665 Week 5 RP - Psychology Individual Assignments and quizzes PDF

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Psychology Individual Assignments and quizzes ...

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Research Proposal Latischa Wells PSYCH 665 7-1-2019 Dr. Schupper

Research Proposal The purpose of this research proposal is to examine the effects of taking placebos with therapy in treating PTSD. The examination of placebos used in therapy, as opposed to medication in therapies, will be used in the study to see if placebos can truly have the same effect as a medicated therapy. Often time’s medication is used to assist veterans with PTSD coupled with therapies. What if placebos could be used as a medication to assist in therapy? Some research studies have shown that placebos can have dramatic effects on people in therapy. According to Carlino, Piedimonte, and Benedetti (2016), “Placebos have long been considered a nuisance in clinical research, for they have always been used as comparators for the validation of new treatments” (p. 597). They have also shown to be useful as treatments as well. They have been shown to be effect in Parkinson’s disease by changing the psychosocial effect by changing the social stimuli. Doing so has altered the chemistry of a person’s brain. All terms associated with this proposal will be used concerning PTSD. Different medications will be examined through literature reviews and explained. The research done with this proposal will determine if placebos can truly work in veterans with PTSD coupled with therapy only. The effects of placebos have shown in other studies to be effective by changing the way we think to create new a new chemistry in the brain, which is similar to the ones induced by drugs. Literature Review In an article titled “Effective Placebo Control Conditions for PTSD Efficacy Research: A Brief Communication,” a study was conducted to see if the use of a placebo and therapy would change between pre-test and post-test. After given pamphlets to read in between testing and therapy, a decrease was shown on the PTSD checklist. The difference was not maintained over

time. After the follow-up, there was no decrease in the post-test. There was an increase when the test was redone 16-18 weeks later taking the participants back to where they started at. The next article “Nature of the placebo and nocebo effect in relation to functional neurologic disorders” examined was conducted to see if the use of a placebo and therapy would change between pre-test and post-test. After given pamphlets to read in between testing and therapy, a decrease was shown on the PTSD checklist. The difference was not maintained over time. After the follow-up, there was no decrease in the post-test. There was an increase when the test was redone 16-18 weeks later taking the participants back to where they started at. Another article titled, “Divalproex in the treatment of posttraumatic stress disorder: a randomized, double-blind, placebo-controlled trial in a veteran population”, was completed to evaluate the efficacy of divalproex for the treatment of PTSD. A double-blind method was used. The participants consisted of 85 US military members that suffered from PTSD. The treatment was split by giving half a placebo, and the other has Divalproex. The results of this study showed that the Divalproex was not an effective treatment when compared to the placebo. In “Treatment of Posttraumatic Stress Disorder by Exposure and/or Cognitive Restructuring”, used the background for this study to unanswered questions from controlled studies of PTSD with the value of cognitive restructuring alone without prolonged exposure therapy and whether its combination with prolonged exposure is enhancing. Exposure, cognitive restructuring, the combination of both ad relaxation were used. Placebos were used regarding coping when the therapist and client were not in contact with each other. “Exposure and cognitive restructuring, by itself or combined, improved PTSD overall.” The next article, “Risperidone Shows No Benefit over Placebo for PTSD,” Risperidone is a widely used antipsychotic used for veterans with PTSD. A study was conducted at the

