Effect of internet-delivered cognitive behavioral therapy on insomnia in convalescent patients with COVID-19: Protocol for a systematic review and meta-analysis.

INTRODUCTION: Coronavirus Disease 2019 (COVID-19) has made a serious public health threat worldwide. Recent evidence has indicated that COVID-19 patients in convalescence frequently experience insomnia, which reduces their quality of life and causes unknown risks. The positive effect of cognitive behavior on insomnia has been well addressed in previous studies. Given the high infectivity and epidemicity of COVID-19, Internet-delivered intervention may be safer than face-to-face treatment. However, whether Internet-delivered cognitive behavioral therapy can effectively improve the insomnia of COVID-19 patients in convalescence has not been completely determined yet. Therefore, we conducted a meta-analysis and systematic review to evaluate the effects of Internet-delivered cognitive behavioral therapy on insomnia in COVID-19 patients in convalescence, with the aim to confer some guidance for its clinical application. METHODS AND ANALYSIS: This systematic review and meta-analysis has been registered in the International Prospective Register of Systematic Reviews (PROSPERO). Two researchers will retrieve the relevant literature on Internet-delivered cognitive behavioral therapy for insomnia in convalescent patients with COVID-19 in PubMed, Web of Science, Embase, MEDLINE, Cochrane Library, Clinical Trials gov, Chinese Biomedical Literature Database (CBM), and Chinese National Knowledge Infrastructure (CNKI) from inception to 11th of December. In addition, we will review the relevant trials and references of the included literature and manually searched the grey literature. The two researchers will independently extracted data and information and evaluated the quality of the included literature. The Review Manager software (version 5.3) and Stata software (version 14.0) will be used for data analysis. The mean difference or the standardized mean difference of 95% CI will be used to calculate continuous variables to synthesize the data. In addition, I2 and Cochrane will be used for heterogeneity assessment. TRIAL REGISTRATION: PROSPERO registration number CRD42021271278.

Introduction

World Health Organization (WHO) has reported that the ongoing pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected 200,840,180 people and resulted in 4,265,903 deaths worldwide by 6th August 2021 [1]. COVID-19 has rapidly developed into a pandemic and seriously threatened public health all over the world [2, 3]. COVID-19 pandemic seriously jeopardizes human physical and mental health [4] and attracts the concerns of numerous researchers [5]. The exploration of novel prevention, diagnosis, and treatment strategies has become a hot topic among scholars [6, 7], but little attention is paid to the mental health of COVID-19 patients in convalescence [8]. Studies have shown that the confirmed patients with COVID-19 tend to experience various psychological disorders such as stress, anxiety, depression, irritability, depression, and despair [9, 10]. Even though the mood of patients recovering from COVID-19 infection has improved, their symptoms of insomnia and fatigue still persist [11]. A considerable number of patients still suffer from insomnia and other symptoms of sleep disorders in the convalescent period [12]. A prospective cohort and nested case-control study has revealed that 29.17% of COVID-19 patients in convalescence experience insomnia [13].

Insomnia is defined as difficulties in falling asleep, maintaining asleep, or waking up too early at least three times per week for at least 3 months [14] and is one of the most common problems experienced by convalescent patients with COVID-19 [13]. COVID-19-related worries and loneliness are the major contributors to clinical insomnia in addition to education status, virus infection, and pre-existing mental health disorders [14, 15]. Poor sleep quality leads to adverse outcomes of physical [16] and mental health [17]. If left untreated, insomnia can aggravate anxiety, depression, and post-traumatic stress disorder and eventually compromise the quality of life [18]. Moreover, severe insomnia disorder or irregular sleep-wake cycle may damage the immune system and inflammatory response and increase the susceptibility to virus infection [19].

