Research Proposal Paper Instructions and Rubric

Introduction

The goal of this assignment is to challenge you to integrate and apply the majority of the information that you will learn through this class over the course of the semester to develop a research proposal. The research proposal can be quantitative or qualitative. Once you have identified a problem, you will then undertake a brief literature review on the topic and come up with objectives/research questions that your proposal will seek to address/answer. You then select an appropriate methodology based on consultation with the instructor. The mode of data collection may include surveys, interviews with key stakeholders, focus groups, or analysis of existing data, among others.

Your research proposal will typically involve:

(1) identifying the problem.

(2) describing the nature and extent of the problem.

(3) conducting a literature review of the problem and what past studies have found with respect to your problem.

(4) identifying gaps in the literature and state the objective(s)/research question(s) that the proposal will be addressing.

(5) proposing a method that you will want to use to carry out the research and explaining the process in detail.

(6) proposing a method that you will use in collecting the data; and

(7) discussing possible implications that could arise if you are able to carry out the proposed research.

Formatting and Submission Guidelines

For All Papers

· Papers should be typed, double spaced, using 1-inch margins, 12-point Times New Roman font.

· Title and reference pages are required. An abstract is not required.

· Follow APA 7th Edition style guidelines.

· The Research Proposal Paper (not including title and reference pages) should be between 8 to 12 pages.

Paper Structure

Please follow the outline below to structure your paper and ensure that you are including all of the relevant information.

I.

Introduction and Background (5 pts.)

a. Introduce the problem and briefly state the magnitude of the problem. E..g., Opioid misuse is a major public health issue in the United States, and has emerged as the greatest contributor to substance overdose-related deaths among adults (United Nations Office on Drugs and Crime, 2017). Recent estimates confirm that opioid addiction among the adult U.S. population is at an all-time high, with some studies reporting that as low as 4% (Edlund et al., 2010; Vowles et al., 2015) to as high as 23% (Jamison, Butler, Budman, Edwards, & Wasan, 2010; Meltzer et al., 2011; Meltzer et al., 2012) of adults in the U.S. are addicted to opioids. Recently, the Centers for Disease Control and Prevention (CDC) examined data on all-cause mortality, and found that drug overdoses exceeded more than 60,000 in 2016, greater than any year on record (O’Donnell, Halpin, Mattson, Goldberger, & Gladden, 2017).

b. Identify the gap in the literature. E.g., Although a number of public health measures have been put in place in the U.S. to address the unprecedented epidemic of opioid overdose (Hahn, 2011; Hampton, 2004; Jones, Fullwood, & Hawthorn, 2012; Substance abuse and mental health services administration, 2009), the use of MBSR as a therapeutic intervention to treat individuals with OUD has not been fully tried and tested, and certainly none among individuals suffering from comorbid CLBP and OUD.

II.

Literature Review (15 pts.)

a. What else has been done in terms of researching this or similar problems and what has past studies found regarding this problem?

b. What has studies found with respect to the effect of age, race, gender, sexual orientation on this problem

c. Where else has your methodology been used?

d. What can we learn from what others have done regarding this problem?

E..g.,
Analyzing data from the CDC, Rudd et al. (2016) also found that the rate of opioid overdose-related deaths in 2014 increased significantly for both sexes across all age and racial groups in the U.S. This increase in opioid overdose-related deaths in part has been attributed to the increased prescribing of opioid analgesics in the management of postoperative pain (Ballantyne, 2017; Paulozzi, Jones, & Mack, 2015; Phillips, Ford, Bonnie, & National Academies of Sciences, Engineering, and Medicine, 2017; Sadhasivam & Chidambaran, 2012; Stumbo et al., 2017). As a result, some treatment interventions have been developed to treat comorbid CLBP and OUD and to prevent relapse. CBT is one behavioral intervention which has received considerable support in treating individuals with SUD, including opioid addiction (Bell, daCosta DiBonaventura, Witt, Ben-Joseph, & Reeve, 2017; Dowell, Haegerich, & Chou, 2016; Park et al., 2016; Rasu, Sohraby, Cunningham, & Knell, 2013). However, a burgeoning number of studies suggests that interventions which include a mindfulness component, such as MBSR, are more effective in preventing relapse than CBT (Bell et al., 2017; Dowell et al., 2016; Park et al., 2016; Rasu et al., 2013).

