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Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial.

ABSTRACT: BACKGROUND:Persistent physical symptoms (PPS), also known as medically unexplained symptoms (MUS), affect approximately 50% of patients in secondary care and are often associated with disability, psychological distress and increased health care costs. Cognitive behavioural therapy (CBT) has demonstrated both short- and long-term efficacy with small to medium effect sizes for PPS, with larger treatment effects for specific PPS syndromes, including non-cardiac chest pain, irritable bowel syndrome (IBS) and chronic fatigue syndrome (CFS). Research indicates that PPS conditions share similar cognitive and behavioural responses to symptoms, such as avoidance and unhelpful beliefs. This suggests that a transdiagnostic approach may be beneficial for patients with PPS. METHODS:A randomised controlled trial (RCT) will be conducted to evaluate the efficacy and cost-effectiveness of a transdiagnostic CBT-based intervention for PPS. 322 participants with PPS will be recruited from secondary care clinics. Participants stratified by clinic and disability level will be randomised to CBT plus standard medical care (SMC) versus SMC alone. The intervention consists of 8 CBT sessions delivered by a qualified therapist over a period of 20?weeks. Outcomes will be assessed at 9, 20, 40- and 52-weeks post randomisation. Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52?weeks after randomisation. Secondary outcomes will include mood, symptom severity and clinical global impression at 9, 20, 40 and 52?weeks. Cost-effectiveness will be evaluated by combining measures of health service use, informal care, loss of working hours and financial benefits at 52?weeks. DISCUSSION:This trial will provide a powered evaluation of the efficacy and cost-effectiveness of a transdiagnostic CBT approach versus SMC for patients with PPS. It will also provide valuable information about potential healthcare pathways for patients with PPS within the National Health Service (NHS). TRIAL REGISTRATION:ClinicalTrials.gov NCT02426788. Registered 27 April 2015. Overall trial status: Ongoing; Recruitment status: No longer recruiting.

SUBMITTER: Chalder T

PROVIDER: S-EPMC6805658 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial.

Chalder Trudie T Patel Meenal M James Kirsty K Hotopf Matthew M Frank Philipp P Watts Katie K McCrone Paul P David Anthony A Ashworth Mark M Husain Mujtaba M Garrood Toby T Moss-Morris Rona R Landau Sabine S

BMC psychiatry 20191022 1

<h4>Background</h4>Persistent physical symptoms (PPS), also known as medically unexplained symptoms (MUS), affect approximately 50% of patients in secondary care and are often associated with disability, psychological distress and increased health care costs. Cognitive behavioural therapy (CBT) has demonstrated both short- and long-term efficacy with small to medium effect sizes for PPS, with larger treatment effects for specific PPS syndromes, including non-cardiac chest pain, irritable bowel s ...[more]

PMID: 31640632

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Project description:IntroductionPersistent physical symptoms (PPS), also known as medically unexplained symptoms are associated with profound physical disability, psychological distress and high healthcare costs. England's annual National Health Service costs of attempting to diagnose and treat PPS amounts to approximately £3 billion. Current treatment relies on a positive diagnosis, life-style advice and drug therapy. However, many patients continue to suffer from ongoing symptoms and general practitioners (GPs) are challenged to find effective treatments. Training GPs in basic cognitive behavioural skills and providing self-help materials to patients could be useful, but availability in primary care settings is limited.Methods and analysisA cluster randomised waiting list, controlled trial will be conducted to assess the feasibility of an integrated approach to care in general practice. Approximately 240 patients with PPS will be recruited from 8 to 12 GP practices in London. GP practices will be randomised to 'integrated GP care plus treatment as usual' or waiting list control. Integrated GP care plus treatment as usual will include GP training in cognitive behavioural skills, GP supervision and written and audio visual materials for both GPs and participants. The primary objectives will be assessment of trial and intervention feasibility. Secondary objectives will include estimating the intracluster correlation coefficient for potential outcome measures for cluster effects in a sample size calculation. Feasibility parameters and identification of suitable primary and secondary outcomes for future trial evaluations will be assessed prerandomisation and at 12 and 24 weeks' postrandomisation, using a mixed-methods approach.Ethics and disseminationEthical approval was granted by the Camberwell St Giles Ethics Committee. Results will be disseminated via peer-reviewed publications and conference presentations. This trial will inform researchers, clinicians, patients and healthcare providers about the feasibility and potential cost-effectiveness of an integrated approach to managing PPS in primary care.Trial registration numberNCT02444520; Pre-results.