University of Yale to see if Risperidone had any warranted effects on veterans with PTSD. The study concluded that it had no greater effect on veterans than the placebo did. The study was conducted over 24 weeks, and the results showed no increase or decrease in answers on the PTSD scale. The article goes on to explain that if this drug does not help with the symptoms of PTSD other drugs along this line should be tested for further use and applicability. The final research article was another comparative article named “Adjunctive Olanzapine for SSRI Resistant Combat-Related PTSD; A Double-Blind Placebo-Controlled Study.” This study examines the use of selective serotonin reuptake inhibitors (SSRI) using a double-blind pilot study for point of reference. The use of placebos was not as efficient as the use of SSRI’s. The SSRI’s had a better outcome in terms of reducing the effects of symptoms in people who suffered from PTSD. Because this research is the first of its kind, it was concluded that more research would need to be conducted. The one thing about all of these articles is that they all use the placebo effect to compare medication in therapy to see if the drugs are valid. All research done previously has been comparative in nature using placebos against specific medications to see if the medicines work. As far as the author’s knowledge there has not any research done to see if a placebo can be used to alter the brains chemistry to have an effective use in PTSD. There is not one article or research study that the author could find to see if a placebo could be given to couple with treatment as an effective means to control PTSD in war veterans. Research Method and Hypothesis The research question and hypothesis will examine: Is a placebo-controlled therapy just as effective as a medication-controlled therapy. There have been many studies showing a correlation between a placebo, and a specific medicine, but no research to show the difference

between just using a placebo with therapy. The goal of this research proposal is to see if a placebo can do what medication does by targeting thoughts about using medication. Some veterans do not want to take medications and sometimes therapy may be enough to help in dealing with PTSD. If veterans were under the assumption that a new medicine (placebo) would help them and completed a trial of the new medication with therapy, would it show that the placebo does work? Placebos have shown to work in Parkinson’s disease by targeting specific neurotransmitters. If specific neurotransmitters can be altered in the brain’s chemistry dealing with PTSD, would we get the same effects? Methods Design Twenty outpatients from the Veterans Administration (VA) with severe cases of PTSD will be used to compare the effects of a placebo with therapy and medication with therapy. The trial will consist of 25 patients who will be receiving their new medication (placebo) and 25 patients who continue using the same medications the VA has prescribed. The therapy will consist of helping veterans with changing their social situations around them by using different words, and rituals to help foster a better healing environment. This will be coupled with prolonged exposure, Eye-Movement Desensitization and Reprocessing (EDMR), and Cognitive Processing Therapy (CPT)/journal writings. The overall timeframe of this experiment will be 20 weeks with an hour session each week. The reason for the longer period of time is to ensure any medication previously in the system makes its way out to allow for the placebo effect to take place. Patients The patients will be all be current patients of the VA. Inclusion criteria will be as follows:

PTSD for six or more months, ages 20-60 years of age, and the absence of brain disease. The patients referred for this trial will be sent screening questionnaires. The respondents who fit the category will have a screening review with a trained professional covering the PTSD, why it happens, the impact it has on the person, their mental state and a structured clinical interview based on the DSM-III category for PTSD. With the review, The Clinician Administered PTSD Scale (CAPS-5), The Davidson Trauma Scale (DTS), and The Trauma and Attachment Belief Scale (TABS) will be used to assess the level of severity for the participants with PTSD. Between the 50 people selected, 25 will be assigned to the placebo group and the others will be assigned to the medication group. Treatment Treatment will consist of with, Eye-Movement Desensitization and Reprocessing (EDMR), and Cognitive Processing Therapy (CPT)/ journal writings and prolonged exposure EDMR will use visual stimulation like moving their finger back and forth in front of your eyes and ask you to recall the traumatizing event. This will include any and all emotions tied to the event. The therapist will teach the participant to guide their thoughts to more pleasant ones. Cognitive Processing Therapy/Journal writings will be part of the therapy for use when not in contact with the therapist. They will include thoughts and feelings for the day and how the person overcame them or did not overcome them. It will help serve to guide the therapist how the sessions are going with the techniques used throughout the process. Prolonged exposure will also be used by teaching the participants of how to gain control of negative thoughts or feelings. This form of therapy helps in talking out some of the things the participants do to avoid remembering the trauma. It teaches them how to face these pent-up emotions head-on.