III.

Objective(s)/Research question(s)/hypothesis(es) (10 pts.)

a. What are your objectives, or what questions are you trying to answer, or what are your hypotheses?*
*If you are proposing a qualitative study then you will not need a hypothesis. You should have a hypothesis if you are proposing to use a quantitative methodology and especially a quasi-, or experimental design.

E.g.,
The following two hypothesis-driven objectives will be addressed: 1) To conduct a randomized clinical trial (RCT) to test the relative efficacy of mindfulness-based stress reduction (MBSR), cognitive behavioral therapy (CBT), and treatment-as-usual (TAU) in treating patients with comorbid opioid-use disorder (OUD) and comorbid chronic low back pain (CLBP). Hypothesis: The MBSR and CBT components of the interdisciplinary intervention program will be more efficacious than the TAU component; 2) To investigate the physical and mental health outcomes produced by these interventions, as well as individual differences in outcomes. Hypothesis: The measurement of individual variations in the biopsychosocial measures will serve as outcomes, and enable us to develop unique “flags” for change to document the efficacy of the interventions.

IV.

Methodology (50 pts.)

a. What will be the sample size?

b. What sampling method will you be using (i.e., probability, non- probability, etc.)?

c. Design (i.e., qualitative, quantitative, exploratory, survey, quasi-, or experimental design, etc.)?

i. If you are proposing a quasi or experimental design, describe in detail the key component of the intervention and how it will be delivered.

E.g.,
Mindfulness has been defined by Kabat-Zinn (1994) as “paying attention in a particular way, on purpose, in the present moment, and non-judgmentally” (p. 4). A key component of MBSR is meditation which is often compared with normal everyday mental functioning, and may be a valuable intervention for individuals with OUD, whose mental state is often craving for substances or preoccupied with thoughts about how to get their “next fix” (Aleksandra Zgierska et al., 2009). MBSR encourages individuals to be mindful of their cravings and acknowledge that these cravings are fleeting (Katz & Toner, 2013). It uses evidence- based practices to lower the likelihood and severity of relapse for individuals with SUD after receiving treatment (Bowen et al., 2014). The intervention draws on select components of relapse-prevention therapy (Marlatt & Gordon, 1985) in identifying underlying risk factors and common precursors of relapse (Daley & Marlatt, 2006; Kabat-Zinn, 1994; Kabat-Zinn & Hanh, 2009; Marlatt & Gordon, 1985). Bowen et al. (2009) undertook a RCT to test the efficacy of MBSR in substance use relapse-prevention and found that, compared with a 12- step program, MBSR was associated with decreased alcohol and drug use during a 2-month post-intervention period, and a decreased craving for drug use and increased acceptance and awareness during a 4-month post- intervention period. Various systematic reviews (Bell et al., 2017; Dowell et al., 2016; Park et al., 2016; Rasu et al., 2013) and meta- analyses (Bell et al., 2017; Dowell et al., 2016; Park et al., 2016; Rasu et al., 2013) have also found MBSR to be effective in helping individuals to cope with their clinical and non-clinical problems. Most recently, Cherkin et al. (2016) and others (Bell et al., 2017; Dowell et al., 2016; Park et al., 2016; Rasu et al., 2013) have also found that MBSR was as effective as CBT in reducing pain and disability in CLBP. To the best of our knowledge, although supported by other studies (see e.g., Brewer et al., 2009; Zgierska et al., 2008) of MBSR in treating individuals with SUD, this present proposal is the first RCT to investigate the efficacy of MBSR, CBT, and treatment-as-usual (TAU) on 12-month follow-up outcomes.

ii. How will be intervention be delivered?