At present, primary health care and outpatient mental health institutions are responsible for the treatment of insomnia [20]. Drug therapy remains the most commonly used intervention method for insomnia. Despite the rapid curative effects, drug therapy fails to achieve radical treatment and also results in many adverse reactions [21-23]. Cognitive behavioral therapy, as an evidence-based option, has been found to effectively improve sleep outcomes [24, 25] and its therapeutic effect is equivalent to or better than that of drug therapy [26]. Since SARS-CoV-2 spreads through close contact between people [27], keeping a distance of more than two meters and using an N-95 mask are the most effective ways to prevent the spread of COVID-19 [28]. Under the guidance of therapists, the effect of Internet-delivered cognitive behavioral therapy on some mental and physical diseases is equivalent to that of face-to-face cognitive behavioral therapy [29], because the possibility of novel coronavirus pneumonia reinfection is unknown [30]. As a kind of digital therapy, Internet-delivered cognitive behavioral therapy provides patients with evidence-based treatment interventions, which are driven by software to prevent, manage, or treat medical disorders or diseases [31]. It can be used independently or in concert with medications, devices, or other therapies [31]. Internet-delivered cognitive behavioral therapy represents a promising option to solve the obstacles of psychotherapy [32], which overcomes several limits related to traditional clinical practice [33] and possesses the advantages of low cost [31], high efficiency [31], and continuous monitoring [33]. Therefore, the cognitive behavioral therapy provided by the Internet may also have potential advantages in improving the insomnia of COVID-19 patients in the convalescent period.

The existing studies have shown that Internet-delivered cognitive behavioral therapy can improve symptoms of insomnia in adults [34]. However, a recent study has also found that Internet-delivered cognitive therapy has no significant effect on improving the insomnia of COVID-19 patients [35]. Therefore, this protocol is established to determine the effectiveness of Internet-delivered cognitive behavioral therapy for relieving insomnia symptoms in newly recovered patients with COVID-19.

Review questions

Under the current COVID-19 epidemic background, can Internet-delivered cognitive therapy improve insomnia in rehabilitative patients?

Objectives

The main purpose of this study is to conduct a systematic review and meta-analysis through randomized controlled trials (RCTs) to determine whether the Internet-delivered cognitive behavioral therapy can relieve insomnia in convalescent patients with COVID-19, improve the sleep quality of convalescent patients with COVID-19, and then improve the psychological condition of these patients.

Materials and methods

The protocol is in line with the Preferred Reporting Items for Systematic Reviews and Meta-analysis for Protocol (PRISMA-P) [36].

Inclusion criteria of the study

This systematic review protocol includes the following studies:

Types of studies

We included randomized controlled trials (RCTs). These trials report the effects of Internet-delivered cognitive behavioral therapy on insomnia in convalescent patients with COVID-19.

Participants

Participants are COVID-19 patients with sleep disorders in the convalescent period. Mental disorders will be involved in the meta-analysis.

Ethics and dissemination

Since this study reviews the published data, ethical approval is not required. The results of this systematic review and meta-analysis will be published in peer-reviewed journals.

Interventions

The intervention group will receive Internet-delivered cognitive behavioral therapy. Internet-delivered cognitive behavioral therapy will be conducted under the guidance of experienced psychotherapists or trained therapists. Patients will log into a secure website to access, read, and download online materials organized in a series of lessons or modules, including cognitive reconstruction, loosening practice, knowledge explanation, health education, and so on.

Comparisons

Patients in the control group will receive routine care, such as self-regulation, medical consultation, and support.

Outcome indicators

The sleep indicators for COVID-19 patients in convalescence will be as follows: (1) sleep quality (SQ), (2) time in bed, (3) sleep time (ST), (4) sleep efficiency (SE), (5) sleep disturbance (SD), (6) daytime function (DF), (7) Pittsburgh Sleep Quality Index (PSQI), and (8) Insomnia Severity Index (ISI).

Search strategy

Two researchers (YC, XZ) will retrieve the relevant English and Chinese literature independently in the following databases from inception to 11th of December: PubMed, Web of Science, Embase, MEDLINE, Cochrane Library, ClinicalTrials.gov, Chinese Biomedical Literature Database (CBM), and Chinese National Knowledge Infrastructure (CNKI). PubMed literature search is as follows: (Table 1).

Table 1

Search strategy for PubMed.

