scholarly journals A randomised controlled trial testing the efficacy of Fit after COVID, a cognitive behavioural therapy targeting severe post-infectious fatigue following COVID-19 (ReCOVer): study protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
T. A. Kuut ◽  
F. Müller ◽  
A. Aldenkamp ◽  
E. Assmann-Schuilwerve ◽  
A. Braamse ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Behavioural Therapy ◽  
Cognitive Behavioural ◽  
Severe Fatigue ◽  
Trial Testing ◽  
Fatigue Severity ◽  
T1 And T2 ◽  
Randomised Controlled

Abstract Background Coronavirus disease 2019 (COVID-19) results in debilitating long-term symptoms, often referred to as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), in a substantial subgroup of patients. One of the most prevalent symptoms following COVID-19 is severe fatigue. Prompt delivery of cognitive behavioural therapy (CBT), an evidence-based treatment that has shown benefit in reducing severe fatigue in other conditions, may reduce post-COVID-19 fatigue. Based on an existing CBT protocol, a blended intervention of 17 weeks, Fit after COVID, was developed to treat severe fatigue after the acute phase of infection with SARS-CoV-2. Method The ReCOVer study is a multicentre 2-arm randomised controlled trial (RCT) to test the efficacy of Fit after COVID on severe post-infectious fatigue. Participants are eligible if they report severe fatigue 3 up to and including 12 months following COVID-19. One hundred and fourteen participants will be randomised to either Fit after COVID or care as usual (ratio 1:1). The primary outcome, the fatigue severity subscale of the Checklist Individual Strength (CIS-fatigue), is assessed in both groups before randomisation (T0), directly post CBT or following care as usual (T1), and at follow-up 6 months after the second assessment (T2). In addition, a long-term follow-up (T3), 12 months after the second assessment, is performed in the CBT group only. The primary objective is to investigate whether CBT will lead to a significantly lower mean fatigue severity score measured with the CIS-fatigue across the first two follow-up assessments (T1 and T2) as compared to care as usual. Secondary objectives are to determine the proportion of participants no longer being severely fatigued (operationalised in different ways) at T1 and T2 and to investigate changes in physical and social functioning, in the number and severity of somatic symptoms and in problems concentrating across T1 and T2. Discussion This is the first trial testing a cognitive behavioural intervention targeting severe fatigue after COVID-19. If Fit after COVID is effective in reducing fatigue severity following COVID-19, this intervention could contribute to alleviating the long-term health consequences of COVID-19 by relieving one of its most prevalent and distressing long-term symptoms. Trial registration Netherlands Trial Register NL8947. Registered on 14 October 2020.

scholarly journals Long-term outcome of therapist-guided internet-based cognitive behavioural therapy for body dysmorphic disorder (BDD-NET): a naturalistic 2-year follow-up after a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024307 ◽  
Author(s):  
Jesper Enander ◽  
Brjánn Ljótsson ◽  
Lina Anderhell ◽  
Martin Runeborg ◽  
Oskar Flygare ◽  
...  
Keyword(s):  
Body Dysmorphic Disorder ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Global Functioning ◽  
Cognitive Behavioural ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectivesMost patients with body dysmorphic disorder (BDD) do not receive evidence-based treatment. A randomised controlled trial (RCT) has found that a therapist-guided internet-based cognitive–behavioural therapy (CBT) programme for BDD (BDD-NET) can be delivered safely via the internet with significant improvements in BDD symptom severity in the short term. The purpose of this study was to evaluate if the therapeutic gains of BDD-NET are maintained 2 years after treatment.SettingAcademic medical centre.ParticipantsA naturalistic 2-year follow-up study of the 88 self-referred adult outpatients with a diagnosis of BDD that had received BDD-NET within the context of the RCT.Primary and secondary outcomesThe primary outcome was the BDD-Yale-Brown Obsessive-Compulsive Scale (YBOCS). Responder status was defined as a ≥30% reduction in symptoms. Remission was defined as no longer meeting Diagnostic and Statistical Manual of Mental Disorders 5th edition criteria for BDD. Secondary outcomes included measures of depression, global functioning and quality of life.ResultsThe efficacy of BDD-NET was sustained long- term, with further improvements observed on the BDD-YBOCS during the follow-up period. At follow-up, 69% (95% CI 57% to 80%) were classified as responders and 56% (95% CI 43% to 69%) were in remission. Gains on depressive symptoms and global functioning were also sustained but not quality of life. A majority of participants reported that the main reason for seeking help for their BDD was the possibility to access the treatment from home.ConclusionBDD-NET is an effective treatment for BDD, and the patients’ gains are maintained in the long term. BDD-NET has the potential to increase access to CBT and may lower the threshold for BDD sufferers to seek help in the first place.Trial registration numberNCT02010619.

