Abstract
Introduction
Post-traumatic stress disorder (PTSD) may affect 10% of women and 5% of men at some stage, and symptoms may persist for several years. Risk factors include major trauma, lack of social support, peritraumatic dissociation, and previous psychiatric history or personality factors.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions to prevent PTSD? What are the effects of interventions to treat PTSD? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 46 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: affect management; antiepileptic drugs; antihypertensive drugs; benzodiazepines; brofaromine; CBT; drama therapy; eye movement desensitisation and reprocessing; fluoxetine; group therapy; hydrocortisone; hypnotherapy; inpatient treatment programmes; Internet-based psychotherapy; mirtazapine; multiple-session CBT; multiple-session collaborative trauma support; multiple-session education; nefazodone; olanzapine; paroxetine; phenelzine; psychodynamic psychotherapy; risperidone; SSRIs (versus other antidepressants); sertraline; single-session group debriefing; single-session individual debriefing; supportive psychotherapy; supportive counselling; temazepam; tricyclic antidepressants; and venlafaxine.
Key Points
Post-traumatic stress disorder (PTSD) is characterised by disabling symptoms of re-experiencing a traumatic event, avoidance behaviour, and hyperarousal (e.g., irritability or hypervigilance), lasting at least 1 month.
PTSD may affect 10% of women and 5% of men at some stage, and symptoms may persist for several years.
Risk factors include major trauma, lack of social support, peritraumatic dissociation, and previous psychiatric or personality factors.
Multiple-session trauma-focused CBT may be effective at preventing development of PTSD in people with psychological distress after a traumatic event.
However, we don't know whether multiple-session trauma-focused CBT is beneficial for people who have experienced a traumatic event but have not been diagnosed with psychological distress.
We don't know whether antiepileptic drugs, antihypertensive drugs, hydrocortisone, multiple-session collaborative trauma support, multiple-session education, single-session group debriefing, or temazepam are beneficial in preventing PTSD.
Single-session individual debriefing may increase the rate of PTSD after a traumatic event compared with no debriefing, and supportive counselling may be less effective than multiple-session CBT at preventing onset of PTSD.
In people with PTSD, trauma-focused CBT improves PTSD symptoms compared with no treatment or with other psychological interventions, including stress management and present-centred therapy. Eye movement desensitisation and reprocessing seems as effective as trauma-focused CBT in the treatment of chronic PTSD.
We don't know whether other psychological treatments (affect management, drama therapy, group therapy, hypnotherapy, inpatient treatment regimens, Internet-based psychotherapy, psychodynamic psychotherapy, or supportive psychotherapy) are beneficial in people with PTSD.
Paroxetine may improve symptoms in people with PTSD. However, venlafaxine does not seem effective at improving symptoms, and the benefits of fluoxetine are unclear.
We found insufficient good evidence to assess the effects of sertraline, tricyclic antidepressants, or benzodiazepines.
We found limited evidence that sertraline and nefazodone may be equally effective at improving symptoms of PTSD, but we don't know how other antidepressants compare with each other in the treatment of PTSD.
We don't know whether antiepileptic drugs, antihypertensive drugs, brofaromine, nefazodone, olanzapine, phenelzine, mirtazapine, or risperidone are beneficial in people with PTSD.
About this condition
Definition
Post-traumatic stress disorder (PTSD) can occur after any major traumatic event. Symptoms include upsetting thoughts and nightmares about the traumatic event, avoidance behaviour, numbing of general responsiveness, increased irritability, and hypervigilance. To fulfil the Diagnostic and Statistical Manual-IV (DSM-IV) criteria for PTSD, an individual must have been exposed to a traumatic event; have at least one re-experiencing, three avoidance, and two hyperarousal phenomena; have had the symptoms for at least 1 month; and the symptoms must cause clinically important distress or reduced day-to-day functioning. It is labelled as acute for the first 3 months and chronic if it lasts beyond 3 months. People with subsyndromal PTSD have all the criteria for PTSD except one of the re-experiencing, avoidance, or hyperarousal phenomena. Acute stress disorder occurs within the first month after a major traumatic event and requires the presence of symptoms for at least 2 days. It is similar to PTSD, but dissociative symptoms are required to make the diagnosis. Treatments for PTSD may have similar effects, regardless of the traumatic event that precipitated PTSD. However, great caution should be applied when generalising from one type of trauma to another.
