Dataset Information

Effectiveness of a blended booster programme for the long-term outcome of cognitive behavioural therapy for MS-related fatigue: A randomized controlled trial.

ABSTRACT:

Background

Cognitive behavioural therapy (CBT) reduces MS-related fatigue. However, studies on the long-term effects show inconsistent findings.

Objective

To evaluate whether a blended booster programme improves the outcome of CBT for MS-related fatigue on fatigue severity at 1-year follow-up.

Method

A multicentre randomized clinical trial in which 126 patients with MS were allocated to either a booster programme or no booster programme (control), after following 20-week tailored CBT for MS-related fatigue. Primary outcome was fatigue severity assessed with the Checklist Individual Strength fatigue subscale 1 year after start of treatment (T52). Mixed model analysis was performed by a statistician blinded for treatment-allocation to determine between-group differences in fatigue severity.

Results

Fatigue severity at 1-year follow-up did not differ significantly between the booster (N = 62) and control condition (N = 64) (B = -2.01, 95% confidence interval (CI) = -4.76 to 0.75). No significant increase in fatigue severity was found at T52 compared with directly post-treatment (T20) in both conditions (B = 0.44, 95% CI = -0.97 to 1.85).

Conclusion

Effects of CBT were sustained up to 1 year in both conditions. The booster programme did not significantly improve the long-term outcome of CBT for MS-related fatigue.

Trial registration

Dutch Trial Register (NTR6966), registered 18 January 2018 https://www.trialregister.nl/trial/6782.

SUBMITTER: de Gier M

PROVIDER: S-EPMC10782645 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of a blended booster programme for the long-term outcome of cognitive behavioural therapy for MS-related fatigue: A randomized controlled trial.

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

Multiple sclerosis (Houndmills, Basingstoke, England) 20231129 1

<h4>Background</h4>Cognitive behavioural therapy (CBT) reduces MS-related fatigue. However, studies on the long-term effects show inconsistent findings.<h4>Objective</h4>To evaluate whether a blended booster programme improves the outcome of CBT for MS-related fatigue on fatigue severity at 1-year follow-up.<h4>Method</h4>A multicentre randomized clinical trial in which 126 patients with MS were allocated to either a booster programme or no booster programme (control), after following 20-week ta ...[more]

PMID: 38018811

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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:IntroductionInternet-based guided self-help and face-to-face CBT have shown to be effective in the treatment of depression, but both approaches might not be an available treatment option for all patients. A treatment which blends internet-based guided self-help with video-based psychotherapy might reduce potential disadvantages of both approaches, while maintaining major advantages such as being location-independent. Additionally, it could provide a stronger focus on patient empowerment and lower resource use compared to traditional face-to-face treatment.AimThe aim of this study is to evaluate patient's experiences with blended internet- and video-based CBT (blended iCBT) treatment and to derive suggestions for the improvement of such services.MethodsSemi-structured interviews were conducted with 15 participants of the blended iCBT treatment as part of the European MasterMind trial. Participants included adults suffering from Major Depressive Disorder. The interview guide assessed patient's experiences regarding the four treatment components program, 1. face-to-face diagnostic interviews, 2. video-based synchronous therapy sessions (VTS), 3. online self-help treatment modules (OTM) as well as 4. behaviour diaries and symptom monitoring. Interviews were analyzed using the framework method and outcomes regarding connections within and between participants and categories were generated by counting the statements within relevant themes.ResultsOverall, patients indicated to have been satisfied with all components of the treatment, highlighting the option to independently work from home in their own pace. While the OTMs allowed for a deeper reflection of the content, the VTS with the therapist were mentioned to provide the personal character of the service. The working alliance with the therapist was experienced as fostering the individual fit of the treatment. Patients reported a high self-perceived treatment effectiveness. Negative effects included that some patients felt overwhelmed by the service, e.g. by working with the content of the OTM as they forced them to address their problems. Within the combination of OTM and VTS, both components were rated as equally important and patients felt that the combination depicted a treatment at least equal to regular face-to-face treatment regarding the perceived effectiveness. Other identified themes included patient's individual factors, reactions in their social environment and suggestions for improvement of the service.DiscussionPredominantly, patients reported positive experiences with the blended iCBT service and rate the treatment as adequate and effective to treat their condition. The importance of the VTS is highlighted. Following this approach might be an option to make affordable and effective evidence-based CBT available independent from regional barriers.

Project description:ObjectiveTo explore participant views on acceptability, mechanisms of change and impact of behavioural activation (BA) delivered by junior mental health workers (MHWs) versus cognitive behavioural therapy (CBT) delivered by professional psychotherapists.DesignSemistructured qualitative interviews analysed using a framework approach.Participants36 participants with major depressive disorder purposively sampled from a randomised controlled trial of BA versus CBT (the COBRA trial).SettingPrimary care psychological therapies services in Devon, Durham and Leeds, UK.ResultsElements of therapy considered to be beneficial included its length and regularity, the opportunity to learn and not dwelling on the past. Homework was an important, although challenging aspect of treatment. Therapists were perceived as experts who played an important role in treatment. For some participants the most important element of therapy was having someone to talk to, but for others the specific factors associated with BA and CBT were crucial, with behavioural change considered important for participants in both treatments, and cognitive change unsurprisingly discussed more by those receiving CBT. Both therapies were considered to have a positive impact on symptoms of depression and other areas of life including feelings about themselves, self-care, work and relationships. Barriers to therapy included work, family life and emotional challenges. A subset (n=2) of BA participants commented that therapy felt too simple, and MHWs could be perceived as inexperienced. Many participants saw therapy as a learning experience, providing them with tools to take away, with work on relapse prevention essential.ConclusionsDespite barriers for some participants, BA and CBT were perceived to have many benefits, to have brought about cognitive and behavioural change and to produce improvements in many domains of participants' lives. To optimise the delivery of BA, inexperienced junior MHWs should be supported through good quality training and ongoing supervision.Trial registration numberISRCTN27473954, 09/12/2011.

Dataset Information

Effectiveness of a blended booster programme for the long-term outcome of cognitive behavioural therapy for MS-related fatigue: A randomized controlled trial.

Background

Objective

Method

Results

Conclusion

Trial registration

Publications

Effectiveness of a blended booster programme for the long-term outcome of cognitive behavioural therapy for MS-related fatigue: A randomized controlled trial.

Similar Datasets

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