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

Long-term effects on income and sickness benefits after work-focused cognitive-behavioural therapy and individual job support: a pragmatic, multicentre, randomised controlled trial

2018 ◽  
Vol 75 (10) ◽  
pp. 703-708 ◽  
Author(s):  
Simon Øverland ◽  
Astrid Louise Grasdal ◽  
Silje Endresen Reme
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioural Therapy ◽  
Work Participation ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundThere is moderate quality evidence that integrating work-directed interventions and components from psychological therapies reduces sickness absence in the medium term. We aimed to extend this evidence by examining objectively ascertained income and work participation status up to 4 years after an intervention to improve outcomes among people who struggle with work from common mental disorder.MethodsThe intervention combined components from cognitive behavioural therapy with principles from supported employment, and compared its efficacy with usual care. Outcomes were derived from registry data with no attrition, in a pragmatic multisite randomised controlled trial (N=1193).ResultsThe intervention group had higher income, higher work participation and more months without receiving benefits over the 10-month to 46-month long-term follow-up period after end of treatment, but differences were not statistically significant. For the group on long-term benefits at inclusion, effect sizes were larger and statistically significant.ConclusionThere were no statistically significant differences between the two groups in the primary outcome in the total population. In a secondary analysis for the subgroup most at risk of permanent work exclusion, long-term outcomes were favourable in the intervention group compared with usual care. The results support integrated work and health services for people on the severe end of work participation challenges.Trial registration numberNCT01146730.

Internet and Face-to-Face Cognitive Behavioural Therapy for Postnatal Depression Compared to Treatment-As-Usual: A Randomised Controlled Trial of MumMoodBooster (Preprint)

2020 ◽  
Author(s):  
Jeannette Milgrom ◽  
Brian G. Danaher ◽  
John R. Seeley ◽  
Christopher J. Holt ◽  
Charlene Holt ◽  
...  
Keyword(s):  
Postnatal Depression ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Treatment As Usual ◽  
Face To Face ◽  
Cognitive Behavioural ◽  
Postnatal Women ◽  
Dsm Iv ◽  
Randomised Controlled