Search number	Search term
#1	(((((Internet[Title/Abstract]) OR (web[Title/Abstract])) OR (web-based[Title/Abstract])) OR (computer[Title/Abstract])) OR (online[Title/Abstract])) OR (digital[Title/Abstract])
#2	"Cognitive Behavioral Therapy"[Mesh]
#3	((((((((((((((((((((((Behavioral Therapies, Cognitive[Title/Abstract]) OR (Behavioral Therapy, Cognitive[Title/Abstract])) OR (Cognitive Behavioral Therapies[Title/Abstract])) OR (Therapies, Cognitive Behavioral[Title/Abstract])) OR (Therapy, Cognitive Behavioral[Title/Abstract])) OR (Therapy, Cognitive Behavior[Title/Abstract])) OR (Cognitive Behavior Therapy[Title/Abstract])) OR (Cognitive Therapy[Title/Abstract])) OR (Behavior Therapy, Cognitive[Title/Abstract])) OR (Behavior Therapies, Cognitive[Title/Abstract])) OR (Cognitive Behavior Therapies [Title/Abstract]))OR (Therapies, Cognitive Behavior[Title/Abstract])) OR (Cognitive Psychotherapy[Title/Abstract])) OR (Cognitive Psychotherapies[Title/Abstract])) OR (Psychotherapies, Cognitive[Title/Abstract])) OR (Psychotherapy, Cognitive[Title/Abstract])) OR (Therapy, Cognitive[Title/Abstract])) OR (Cognitive Therapies[Title/Abstract])) OR (Therapies, Cognitive[Title/Abstract])) OR (Cognition Therapy [Title/Abstract])) OR (Therapy, Cognition[Title/Abstract])) OR (Cognition Therapies[Title/Abstract])) OR (Therapies, Cognition[Title/Abstract])
#4	#2 OR #3
#5	"Sleep Initiation and Maintenance Disorders"[Mesh]
#6	((((((((((((((((((((((((((Disorders of Initiating and Maintaining Sleep[Title/Abstract]) OR (DIMS[Title/Abstract])) OR (Early Awakening [Title/Abstract])) OR (Awakening, Early[Title/Abstract])) OR (Nonorganic Insomnia[Title/Abstract])) OR (Insomnia, Nonorganic[Title/Abstract])) OR (Primary Insomnia[Title/Abstract])) OR (Insomnia, Primary[Title/Abstract])) OR (Transient Insomnia[Title/Abstract])) OR (Insomnia, Transient[Title/Abstract])) OR (Rebound Insomnia[Title/Abstract])) OR (Insomnia, Rebound[Title/Abstract])) OR (Secondary Insomnia [Title/Abstract])) OR (Insomnia, Secondary[Title/Abstract])) OR (Sleep Initiation Dysfunction[Title/Abstract])) OR (Dysfunction, Sleep Initiation[Title/Abstract])) OR (Dysfunctions, Sleep Initiation[Title/Abstract])) OR (Sleep Initiation Dysfunctions[Title/Abstract])) OR (Sleeplessness[Title/Abstract])) OR (Insomnia Disorder[Title/Abstract])) OR (Insomnia Disorders[Title/Abstract])) OR (Insomnia[Title/Abstract])) OR (Insomnias[Title/Abstract])) OR (Chronic Insomnia[Title/Abstract])) OR (Insomnia, Chronic[Title/Abstract])) OR (Psychophysiological Insomnia[Title/Abstract])) OR (Insomnia, Psychophysiological[Title/Abstract])
#7	#5 OR #6
#8	"COVID-19"[Mesh]
#9	((((((((((((((((((((((((((((((((((COVID 19[Title/Abstract]) OR (COVID-19 Virus Disease[Title/Abstract])) OR (COVID 19 Virus Disease[Title/Abstract])) OR (COVID-19 Virus Diseases[Title/Abstract])) OR (Disease, COVID-19 Virus[Title/Abstract])) OR (Virus Disease, COVID-19[Title/Abstract])) OR (COVID-19 Virus Infection[Title/Abstract])) OR (COVID 19 Virus Infection[Title/Abstract])) OR (COVID-19 Virus Infections[Title/Abstract])) OR (Infection, COVID-19 Virus[Title/Abstract])) OR (Virus Infection, COVID-19[Title/Abstract])) OR (2019-nCoV Infection[Title/Abstract])) OR (2019 nCoV Infection[Title/Abstract])) OR (2019-nCoV Infections[Title/Abstract])) OR (Infection, 2019-nCoV[Title/Abstract])) OR (Coronavirus Disease-19[Title/Abstract])) OR (Coronavirus Disease 19[Title/Abstract])) OR (2019 Novel Coronavirus Disease[Title/Abstract])) OR (2019 Novel Coronavirus Infection[Title/Abstract])) OR (2019-nCoV Disease[Title/Abstract])) OR (2019 nCoV Disease[Title/Abstract])) OR (2019-nCoV Diseases[Title/Abstract])) OR (Disease, 2019-nCoV[Title/Abstract])) OR (COVID19[Title/Abstract])) OR (Coronavirus Disease 2019[Title/Abstract])) OR (Disease 2019, Coronavirus[Title/Abstract])) OR (SARS Coronavirus 2 Infection[Title/Abstract])) OR (SARS-CoV-2 Infection[Title/Abstract])) OR (Infection, SARS-CoV-2[Title/Abstract])) OR (SARS CoV 2 Infection[Title/Abstract])) OR (SARS-CoV-2 Infections[Title/Abstract])) OR (COVID-19 Pandemic[Title/Abstract])) OR (COVID 19 Pandemic[Title/Abstract])) OR (COVID-19 Pandemics[Title/Abstract])) OR (Pandemic, COVID-19[Title/Abstract])
#10	#8 OR #9
#11	#1 AND #4 AND #7 AND #10

