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Open access Protocol
Effectiveness and feasibility of internet- BMJ Open: first published as 10.1136/bmjopen-2019-036034 on 22 April 2020. Downloaded from
based and mobile-based interventions
for individuals experiencing
bereavement: a systematic
review protocol
Melanie Luppa , Margrit Löbner, Alexander Pabst, Christine Schlapke,
Janine Stein, Steffi G Riedel- Heller
To cite: Luppa M, Löbner M, AbStrACt Strengths and limitations of this study
Pabst A, et al. Effectiveness Introduction Internet- based and mobile- based
and feasibility of internet- based interventions (IMIs) provide an innovative and efficient
and mobile- based interventions self- management tool for mental health problems. This ► First study that provides a comprehensive summary
for individuals experiencing systematic review aims to summarise and critically of studies investigating effectiveness and feasibility
bereavement: a systematic evaluate studies addressing the effectiveness and of internet- based and mobile- based interventions
review protocol. BMJ Open feasibility of IMIs for normal and complicated grief in (IMIs) for normal and complicated grief in bereaved
2020;10:e036034. doi:10.1136/ adults.
bmjopen-2019-036034 bereaved adults. ► Possibility of usage of these IMIs in healthcare as
► Prepublication history and Methods and analysis The databases MEDLINE, additional intervention tools as well as low-threshold
additional material for this Cochrane Library, PsycINFO, Embase and Web of treatment options.
paper are available online. To Science and Google Scholar (for ‘grey’ literature) will ► Application with the necessary caution of these IMIs
view these files, please visit be systematically searched for feasibility studies or seems to be required not to interfere with natural
the journal online (http:// dx. doi. randomised controlled trials of IMIs for bereaved adults grief processes.
org/ 10. 1136/ bmjopen- 2019- who were experiencing normal/complicated grief. Data
036034). will be extracted and evaluated independently by two
Received 02 December 2019 reviewers from studies eligible for inclusion. Quality of The effectiveness of IMIs has been shown http://bmjopen.bmj.com/
Revised 28 February 2020 evidence will be assessed, and results will be synthesised for treating depression (eg, refs 2–4), anxiety
Accepted 20 March 2020 qualitatively and pooled meta- analytically, if sufficient (eg, refs 5 6), post- traumatic stress disorder
outcome data are available. Preferred Reporting Items for
Systematic Reviews and Meta- Analyses standards and (PTSD; eg, refs 7–9) and other mental health
1
Grades of Recommendation, Assessment, Development problems. However, less is currently known
and Evaluation methodology will be used. about IMIs for individuals experiencing
Ethics and dissemination No primary data will be normal or complicated grief.
collected; thus, ethical approval is not required. The results In general, grief is defined as a typical reac-
will be disseminated through a peer- reviewed publication 10 on September 28, 2022 by guest. Protected by copyright.
tion to the loss of a significant other and
and conference presentations. is associated with symptoms such as intense
trial registration number CRD42019131428. subjective distress, loneliness and somatic
symptoms, for example, tightness of the
11 12
© Author(s) (or their throat or need for sighing. Recently, the
employer(s)) 2020. Re- use bACkground concept of an abnormal reaction to loss has
permitted under CC BY- NC. No Self- management is a widely used approach been proposed and is included as a disorder
commercial re- use. See rights within the medical healthcare system for in the Diagnostic Statistical Manual of Mental
and permissions. Published by improving patients’ knowledge, capabilities Disorders, Fifth Edition, and is expected to be
BMJ. and skills in managing their health prob- included in the International Statistical Classi-
Institute of Social Medicine, lems. Internet- based and mobile- based inter- fication of Diseases and Related Health Problems,
Occupational Health and Public ventions (IMIs) provide an innovative and 11th Revision as a new diagnosis. The disor-
Health, University of Leipzig, efficient self- management tool for mental
Faculty of Medicine, Leipzig, ders complicated, traumatic or prolonged
Sachsen, Germany health problems. In recent years, web- based grief (subsequently summarised under
Correspondence to self- management interventions have gained complicated grief) and complicated grief are
Dr Melanie Luppa; increasing attention as effective supplemen- described as ‘a syndrome of prolonged and
Melanie. Luppa@ medizin. uni- tary treatment elements to standard mental intense grief that is accompanied by compli-
leipzig. de health treatment.1 13
cations that derail the progress of grief’.