Incidence/ Prevalence
One large cross-sectional study in the USA found that 1/10 (10%) women and 1/20 (5%) men experience PTSD at some stage in their lives.
Aetiology/ Risk factors
Risk factors include major trauma, such as: rape; a history of psychiatric disorders; acute distress and depression after the trauma; lack of social support; and personality factors.
Prognosis
One large cross-sectional study in the USA found that over a third of people with previous PTSD continued to satisfy the criteria for PTSD 6 years after initial diagnosis. However, cross-sectional studies provide weak evidence about prognosis.
Aims of intervention
To reduce initial distress after a traumatic event; to prevent PTSD and other psychiatric disorders; to reduce levels of distress in the long term; to improve function and quality of life; with minimal adverse effects.
Outcomes
Prevention: incidence of PTSD; symptoms that may lead to a diagnosis of PTSD (anxiety, depression, avoidance, intrusive symptoms). Treatment: incidence of PTSD, and symptom severity assessed by continuous measures. Continuous measures for assessing changes in symptoms include Impact of Event Scale (range 0–75), Post-traumatic Stress Diagnostic Scale (range 0–51), Clinician Administered PTSD Scale (0–136), Trauma Symptom Checklist 40 (range 0–160), Post-traumatic Stress Disorder Checklist (17 items graded from 1 = not at all to 5 = extremely), and Clinical Global Impression Scale (a composite measure of symptoms and everyday functioning; range very much worse–very much improved). Symptoms assessed include anxiety, depression, intrusion, and avoidance. Changes in continuous measures are often expressed as effect sizes. It is difficult to interpret effect sizes in terms of clinical importance. Some categorise effect sizes of less than 0.5 as small, 0.5–0.8 as medium, and greater than 0.8 as large. Prevention and treatment: Adverse effects of treatment.
Methods
Clinical Evidence search and appraisal March 2009. The following databases were used to identify studies for this systematic review: Medline 1966 to March 2009, Embase 1980 to March 2009, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2009, Issue 1 (1966 to date of issue). An additional search was carried out for the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the contributor for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews of RCTs and RCTs in any language, at least single blinded, and containing more than 20 individuals of whom more than 80% were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as “open”, “open label”, or not blinded unless blinding was impossible. We included systematic reviews of RCTs and RCTs where harms of an included intervention were studied applying the same study design criteria for inclusion as we did for benefits. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).
Table.
GRADE Evaluation of interventions for Post-traumatic stress disorder.
| Important outcomes | Incidence of PTSD, Symptom severity | ||||||||
| Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of interventions to prevent post-traumatic stress disorder? | |||||||||
| 1 (26) | Incidence of PTSD | Antiepileptics versus placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and for methodological issues (not carrying out a statistical assessment, and being underpowered to detect a clinically meaningful difference). Directness point deducted for inclusion of people without risk factors for PTSD after exposure to a traumatic event |
| 2 (59) | Incidence of PTSD | Antihypertensive drugs versus placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data, methodological issues (poor follow-up, not carrying out a statistical assessment, and being underpowered to detect a clinically meaningful difference). Directness point deducted for inclusion of people without risk factors of PTSD after traumatic event |
| 1 (20) | Incidence of PTSD | Hydrocortisone versus saline | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for generalisability of results (narrowness of population) |
| 3 (156) | Incidence of PTSD | Multiple-session CBT versus supportive counselling (people with acute stress disorder) | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 2 (248) | Incidence of PTSD | Multiple-session CBT versus no treatment or standard care (all people exposed to a traumatic event) | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for no statistical assessment in one RCT. Directness point deducted for variation in measures used |
| 1 (151) | Incidence of PTSD | CBT plus education versus no treatment | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and for incomplete reporting of results. Directness point deducted for statistically significant difference between groups in baseline risk of PTSD |
| 3 (224) | Incidence of PTSD | Multiple-session collaborative trauma support versus no treatment/usual care/immediate review | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and lack of power to detect clinically important result in one RCT. Directness point deducted for unclear outcome assessment and for variation in measures used |
| 1 (77) | Symptom severity | Early versus delayed group debriefing | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for non-specification of population |
| 2 (238) | Incidence of PTSD | Individual debriefing versus no debriefing | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted incomplete reporting of results |
| 1 (22) | Incidence of PTSD | Temazepam versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and for methodological issues (not carrying out a statistical assessment, and being underpowered to detect a clinically meaningful result) |
| What are the effects of interventions to treat post-traumatic stress disorder? | |||||||||
| 1 (48) | Symptom severity | Affect management versus waiting list control | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for inclusion of a co-intervention (drug treatment in affect management arm) |