BACKGROUND Previous research confirms that symptoms of postnatal depression (PND) can be ameliorated through internet-delivered psychological interventions. To date, no research has examined the efficacy of such interventions compared directly to face-to-face (FTF) treatment in women clinically diagnosed with PND. OBJECTIVE We aimed to compare the efficacy of one of the first Web-based cognitive behavioural therapy (internet CBT + coach calls) interventions for PND (MumMoodBooster: MMB) with FTF-CBT in a randomised controlled trial (RCT). METHODS One hundred and sixteen postnatal women with a DSM-IV diagnosis of major or minor depression were randomised to either MMB (n = 39), FTF-CBT (n = 39) or a treatment as usual control condition (TAU, n = 38). Diagnostic status was determined at baseline and at a 21-week follow-up using the Structured Clinical Interview for the DSM-IV (SCID-IV). Severity of anxious and depressive symptoms were evaluated with the Depression Anxiety Stress Scales (DASS-21) and the Beck Depression Inventory – Revised (BDI-II) at baseline, 12 weeks (post-treatment) and at 21 weeks follow-up. RESULTS Ninety two percent of participants had a diagnosis of major depression at baseline. Rates of remission from the major or minor depressive episode at 21 weeks in both the FTF-CBT and the MMB groups were superior to TAU (Relative Risk = 0.59 and 0.68 respectively) and they were not significantly different from each other. Whilst remission rates differed between TAU and FTF-CBT, growth models showed that, in terms of symptom reduction across time, the FTF-CBT treatment was not significantly better than TAU. By comparison, MMB was statistically superior to both TAU and FTF-CBT in reducing symptoms of depression, anxiety and stress from baseline to 21 weeks follow-up (large and moderate effect sizes). Thus, after 21 weeks, symptom scores for depression and anxiety in women receiving MMB were approximately 50% lower than the average scores in both TAU and FTF-CBT. CONCLUSIONS In this RCT, MMB was at least as effective as FTF-CBT in achieving remission from a diagnosed postnatal depressive episode. MMB was superior to both TAU and FTF-CBT in encouraging and maintaining reduction of symptom severity over 21 weeks follow-up for depressed postnatal women. These findings replicate results of prior studies of MMB that showed clinically significant improvements in depressive symptoms and they provide direct empirical support that internet delivered treatment for depressed postnatal women is a viable alternative to face-to-face treatment. Advantages of internet treatment include anonymity, convenience and catering for women who would prefer not to, or cannot, access face-to-face treatments. The generalisability of results needs to be examined by future research since RCTs of internet-based versus face-to-face treatments necessarily involve a subset of people who are willing to undertake either modality of treatment. CLINICALTRIAL The protocol for this trial was registered prospectively on the Australia and New Zealand Clinical Trials Registry (trial id ACTRN12613000881730); https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364683&isReview=true.

scholarly journals Sleep Treatment Outcome Predictors (STOP) Pilot Study: a protocol for a randomised controlled trial examining predictors of change of insomnia symptoms and associated traits following cognitive–behavioural therapy for insomnia in an unselected sample

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e017177 ◽  
Author(s):  
Dan Denis ◽  
Thalia C Eley ◽  
Fruhling Rijsdijk ◽  
Helena M S Zavos ◽  
Robert Keers ◽  
...  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Cognitive Behavioural ◽  
Ethical Approval ◽  
Unselected Sample ◽  
Randomised Controlled

IntroductionCognitive–behavioural therapy for insomnia (CBT-I) leads to insomnia symptom improvements in a substantial proportion of patients. However, not everyone responds well to this treatment, and it is unclear what determines individual differences in response. The broader aim of this work is to examine to what extent response to CBT-I is due to genetic and environmental factors. The purpose of this pilot study is to examine feasibility of a design to test hypotheses focusing on an unselected sample, that is, without selection on insomnia complaints, in order to plan a larger behavioural genetics study where most participants will likely not have an insomnia disorder.Methods and analysisA two parallel-group randomised controlled trial is being conducted across three London universities. Female students (minimum age 18 years) enrolled on a psychology programme at one of the three sites were invited to participate. The target number of participants to be recruited is 240. Following baseline assessments, participants were randomly allocated to either the treatment group, where they received weekly sessions of digital CBT-I for 6 weeks, or the control group, where they completed an online puzzle each week for 6 weeks. Follow-up assessments have taken place mid-intervention (3 weeks) and end of intervention (6 weeks). A 6-month follow-up assessment will also occur. Primary outcomes will be assessed using descriptive statistics and effect size estimates for intervention effects. Secondary outcomes will be analysed using multivariate generalised estimating equation models.Ethics and disseminationThe study received ethical approval from the Research Ethics and Integrity subcommittee, Goldsmiths, University of London (application reference: EA 1305). DNA sample collection for the BioResource received ethical approval from the NRES Committee South Central—Oxford (reference number: 15/SC/0388). The results of this work shall be published in peer-reviewed journals.Trial registration numberNCT03062891; Results.

Sign in / Sign up

Export Citation Format

Share Document