Dataset Information

Blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis: A non-inferiority RCT.

ABSTRACT:

Background

Cognitive behavioural therapy (CBT) reduces multiple sclerosis (MS)-related fatigue. Implementation of face-to-face CBT is hindered by limited treatment capacity and traveling distances to treatment locations.

Objective

Evaluate whether blended CBT (online treatment modules supported with guidance by a therapist) is non-inferior to face-to-face CBT in reducing fatigue severity in severely fatigued patients with MS.

Method

A non-inferiority multicentre randomized clinical trial, in which 166 patients with MS were allocated to either face-to-face or blended CBT. Primary outcome was fatigue severity assessed with the Checklist Individual Strength fatigue subscale directly post-treatment (week 20). Mixed model analysis was used by a statistician blinded for allocation to determine between-group differences post-treatment. The upper limit of the 95% confidence interval (CI) was compared to a pre-specified non-inferiority margin of 5.32.

Results

Blended CBT (N = 82) was non-inferior to face-to-face CBT (N = 84) (B = 1.70, 95% CI: -1.51 to 4.90). Blended CBT significantly reduced therapist time (B = -187.1 minutes, 95% CI: 141.0-233.3). Post hoc analysis showed more improvement (B = -5.35, 95% CI: -9.22 to -1.48) when patients received their preferred treatment. No harm related to treatment was reported.

Discussion

Blended CBT is an efficient alternative to face-to-face CBT. Offering the preferred CBT format may optimize treatment outcome.

SUBMITTER: de Gier M

PROVIDER: S-EPMC10503237 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

Blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis: A non-inferiority RCT.

de Gier Marieke M Beckerman Heleen H Twisk Jos J Knoop Hans H de Groot Vincent V

Multiple sclerosis (Houndmills, Basingstoke, England) 20230725 10

<h4>Background</h4>Cognitive behavioural therapy (CBT) reduces multiple sclerosis (MS)-related fatigue. Implementation of face-to-face CBT is hindered by limited treatment capacity and traveling distances to treatment locations.<h4>Objective</h4>Evaluate whether blended CBT (online treatment modules supported with guidance by a therapist) is non-inferior to face-to-face CBT in reducing fatigue severity in severely fatigued patients with MS.<h4>Method</h4>A non-inferiority multicentre randomized ...[more]

PMID: 37489562

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Project description:BACKGROUND:Cognitive behavioural therapy (CBT) has been found to be effective in reducing fatigue severity in MS patients directly following treatment. However, long-term effects are inconsistent leaving room for improvement. In addition, individual face-to-face CBT draws heavily on limited treatment capacity, and the travel distance to the treatment centre can be burdensome for patients. Therefore, we developed "MS Fit", a blended CBT for MS-related fatigue, based on a face-to-face CBT protocol found effective in a previous study, and "MS Stay Fit", internet-based booster sessions to improve long-term effectiveness of CBT for MS-related fatigue. This article presents the protocol of two randomised clinical trials (RCTs) conducted within one study investigating (1) the non-inferiority of MS Fit compared with evidence-based face-to-face CBT for MS-related fatigue and (2) the effectiveness of MS Stay Fit on the long-term outcome of fatigue compared with no booster sessions. METHODS/DESIGN:The first part of this study is an observer-blinded non-inferiority multicentre RCT, in which 166 severely fatigued MS patients will be randomly assigned (1:1 ratio, computer-generated sequence) to either face-to-face CBT or blended CBT (MS Fit) for fatigue. The primary endpoint is at 20 weeks after baseline. After this post-treatment assessment, patients will be randomly assigned again (1:1 ratio, computer generated sequence) to either MS Stay Fit consisting of two booster sessions at 2 and 4 months after end of treatment or no booster sessions. The primary endpoint of the second study is 52 weeks after baseline. Primary outcome measure in both studies is fatigue severity assessed with the fatigue severity subscale of the Checklist Individual Strength (CIS20r). Outcomes will be assessed at baseline (T0), at the end of treatment (T20), and after 39 and 52 weeks (T39 and T52). DISCUSSION:If MS Fit is found to be non-inferior to face-to-face CBT, it will improve the accessibility of this treatment. In addition, the study aims to test whether it is possible to improve long-term effectiveness of CBT for MS-related fatigue with MS Stay Fit. TRIAL REGISTRATION:Dutch Trial Register (NTR6966), registered 18 January 2018 https://www.trialregister.nl/trial/6782 WORLD HEALTH ORGANIZATION (WHO) TRIAL REGISTRATION DATA SET: All items from the WHO Trial Registration Data Set can be found within the protocol.

