Changes through peer review process from submitted manuscript to published paper
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and everything actually happened inside the Journal BMJ Paediatrics Open 
-> Cognitive behavior therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: An exploratory randomized trial
Manuscript ID bmjpo-2019-000620
Date Submitted by theAuthor December 3, 2019
"Power calculation and statistical analyses
In a previous research project from our institution, the mean (standard deviation, SD) steps/day count (primary endpoint) for CFS adolescents was approximately 4500 (2400) [29]. In the present study, a total of 50 participants were assumed to be available for endpoint evaluation; that given, the power to detect a difference of 2000 steps/day is about 80 % (α=0.05). This effect size is rather large; however, as CBT alone is documented to have a moderate effect in CFS, only a substantial effect size is of direct clinical interest."
Abstract
Background
Cognitive behaviour therapy (CBT) is effective in chronic fatigue syndrome. However, CBT has not been investigated in post-infective chronic fatigue (CF), nor is it known whether addition of therapeutic elements from other disciplines might increase effectiveness and feasibility. The present study explored the combination of CBT and music therapy for CF following Epstein-Barr virus (EBV) infection in adolescents.
Methods
A total of 200 adolescents (12-20 years old) with acute EBV infection were followed prospectively and classified as CF cases or non-CF cases at 6 months. The CF-cases were eligible for a randomized controlled trial comparing combined CBT and music therapy (10 therapy sessions and related homework) against treatment as usual (regular visits to the general practitioner). Endpoint evaluation was concealed for therapists and participants. Primary endpoint was physical activity (steps/day) at 3 months follow-up; secondary endpoints included symptom scores, recovery rate and possible harmful effects. Total followup time was 15 months.
Results
A total of 91 CF cases were eligible, and a total of 43 were included; 21 were allocated to the intervention group and 22 to the control group. In intention-to-treat analyses, there was no statistically significant difference in number of steps/day (difference [95 % confidence interval]=-1158 [-2642 to 325], p=0.122), but a trend towards improvement of post exertional malaise in the intervention group at 3 months. At 15 months follow-up, there was a trend towards higher recovery rate in the intervention group. No harmful effects were recorded, and compliance was 99 % among the participants that completed the mental training program.
Conclusion
Combined CBT and music therapy tended to improve recovery and symptoms of postexertional malaise, did not cause harm, and appeared feasible in adolescents suffering from CF after Epstein-Barr virus infection. These preliminary findings should be addressed in further research.
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-> Cognitive behavior therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: A feasibility study
Journal: BMJ Paediatrics Open
Manuscript ID bmjpo-2019-000620.R1
Date Submitted by the Author 9feb2020
"Power considerations and statistical analyses
In CFS, the effect of CBT alone is often reported to be moderate [5]. In a previous research
project from our institution, CFS adolescents had a mean (SD) steps/day count of approximately 4500 (2400), and a mean (SD) CFQ total score of 19.1 (6.3) [34]. This given, more than 120 participants would be needed in order to detect a moderate effect size (Cohen’s d≈0.5), such as an increase in steps/day of 1200 or a reduction in CFQ total score of 3 (α=0.05, β=0.2). In the present study, the total number of eligible individuals were 91 (defined as CF cases 6 months after acute EBV infection), and only 43 consented to inclusion. Hence, the study was strongly underpowered regarding efficacy, and the results should be interpreted accordingly."
Abstract
Background
Cognitive behaviour therapy (CBT) is effective in chronic fatigue syndrome. However, CBT has not been investigated in post-infectious chronic fatigue (CF), nor is it known whether addition of therapeutic elements from other disciplines might be feasible. We studied the feasibility of a combined CBT and music therapy intervention for CF following Epstein-Barr virus (EBV) infection in adolescents.
Methods
Adolescents (12-20 years old) participating in a post-infectious cohort study who developed CF six months after an acute EBV-infection were eligible for the present feasibility study. A combined CBT and music therapy program (10 therapy sessions and related homework) was compared to care as usual in a randomized controlled design. Therapists and participants were blinded to outcome evaluation. Endpoints included physical activity (steps/day), symptom scores, recovery rate and possible harmful effects. Total follow-up time was 15 months.
Results
A total of 43 individuals with post-infectious CF were included; 21 were allocated to the intervention group and 22 to the control group. Seven individuals left the study during the first three months, leaving 15 in the intervention group and 21 in the control group at three months follow-up. In intention-to-treat analyses, number of steps/day tended to decrease (difference [95 % confidence interval]=-1158 [-2642 to 325]), whereas post exertional malaise tended to improve (difference [95 % confidence interval]=-0.4 [-0.9 to 0.1]) in the intervention group at three months. At 15 months follow-up, there was a trend towards higher recovery rate in the intervention group (62 % vs 37 %). No harmful effects were recorded, and compliance was high among the participants that completed the mental training program.
Conclusion
An intervention study of combined CBT and music therapy in post-infectious CF is feasible,
and appears acceptable to the participants. The tendencies towards positive effects on
patients’ symptoms and recovery might justify a full-scale clinical trial.
