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Post-traumatic stress disorder (PTSD) is a hampering anxiety disorder caused by the exposure to traumatic events, for example, war, disaster, an interpersonal event like physical or sexual assault, accident, etc. There are three main symptoms of PTSD, one those related to re-experiencing the event, two: avoidance and arousal and three: distress and impairments caused by the first two symptoms (Hetrick et al. 2010).
The person affected with PTSD has to face issues of economic instability, which not only affects the person mentally but also hampers the quality of life. As a person affected with PTSD is observed to be depressed most of the time, absence from the workplace is also seen to increase. This again affects the employment of the PTSD person as unemployment is common due to high rate of absence from work. In addition, for treating patients of PTSD, it requires medicines and other long-term treatments, which are very expensive. This negatively influences the patients’ lifestyle with reduced economic stability. Patients have to spend large amount of money on treatments, which makes their life miserable as other expenses are also high. This is supported by Endicott et al. (1976), in terms of a PTSD patient having lesser income cannot contribute much in leading a healthy lifestyle. This reflects on the degradation in the quality of life of the patient due to economic downfall from different angles.
Antidepressant is the most commonly used pharmacological intervention for the treatment of PTSD (Davidson 1999). However, guidelines from national institute for clinical excellence (NICE) suggest that people recover from PTSD effectively when a combination of both pharmacotherapy and psychological therapy is used. Kessler et al. (1995) stated that men are 8.1% more likely to develop PTSD after a traumatic event than 20.4% in women. Other than these interventions, there exist some legal and organisational policies, which are implemented towards better care of patients with PTSD. The legal and organisational policies are not only effective for providing enhanced care to patients; it also contributes in improving the quality of life of the patient. In addition, as patients have their right to obtain respect from the service providers of healthcare organisations, these legal policies are helpful in maintaining the rights of the patient.
Care Act 2014-This Act sheds light on the right of every individual including patients of PTSD to get proper treatments from the healthcare organisation. This also reflects on the service providers’ duty to maintain well-being of the patients by providing utmost care services depending on the nature of the disease. Care Act 2014 stresses on the fact of respecting patients when providing care services along with noting their choices and decisions. As PTSD patients are in mentally depressed state, therefore, there emotional wellbeing along with their physical wellbeing needs to be maintained as per their right. On the other hand, PTSD patients with the healthcare organisations often have to face discrimination and abuse from others or service providers. Hence, the Act also emphasises on protecting patients from abuse, discrimination and negligence. Along with this, it is duty of the local authorities to provide support to the PTSD patients in terms of financial support so that quality of life can be improved (Legislation.gov.uk, 2016).
Safeguarding Vulnerable Adults 2015- In context of patients of PTSD facing challenges in their life due to the post-traumatic disorder, they also faces issues of abuse, negligence and harm. Being vulnerable makes them weak towards society, and they are susceptible to be neglected by the society as well as in receiving proper treatments. According to Simon et al. (2008), Safeguarding Vulnerable Adults 2015 imposes rights of these patients to remain free from harassments within the society. Not only this is reflected, but service providers with the healthcare organisations have the responsibility of protecting these patients from abusers as well as counselling the victim. It also reflects on the fact of giving enhance attention to PTSD patients so that they face lesser issues of negligence with the healthcare organisation.
Maintaining Dignity- Every individual has achieved certain degree of respect and dignity before facing health issues or diseases such as PTSD. After their health deteriorates immensely, people neglect them and they get lesser respect from the society. Hence, maintaining dignity of patients within the healthcare and getting equal respect from the society helps patients of PTSD to recover from their severe condition. PTSD patients are in the depressed state and giving them respect and treating them with dignity makes them feel valuable in the society, which has positive effects of improving their state of mind.
Confidentiality of information- Within healthcare organisations, where PTSD patients are treated with appropriate care services and medications, service providers are required to keep patients’ information confidential. Organisational policies such as confidentiality of information in association with Data Protection Act 1998 reflect on the issue of protecting information of patients from disclosing to others (Legislation.gov.uk, 2016). As argued by Kessler et al. (1995), often service providers face dilemma of unable to disclose patient’s history and details even to the required health professionals other than doctors. Therefore, to overcome this issue, Data Protection Act 1998 expressed taking contents of the patient as well as from the doctors before disclosing facts about patient to other professionals. This is beneficial for PTSD patients in terms of not getting identified in the society as a vulnerable person, which affects their dignity and respect.
Cost-effectiveness of two open labels randomised controlled trials (RCT) with the same number of patients allocated into the two groups in the ratio of 1:1. Eligible patients will be recruited from existing sexual health clinics, a referral from GP and charities that look after abused women.For more information refer to appendix 1
The study will take place in selected existing two trauma sexual health outpatient clinics. The trial will aim to recruit 430 participants with PTSD. Informed consent will be sought prior to the trial by a trained research assistant to help reduce social desirability that takes place between doctor and patient. The programme will run for a period of one year with assessments taken at baseline and six months, ten and twelve months.
Ethical approval will be obtained from the Ethical Research Committee. There will be confidentiality of data. Allocation list will be produced and patients assign to either group; this will be performed by a statistician that is not part of the study and the list will then be given to the study data manager.