The results will be monitored, and a detailed report will be done at 5, 10, 15 and 20 weeks. Each of these milestones will be monitored to see how effective the placebo is working against the medicated participants. Improvement will be tracked with both sides. It will also be monitored between treatment comparisons. Another round of surveys will be given with the milestone weeks to have the participants rate themselves to see if they feel like they have improved or declined in their symptoms and feelings throughout the process. The analysis will be done at the end of the 20-week period to test to see how the patients feel and are coping with PTSD after they have completed the program. All other details for collecting data will be used on the test-retest scale to see if the placebo played any role in helping one cope with PTSD. Ethical Considerations Many ethical considerations will be taken into account to ensure the privacy of the participants. A consent form will be given and signed before any trials are to begin. If at any point the participant feels they do not want to participate any longer, they can opt out of the research. They will be informed that this research is strictly voluntary. The researcher will also enforce that all people providing therapy and medication are professionals that are fully trained to complete this research trial. The therapy will be conducted on the VA grounds in case of an emergency and ensure that no harm will come to them. Confidentiality will be regarded in the utmost of importance and will be relayed to the participants. None of the information attained throughout the process will be granted to anyone outside of the VA or research team. Discussion: Expected Results, Conclusions, and Limitations The expected result should yield enough information to help further the use of placebos when treating veterans with PTSD. Placebos can have a strong effect on our psyche. If used in the correct way, they can be tools to help us get where we want to go in the treatment of PTSD

without the use of medicines. All medicines have side effects, and some might need to be coupled with others to make things normal. For instance, if a medicine helps deal with anxiety, and is given to a patient, but may cause insomnia, the psychiatrist may have to provide a sleep aid. If a placebo does what it is intended to do, it could help ease one of the side effects to one or many medications. The goal here is to help people without the use of medications. If a person can learn how to cope with therapy without medication, we might be able to move in a new direction to help with battling PTSD. After the research has been done the results will show if more research needs to be done or if the placebo effect does not do what it was intended to do with this hypothesis and research question. Limitations of this exercise could include a variety of things. Participants dropping out, the group who was supposed to take their medicine doesn’t, and individuals who do not have the time to complete their therapies. The group, the researchers pull from is already there and admitted to the VA. Another limitation is that the time periods for therapy may be too short or too long depending on conflict of scheduling. The data could also allow significant differences with the levels of PTSD participants in the research. If the research does go well, a six-month follow-on may be required to see if the improvements are maintained or decline.

References Barabasz, A. (2014, October). Effective Placebo Control Conditions for PTSD Efficacy Research: A Brief Communication, 62(4), 492. doi:10.1080/00207144.2014.932654 Carlino, E., Piedimonte, A., & Benedetti, F. (2016). Nature of the placebo and nocebo effect in relation to functional neurologic disorders. NCBI, 136(), 597-606. Davis, L. L., Davidson, J. r., & Ward, C. L. (2008, February). Divalproex in the treatment of posttraumatic stress disorder: a randomized, double-blind, placebo-controlled trial in a veteran population. Journal of clinical psychopharmacology, 28(1), 84-88. doi:10.1097/JCP.0b013e318160f8 Marc-Antoine Crocq, M. (2018). From shell shock and war neurosis to posttraumatic stress disorder: a history of psychotraumatology. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3181586/ Marks, Isaac, Lovell, K., & Noshirvani, H. (1998, April). Treatment of Posttraumatic Stress Disorder by Exposure and/or Cognitive Restructuring. Arch Gen Psychiatry, 55(4), 317325. doi:10.1001/archpsyc.55.4.317 Sinclair, L. (2011, September). Risperidone Shows No Benefit Over Placebo for PTSD. Psychiatric News, 46(17), 21. doi:10.1176/pn.46.17.psychnews_46_17_21_1 Stein, M. B., Kline, N. A., & Matloff, J. L. (2002, October). Adjunctive Olanzapine for SSRI Resistant Combat-Related PTSD; A Double Blind Placebo-Controlled Study. The American Journal of Psychiatry, 159(10), 1777-1779. doi:10.1176/appi.ajp.159.10.1777...