Luppa M, et al. BMJ Open 2020;10:e036034. doi:10.1136/bmjopen-2019-036034 1
Open access
BMJ Open: first published as 10.1136/bmjopen-2019-036034 on 22 April 2020. Downloaded from
objECtIvES
The planned review aims to systematically evaluate and
synthesise the evidence base of randomised controlled
trials (RCTs) reporting, the effectiveness of IMIs (ie,
improvement of objective parameters) and the feasibility
of IMIs (eg, usability, satisfaction, acceptability, under-
standability and usefulness) for individuals aged 18 years
and older who experienced the death of a significant
other. Depending on the number of eligible studies,
assessment tools and quality of the studies reported, we
will also combine data across RCTs to estimate pooled
effect sizes for the considered outcomes.
MEthodS And AnAlySIS
This protocol outlines the strategies for conducting a
systematic review and meta- analysis of RCTs that exam-
ined the effectiveness of IMIs for bereavement. It is based
Figure 1 Flow diagram of the planned study selection on the Preferred Reporting Items for Systematic Reviews
process adapted from the Preferred Reporting Items for and Meta- Analyses (PRISMA) for systematic review proto-
Systematic Reviews and Meta- Analyses statement. 24 25 The protocol describes
cols (PRISMA- P) guidelines.
the planned strategy to systematically evaluate and
synthesise data from RCTs and feasibility studies on IMIs
In contrast to uncomplicated grief, clinically significant for bereaved individuals. We will apply the four- phase
impairment in social, occupational or other important PRISMA flow diagram (figure 1) for our study selection
areas of functioning must be present.13 14 The diagnosis of process.
complicated grief is given only after a period of 6 months
following the loss event if the person is still suffering Eligibility criteria
from separation stress as well as cognitive, emotional and The systematic review will be divided into two parts: effec-
14 tiveness studies and feasibility studies on IMIs (study
behavioural symptoms.
Because grief can affect many areas of life15 16 and is one design criteria) that include adults (18 years and older)
of the major contributors to the development of mental who experienced the death of a significant other and were http://bmjopen.bmj.com/
health disorders, providing IMIs as a low-threshold treat - suffering from normal or complicated grief (participant
ment option may enable more people to receive treat- criteria). Any measures of effectiveness (ie, improvement
ment than through face- to- face interventions alone17 to of objective parameters) and feasibility (eg, usability,
prevent the development of mental health disorders. satisfaction, acceptability, understandability and useful-
Major depression, generalised anxiety disorder and PTSD ness) (outcome criteria) of IMIs related to bereavement
are particularly closely related to the symptoms of compli- will be included. Onset data from clinician- rated scales
cated grief, but differences between the disorders have will be prioritised over self-report questionnaires. The
14 18 intervention must have been a psychological interven- on September 28, 2022 by guest. Protected by copyright.
also been reported. 26
To date, a number of IMIs for bereavement problems tion according to Kampling et al criteria: CBT, psycho-
exist in the international research literature. Internet- dynamic psychotherapy, behaviour therapy or behaviour
based cognitive–behavioural therapy (CBT) interventions modification, systemic therapy, third wave CBT, human-
were reported to be effective in treating patients with istic therapy, integrative therapy or to other psychological-
19 orientated interventions and must have been provided
complicated grief but not for those with uncomplicated in an online setting (intervention criteria). In RCTs, the
20
grief. Some researchers have urged caution in imple- comparison group must be either ‘treatment as usual’,
menting interventions too early or across a wide range ‘waiting list’, ‘attention placebo’ (inactivity on the part
of bereavement-related distress so as to not interfere with of both researchers and participants) or ‘psychological
21 22
natural grief processes. One study showed that IMIs placebo’ (activity on the part of participants and inactivity
23
for PTSD improve symptoms of complicated grief. To of researchers). We will consider articles that are written
our knowledge, there are no previous systematic reviews in either English or German (language criteria). The
summarising the effectiveness and feasibility of IMIs for literature search will not be restricted by publication date.
