Clinical Psychology Unit, Department of Psychology, University of Sheffield
Psychological Health Sheffield, Sheffield Care Trust
Department of Accident and Emergency Medicine, Northern General Hospital, Sheffield, UK
Correspondence: Professor Graham Turpin, Clinical Psychology Unit, Department of Psychology, University of Sheffield, Western Bank, Sheffield S10 2TN, UK. Tel: +44 (0)114 2226632; fax: (0)114 2226610; e-mail: G.turpin{at}shef.ac.shef.ac.uk
Declaration of interest None. Funding detailed in Acknowledgements.
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ABSTRACT |
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Aims We assessed the efficacy of providing such self-help information.
Method Patients who had experienced trauma were randomised to two groups: those given (n=75) and not given (n=67) a self-help booklet. Psychological assessments were completed within 2, 10-12 and 24-26 weeks.
Results Post-traumatic stress disorder (PTSD), anxiety and depression decreased (P50.05) with time but there were no group differences in PTSD or anxiety. The controls were less depressed (P50.05) at follow-up. There was a reduction in PTSD caseness within the control (50%) compared with the intervention (20%) group which was almost significant (P50.06).
Conclusions This trial failed to support the efficacy of providing self-help information as a preventive strategy to ameliorate PTSD.
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INTRODUCTION |
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METHOD |
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Procedure
Approval was obtained from the North Sheffield Research Ethics Committee.
In liaison with consultant medical staff, clerical staff identified those
patients visiting A&E following an RTA, occupational injury or assault.
Prior to contact, patients were checked to ensure that they met the inclusion
criteria and were not too physically unstable to be approached for
consent.
Patients were first contacted by letter, asked to read an information sheet, and if they agreed to take part in the study, to return the consent form in a prepaid envelope provided. Within 2 weeks of A&E attendance they were sent the first questionnaire designed to gather baseline demographic data and information about the accident. On return of this questionnaire, participants were assigned, using random number tables by a masked independent investigator, to either the intervention or control groups. Participants within the intervention group were sent a self-help booklet about emotional reactions to physical injury, within 6-8 weeks of their attendance. Participants in the control group were sent a letter without the patient information. Four weeks later all participants were sent a second questionnaire to assess differences in psychological outcome. A follow-up questionnaire was sent to both groups between 24 and 26 weeks following attendance. Control participants were offered a copy of the self-help booklet at the end of the study.
Self-help information booklet
The self-help information comprised a booklet (8 pages, 550 words) entitled
'Responses to traumatic injury' and was based on a leaflet developed by the
Psychology Department at Harrogate District Hospital. In the leaflet, common
physiological, psychological and behavioural reactions to traumatic injury are
described and normalised. Advice regarding non-avoidance and emotional support
is also given, together with information on seeking further help. The booklet
was approved by the Northern General Hospital's Patient Information Group,
which included a user representative, and had a Flesch-Kincaid reading age
(determined through Microsoft Word) of 8 years, well below the ceiling of 12
years recommended for use in the National Health Service (NHS).
Measures
Questionnaires at baseline (2 weeks), post-intervention (10-12 weeks) and
follow-up (24-26 weeks) included the self-report measures below, together with
questions relating to demographic information and the nature of the injury.
The main outcomes were assessed as the difference in the following measures
between baseline and post-intervention functioning 10-12 weeks after the
accident.
Post-Traumatic Diagnostic Scale
The Post-Traumatic Diagnostic Scale (PDS) was selected as the primary
outcome measure and is designed to self-assess PTSD according to DSM-IV
criteria (American Psychiatric Association,
1994). The scale has good agreement with the Structured Clinical
Interview for Diagnosis (Foa et
al, 1997). The PDS asks about difficulties experienced over
the previous 4 weeks. However, the wording of the questionnaire at baseline
was changed to reflect difficulties since the incident.
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) was selected as a
secondary outcome measure to reflect more general psychological sequelae and
is widely used to assess levels of anxiety and depression
(Snaith & Zigmond,
1994).
At follow-up patients within the intervention group were asked whether they had read the booklet and to rate how useful they had found it; they were also given the opportunity to complete some open questions about their experiences.
Statistical analysis
Questionnaires were analysed using SPSS for Windows Version 11.