| 2 (270) | Symptom severity | Antiepileptic drugs versus placebo | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for low number of comparators |
| 1 (45) | Symptom severity | Brofaromine versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 9 (541) | Symptom severity | CBT versus no treatment or usual care | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for methodological issues across RCTs (e.g., no statistical assessment, incomplete reporting, and baseline difference in population) |
| 15 (744) | Incidence of PTSD | CBT versus no treatment or usual care | 4 | 0 | 0 | 0 | 0 | High | |
| 2 (335) | Symptom severity | CBT versus present-centred therapy | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for not carrying out a statistical assessment. Consistency point deducted for conflicting results (different direction of effect between RCTs) |
| 1 (284) | Incidence of PTSD | CBT versus present-centred therapy | 4 | 0 | 0 | 0 | 0 | High | |
| 6 (284) | Incidence of PTSD | CBT versus stress management | 4 | 0 | 0 | 0 | 0 | High | |
| 5 (286) | Incidence of PTSD | CBT versus supportive psychotherapy, psychodynamic psychotherapy, or hypnotherapy | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for combined analysis of multiple interventions in comparison group |
| 6 (193) | Incidence of PTSD | Eye movement desensitisation and reprocessing (EMDR) versus no treatment or usual care | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for inclusion of active treatments in no treatment/usual care group in review |
| 3 (84) | Incidence of PTSD | EMDR versus stress management | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 6 (220) | Incidence of PTSD | EMDR versus CBT | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (59) | Symptom severity | EMDR versus fluoxetine | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for inclusion of co-intervention (exposure therapy) |
| 1 (59) | Incidence of PTSD | EMDR versus fluoxetine | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for inclusion of co-intervention (exposure therapy) |
| 3 (771) | Symptom severity | Fluoxetine versus placebo | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for methodological issues (incomplete reporting of results, unclear rate of follow-up, no statistical assessment between groups). Directness points deducted for inclusion of co-intervention (exposure therapy in one RCT) and uncertainty of beneficial effect (high placebo response) |
| 1 (59) | Incidence of PTSD | Fluoxetine versus placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality point deducted for sparse data and incomplete reporting of results. Directness point deducted for inclusion of co-intervention (exposure therapy) |
| 1 (48) | Incidence of PTSD | Group CBT versus no treatment or usual care | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for combined analysis of multiple interventions in comparison group |
| 1 (360) | Incidence of PTSD | Group CBT versus present-centred therapy | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (71) | Symptom severity | Group CBT plus individual CBT versus no treatment | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (112) | Symptom severity | Hypnotherapy versus waiting list control | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for narrowness of symptoms assessed (only intrusion/avoidance) |
| 1 (25) | Symptom severity | Internet-based psychotherapy versus waiting list control | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for narrowness of symptoms assessed (only intrusion/avoidance) |
| 1 (21) | Symptom severity | Mirtazapine versus placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and methodological issues (poor follow-up). Directness point deducted for differences in severity of symptoms at baseline |
| 1 (19) | Symptom severity | Olanzapine versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for narrow inclusion criteria (people not responding to SSRI) |
| 3 (1070) | Symptom severity | Paroxetine versus placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (37) | Symptom severity | Phenelzine versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (112) | Symptom severity | Psychodynamic psychotherapy versus waiting list control | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for narrowness of symptoms assessed (only intrusion/avoidance) |
| 3 (123) | Symptom severity | Risperidone versus placebo | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for sparse data. Consistency point deducted for conflicting results. Directness point deducted for range of additional medication being taken |
| 7 (1289) | Symptom severity | Sertraline versus placebo | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for methodological issues (no statistical assessment in 1 RCT). Consistency point deducted for conflicting results (different direction of effect for sertraline) |
| 2 (747) | Incidence of PTSD | Sertraline versus placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 2 (97) | Symptom severity | Sertraline versus nefazodone | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and methodological issues (no statistical data for between group comparison reported). Directness point deducted for significant difference between groups in baseline scores |
| 1 (51) | Incidence of PTSD | Supportive psychotherapy versus waiting list control | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (73) | Incidence of PTSD | Supportive psychotherapy versus CBT | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 2 (81) | Symptom severity | Tricyclic antidepressants versus placebo | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for sparse data. Consistency point deducted for conflicting results with different TCA |
| 1 (358) | Symptom severity | Venlafaxine versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results (absolute symptom scores not reported) |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.