**
-> Cognitive behavior therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: A feasibility study
Manuscript ID bmjpo-2019-000620.R2
Date Submitted by the Author 10mars2020
"Power considerations and statistical analyses
As this was a feasibility study, a formal power calculation was not considered necessary. It should be noted, though, that in a previous research project from our institution, CFS adolescents had a mean (SD) steps/day count of approximately 4500 (2400), and a mean (SD) CFQ total score of 19.1 (6.3) [34]. This given, more than 120 participants would be needed in order to detect a moderate effect size (Cohen’s d≈0.5), such as an increase in steps/day of 1200 or a reduction in CFQ total score of 3 (α=0.05, β=0.2). In the present study, the total number of eligible individuals were 91 (defined as CF cases 6 months after acute EBV infection), and only 43 consented to inclusion. Hence, the study was strongly underpowered regarding efficacy."
Abstract
Background
Cognitive–behavioural therapy (CBT) is effective in chronic fatigue syndrome. However, CBT has not been investigated in postinfectious chronic fatigue (CF), nor is it known whether addition of therapeutic elements from other disciplines might be feasible. We studied the feasibility of a combined CBT and music therapy intervention for CF following Epstein-Barr virus (EBV) infection in adolescents.
Methods
Adolescents (12–20 years old) participating in a postinfectious cohort study who developed CF 6 months after an acute EBV infection were eligible for the present feasibility study. A combined CBT and music therapy programme (10 therapy sessions and related homework) was compared with care as usual in a randomised controlled design. Therapists and participants were blinded to outcome evaluation. Endpoints included physical activity (steps/day), symptom scores, recovery rate and possible harmful effects, but the study was underpowered regarding efficacy. Total follow-up time was 15 months.
Results
A total of 43 individuals with postinfectious CF were included (21 intervention group, 22 control group). Seven individuals left the study during the first 3 months, leaving 15 in the intervention group and 21 in the control group at 3 months’ follow-up. No harmful effects were recorded, and compliance with appointment was high. In intention-to-treat analyses, number of steps/day tended to decrease (difference=−1158, 95% CI −2642 to 325), whereas postexertional malaise tended to improve (difference=−0.4, 95% CI −0.9 to 0.1) in the intervention group at 3 months. At 15 months’ follow-up, there was a trend towards higher recovery rate in the intervention group (62% vs 37%).
Conclusion
An intervention study of combined CBT and music therapy in postinfectious CF is feasible, and appears acceptable to the participants. The tendencies towards positive effects on patients’ symptoms and recovery might justify a full-scale clinical trial.
**
published paper
Cognitive–behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study
"Power considerations and statistical analyses
As this was a feasibility study, a formal power calculation was not considered necessary. It should be noted, though, that in a previous research project from our institution, CFS adolescents had a mean (SD) steps/day count of approximately 4500 (2400), and a mean (SD) CFQ total score of 19.1 (6.3). This given, more than 120 participants would be needed in order to detect a moderate effect size (Cohen’s d≈0.5), such as an increase in steps/day of 1200 or a reduction in CFQ total score of 3 (α=0.05, β=0.2). In the present study, the total number of eligible individuals was 91 (defined as CF cases 6 months after acute EBV infection), and only 43 consented to inclusion. Hence, the study was strongly underpowered regarding efficacy."
Abstract
Background Cognitive–behavioural therapy (CBT) is effective in chronic fatigue syndrome. However, CBT has not been investigated in postinfectious chronic fatigue (CF), nor is it known whether addition of therapeutic elements from other disciplines might be feasible. We studied the feasibility of a combined CBT and music therapy intervention for CF following Epstein-Barr virus (EBV) infection in adolescents.
Methods Adolescents (12–20 years old) participating in a postinfectious cohort study who developed CF 6 months after an acute EBV infection were eligible for the present feasibility study. A combined CBT and music therapy programme (10 therapy sessions and related homework) was compared with care as usual in a randomised controlled design. Therapists and participants were blinded to outcome evaluation. Endpoints included physical activity (steps/day), symptom scores, recovery rate and possible harmful effects, but the study was underpowered regarding efficacy. Total follow-up time was 15 months.
Results A total of 43 individuals with postinfectious CF were included (21 intervention group, 22 control group). Seven individuals left the study during the first 3 months, leaving 15 in the intervention group and 21 in the control group at 3 months’ follow-up. No harmful effects were recorded, and compliance with appointment was high. In intention-to-treat analyses, number of steps/day tended to decrease (difference=−1158, 95% CI −2642 to 325), whereas postexertional malaise tended to improve (difference=−0.4, 95% CI −0.9 to 0.1) in the intervention group at 3 months. At 15 months’ follow-up, there was a trend towards higher recovery rate in the intervention group (62% vs 37%).
Conclusion An intervention study of combined CBT and music therapy in postinfectious CF is feasible, and appears acceptable to the participants. The tendencies towards positive effects on patients’ symptoms and recovery might justify a full-scale clinical trial.
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