Project description:BackgroundFatigue is the most frequent and burdensome symptom of patients with diffuse glioma. It is closely linked to decreased health-related quality of life and symptoms such as depression and sleep disturbances. Currently, there is no evidence-based treatment that targets severe fatigue in patients with brain tumours. Cognitive behavioural therapy is aimed at fatigue-maintaining beliefs and behaviour. This therapy has been proven effective in reducing severe fatigue in cancer survivors and patients with multiple sclerosis. A blended therapy program combines sessions with a therapist with therapist-guided web-based therapy modules. The aim of this randomized controlled trial is to determine the efficacy of blended cognitive behavioural therapy in treating severe fatigue in patients with diffuse glioma.MethodsWe will include a maximum of 100 patients with diffuse glioma with clinically and radiologically stable disease and severe fatigue (i.e. Checklist Individual Strength, subscale fatigue severity ≥ 35). Patients will be randomized to blended cognitive behavioural therapy or a waiting list condition. The 12-week intervention GRIP on fatigue consists of five patient-therapist sessions and five to eight individualized web-based therapy modules supported by email contact. The primary outcome measure is fatigue severity. Secondary outcome measures include sleep quality, health-related quality of life, depression, anxiety, functional impairment and subjective and objective cognitive functioning. Primary and secondary outcome measures will be assessed at baseline and after 14 and 24 weeks. Magnetoencephalography and MRI will be used to evaluate potential biomarkers for intervention success. This trial has a Bayesian design: we will conduct multiple interim analyses to test for efficacy or futility of the trial. This is the first trial within the GRIP trial platform: a platform developing four to five different interventions for the most common symptoms in patients with diffuse glioma.DiscussionThe results of the GRIP on fatigue trial will provide information about the efficacy of this intervention on fatigue in patients with diffuse glioma. Multiple other outcomes and possible predictors of treatment success will also be explored.Trial registrationNetherlands Trial Register NL8711 . Registered on 14 June 2020.

Project description:BackgroundInternet 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/designThe 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.DiscussionThis 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 registrationClinicalTrials.gov NCT02796573 . Registered June 1st 2016. Currently recruiting participants.

Project description:BackgroundConventional face-to-face weight loss and weight control programs are very labor intensive for both the patient and the provider. It is unclear to what extent conventional programs can be (partially) completed by mobile health (mHealth) apps.ObjectiveThe aim of this study was to compare the effectiveness of different weight loss programs using a combination of conventional and mobile programs among adults who are overweight (body mass index [BMI]>29 kg/m²).MethodsA single-blinded randomized controlled trial among obese adults was performed from September 2015 to March 2016. The study took place in Leuven, Belgium. Of the 102 eligible (BMI >29 kg/m²) adults, 81 (79%) completed the study. The three intervention groups consisted of a conventional face-to-face weight loss program, a weight loss app program (app group), and a partial face-to-face and partial app program (combi group). All intervention groups received the same advice from a dietician and a physical activity coach during a 12-week period. The control group did not receive any information during the same period. Primary outcomes were weight reduction (5% decrease of baseline weight in kg), BMI, metabolic risk factors, dietary pattern, and physical activity.ResultsSignificant more participants in all three intervention groups lost at least 5% or more of their weight at baseline compared with the control group. No significant difference was found between the combi group and the conventional group. A trend was found that more participants in the combi group lost 5% or more compared with the app group (19%), P=.06. A significant time x group effect was found for BMI and metabolic risk factors, with the control group having the worst results and the combi group being significantly better with regard to BMI compared with the app group. No significant group x time effects were found for the intake of different food and drinks and moderate to vigorous physical activity (MVPA).ConclusionsThe results of this study show that a conventional weight loss program could partially be completed with an mHealth program without affecting the effectiveness.Trial registrationClinicaltrials.gov NCT02595671; https://clinicaltrials.gov/ct2/show/NCT02595671 (Archived by WebCite at http://www.webcitation.org/6w1H0x1Q6).

Project description:BackgroundDepression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy-cognitive behavioural therapy (CBT)-is complex and costly. A simpler therapy-behavioural activation (BA)-might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression.MethodsIn this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity [Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19], antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat [mITT]) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol [PP]). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954.FindingsBetween Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points [SD 7·5], BA 8·4 PHQ-9 points [7·0], mean difference 0·1 PHQ-9 points [95% CI -1·3 to 1·5], p=0·89; PP: CBT 7·9 PHQ-9 points [7·3]; BA 7·8 [6·5], mean difference 0·0 PHQ-9 points [-1·5 to 1·6], p=0·99). Two (1%) non-trial-related deaths (one [1%] multidrug toxicity in the BA group and one [1%] cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three [2%] participants in the BA group (two [1%] patients who overdosed and one [1%] who self-harmed) and eight (4%) participants in the CBT group (seven [4%] who overdosed and one [1%] who self-harmed).InterpretationWe found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals.FundingNational Institute for Health Research.