The outcome measures will be continuous changes in GAF (Endicott et al., 1976) and World Health Organisation Disability Assessment Schedules II-36 WHO-DAS (Pocock, 1983). The study sample size will be effectively powered by calculating sample size satisfactorily to identify variance in the group thereby producing valid results (Anderson, 1980, Anderson et al., 1986).
The primary outcome measures will look at the change in PTSD severity from baseline to endpoint using valid and reliable clinician- administered PTSD scale (CAPs Blake, 1990).
NICE reported that in many situations co-morbid problems secondary to the PTSD, such as depression, general anxiety or alcohol or substance misuse, get better with trauma-focused psychological treatment. Treatment findings of PTSD show that with effective treatment of PTSD, co-morbid signs of depression and anxiety are reduced.
QALYs will measure improvements in Social Functioning, Global functioning scores and this will be based on EuroQol EQ-5D questionnaire, GAF (a structured scoring system with a minimum score of 0 and a maximum of 100) and Work and Social Adjustment Scale (Mundt, 2002). The study will also measure client satisfaction with the service using the Client Satisfaction Questionnaire.
The costs include costs of healthcare within and outside of the programme. Indirect costs include the cost of the police investigation; refurbishment of clinic facilitates to accommodate changes in the programme. The final cost will be calculated as the summation of products of the volumes of resources to be used alongside their individual unit cost. Resources can be identified by conducting search for relevant information on databases such as Pubmed, EBSCO, Medline, and so on. Information will be obtained by searching from these databases with relevant topics and based on the inclusion criterion appropriate journals and information will be selected.
In healthcare organisations, for treating patients of PTSD, unit cost per hour of contact with clients is £15 and for 12 sessions it is £183. Capital costs are estimated to be £7435 per year, which includes sharing basis for treatment process. Local authority expenses are £34 for attending each client. In addition, cost of healthcare services per residents is £75 per resident per week and for obtaining social services is £107 per resident per week.
The trial will use clinical report forms of both physician and patient centred and the European version of PTSD severity indexes to collect data from following –up visits to the healthcare resources, travel expenses. Wellbeing related quality of life will be accessed using the disease-specific tool and psychiatric morbidity with a validated questionnaire.
This can be alligned with the Care Act 2014 policy, which stresses on providing better care services along with im proving quality of life of PTSD patients.
The study will use the cost-effective method of economic evaluation to assess the intervention at the end of the trial, alternative treatment which in this case is “treatment as usual” will be assessed on costs and significant health-related gains. Economic evaluation can also be linked with the Care Act 2014, which emphasises on the responsibility of local authorities support patients in financial aspects. The willingness to pay threshold (WTP) will be ascertained to ensure that it is in line with NICE guideline of £30, 000 and if the ICER < WTP the study will be considered as being cost-effectiveness.
Statistical Package for Social Science (SPSS IBM, 2006) is to be used for the quantitative analysis.
Intention to treat analysis will be performed on all participants that were recruited into the trial. Mantel-Haenszel X2 test adjusted for the stratification variable will be used to compare between the groups the proportions of patients that responded. The difference between the 2-arm summarised by average and standard deviations with a 95% confidence interval in both groups after adjusting for bias and using accelerated non-parametric bootstrapping drawing up 15 000 samples. Multi-way sensitivity analysis will be performed to examine the robustness of cost suitability of intervention (WTP to pay up to £30,000) to variations in unit cost and UK time trade-off based health utility algorithm. This evaluation can be linked with the confidentiality of information and Care Act 2014. This is because, these policies highlights the importance of respecting patients’ identity and protecting personal information.
The findings of the study will be reported in line with revised CONSORT guidelines; the study does not plan to carry out interim analyses however the data will be cleaned prior to analysis. The findings will show the interaction between the many parts of the intervention and how they yield proposed outcomes. It will also show to patients, families or caregivers any specific component of the intervention acceptable to them. All costs will be calculated for both arms of treatment and cost-effectiveness of the intervention will be compared to treatment.
Monitoring and safety of the study will be regulated by an independent committee that will include mental health professionals, user group representation and caregiver groups. They will review the protocol before the trial begins and data will be sent to the committee quarterly including data of dropouts and participants who did not consent to the study.
Implementation of combined therapy does not require major organizational change as most of the clinicians and mental health nurses are already trained in their respective areas, rather it will give staff the opportunity to know that with adequate support the changes made to adequately look after patients with PTSD can be feasible.
Inclusion criteria will be women diagnosed with PTSD assessed using a structured clinical interview based on the DSM-IV (Cohen, 2007) and are re-experiencing distressing events, avoidance or arousal in at least four weeks (Ballenger, 2004). Patients already diagnosed with a psychotic disorder are excluded.
The control group will receive treatment as usual which will be selective serotonin reuptake inhibitors (SSRIs); an antidepressant which may work in adjusting disparities in neurotransmitters believed to play a role in initiating and /or preserving PTSD symptoms (Stein, 2000). Participants in the intervention will receive both the SSRIs and trauma-focused psychological interventions. The subjects will receive ten sessions two times a week. Both arms of the trial will be delivered at the sexual health clinic.
Formula used to calculate the sample size
Costs and predicted expenses for the trial
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