Multivariate analyses of variance (MANOVAs) and analyses of variance (ANOVAs)
were used to compare groups (control and intervention) for outcome measures
across time intervals. All results were taken as significant at the level of
P50.05 employing two-tailed tests unless specified otherwise. Power
analysis, using a previously observed
(Ehlers et al, 2003)
small effect size of 0.27 for change in the PDS following provision of an
information booklet, indicated a total sample size of 120 would be sufficient
for an alpha level of 0.05 and power of 0.80 (Erdfelder et al,
1996). On the basis of previous
research (Mason et al,
2002a,b)
we had estimated attrition from the trial of around 30%. Both
intention-to-treat and completer analyses were conducted. The former included
all participants who consented as per the protocol, including some
administrative drop-outs and those that reported that they had not read the
booklet (baseline values were substituted at all subsequent points in the
analysis for these participants). However, the results focus on those
completing the analysis to obtain representative changes in outcome.
Qualitative data from the open-ended questions asked at follow-up were
analysed using content analysis (Patton,
1987), which involves identifying the frequency of themes within
the data.
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RESULTS |
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Differences between non-responders, responders and those who dropped out
Differences between responders (n 291), non-responders
(n=2527) and those who dropped out from the intervention
(n=69) are summarised in Table
1.
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At baseline, significant differences were found between responders
(n 291) and non-responders (n 2527) for trauma type
(2(2)=4.52, P<0.001) which resulted from a higher
proportion of occupational injuries and assaults in the non-responders.
Conversely, there were more RTAs among responders than non-responders. There
was also a higher (w2(1) 40.62, P50.001) proportion of
males (72.5%) in the non-responders than the responders (54.6%).
Non-responders were also significantly younger (t(2816)=5.44,
P50.001) than the responders (mean 33.07 v. 37.35 years;
s.d.=12.15 v. 12.76). Post-intervention, the only difference
(t(289) 2.841, P50.001) between those remaining in the study
and those who dropped out was age: those who dropped out were younger
(mean=33.58, s.d. 11.20) than those who completed (mean=38.52, s.d.=11.20). A
similar analysis comparing original responders with those who dropped out at
follow-up revealed only a significant gender effect (
2(1)
3.97, P50.05), with more men remaining in the study.
No other significant differences were found between responders and those who dropped out with respect to accident type, gender, employment status, marital status or alcohol intake (P50.23). Similarly, a MANOVA and three 263 ANOVAs were employed to assess significant differences between responders and those who dropped out on measures of psychological disorder at baseline. Neither MANOVA (Wilks' lambda F(3,238)=0.99, P 0.68) nor separate ANOVAs revealed significant differences between responders and those who dropped out regarding symptom severity, (Fs(1,287)50.85, P40.36).
Comparison of groups prior to intervention
Characteristics of the groups are presented in
Table 2. The groups were
compared using appropriate statistics, but as expected no differences were
observed.
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Effects of the intervention
The effect of providing an information booklet was assessed by comparing
group differences across time, with relation to symptom severity for PTSD,
anxiety and depression and the prevalence of clinical caseness. The primary
outcome measure, however, was reduction in symptom severity in the PDS 4 weeks
following the intervention. Initially, MANOVA was used to assess group
differences in improvement scores (post-intervention7baseline) for symptom
severity scores for PDS, anxiety and depression. No significant differences
were found for either the analysis of those completing the study (Wilks'
lambda F(3,138)=0.94, P=0.12) or intention-to-treat
including just the non-readers (Wilks' lambda F(3,152)=0.97,
P=0.18) or the total respondent sample (Wilks' lambda
F(3,218)=0.98, P=0.19).
Given that the intervention might have differentially targeted the various
outcome measures employed, with a greater emphasis on PTSD symptoms,
individual univariate tests were also conducted comparing baseline and post
intervention. Analysis of changes in PDS severity only revealed a time effect
(F(1,140)=5.93, P<0.05), whereby scores decreased
post-intervention (mean=10.30 v. 8.93, s.d.=11.14 v. 11.68),
all other effects and interactions were not significant (P=0.57). The
findings from the intention-to-treat analyses were all consistent, with time
being the only significant effect. Across the 142 patients who completed,
caseness for meeting criteria for PTSD according to the PDS was also assessed
and yielded 44 (31%) at baseline. Post-intervention, only 21% of patients from
the intervention group (5/24) had improved, whereas 50% from the control group
(10/20) showed improvement and were no longer classified as having PTSD. This
difference between the groups almost reached significance
(2(1)=4.13, P=0.06).
The pattern of findings for anxiety and depression were similar to those described above. Significant time effects were found for reductions in caseness and severity for both anxiety (w2(1) 31, P50.001; F(1,140)=5.29, P<0.05) and depression (w2(1)=32.58, P50.001; F (1,140) 4.47, P=0.05). No significant differences between groups for anxiety or depression were obtained in either caseness (w2(1)=1.71 and 1.25, P40.19) or severity (F(1,140)=0.84 and 0.70, P 0.73 and 0.40). No interactions were significant. Analyses based on intention-to-treat, which included all participants as per protocol, yielded an identical pattern of significant effects, with the exception of an almost significant group effect for depression (F(1,220)=3.76, P 0.054): the booklet group was more depressed (mean 4.88) than the control (mean=3.80).