bereaved individuals—for normal as well as complicated
grief. The results of this review and meta- analysis will Information sources and search strategy
therefore address this gap in the literature. This protocol Systematic literature searches will be conducted in the data-
describes the rationale and design of the planned system- bases MEDLINE (PubMed interface), Cochrane Library
atic review and meta- analysis. (Cochrane Database of Systematic Reviews, Cochrane
2 Luppa M, et al. BMJ Open 2020;10:e036034. doi:10.1136/bmjopen-2019-036034
Open access
BMJ Open: first published as 10.1136/bmjopen-2019-036034 on 22 April 2020. Downloaded from
Central Register of Controlled Trials (CENTRAL) and data. Difficulties with data extraction will be discussed
Cochrane Methodology Register), PsycINFO, Embase, and the form will be adopted accordingly. Data from each
Web of Science (Science and Social Science Citation study will be extracted by both reviewers (MeL and CS)
Index) and Google Scholar (for ‘grey’ literature) by MeL independently, and reliability of data extraction will be
and CS independently. A combination of the following checked in a random sample of studies. Discrepancies
search terms will be used: (1) bereavement or widow- between the two reviewers will be discussed with a senior
hood or grief; and (2) online or web or computer or researcher (SGR- H). Missing data will be requested from
mobile or e- health or internet; and (3) intervention or study authors.
psychotherapy or cognitive behavioural therapy or CBT. The following data will be extracted:
The draft of the full MEDLINE search strategy is avail- 1. Study identification items: for example, first author,
able in online supplementary appendix 1. If feasible, year of publication and country.
medical subject headings will be used as search terms. 2. Study design characteristics: for example, sample size,
The finalised MEDLINE search strategy will be adapted recruitment strategy, inclusion/exclusion criteria, cir-
to the syntax and subject headings specifications of the cumstances of the loss (eg, violent death and suicide),
other databases. We will initially screen titles and abstracts control group, diagnostic criteria/assessment of nor-
for eligibility. Full texts will then be assessed for criteria, mal/prolonged/complicated grief, assessment of co-
and the reference lists of included articles and systematic occurring conditions (eg, Major depression, PTSD and
reviews will be hand searched to identify further poten- concurrent pharmacotherapy/psychotherapy), assess-
tially relevant studies. Finally, we will conduct a grey ment of suicidal ideation or behaviour, interventions
literature search for unpublished studies using Google design/type, duration of intervention and length of
and Google Scholar with the above- named search terms. follow- up assessments.
If applicable and necessary, we will contact researchers 3. Participants characteristics: for example, mean age,
directly to gather further relevant non-published data. age range and gender.
The searches will be rerun just before the final analyses 4. Methodological aspects: risk of bias and study limita-
so that more recent studies can be retrieved. tions.
5. Outcomes: (A) effectiveness: primary outcome mea-
data management sures: reduction of grief symptoms; secondary out-
References and data will be managed using the Review come measures: reduction of depression, anxiety,
Manager (RevMan) software package V.5.3 (by the somatisation or PTS symptoms or suicidal ideation or
Nordic Cochrane Centre, The Cochrane Collaboration, behaviour and (B) feasibility: usability, satisfaction,
Copenhagen, Denmark, 2014). RevMan is specifically acceptability, understandability and usefulness; onset
designed for managing and analysing systematic review data from clinician- rated scales will be prioritised over http://bmjopen.bmj.com/
data from bibliographical management to data synthesis. self- report questionnaires. All different time frames of
If feasible, additional data analyses and meta- analysis will follow- up assessments will be included.
be conducted using Stata V.13.1 SE.
Quality assessment
Selection process The methodological quality of included studies will be
All titles and abstracts of articles will be screened inde- assessed by two researchers (MeL and CS) independently
pendently by two reviewers (MeL and CS). At this stage, using the Cochrane Collaboration Tool for Assessing Risk
27
articles will be divided into potentially relevant, irrelevant of Bias in RCTs. As recommended, each study will be
or uncertain. Reasons for exclusion of irrelevant articles assessed in the following domains: (1) selection bias, that on September 28, 2022 by guest. Protected by copyright.
