Criteria for considering studies for this review
Types of studies
Randomised controlled trials that consider one or more well-specified sports, games or play-based interventions for the treatment of PTSD will be included. Cross-over trials, cluster randomized trials and factorial trials will be included. Non-randomized intervention studies will be excluded.
Types of participants
Participants, aged 5 years and older of either gender who have been diagnosed with Post Traumatic Stress Disorder using criteria outlined in the Diagnostic and Statistical Manual for Mental Disorder (DSM IV). The precipitating event to the diagnosis of PTSD is not important for inclusion.
Types of interventions
We define 'sport interventions' as being any intervention that focuses on an organized physical activity done alone or with a group. Such interventions include competitive and non-competitive sports and games. We define physical activity as any movement involving large skeletal muscles. Sport is 'all forms of physical activity that contribute to physical fitness, mental well-being and social interaction. These include play, recreation, organised, casual or competitive sport, and indigenous sports or games' (UN inter-agency task force on sport for development and peace 2005). Play and games, as defined by the non-governmental organisation UK Play Therapy, includes any 'physical or mental leisure activity that is undertaken purely for enjoyment or amusement and has no other objective' (PTUK Ltd. 2006). Sports, games and play-based interventions include art or music therapy and exclude psychological interventions such as relaxation therapy or cognitive behavioural therapy.
Sports and play interventions are included as long as they are adequately described by trialists to facilitate replication. Interventions can be administered by health professionals, teachers, coaches, community leaders or any other lay person. Interventions can be administered in any form (e.g. one on one, group activities, or written materials). The interventions may be of any duration, intensity or frequency.
Sports and play interventions will be compared with:
1. usual care;
2. pharmacological interventions;
3. psychosocial interventions e.g. individual counseling, group therapy, CBT.
Trials will be excluded on the basis of the intervention if:
1. The intervention is complex and includes pharmacological, biological and social components, and the results are not presented separately for the effect of the sports, games or play component of the intervention.
2. The intervention is aimed at the prevention rather than treatment of PTSD.
Types of outcome measures
The primary outcome measures comprise:
1. Diagnostic status of PTSD as determined by a standardised structured interview or scale (e.g. the clinician administered PTSD Scale)
2. Self or observer report of PTSD symptoms using standard or non-standardised questionnaires (e.g. the Child PTSD symptoms scale or the Impact of Events Scale).
Secondary outcomes measures comprise:
1. Diagnostic status or self-report of symptoms of anxiety and/or depression measured using validated instruments (e.g. the Beck Depression Inventory).
2. Global assessment of functioning including quality of life and physical and social functioning, measured using validated instruments (e.g. the Sheehan Disability Scale).
Outcome measures will not form part of the search or inclusion criteria for the review.
Search methods for identification of studies
The CCDAN registers will be searched using the following terms;
Diagnosis = "Post-Traumatic Stress Disorders"
Intervention = art or sport* or music or exercise
Notes = prevent*
Free-text = debrief* or "crisis intervention*" or "trauma* stress" or "trauma* event" or catastroph* or emergenc*
Additional searches will include
Cochrane Central register of Controlled Trials
Searching other resources
Anxiety Stress and Coping and the Journal of Sports Sciences will be handsearched (this list of journals may be expanded to include other journals determined by leading researchers in the field)
Grey and unpublished material will be sought through handsearching relevant journals and searching the controlled-trials database.
Data collection and analysis
Selection of studies
The Depression, Anxiety and Neurosis Group Trials Search Coordinator will run the relevant search strategies across databases. Two reviewers (SL and MD) will separately check the titles and abstracts of the citations identified by the search to determine whether each study meets the pre-determined inclusion criteria. In case of doubt or disagreement, the full article will be obtained for inspection. Full texts of all potentially relevant studies will be obtained and independently assessed to determine whether they meet inclusion criteria. In the event of a disagreement, a third reviewer (RH) will be consulted to resolve the issue. Identified studies will be tracked using an electronic reference manager (Endnote).
Data extraction and management
The two reviewers (SL) and (MD) will extract the data from the trial reports using a data extraction form designed for this review. All disagreements will be resolved by consulting with a third reviewer (RH). Where appropriate, trial authors will be contacted for information missing from the trial report.
Assessment of risk of bias in included studies
Two authors (SL and MD) will independently assess the methodological quality of selected trials. In the event of a disagreement, a third reviewer (RH) will be consulted.
As there is empirical evidence that the quality of allocation concealment affects the results of trials, the adequacy of concealment of treatment allocation will be assessed using the criteria developed by Schulz and colleagues (Schulz, Chalmers et al. 1995).
A = Trials deemed to have taken adequate measures to conceal allocation (i.e. central randomisation; serially numbered, opaque, sealed envelopes; or other description that contained elements convincing of concealment).
B = Trials in which the authors either did not report an allocation concealment approach at all or reported an approach that did not fall into one of the other categories.
C = Trials in which concealment was inadequate (such as alternation or reference to case record numbers or to dates of birth).