Literature selection and data extraction

Literature selection

The literature screening process will follow the steps in the PRISMA flow chart (Fig 1). Firstly, after retrieving all databases, we will use Endnote 9.0 software to eliminate duplicate studies. Then, the two researchers will independently examined the titles and abstracts of the documents obtained after weight removal and preliminarily screened the documents. Subsequently, the two researchers will independently read the preliminarily screened literature according to the inclusion and exclusion criteria we formulate in advance. Finally, the literature screened by the two researchers will be compared to determine the literature finally included in the analysis. A third independent researcher will be consulted to achieve a final consensus in case of disagreement between both researchers.

Fig 1

Flow diagram of study selection process.

Data extraction

The extraction of data and information in the literature will be completed by two researchers independently, including first author, publication date, country, intervention implementer, sample number, sample age, sample source, intervention time of online cognitive behavioral therapy, intervention frequency, dropout rate, insomnia assessment tool, and other details. Data will be collected and analyzed in the near future.

Risk of bias assessment in the included literature

The two researchers will use the Cochrane bias risk assessment tool to independently assess the risk of publication bias of each included literature (random sequence generation, random assignment concealment, blind method, incomplete result data, selective reporting bias, and other bias). The bias risk will include the risk of high, unclear, or low bias [37]. If there are any differences in the assessment, a third researcher will be consulted to resolve the dispute.

Data synthesis and statistical analysis

Review Manager 5.3 software and Stata 14.0 software will be used for quantitative data analysis, including overall forest mapping, heterogeneity analysis, subgroup analysis, sensitivity analysis, and funnel mapping. For the diverse insomnia assessment tools, the standardized mean difference (SMD) and its 95% confidence interval (CI) will be used to describe the size of the effect. On the contrary, the mean difference (MD) and 95% CI will be used to represent the size of the effect.

Assessment of heterogeneity

The heterogeneity assessment will be conducted using the Rev Man 5.3 software. The Chi-Squared test and I will be adopted to examine the statistical heterogeneity of the included studies. The random-effect model (P ≤ 0.1 and I > 50%) or fixed-effect model (P > 0.1 and I ≤ 50%) will be selected according to the values of P and I.

Subgroup analysis

When heterogeneity is found in the results, subgroup analysis will be performed on the basis of ensuring sufficient data. The criteria will include characteristics (such as country or sample source), study quality, type of control intervention, and duration. In addition, we will analyze any other subgroups reported in the literature.

Assessment of reporting bias

Publication bias will be assessed by visual inspection of the funnel plot asymmetry and Egger’s regression test [38].

Sensitivity analysis

The robustness of analysis results will be explored by sensitivity analysis. Sensitivity analysis will be performed by excluding each uncertain factor to determine the sensitive factor exerting an important impact on the overall results.

Quality of evidence

The researchers will assess the quality of evidence for the entire study in accordance with the Grades of Recommendation, Assessment, Development, and Evaluation system established by the WHO and international organizations. The GRADE system will rate the quality of evidence as “high,” “medium,” “low,” and “lowest” [39].

Discussion

Insomnia seriously impairs the quality of life of COVID-19 patients in convalescence and causes severe mental disorders such as anxiety, depression, and fear [40]. Therefore, the use of scientific psychological intervention to treat insomnia is of great practical significance. Previous studies have shown that Internet-delivered cognitive behavioral therapy can make insomnia patients achieve lasting sleep improvement over a period of time with fewer side effects [41]. Based on the existing evidence, we reasonably speculate that cognitive behavioral therapy can also relieve the insomnia of COVID-19 patients in convalescence.