Project description:IntroductionWe explored the working alliance as measured by both clients and therapists. The working alliance has been known to predict the outcome of psychotherapy and is often considered an important common factor. This study raised the question of how to conceptualize the working alliance in the blended format.MethodsThis was an exploratory study derived from a randomized controlled trial comparing bCBT and face-to-face cognitive behavioural therapy (ftf CBT) on depression. The change in depressive symptoms was measured with the Patient Health Questionnaire (PHQ-9) and the working alliance was measured using the Working Alliance Inventory.AnalysesCorrelation coefficients were calculated for the working alliance as reported by clients and therapists, working alliance was then examined at item and dimension level (task, bond, goal). Linear regression models were applied to investigate the predictive value of the working alliance on treatment outcome. Interaction between the level of working alliance and treatment condition was also considered.ResultsClient and therapist working alliance ratings correlated at r = 0.44 and clients rated the working alliance higher than therapists (x̄ clients = 48.6, x̄ therapists = 44.6). ftf CBT and bCBT had comparable joint working alliance ratings (x̄ ftf = 46.4, x̄ bCBT = 46.8). Items had little deviation apart from item 4 with high positive values. The level of working alliance from the total sample did not significantly predict outcome based on the client's perspective. Contrarily, seen from the therapist's perspective, it did (b = 0.00, p = .044). Using the mean from these predictors as a composite variable, was also significant (b = 0.00, p = .039, R2 adj = 0.07). There was no significant interaction with treatment condition.DiscussionClients and therapists may lay emphasis on different aspects of the working alliance. The finding that therapist-rated working alliance was better than client working alliance at predicting outcome went against common findings; this pattern may be specific to bCBT.ConclusionClients rated the working alliance slightly higher than therapists on average. Clients and therapists as well as treatment conditions had different profiles on dimension deviations. Therapist ratings of the working alliance appeared to better predict treatment outcome than client ratings. Joint working alliance predicted outcome using client and therapist composite means. The working alliance was equally strong in ftf CBT and bCBT. The absence of interaction with treatment condition indicated that the working alliance was equally predictive of outcome in ftf CBT as in bCBT.

Project description:BackgroundAnxiety disorders are highly prevalent and cause substantial economic burden. Blended cognitive-behavioural therapy (bCBT), which integrates Internet-based CBT and face-to-face CBT (ftfCBT), is an attractive and potentially cost-saving treatment alternative to conventional CBT for patients with anxiety disorders in specialised mental health care. However, little is known about the effectiveness of bCBT in routine care. We examined the acceptability, effectiveness and cost-effectiveness of bCBT versus ftfCBT in outpatient specialised care to patients with panic disorder, social anxiety disorder and generalised anxiety disorder.Methods and findingsPatients with anxiety disorders were randomised to bCBT (n = 52) or ftfCBT (n = 62). Acceptability of bCBT and ftfCBT were evaluated by assessing treatment preference, adherence, satisfaction and therapeutic alliance. Costs and effects were assessed at post-treatment and one-year follow-up. Primary outcome measure was the Beck Anxiety Inventory (BAI). Secondary outcomes were depressive symptoms, general psychopathology, work and social adjustment, quality of life and mastery. Incremental cost-effectiveness ratios (ICERs) were computed from societal and healthcare perspectives by calculating the incremental costs per incremental quality-adjusted life year (QALY). No significant differences between bCBT and ftfCBT were found on acceptability or effectiveness measures at post-treatment (Cohen's d between-group effect size on BAI = 0.15, 95% CI -0.30 to 0.60) or at one-year follow-up (d = -0.38, 95% CI -0.84 to 0.09). The modelled point estimates of societal costs (bCBT €10945, ftfCBT €10937) were higher and modelled point estimates of direct medical costs (bCBT €3748, ftfCBT €3841) were lower in bCBT. The acceptability curves showed that bCBT was expected to be a cost-effective intervention. Results should be carefully interpreted due to the small sample size.ConclusionsbCBT appears an acceptable, clinically effective and potentially cost-saving alternative option for treating patients with anxiety disorders. Trials with larger samples are needed to further investigate cost-effectiveness.Trial registrationNetherlands Trial Register: NTR4912.

Dataset Information

Blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis: A non-inferiority RCT.

Background

Objective

Method

Results

Discussion

Publications

Blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis: A non-inferiority RCT.

Similar Datasets

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