will be given. Potentially relevant and uncertain articles is, descriptions of the (1a) method of randomisation and
will be read in full text independently by MeL and CS, (1b) concealment of allocation; (2) performance bias,
and study eligibility based on the established criteria spec- that is, description of the methods of blinding partici-
ified above will be assessed. At each stage of the selection pants and researchers; (3) detection bias, that is, descrip-
process, any discrepancies will be discussed between the tion of the methods of blinding outcome assessment; (4)
two reviewers. When discrepancies cannot be resolved, attrition bias, that is, description of incomplete outcome
input from a third senior researcher (SGR- H) will be data; (5) reporting bias, that is, description of selective
obtained. outcome reporting; and (6) other bias, that is, descrip-
tion of important concerns about other biases. Studies
data collection process and data items will be rated as ‘high’, ‘low’ or ‘unclear’. These assess-
A standardised data extraction form will be used to extract ments will be used to inform the corresponding Grades
data from included studies. Extracted data will include of Recommendation, Assessment, Development and
study characteristics, participant characteristics, meth- Evaluation (GRADE) assessment of study limitations (see
28
odological factors and outcome data. A pilot version of table 5.6 of the GRADE handbook. Specifically, ‘low
the data extraction form will be tested independently by risk of bias’ would indicate ‘no limitation’; ‘unclear risk
the two reviewers (MeL and CS) on a subsample of rele- of bias’ would indicate either ‘no limitation’ or ‘serious
vant studies to ensure correct extraction of all relevant limitation’; and ‘high risk of bias’ would indicate either
Luppa M, et al. BMJ Open 2020;10:e036034. doi:10.1136/bmjopen-2019-036034 3
Open access
BMJ Open: first published as 10.1136/bmjopen-2019-036034 on 22 April 2020. Downloaded from
‘serious limitation’ or ‘very serious limitation’ in the this review could motivate other researchers to construct
GRADE approach. Any disagreement between the two and test in randomised trials new or modified internet-
reviewers will be resolved by discussions with involvement based or mobile-based inter
ventions for bereaved adults.
of a third review author where necessary. Study authors
will be contacted for further methodological information Amendments
if needed. In the risk of bias table, results of the judge- In the event of protocol amendments, we will provide
ments will be shown for each domain. the date, a description of and rationale for of each
amendment.
data synthesis and presentation
A narrative synthesis for all included studies and relevant Contributors All authors contributed substantially to the conception of the work;
characteristics listed under ‘data collection process’ will MeL and CS drafted the manuscript; AP, MaL, JS and SGR- H revised the manuscript
be provided in text and ‘summary of findings’ tables. critically for important intellectual content; all authors finally approved the version
to be published. All authors gave agreement to be accountable for all aspects of the
Characteristics of the study, sample, intervention and work.
control condition will be presented first, followed by Funding This publication is part of the AgE health study and was funded by the
outcome measurements, effect sizes and overall results. German Federal Ministry of Education and Research (reference number: 01GY1613).
Only studies that provide a quantitative measure of grief Competing interests None declared.
symptoms will be included in the meta- analysis. We will Patient consent for publication Not required.
2 statistics and funnel
analyse heterogeneity by providing I Ethics approval Ethical approval and consent to participate are not required as no
and forest plots. According to the Cochrane standards, primary data will be collected. The results of this systematic review are intended
we suppose a moderate level of heterogeneity between to be published in an international peer- reviewed journal. Results may also be
2 29 presented at relevant professional conferences and meetings.
studies for I values ranging from 30% to 60%. If studies
2 Provenance and peer review Not commissioned; externally peer reviewed.
fail to show sufficient heterogeneity (I <60%) in at least
30
two trials, meta-analytic pooling will not be undertaken. open access This is an open access article distributed in accordance with the
However, inconsistency may occur from differences in Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which
29 permits others to distribute, remix, adapt, build upon this work non-commercially ,
study characteristics. Therefore, we will explore sources and license their derivative works on different terms, provided the original work is
of heterogeneity in subgroups of studies in terms of type properly cited, appropriate credit is given, any changes made indicated, and the use
of grief or intervention type. A random effects model will is non- commercial. See: http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.
be applied. We will estimate standardised mean differ- Author note All authors approved the final version of the manuscript.
ence values and the respective 95% CIs. We will follow the
Cochrane Handbook for Systematic Reviews of Interven- orCId id
27 Melanie Luppa http:// orcid. org/ 0000- 0003- 3927- 6728
tions to deal with missing data.
Data analyses will be performed using RevMan V.5.3
software from the Cochrane Collaboration Tool for http://bmjopen.bmj.com/
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