scholarly journals Comparing cognitive-behavioural psychotherapy and psychoeducation for non-specific symptoms associated with indoor air: a randomised control trial protocol

BMJ Open ◽  
2016 ◽  
Vol 6 (6) ◽  
pp. e011003 ◽  
Author(s):  
Sanna Selinheimo ◽  
Aki Vuokko ◽  
Markku Sainio ◽  
Kirsi Karvala ◽  
Hille Suojalehto ◽  
...  
Keyword(s):  
Indoor Air ◽  
Randomised Control Trial ◽  
Trial Protocol ◽  
Cognitive Behavioural ◽  
Specific Symptoms

scholarly journals The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Moira Kelly ◽  
Liz Steed ◽  
Ratna Sohanpal ◽  
Hilary Pinnock ◽  
Amy Barradell ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Process Evaluation ◽  
Health Professionals ◽  
Randomised Control Trial ◽  
Chronic Obstructive ◽  
Trial Protocol ◽  
Process Data ◽  
Obstructive Pulmonary Disease ◽  
Cognitive Behavioural

Abstract Background TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here, we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted. Methods We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; and exploration with all stakeholders (including management/policy-makers) on future implementation. Normalisation process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated. Conclusion Detailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation. Trial registration ISRCTN ISRCTN59537391. Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.

scholarly journals The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD)

2021 ◽  
Author(s):  
Moira Kelly ◽  
Liz Steed ◽  
Ratna Sohanpal ◽  
Hilary Pinnock ◽  
Amy Barradell ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Process Evaluation ◽  
Health Professionals ◽  
Randomised Control Trial ◽  
Chronic Obstructive ◽  
Trial Protocol ◽  
Process Data ◽  
Obstructive Pulmonary Disease ◽  
Cognitive Behavioural

Abstract Background TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted. Methods We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; exploration with all stakeholders (including management/policy-makers) on future implementation. Normalization process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated. Conclusion Detailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms, and to examine the relationship with outcomes. In this way learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation. Trial registration ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018.

scholarly journals Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to activity management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): amendment to the published protocol

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Emma Anderson ◽  
Daisy Gaunt ◽  
Chris Metcalfe ◽  
Manmita Rai ◽  
William Hollingworth ◽  
...  
Keyword(s):  
Chronic Fatigue Syndrome ◽  
Cost Effective ◽  
Chronic Fatigue ◽  
Behavioural Therapy ◽  
The Internet ◽  
Trial Protocol ◽  
Fatigue Syndrome ◽  
Therapy Program ◽  
Cognitive Behavioural ◽  
Activity Management

Abstract The FITNET-NHS Trial is a UK, national, trial investigating whether an online cognitive behavioural therapy program (FITNET-NHS) for treating chronic fatigue syndrome/ME in adolescents is clinically effective and cost-effective in the NHS. At the time of writing (September 2019), the trial was recruiting participants. This article presents an update to the planned sample size and data collection duration previously published within the trial protocol. Trial registration ISRCTN, ID: 18020851. Registered 8 April 2016.

Effects of a Brief Transdiagnostic Cognitive Behavioural Group Therapy on Disorder Specific Symptoms

2018 ◽  
Vol 47 (1) ◽  
pp. 1-15 ◽  
Author(s):  
Hafrún Kristjánsdóttir ◽  
Baldur Heiðar Sigurðsson ◽  
Paul Salkovskis ◽  
Engilbert Sigurðsson ◽  
Magnús Blöndahl Sighvatsson ◽  
...  
Keyword(s):  
Anxiety Disorders ◽  
Treatment Effects ◽  
Mental Health Problems ◽  
Effect Sizes ◽  
Low Intensity ◽  
Cognitive Behavioural ◽  
Wide Range ◽  
Common Mental Health Problems ◽  
Specific Symptoms ◽  
Group Therapies

Background:In recent years, cognitive behavioural group therapies (CBGT) have been increasingly deployed as a strategy to increase the efficiency and cost-effectiveness in treatment of common mental health problems. The vast majority of these therapies are disorder specific, but in the last few years there has been growing interest in transdiagnostic CBGT.Aims:The aim of this study was twofold: to evaluate the treatment effects of transdiagnostic CBGT on disorder specific symptoms and what (if any) differences would be observed in the treatment effects with regard to general as opposed to disorder specific symptoms measured pre- and post-treatment.Method:The participants were 233 adult patients diagnosed with depression and/or anxiety disorders. They underwent a 6-week transdiagnostic CBGT. To compare treatment effects on general and disorder specific symptoms, raw scores on all measures were converted to standardized scores.Results:Pre–post differences were significant and there was no evidence that treatment was differentially effective for general and disorder specific symptoms. Effect sizes ranged from medium to large.Conclusion:The 6-week transdiagnostic CBGT is feasible for a wide range of mood and anxiety disorders. The results indicate that low-intensity transdiagnostic group therapies may have similar effects on both general and disorder specific symptoms.

scholarly journals Cognitive-behavioural therapyv.structured care for medically unexplained symptoms: randomised controlled trial

2008 ◽  
Vol 193 (1) ◽  
pp. 51-59 ◽  
Author(s):  
A. Sumathipala ◽  
S. Siribaddana ◽  
M. R. N. Abeysingha ◽  
P. De Silva ◽  
M. Dewey ◽  
...  
Keyword(s):  
Primary Care ◽  
Cognitive Behavioural Therapy ◽  
Primary Care Physicians ◽  
Medically Unexplained Symptoms ◽  
Behavioural Therapy ◽  
Randomised Control Trial ◽  
Structured Care ◽  
Cognitive Behavioural ◽  
Medically Unexplained ◽  
Unexplained Symptoms

BackgroundA pilot trial in Sri Lanka among patients with medically unexplained symptoms revealed that cognitive-behavioural therapy (CBT) administered by a psychiatrist was efficaciousAimsTo evaluate CBT provided by primary care physicians in a comparison with structured careMethodA randomised control trial (n=75 in each arm) offered six 30 min sessions of structured care or therapy. The outcomes of the two interventions were compared at 3 months, 6 months, 9 months and 12 monthsResultsIn each arm, 64 patients (85%) completed the three mandatory sessions. No difference was observed between groups in mean scores on the General Health Questionnaire or the Bradford Somatic Inventory, or in number of complaints or patient-initiated consultations at 3 months. For both groups, all outcome measures improved at 3 months, and remained constant in the follow-up assessmentsConclusionsCognitive–behavioural therapy given by primary care physicians after a short course of training is no more efficacious than structured care. Natural remission is an unlikely explanation for improvements in people with chronic medically unexplained symptoms, but lack of a ‘treatment as usual’ arm limits further conclusions. Further research on enhanced structured care, medical assessment and structured care incorporating simple elements of CBT principles is worthy of consideration

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