Due to the impact of methodological quality, information bias, and adequacy of results reporting of the included literature, the therapeutic effect of Internet-delivered cognitive behavioral therapy on insomnia in COVID-19 patients in convalescence may be affected. Therefore, we need to conduct large-scale and high-quality research in the future to obtain more accurate results.

PRISMA-P 2009 checklist.

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3 Mar 2022

24 Mar 2022

Dear Editor,

We would like to resubmit the revised manuscript entitled “Effect of Internet-delivered cognitive behavioral therapy on insomnia in convalescent patients with COVID-19: protocol for a systematic review and meta-analysis (PONE-D-21-40745)” for consideration by PLOS ONE. We would like to thank the reviewers for thoroughly reviewing our manuscript and making many thoughtful comments. We were very pleased to see that reviewers recognized the novelty and potential significance of our work. We have added significant new contents, described in detail below, and revised the manuscript to address reviewers’ comments. In the Revised Manuscript with Track Changes, the contents we added are marked in green and the contents we deleted are marked in red. Here are our point-by-point responses:

Yan Chen

Institute of Chronic Disease Risks Assessment, School of nursing and health,

Henan University

Kaifeng, Henan, China

E-mail address: chenyan8251@126.com

March 23, 2022

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Answer:

We have used PRISMA guidelines to help improve the reporting quality of this study. At the same time, we have uploaded a copy of the completed PRISMA checklist as supporting information.

5. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Answer:

We have carefully examined the reference list to ensure its completeness and correctness.

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

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Reviewer #1: Yes

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Answer: Thank you very much for your valuable comments. We have carefully polished the language of the manuscript to make it readable and standard.

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Number 7:

Reviewer #1: The article by Chen et al. presented the study design of a metanalysis and systematic research to evaluate the effects of internet-delivered cognitive behavioral therapy on insomnia in COVID-19 patients in convalescence. Methods are sounds, however there are some minor concerns:

In the abstract section:

1) “In addition. I2 and Cochrane will be used for heterogeneity assessment.” I don’ understand the full stop just after “In addition”. AMEND

Answer:

Thank you very much for your careful review. We have corrected the writing errors caused by our carelessness.

In the introduction section:

2) “and despair [9, 10], Even” comma or full stop? AMEND.

Answer:

We have changed "comma" to "full stop" here.

3) “Insomnia is defined as the subjective perception of difficulties in falling asleep, maintaining asleep, and early morning awakening at least three times per week for at least 3 months[13].” Imsonnia not is a subjective perception and the article that is cited does not define it as a subjective perception. Please correct.

Answer:

Thank you for your valuable comments. We have carefully checked the quoted articles and made the following changes to the definition of insomnia:

Insomnia is defined as difficulties in falling asleep, maintaining asleep, or waking up too early at least three times per week for at least 3 months [13] and is one of the most common problems experienced by convalescent patients with COVID-19 [14].

4) “Till now, Previous studie” comma or full stop? AMEND.

Answer:

Thank you for your careful review. It is correct to use comma here, and we have changed the description of this sentence. Please review it again.

5) “But a recent study found that Internet cognitive”. Use “However” instead of “But”.

Answer:

Thank you for your suggestion. We have replaced "But" with "However".

6) There are many examples of internet-delivered therapy for neurological diseases and a recent review of the literature thoroughly presented them. I suggest to briefly discuss it in the introduction section (PMID: 34018047).

Answer:

Thank you for your constructive suggestions. We refer to a recent review and add the following contents to make the manuscript more comprehensive:

As a kind of digital therapy, Internet-delivered cognitive behavioral therapy provides patients with evidence-based treatment interventions, which are driven by software to prevent, manage, or treat medical disorders or diseases [31]. It can be used independently or in concert with medications, devices, or other therapies [31]. Internet-delivered cognitive behavioral therapy, as a promising method to solve psychotherapy obstacles [32], can overcome several limits related to traditional clinical practice [33].

The article could improve with a revision by an english native speaker.

Answer:

We have carefully polished the language of the manuscript to make it more professional and more suitable for publication.

