures of psychotic experiences, symptoms and internalised stigma.ResultsNegative appraisals of experiences were significantly reduced in the group assigned to cognitive therapy (estimated difference at 12 months was −1.36 (95% Cl −2.69 to −0.02), P = 0.047). There was no difference in social acceptability of experiences (estimated difference at 12 months was 0.46, 95% Cl −0.05 to 0.98, P = 0.079).ConclusionsThese findings suggest that, rather than increasing internalised stigma, cognitive therapy decreases negative appraisals of unusual experiences in young people at risk of psychosis; as such, it is a non-stigmatising intervention for this population.

scholarly journals Combining CBT and sertraline does not enhance outcomes for anxious youth: a double-blind randomised controlled trial

2021 ◽  
pp. 1-9
Author(s):  
Jennifer L. Hudson ◽  
Lauren F. McLellan ◽  
Valsamma Eapen ◽  
Ronald M. Rapee ◽  
Viviana Wuthrich ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Anxiety Disorders ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Anxiety Symptoms ◽  
Randomised Control Trial ◽  
Double Blind ◽  
Cognitive Behavioural ◽  
Anxious Youth ◽  
Randomised Controlled

Abstract Background Anxiety disorders are the most prevalent mental disorder in children and young people. Developing effective therapy for these children is critical to reduce mental disorders across the lifespan. The study aimed to evaluate the efficacy of combining cognitive behavioural therapy (CBT) and sertraline (SERT) in the treatment of anxiety in youth, using a double-blind randomised control trial design. Methods Ninety-nine youth (ages 7–15 years) with an anxiety disorder were randomly allocated to either individual (CBT) and SERT or individual CBT and pill placebo and assessed again immediately and 6 months after treatment. Results There were no significant differences between conditions in remission of primary anxiety disorder or all anxiety disorders. Furthermore, there were no significant differences in rates of change in diagnostic severity, parent-reported anxiety symptoms, child-reported anxiety symptoms or life interference due to anxiety. Conclusions The efficacy of CBT for children and adolescents with anxiety disorders is not significantly enhanced by combination with a short-term course of anti-depressants over and above the combined effects of pill placebo.

Experiential cognitive therapy (ECT) for the treatment of panic disorder with agoraphobia: A preliminary controlled trial

2003 ◽  
Author(s):  
Francesco Vincelli ◽  
S. Bouchard ◽  
Y. H. Choi ◽  
E. Molinari ◽  
B. Wiederhold ◽  
...  
Keyword(s):  
Panic Disorder ◽  
Cognitive Therapy ◽  
Controlled Trial

scholarly journals 71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Wrist Fracture ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Point Of Care Ultrasound ◽  
Distal Radial Fractures ◽  
Definitive Trial ◽  
Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

scholarly journals AB0903-HPR DURATION OF TELEPHONE CONSULTATIONS AMONGST RHEUMATOLOGY PRACTITIONERS IN A DISTRICT GENERAL HOSPITAL - ADAPTING TO REMOTE CONSULTATION IN A COVID-19 PANDEMIC

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1474.1-1474
Author(s):  
L. Parker ◽  
F. Coldstream
Keyword(s):  
General Hospital ◽  
Controlled Trial ◽  
Clinical Care ◽  
District General Hospital ◽  
British Society ◽  
Nice Guideline ◽  
Face To Face ◽  
Co Morbidity ◽  
Randomised Controlled ◽  
Remote Consultations