Glossary
- Affect management
A group treatment focusing on regulation of mood.
- Anxiety management
Involves teaching techniques to reduce anxiety levels. Examples include muscular relaxation, in which individuals are taught to alternately tense and relax specific muscle groups and breathing retraining to avoid overbreathing.
- Avoidance
A characteristic symptom of post-traumatic stress disorder, whereby reminders, thoughts, or situations that remind the individual of the trauma are avoided.
- Clinical Global Impression Scale
A one-item, observer-rated scale for measuring the severity of a condition. It has been investigated for validity and reliability. The scale is scored from 0 (not ill at all) to 7 (severely ill).
- Cognitive behavioural therapy
Covers a variety of techniques. Imaginal exposure entails exposure to a detailed account or image of what happened. Real life exposure involves confronting real life situations that have become associated with the trauma and cause fear and distress. Cognitive therapy entails challenging distorted thoughts about the trauma, the self, and the world. Eclectic psychotherapy is a combination of trauma-focused cognitive behavioural therapy and psychodynamic psychotherapy. Imaginal flooding involves the intense reliving of the traumatic experience. Memory structuring involves listening to and clarifying the individual's narrative and structuring it for them to repeat to friends and family. Prolonged exposure entails repeated exposure to memories of the trauma, and to non-dangerous real life situations that are avoided because of trauma related fear. Stress inoculation entails instruction in coping skills and some cognitive techniques such as restructuring. Supportive listening involves actively listening to the individual's narrative and clarifying factual, sensory, and affective details.
- Dissociative symptoms
Involves a disruption to memory or perception of the environment; for example, an inability to recall details of a traumatic event that cannot be accounted for by ordinary forgetfulness or an organic cause such as head injury.
- Drama therapy
Uses drama as a form of expression and communication.
- Eye movement desensitisation and reprocessing (EMDR)
Involves asking the person to focus on the traumatic event, a negative cognition associated with it, and the associated emotions. The person is then asked to follow the therapist's finger as it moves from side to side.
- High-quality evidence
Further research is very unlikely to change our confidence in the estimate of effect.
- Hyperarousal
A characteristic group of symptoms in post-traumatic stress disorder, including increased irritability, sleeping difficulties, hypervigilance, increased startle, and reduced concentration.
- Hypnotherapy
Involves hypnosis to allow people to work through the traumatic event.
- Inpatient treatment programmes
Individuals receive a planned package of care, usually as a group, as inpatients. The programmes can include various techniques, including cognitive behavioural therapy, group therapy, and medication.
- Internet-based psychotherapy
A protocol-driven treatment delivered through the internet, which includes psychoeducation and cognitive reappraisal.
- Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
- Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
- Present focused group therapy
A group intervention that involves identifying and modifying patterns of behaviour that have arisen from their past traumatic experience.
- Psychological debriefing
Detailed consideration of the traumatic event and the normalisation of psychological reactions.
- Subsyndromal post-traumatic stress disorder
This term is sometimes used to describe individuals with traumatic stress symptoms who would not fulfil the full Diagnostic and Statistical Manual (DSM)-IV or International classification of mental and behavioural disorders (ICD-10) criteria for a diagnosis of post-traumatic stress disorder.
- Supportive counselling
A non-directive intervention dealing with current issues rather than the trauma itself.
- Supportive psychotherapy
A non-directive intervention that involves helping an individual to explore their thoughts, feelings, and behaviour with the aim of achieving a clearer understanding of self and the ability to cope with situations more effectively.
- Trauma focused group therapy
A group intervention that involves reconstructing a past traumatic event, identifying and modifying negative self images associated with it, and integrating memories of the event into the individual's conscious awareness of self and others.
- Very low-quality evidence
Any estimate of effect is very uncertain.
Disclaimer
The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients.To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.
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