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Reviewer #1: No

Thank you for your consideration of our manuscript.

Yours sincerely,

Yan Chen

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4 Apr 2022

6 Apr 2022

Dear Editor,

We would like to resubmit the revised manuscript entitled “Effect of Internet-delivered cognitive behavioral therapy on insomnia in convalescent patients with COVID-19: protocol for a systematic review and meta-analysis (PONE-D-21-40745R1)” for consideration by PLOS ONE. We would like to thank the reviewers for thoroughly reviewing our manuscript and making many thoughtful comments. We were very pleased to see that reviewers recognized the novelty and potential significance of our work. We have added significant new contents, described in detail below, and revised the manuscript to address reviewers’ comments. In the Revised Manuscript with Track Changes, the contents we added are marked in green and the contents we deleted are marked in red. Here are our point-by-point responses:

Yan Chen

Institute of Chronic Disease Risks Assessment, School of nursing and health,

Henan University

Kaifeng, Henan, China

E-mail address: chenyan8251@126.com

April 6, 2022

Journal Requirements:

(1) The date of the search run was the 30th of July in the manuscript, while the PROPSERO entry was the 11th of December. Please, can you clarify when the search was run?

Answer: Thank you very much for your careful review. The search run in the registration protocol is the 30th of July. However, given the prevalence of COVID-19 epidemic, we consider that there may be more published articles that meet the criteria of the study. To expand the search scope, the search run in the manuscript is the 11th of December. Combined with the your comments, we have changed the retrieval time to the 30th of July in the manuscript to make it consistent with the research protocol.

(2) Please, in the Methods section, can you clarify whether the data have already been collected and analyzed?

Answer: Thank you for your valuable comments. Till now, the data have already been collected and analyzed. We have clarified it in the Methods section.

(3) Ideally, Study Protocols should be written in the present tense. We noted that the tense used in the manuscript is the past tense. Could you please correct accordingly?

Answer: Thank you very much for your valuable comments. We have carefully modified the tense used in the manuscript.

(4) We noted significant overlap between your work and the article titled ". Efficacy and safety evaluation of bright light therapy in patients with post-stroke insomnia: a protocol of systematic review and meta-analysis" (Lei H et al. Medicine. 2021;100:50(e27937)). Please, can you comment on this?

Answer: Thanks for your careful review. As you pointed out, the study entitled "Efficacy and safety evaluation of bright light therapy in patients with post-stroke insomnia: a protocol of systematic review and meta-analysis (PMID: 34918641) has some similarities in the selection of outcome indicators with our study. However, after careful reading, we find great differences in the design of the two studies. Firstly, the research objects are different. The research objects of our study are COVID-19 patients in rehabilitation, while the above study (PMID:34918641) focuses on the insomnia population with stroke. Although the two studies all use insomnia as an outcome indicator, insomnia in stroke patients may be caused by nervous system damage, and our study is aimed at insomnia in COVID-19 rehabilitation patients. Secondly, the intervention methods are different. Our study uses Internet-delivered cognitive behavioral therapy. Cognitive behavioral therapy, as an evidence-based option, has been found to effectively improve sleep outcomes [1, 2] and its therapeutic effect is equivalent to or better than that of drug therapy [3]. However, the above study (PMID:34918641) selects bright light therapy (Typically, patients are instructed to be exposed to bright light at a constant distance every day[4]).

References

[1] Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 4; 163(3):191-204. https://doi.org/10.7326/M14-2841 PMID: 26054060

[2] Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. 2006; 25(1):3-14. https://doi.org/10.1037/0278-6133.25.1.3 PMID: 16448292

[3] Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002; 159(1):5-11. https://doi.org/10.1176/appi.ajp.159.1.5 PMID: 11772681

[4] van Maanen A, Meijer AM, van der Heijden KB, Oort FJ. The effects of light therapy on sleep problems: A systematic review and meta-analysis. Sleep Med Rev. 2016; 29:52-62. http://doi.org/ 10.1016/j.smrv. PMID: 26606319