Background:The Covid-19 pandemic has resulted in a rapid adoption of remote consultations in order to limit face to face clinical contact wherever appropriate, as recommended by the British Society for Rheumatology. The same clinic templates which existed for face-to-face encounters have been retrospectively adapted, without consideration of any potential difference in duration of consultations. Rheumatology practitioners from a variety of clinical backgrounds work alongside the rheumatology consultants, providing clinical care to patients with both inflammatory arthritis and connective tissue disease.Objectives:To record the duration of all scheduled telephone consultations carried out by advances rheumatology practitioners in a 4-week period.Methods:All scheduled telephone clinic encounters over a 4-week period were timed and the duration recorded in a spreadsheet. Data was collected in real time by all 8 rheumatology advanced practitioners working within the rheumatology department of a district general hospital, following each clinic episode.Results:Data was recorded from a total of 337 clinic appointments. Of these, 317 (94%) were booked as routine, 3 (0.9%) as urgent, 4 (1.2%) were expedited following an advice line contact, and 13 (3.9%) no data was recorded. 28 (8%) of the patients did not answer when contacted. 80 (24%) clinic appointments lasted 15 minutes or less, 186 (55%) lasted 16 - 30 minutes, 37 (11%) lasted 31 - 45 minutes, and 6 (2%) lasted 46 - 60 minutes. The average duration was 22 minutes.Conclusion:Within this department, remote consultations appear to have a similar duration when compared against the traditional clinic template for a fully face-to-face clinic, with some encounters lasting significantly longer than the planned duration. This would appear to differ to telephone consultations used in other settings, such as general practice where the duration is reportedly shorter1. This may be representative of the additional complexity and co-morbidity of a typical rheumatology patient, or due to the multi-faceted nature of a rheumatology follow-up appointment2. Although remote consultations are effective in limiting risk of exposure to Covid-19, they may not offer a quicker or more efficient service compared with the face-to-face model. Further study in this field is required to evaluate this widely adopted new pattern of working.References:[1]Pinnock H, Bawden R, Proctor S, Wolfe S, Scullion J, Price D, Sheikh A. Accessibility, acceptability, and effectiveness in primary care of routine telephone review of asthma: pragmatic, randomised controlled trial. BMJ. 2003 Mar 1;326(7387):477-9. doi: 10.1136/bmj.326.7387.477. PMID: 12609944; PMCID: PMC150181.[2]National Institute for Health and Care Excellence (NICE) (2018) rheumatoid arthritis in adults: management (NICE Guideline NG100). Available at https://www.nice.org.uk/guidance/ng100 [Accessed 05 January 2021].Disclosure of Interests:None declared

Protocol for a feasibility randomised controlled trial comparing cognitive functional therapy with usual physiotherapy care in people with persistent low back pain

2021 ◽  
pp. 1-14
Author(s):  
Christopher Newton ◽  
Gurpreet Singh ◽  
David Nolan ◽  
Vicky Booth ◽  
Claire Diver ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Low Back ◽  
Functional Therapy ◽  
Randomised Controlled ◽  
The Uk ◽  
Feasibility Rct

BACKGROUND: Combined physical and psychological programmes (CPPP) are recommended for people with disabling low back pain (LBP). Cognitive Functional Therapy (CFT) is a physiotherapist-led low intensity CPPP with positive effects in previous studies. The clinical and cost effectiveness of CFT has not previously been evaluated in a randomised controlled trial (RCT) in the United Kingdom (UK) National Health Service (NHS). Before a definitive RCT can be completed it is necessary to determine if completing such a study is possible. PURPOSE: To determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care for people with persistent LBP in the UK NHS. METHODS: A pragmatic two-arm parallel feasibility RCT comparing CFT with usual physiotherapy care for people with persistent LBP will be completed. Sixty participants will be randomly allocated to receive CFT or usual physiotherapy care. The primary outcome will be feasibility of completing a definitive RCT. Participant reported outcome measures will be recorded at baseline, three, six and twelve-month follow-up, including disability, pain intensity, quality of life and psychosocial function. Data will be analysed descriptively. A qualitative process evaluation will explore the acceptability of the research processes and interventions. DISCUSSION: The rationale and methodological design of a mixed methods feasibility RCT is presented. This study aims to inform the planning, design and completion of a future definitive RCT in the UK NHS. The results will be disseminated through peer reviewed open access journal publication.

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