Project description:BackgroundPatients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an 'integrated GP care' approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit.MethodsA feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to 'integrated GP care plus treatment as usual' or 'treatment as usual'. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level.ResultsTwo thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small.ConclusionsIt was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients'/GPs' utilisation of audio/visual and training resources before proceeding to a full trial evaluation.Trial registrationNCT02444520 (ClinicalTrials.gov).

Project description:BackgroundThere is a need for long-term effectiveness trials of transdiagnostic treatments. This study investigates the effectiveness and diagnosis-specific trajectories of change in adolescent patients attending SMART, a 6-week transdiagnostic CBT for anxiety and depression, with 6-month follow-up.MethodsA randomized controlled trial with waiting list control (WLC) was performed at three child and adolescent mental health outpatient services (CAMHS) in Norway. Referred adolescents (N = 163, age = 15.72, 90.3% females) scoring 6 or more on the emotional disorders subscale of the Strengths and Difficulties Questionnaire (SDQ) were randomly assigned to treatment or to WLC. Long-term follow-up (N = 83, baseline age = 15.57, 94% females) was performed 6 months after treatment completion (Mean = 7.1 months, SD = 2.5). Linear mixed model analysis was used to assess time by group effects in patients with no diagnosis, probable anxiety, depressive disorder, and combined anxiety and depressive disorder.ResultsAlmost one third (31%) obtained full recovery according to the inclusion criterium (SDQ emotional). There was highly significant change in all outcome variables. Effect sizes (ES) were largest for general functioning, measured with CGAS (ES: d = 2.19), and on emotional problems measured with SDQ (ES: d = 2.10), while CORE-17, BDI-II and CGAS all obtained ES's close to 1. There were no significant time by diagnostic group interactions for any outcomes, indicating similar trajectories of change, regardless of diagnostic group. Waiting 6 weeks for treatment had no significant impact on long-term treatment effects.LimitationsPossible regression to the mean. Attrition from baseline to follow-up.ConclusionsSix weeks of transdiagnostic treatment for adolescents with emotional problems showed highly significant change in emotional symptoms and functioning at 6-month follow-up. Patients with anxiety, depression, combined anxiety and depression, and emotional problems with no specific diagnoses, all had similar trajectories of change. Hence this transdiagnostic SMART treatment can be recommended for adolescent patients with symptoms within the broad spectrum of emotional problems.Trial registrationClinicalTrials.gov Identifier: NCT02150265. First registered May 29, 2014.

Project description:IntroductionEmotional disorders (anxiety and depressive disorders) are a relevant public health concern associated with high prevalence, high costs, and important disability. Therefore, research priorities include designing and testing cost-effective interventions to reach everyone in need. Internet-delivered interventions for emotional disorders are effective and can help to disseminate and implement evidence-based treatments. However, although these treatments are generally effective, not all patients benefit from this treatment format equally. Blended treatments are a new form of intervention that combines the strengths of face-to-face and Internet approaches. Nevertheless, research on blended interventions has focused primarily on individual therapy, and less attention has been paid to the potential of using this format in group psychotherapy. This study aims to analyze the feasibility of blended transdiagnostic group CBT for emotional disorders. The current article describes the study protocol for this trial.Method and analysisA one-armed pilot trial will be conducted. Participants will be 30 adults suffering from DSM-5 anxiety and/or depressive disorders. The treatment consists of a blended transdiagnostic group intervention delivered during a period of 24 weeks. Groups of 6 to 10 patients will attend a total of eight 2-hour, face-to-face sessions, alternated with the use of an online platform where they will find the contents of the treatment protocol. The intervention has four core components: present-focused awareness, cognitive flexibility, identification and modification of behavioral and cognitive patterns of emotional avoidance, and interoceptive and situational exposure. These components are delivered in 16 modules. Assessments will be performed at baseline, during the treatment, at post-treatment, and at 3-month follow-up. Clinical and treatment acceptability outcomes will be included. Quantitative and qualitative data (participants' views about blended group psychotherapy) will be analyzed.Ethics and disseminationThe trial has received ethical approval from the Ethics Committee of Universitat Jaume I (September 2019) and will be conducted in accordance with the study protocol, the Declaration of Helsinki, and good clinical practice. The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal.Trial registrationClinicalTrials.gov Identifier: NCT04008576. Registered 05 July 2019, https://clinicaltrials.gov/ct2/show/NCT04008576.