Follow-up
A separate analysis of those patients (n=100) who completed
questionnaires throughout the study and at follow-up revealed significant
effects of time in symptom severity for PDS (F(1,98) 6.22,
P50.05) and for anxiety and depression (F(1,98)=2.83 and
3.35; P50.05 respectively) but no group differences (P40.5).
There was also a significant interaction of group6time (F(1,98)=3.14,
P50.05) for depression, whereby severity decreased further in the
control rather than in the intervention group. Caseness was assessed across
the three time periods and between groups, using a 362 randomisation test
(Todman & Dugard, 2001).
The only significant effect was across time for anxiety (F(2)=3.57,
P50.05); all other main effects (P40.21) and their
interactions (P40.13), were non-significant across all three
measures. Changes in caseness and symptom severity across all three time
periods are displayed in Table
3.
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Injury type
Additional subgroup analyses were conducted to assess whether the type of
injury might have affected the outcome. A MANOVA comparing injury types for
PTSD, anxiety and depression severity scores was significant (Wilks' lambda
F(6,268)=0.83, P50.001). However, univariate analyses
revealed only significant time effects (P50.04) for PDS and anxiety
severity, irrespective of whether completer or intention-to-treat analyses
were performed, and reflected a decline in scores. Depression revealed no
significant effects. In order to adjust for the possible combined effects of
injury type and associated PTSD severity on outcome, a series of analyses of
covariance (ANCOVAs) was run using the baseline PDS score as the covariate
against post-intervention outcomes for PTSD, anxiety and depression. None of
these ANCOVAs was significant (F(1,139)=0.34, 1.57 and 0.48,
P=0.56, 0.21 and 0.36, respectively). Similar analyses based on
intention-to-treat analyses were also non-significant (P50.59).
Patient perception of the self-help booklet
Out of 75 patients, 68 rated the usefulness of the booklet on a scale of 0
(not useful) to 5 (very useful), resulting in a mean rating of 2.98 (median=3,
mode 4, range 5). Overall, 66% deemed the booklet useful. With respect to the
content analysis, 38% of people completed the qualitative portion of the
questionnaire. When asked what was particularly helpful, 16 people (47%)
referred to information and advice and 11 people (32%) the normalisation of
reactions.
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DISCUSSION |
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What can we conclude, therefore, about the utility of providing information to A&E attenders following injury? The provision of self-help materials is strongly advocated within the NHS as a means of informing patients of their condition and its treatment (Department of Health, 2001; King's Fund, 2003). Moreover, psychoeducation generally is said to have proven efficacy (e.g. Gould & Clum, 1993). In contrast, these data argue against the provision of information and suggest that providing information may not only be ineffective but may even have a detrimental effect. Such a conclusion is consistent with previous reviews of other early interventions such as debriefing (e.g. Bisson, 2003) and resonate with authors who have warned of the dangers of sensitising trauma victims and disrupting the natural recovery process (Herbert & Sageman, 2004). We suggest, however, a degree of caution in reaching both these conclusions given that this is the first systematic study to specifically assess the efficacy of provision of information.
How generalisable was the trial?
What would argue against the conclusion that provision of information is
ineffective? First, we need to assess whether the current trial recruited a
sample sufficiently representative of A&E attenders. Unfortunately, only
around 10% of eligible patients consented to participate in the trial. This
reluctance to participate may reflect previously reported low uptake rates and
high attrition for traumatised populations accessing therapy
(Rose et al, 1999;
Weisaeth, 2001). Even so, this
does not necessarily indicate that A&E attenders would not utilise
routinely provided information but may reflect a reluctance to volunteer for
research. Were those recruited characteristic of the overall population of
A&E attenders? Analysis of trial responders and non-responders did
indicate some differences; participants were more likely to have been injured in RTAs, whereas non-participants were more likely to be male and younger, and have received occupational injuries. Those who dropped out from follow-up were more likely to be women. These data are generally consistent with patterns of recruitment and dropout in our previous research (Mason et al, 2002a,b) but may also reflect the acceptability of an information leaflet to these different groups of A&E attenders. Given the wide variation in the prevalence of PTSD following injury (O'Donnell et al, 2003), however, it is difficult to conclude that the trial sample was not generally representative of A&E samples.
How sensitive was the trial?
