Comparison of telemedicine-assisted psychotherapy, exercise therapy, or a combination of both in patients with post-COVID-19 syndrome (TelPoCo): study protocol for a randomized controlled trial.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Trials Pub Date : 2025-07-20 DOI:10.1186/s13063-025-08968-7
Sebastian Beyer, Mariel Nöhre, Isabell Pink, Sebastian Häckl, Nele Henrike Thomas, Frank Klawonn, Uwe Tegtbur, Martina de Zwaan, Sven Haufe
{"title":"Comparison of telemedicine-assisted psychotherapy, exercise therapy, or a combination of both in patients with post-COVID-19 syndrome (TelPoCo): study protocol for a randomized controlled trial.","authors":"Sebastian Beyer, Mariel Nöhre, Isabell Pink, Sebastian Häckl, Nele Henrike Thomas, Frank Klawonn, Uwe Tegtbur, Martina de Zwaan, Sven Haufe","doi":"10.1186/s13063-025-08968-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Post-COVID-19 syndrome (PCS) presents in a multitude of ways, with fatigue, physical constraints, and diminished quality of life being common symptoms. It is becoming increasingly clear that unimodal behavioral interventions do benefit all PCS patients. Adherence to and response to isolated psychotherapy or physical activity interventions vary greatly, with certain patients benefit more from one form of therapy, or even a combination, than others do. The study aims to compare the effects of a single exercise therapy, psychotherapy, and a combination of both therapies.</p><p><strong>Methods: </strong>The study will be conducted as a prospective, randomized controlled, open-label trial with 3 treatment arms (exercise therapy, psychotherapy, and combined therapy). According to the sample size calculation, 65 participants will be enrolled in each group. The primary outcome is the change of PCS fatigue symptoms from baseline to 3 months, estimated by the Fatigue Assessment Scale. Secondary endpoints include changes in further measures of fatigue (Chalder Fatigue Skala, Multidimensional Fatigue Inventory, Post-exertional Malaise Scale, Bell Scale), health-related quality of life (Short Form-36 and Brief Illness Perception Questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale), and work ability (Work Ability Index). The intervention lasts for 3 months and includes online therapy sessions of 50 min every 2 weeks or in case of lack of concentration or fatigue this could be split to two 25-min sessions (all equating to a total of 300 min of specialist care). The psychotherapy adopts a short-term and coping-oriented approach based on the unique requirements of each patient from a psychotherapeutic perspective. Exercise therapy involves a personalized physical activity plan customized to suit the patient's requirements, with tracking day-to-day physical activity along with daily moderate endurance and strengthening workouts. An ANCOVA model, including the stratification factors sex and BMI, will be used for the primary analysis of Fatigue Assessment Scale. Significance tests will be based on the group differences in least square means and corresponding 95% CIs.</p><p><strong>Discussion: </strong>Due to the current relevance of the issue, the unclear evidence so far, and the lack of appropriately powered randomized studies, it is crucial to assess potentially effective concepts for treating patients with PCS. Future therapy decisions will benefit from answering the question of whether combined therapies hold a significant advantage over unimodal therapeutic approaches, as well as identifying predictors that indicate an advantage of certain therapies for particular patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06042751 . Registered on 21 September 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"251"},"PeriodicalIF":2.0000,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12278562/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-025-08968-7","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Post-COVID-19 syndrome (PCS) presents in a multitude of ways, with fatigue, physical constraints, and diminished quality of life being common symptoms. It is becoming increasingly clear that unimodal behavioral interventions do benefit all PCS patients. Adherence to and response to isolated psychotherapy or physical activity interventions vary greatly, with certain patients benefit more from one form of therapy, or even a combination, than others do. The study aims to compare the effects of a single exercise therapy, psychotherapy, and a combination of both therapies.

Methods: The study will be conducted as a prospective, randomized controlled, open-label trial with 3 treatment arms (exercise therapy, psychotherapy, and combined therapy). According to the sample size calculation, 65 participants will be enrolled in each group. The primary outcome is the change of PCS fatigue symptoms from baseline to 3 months, estimated by the Fatigue Assessment Scale. Secondary endpoints include changes in further measures of fatigue (Chalder Fatigue Skala, Multidimensional Fatigue Inventory, Post-exertional Malaise Scale, Bell Scale), health-related quality of life (Short Form-36 and Brief Illness Perception Questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale), and work ability (Work Ability Index). The intervention lasts for 3 months and includes online therapy sessions of 50 min every 2 weeks or in case of lack of concentration or fatigue this could be split to two 25-min sessions (all equating to a total of 300 min of specialist care). The psychotherapy adopts a short-term and coping-oriented approach based on the unique requirements of each patient from a psychotherapeutic perspective. Exercise therapy involves a personalized physical activity plan customized to suit the patient's requirements, with tracking day-to-day physical activity along with daily moderate endurance and strengthening workouts. An ANCOVA model, including the stratification factors sex and BMI, will be used for the primary analysis of Fatigue Assessment Scale. Significance tests will be based on the group differences in least square means and corresponding 95% CIs.

Discussion: Due to the current relevance of the issue, the unclear evidence so far, and the lack of appropriately powered randomized studies, it is crucial to assess potentially effective concepts for treating patients with PCS. Future therapy decisions will benefit from answering the question of whether combined therapies hold a significant advantage over unimodal therapeutic approaches, as well as identifying predictors that indicate an advantage of certain therapies for particular patients.

Trial registration: ClinicalTrials.gov NCT06042751 . Registered on 21 September 2023.

远程医疗辅助心理治疗、运动治疗或两者结合在covid -19后综合征(TelPoCo)患者中的比较:一项随机对照试验的研究方案。
背景:covid -19后综合征(PCS)表现为多种形式,常见症状包括疲劳、身体限制和生活质量下降。越来越清楚的是,单模行为干预确实有利于所有PCS患者。对单独的心理治疗或身体活动干预的依从性和反应差异很大,某些患者从一种治疗形式,甚至是组合治疗中受益更多,而不是其他人。这项研究旨在比较单一运动疗法、心理疗法和两种疗法结合的效果。方法:该研究将采用前瞻性、随机对照、开放标签试验,分为3个治疗组(运动疗法、心理疗法和联合疗法)。根据样本量计算,每组65人。主要观察指标是通过疲劳评估量表估计的PCS疲劳症状从基线到3个月的变化。次要终点包括进一步测量疲劳(Chalder疲劳量表、多维疲劳量表、运动后不适量表、贝尔量表)、健康相关生活质量(简短表格36和简短疾病感知问卷)、焦虑和抑郁(医院焦虑和抑郁量表)和工作能力(工作能力指数)的变化。干预持续3个月,包括每两周50分钟的在线治疗,或者在注意力不集中或疲劳的情况下,可以分成两次25分钟的治疗(总共相当于300分钟的专科护理)。心理治疗从心理治疗的角度出发,根据每个患者的独特需求,采用短期应对为主的方法。运动疗法包括一项个性化的身体活动计划,根据患者的需求定制,跟踪每天的身体活动,以及每天适度的耐力和强化锻炼。采用ANCOVA模型,包括分层因素性别和BMI,对疲劳评估量表进行初步分析。显著性检验将基于最小二乘均值和相应95% ci的组差异。讨论:由于该问题的当前相关性,到目前为止证据不明确,以及缺乏适当的随机研究,评估治疗PCS患者的潜在有效概念至关重要。未来的治疗决策将受益于回答联合治疗是否比单模治疗方法具有显著优势的问题,以及确定表明某些治疗对特定患者具有优势的预测因素。试验注册:ClinicalTrials.gov NCT06042751。于2023年9月21日注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信