Project description:BACKGROUND:Internet based cognitive behavioural therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (ftf) consultations in a blended format (B-CBT) may produce a new treatment format with multiple benefits from both traditional CBT and iCBT such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. The primary aim of the present study is to compare directly the clinical effectiveness of B-CBT with face-to-face CBT for adult major depressive disorder. METHODS/DESIGN:The study is designed as a two arm randomised controlled non-inferiority trial comparing blended CBT for adult depression with treatment as usual (TAU). In the blended condition six sessions of ftf CBT is alternated with six to eight online modules (NoDep). TAU is defined as 12 sessions of ftf CBT. The primary outcome is symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Additionally, the study will include an economic evaluation. All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. Participants are randomised on an individual level by a researcher not involved in the project. The primary outcome is analysed by regressing the three-month follow-up PHQ-9 data on the baseline PHQ-9 score and a treatment group indicator using ancova. A sample size of 130 in two balanced groups will yield a power of at least 80% to detect standardised mean differences above 0.5 on a normally distributed variable. DISCUSSION:This study design will compare B-CBT and ftf CBT in a concise and direct manner with only a minimal of the variance explained by differences in therapeutic content. On the other hand, while situated in routine care, ecological validity is somewhat compromised by the controlled manner in which the study is conducted. TRIAL REGISTRATION:ClinicalTrials.gov NCT02796573 . Registered June 1st 2016. Currently recruiting participants.

Project description:INTRODUCTION:Current management of concussion consists of early education, rest until symptom free, with gradual return to school and physical activity protocols. Although this management strategy is effective for most youth who sustain a concussion, it is not an appropriate strategy for youth with persistent postconcussion symptoms. Prolonged rest and periods of restricted activity may place youth at risk for secondary issues and contribute to the chronicity of postconcussion symptoms. The purpose of this study is to evaluate the efficacy of an active rehabilitation protocol for youth who are slow to recover from concussion. It is hypothesised that an active rehabilitation intervention can reduce persistent postconcussion symptoms, improve function and facilitate return to activity. This article describes the research protocol. METHODS AND ANALYSIS:This is a randomised clinical trial with blinded outcome measurement. Participants will be recruited and randomly assigned to 1 of 2 treatment groups, an active rehabilitation intervention or a standard care education group. Both groups will receive standard care education. However, the active rehabilitation group will participate in an additional low-intensity exercise programme consisting of aerobic, coordination and visualisation exercises. Both the active rehabilitation and the standard care education interventions will be 6?weeks in duration. The primary outcome measure is postconcussion symptoms. Secondary outcome measures include functional recovery (cognitive, motor, psychosocial and emotional functioning) and return to activity. Outcome measures will be administered preintervention and postintervention. The primary outcome measure will also be repeated 2?weeks into the intervention period. ETHICS AND DISSEMINATION:This study has been approved by the Holland Bloorview Kids Rehabilitation Hospital research ethics board (REB # 13-459). The findings from this study will be shared with the general public, sport associations, relevant brain injury organisations and healthcare professionals. TRIAL REGISTRATION NUMBER:NCT02257749.

Dataset Information

Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial.

Publications

Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial.

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