Although there were some differences between participants and
non-participants, the random allocation to the two trial groups was
successful; neither the individual groups nor those who dropped out of the
trial differed substantially. The retention rates for the trial participants
was 76.3% post-intervention and 70.4% at follow-up which compare reasonably
with rates for other trials involving brief psychological interventions. It is
unlikely, therefore, that overall group characteristics might have accounted
for the lack of significant effects of the intervention. Similarly, the sample
sizes ought to have had sufficient statistical power to demonstrate a medium
effect size for the primary outcome measure. Indeed, significant improvements
in symptom severity and associated reductions in caseness were obtained across
time, but no overall group differences were obtained. Some individual group
differences did emerge but these were the opposite direction to that
hypothesised. The control group behaved differently to the intervention group
post-intervention with a trend towards lower PTSD caseness and depression
severity. Similarly, although there were no overall group differences at
follow-up, the control group again showed a significant decrease in
depression. Taken together, these effects suggest greater improvement within
the control group. However, it should be recognised that these apparently
detrimental effects require replication to rule out the possibility of type 1
errors arising from multiple outcome assessments.
Relationship to other early intervention studies
If we conclude that the current trial fails to provide support for the use
of patient information, how does this relate to existing literature? As we
have already indicated, reviews of psychological debriefing have stressed
negative or contraindicative results. In contrast, some recent studies
(Litz et al, 2002;
Ehlers et al, 2003;
Bisson et al, 2004) of
targeted, early cognitive-behavioural interventions have suggested more
promising results. Ehlers et al
(2003) employed an information
booklet as a control condition but failed to demonstrate any significant
effects compared with an assessment-only control. A similar lack of effect of
education compared with either assessment only or a debriefing and education
condition was also observed by Rose et al
(1999). O'Donnell and
colleagues assessed the provision of a more extensive psychoeducational
booklet to patients attending a regional trauma centre (M. Creamer, personal
communication, 2005). They found that those who had received the booklet
reported less deterioration in quality of life and a non-significant increase
in symptoms compared with those who did not receive a booklet. Finally, very
high levels of patient satisfaction have been reported
(Robertson et al,
2002) for a similar self-help booklet, but unfortunately the
efficacy of the leaflet in reducing symptoms was not investigated. It would
appear therefore that other researchers have also failed to obtain convincing
evidence of the efficacy of self-help information when used in isolation.
Need for future research
Before we finally conclude the ineffectiveness of information provision, we
must consider some further questions. Many have argued
(Litz et al, 2002;
Ehlers & Clark, 2003) that
early interventions ought to be targeted at those patients who are unable to
recover naturally from trauma. This can be achieved either by a 'stepped care'
approach, whereby interventions are delayed until a time from the injury when
the recovery process ought to be complete (e.g. 6 months) and then identifying
patients who are still symptomatic, or by employing predictors of later PTSD.
Future research, therefore, might determine whether psychoeducation is more
efficacious when it is more effectively targeted at those in need.
Unfortunately, the results of a recently completed psychoeducation study with
A&E patients identified on the basis of acute stress disorder has also
failed to demonstrate any efficacy of self-help provision
(Scholes, 2004).
It may also be the case that the content of the information booklet was not sufficient. Researchers (Rosen et al, 2003) have stressed the limitations of self-help approaches to psychological problems. More specifically it has been suggested (Litz et al, 2002) that information for trauma ought to be more action-orientated, encouraging patients to reduce avoidance and confront their traumatic memories, and should emphasise the importance of cognitive restructuring and social support. The current booklet was more an information than a detailed self-help guide but a recent study of a more extensive guide again failed to obtain differences (Scholes, 2004).
Finally, a particularly important issue regarding effective treatment of chronic PTSD is early diagnosis and encouragement of trauma victims to present later for treatment within primary care settings. Indeed, recent guidance (National Collaborating Centre for Mental Health, 2005) suggests 'watchful waiting' and follow-up assessments 4 weeks after trauma to establish whether adverse psychological effects have been exacerbated or failed to dissipate. However, the interface between emergency and primary care is by its very nature sporadic and unsystematic. Moreover, there are resource implications and an accompanying reluctance in primary care to routinely screen for PTSD following traumatic events or attendance at A&E departments. This might effectively place responsibility for seeking subsequent treatment very much with the patient; information booklets which are considered helpful have an important role in prompting patients at risk for chronic PTSD to seek future treatment, if their initial psychological disturbance is not resolved during the recovery period.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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REFERENCES |
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Received for publication July 12, 2004. Revision received October 14, 2004. Accepted for publication October 18, 2004.
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