Trials will be considered to have adequate sequence generation if, for example, they report using a random-number table or a computer random number generator. This qualitative quality assessment will not be used as a threshold for inclusion of studies, but as a possible explanation for differences between studies when interpreting the results of the review (Schulz, Chalmers et al. 1995).
Quality of blinding of outcome assessment, the extent of losses to follow-up, and analysis by intention to treat will be documented and synthesised using the methods for assessing the risk of bias described in the Cochrane Handbook. As we consider it unlikely that any sports, games or play-based intervention can be administered double-blind, this will not be included in an assessment of study quality. The method of generation of allocation sequences will be documented.
Measures of treatment effect
For dichotomous outcomes, such as the presence or absence of a diagnosis of PTSD, we will calculate the risk difference with 95% confidence intervals.
We will calculate the standardized mean differences for continuous outcomes if:
a) means and standard deviations are available either in the original article or from the authors;
b) there is no clear evidence of a skewed distribution (i.e where there is minimum or maximum score, the mean minus this score and divided by the standard deviation should not be less than 2).
Differences in the direction of the scale between studies will be corrected by multiplying the mean of one set of trials by -1. Where measurements are comparable and on the same scale (such as using the same tool to measure depression) these will be combined to obtain weighted mean differences. Where different scales are used to measure the same clinical outcome in different ways, standardized mean differences will be used in order to combine results across scales.
Unit of analysis issues
Trials will be analysed at the level of participants. Where cross-over trials are identified (and cross-over design is thought to be appropriate), consideration will be given to whether serious carry-over may have occurred. If carry-over is not thought to be a problem, advice will be sought from a statistician about whether appropriate methods of analysis have been used. If so, the effect estimate will be included in a meta-analysis using the generic inverse variance method as described in the Cochrane Handbook.
Where cluster-randomized trials are identified (and cluster-randomisation is thought to be suitable), advice will be sought from a statistician about whether the appropriate methods of analysis have been used. Effect estimates and their standard errors from correct analyses of cluster-randomized trials will be meta-analysed using the generic inverse variance method in RevMan version 5.
Where appropriate, sensitivity analyses will be undertaken to investigate the effects of incorporating data from cross-over and cluster randomised trials in this review.
Dealing with missing data
Missing data and attrition rates will be assessed for each of the included studies, and the number of participants who are included in the final analysis will be reported as a proportion of all participants in the study. Trialists will be contacted to obtain missing data. Reasons given for missing data will be provided in the narrative summary and the extent to which the results are altered by missing data will be ascertained. Assessment will be made of the extent to which studies have conformed to an intention-to-treat analysis. The extent to which the results are altered by missing data will be determined by a sensitivity analysis for dichotomous data, as suggested by Deeks in the Cochrane Handbook, where it is firstly assumed that "all missing participants in the first group experienced the event and those in the second group did not and then assume the opposite".
Assessment of heterogeneity
Heterogeneity of results will be tested by comparing the confidence intervals of the studies (presented graphically) and by performing a chi-square test. To quantify the inconsistency in the results statistically, we will use I² (Higgins, Thompson et al. 2003). Values greater than 50% indicates substantial heterogeneity and the reasons for such will be explored. Possible explanations could be clinical or methodological diversity. Possible causes of statistical heterogeneity are expected and pre-specified as follows:
a) clinical heterogeneity due to variation in the participants, interventions and outcomes used by the studies;
b) methodological heterogeneity due to variability in trial design and quality.
If there is substantial statistical heterogeneity, a random effects meta-analysis will only be performed where studies report similar interventions, and where data are available and sufficiently clinically and methodologically homogeneous. If statistical heterogeneity is not present, a fixed-effect meta-analysis will be performed, and potential differences between subgroups will be explored according to a priori criteria set out below.
Assessment of reporting biases
To determine if this review was likely to have been affected by reporting biases and, in particular, publication bias, a funnel plot will be prepared and checked for asymmetry.
Prior to inspection for statistical heterogeneity (as described above), a fixed effect model will be used to synthesise the data. Where statistically significant heterogeneity is identified, a random effects model will be used, but only where trials appear to be clinically and methodologically homogeneous. Where data are available, sports, games and play-based interventions will be compared with usual care, pharmacological and psychosocial interventions. Different types of sports, games and play-based interventions will also be compared with one another.
Subgroup analysis and investigation of heterogeneity
Subgroup analyses will be performed where data are available on:
a. Adults versus children/adolescents (up to and including 18 years of age)
c. Self-administered versus clinician-administered scales
d. Different types of sports, games and play-based interventions
e. Interventions involving differing levels of exercise
The first two factors have been identified as being important as they affect an individual's inclination or opportunity to engage with, and benefit from, sports, games and play interventions. The inclusion of the third factor is based on potential differences in the reliability and validity of self-administered questionnaires.
In order to assess the robustness of the review conclusions to decisions taken during the review process, sensitivity analyses will be performed according to whether allocation concealment was adequate vs. inadequate.