Submitted filename: Response to Reviewers.docx

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11 Apr 2022

16 Apr 2022

Dear Editor,

We would like to resubmit the revised manuscript entitled “Effect of Internet-delivered cognitive behavioral therapy on insomnia in convalescent patients with COVID-19: protocol for a systematic review and meta-analysis (PONE-D-21-40745R1)” for consideration by PLOS ONE. We would like to thank the reviewers for thoroughly reviewing our manuscript and making many thoughtful comments. We were very pleased to see that reviewers recognized the novelty and potential significance of our work. We have added significant new contents, described in detail below, and revised the manuscript to address reviewers’ comments. In the Revised Manuscript with Track Changes, the contents we added are marked in green and the contents we deleted are marked in red. Here are our point-by-point responses:

Yan Chen

Institute of Chronic Disease Risks Assessment, School of nursing and health,

Henan University

Kaifeng, Henan, China

E-mail address: chenyan8251@126.com

April 17, 2022

Journal Requirements:

1) we noted that the data analysis for this study in now completed, as you reported in the Methods section. Study Protocol are articles type for which data collection and analysis cannot be completed at the moment of submission. Please, remove the sentence from the Methods.

Answer: Thank you for your valuable comments. We have deleted the sentence "Till now, the data have already been collected and analyzed." and further clarified it in the Methods.

2) Please, edit your manuscript with the present or future tense in order to make it conform to the Study Protocol criteria. Study protocol present the proposal of a study, and the manuscript should read as something you are proposing to do.

Answer: Thank you very much for your valuable comments. We have carefully modified the tense used in the manuscript.

3) The search date between the manuscript and the PROSPERO entry are still inconsistent. As you extended the search strategy to the 11th of December, please report this into the main text of the manuscript.

Answer: Thank you very much for your careful review. The search run in the registration protocol is the 30th of July. However, given the prevalence of COVID-19 epidemic, we consider that there may be more published articles that meet the criteria of the study. Hence, the search run in the manuscript is the 11th of December so as to expand the search scope. In consideration of your comments, we have clarified it in the main text of the manuscript.

4) We appreciate your response on the differences between your study and Lei H et al. Medicine. 2021;100:50(e27937). However, we feel you did not provide sufficient explanation on why the search strategies are similar. Please, clarify this point."

Answer: Thanks for your careful review. As you pointed out, the study entitled "Efficacy and safety evaluation of bright light therapy in patients with post-stroke insomnia: a protocol of systematic review and meta-analysis (PMID: 34918641) has some similarities with our study in search strategies.

After careful review, we found that the similarity is mainly due to two reasons. Firstly, this study (PMID: 34918641) is different from our study in the research object, but it is the same in the analysis of the outcome index, namely insomnia. Secondly, both the study (PMID:34918641) and our study use subject words [Sleep Initiation and Maintenance Disorders[Mesh]] combined with entry terms [(Disorders of Initiating and Maintaining Sleep) OR (Disorders of Initiating and Maintaining Sleep) OR (Early Awakening) OR (Awakening, Early) OR (Nonorganic Insomnia) OR (Insomnia, Nonorganic) OR (Primary Insomnia) OR (Insomnia, Primary) OR (Transient Insomnia) OR(Insomnia, Transient) OR (Rebound Insomnia) OR (Insomnia, Rebound) OR (Secondary Insomnia) OR (Insomnia, Secondary) OR (Sleep Initiation Dysfunction) OR (Dysfunction, Sleep Initiation) OR (Dysfunctions, Sleep Initiation) OR (Sleep Initiation Dysfunctions) OR (Sleeplessness) OR (Insomnia Disorder) OR (Insomnia Disorders) OR (Insomnia) OR (Insomnias) OR (Chronic Insomnia) OR (Insomnia, Chronic) OR (Psychophysiological Insomnia) OR (Insomnia, Psychophysiological)] to retrieve the PubMed. This scientific approach can help to obtain more comprehensive search results. Therefore, due to the same outcome index and search method, the two studies are similar in search strategies.

Thank you for your consideration of our manuscript.

Yours sincerely,

Yan Chen

Submitted filename: Response to Reviewers.docx

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30 May 2022

Effect of Internet-delivered cognitive behavioral therapy on insomnia in convalescent patients with COVID-19: protocol for a systematic review and meta-analysis

PONE-D-21-40745R3

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Reviewers' comments:

2 Jun 2022

PONE-D-21-40745R3

Effect of Internet-delivered cognitive behavioral therapy on insomnia in convalescent patients with COVID-19: protocol for a systematic review and meta-analysis

Dear Dr. Chen:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

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