E.g.,
The MBSR intervention group will receive an integrated mindfulness-based meditation, which will be a manualized 10-week intervention designed to reduce risk factors associated with addiction and psychosocial distress due to pain (Kabat-Zinn, 1982; Kabat-Zinn, 1994). Following the approach suggested by Garland et al. (2016), the MBSR sessions will involve mindfulness training to target automatic-habit behavior that can help regulate negative emotions and foster a sense of meaningfulness in life. MBSR participants will be provided with psychoeducation on topics about substance use and addiction, as well as general coping skills for CLBP.

d. How are you going to collect your data? (e.g., in-depth interview, focus group discussions, face-to-face questionnaire, mailed questionnaire, telephone question, or online survey?)

e. If qualitative, state some of the key interview questions or focus group questions and include an interview guide as an appendix

f. Measurement (NOT NEEDED IF YOU ARE PROPOSING A QUALITATIVE STUDY)

i. What is your dependent and independent variables and how will you measure them?

ii. What has past studies found with respect to the reliability and validity of your measures?

V.

Implications (5 pts.)

a. What are some of the possible implications that could results from undertaken this research?

VI.

References Page (5 pts.)

a. See next page for example.

VII.

Overall Quality (10 pts.)

a. APA style throughout the paper

b. Organization of paper

c. Clarity of writing and statements

d. Formatting and submission guidelines followed.

References

Ballantyne, J. C. (2017). Opioids for the treatment of chronic pain: Mistakes made, lessons learned, and future directions. Anesthesia and Analgesia, 125(5), 1769-1778.

Bell, J. A., daCosta DiBonaventura, M., Witt, E. A., Ben-Joseph, R., & Reeve, B. B. (2017). Use of the SF-36v2 health survey as a screen for risk of major depressive disorder in a US population-based sample and subgroup with chronic pain. Medical Care, 55(2), 111-116.

Bowen, S., Chawla, N., Collins, S. E., Witkiewitz, K., Hsu, S., Grow, J., . . . Larimer, M.

E. (2009). Mindfulness-based relapse prevention for substance use disorders: A pilot efficacy trial. Substance Abuse, 30(4), 295-305.

Bowen, S., Witkiewitz, K., Clifasefi, S. L., Grow, J., Chawla, N., Hsu, S. H., . . . Lustyk,

M. K. (2014). Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: A randomized clinical trial. JAMA Psychiatry, 71(5), 547-556.

Brewer, J. A., Sinha, R., Chen, J. A., Michalsen, R. N., Babuscio, T. A., Nich, C., . . .

Potenza, M. N. (2009). Mindfulness training and stress reactivity in substance abuse: Results from a randomized, controlled stage I pilot study. Substance Abuse, 30(4), 306-317.

Cherkin, D. C., Sherman, K. J., Balderson, B. H., Cook, A. J., Anderson, M. L., Hawkes,

R. J., . . . Turner, J. A. (2016). Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: A randomized clinical trial. JAMA, 315(12), 1240-1249.

Daley, D. C., & Marlatt, G. A. (2006). Overcoming your alcohol or drug problem: Effective recovery strategies. New York: Oxford University Press.

Dowell, D., Haegerich, T. M., & Chou, R. (2016). CDC guideline for prescribing opioids for chronic pain—United States, 2016. JAMA, 315(15), 1624-1645.

Edlund, M. J., Martin, B. C., Fan, M., Devries, A., Braden, J. B., & Sullivan, M. D. (2010). Risks for opioid abuse and dependence among recipients of chronic opioid therapy: Results from the TROUP study. Drug and Alcohol Dependence, 112(1), 90- 98.

Garland, E. L., Roberts-Lewis, A., Tronnier, C. D., Graves, R., & Kelley, K. (2016).

Mindfulness-oriented recovery enhancement versus CBT for co-occurring substance dependence, traumatic stress, and psychiatric disorders: Proximal outcomes from a pragmatic randomized trial. Behaviour Research and Therapy, 77, 7-16.

Hahn, K. L. (2011). Strategies to prevent opioid misuse, abuse, and diversion that may also reduce the associated costs. American Health & Drug Benefits, 4(2), 107-114.

Hampton, T. (2004). Physicians advised on how to offer pain relief while preventing opioid abuse. JAMA, 292(10), 1164-1166.

Jamison, R. N., Butler, S. F., Budman, S. H., Edwards, R. R., & Wasan, A. D. (2010). Gender differences in risk factors for aberrant prescription opioid use. The Journal of Pain, 11(4), 312-320.

Jones, B. A., Fullwood, H., & Hawthorn, M. (2012). Preventing prescription drug abuse in adolescence: A collaborative approach. The Prevention Researcher, 19(1), 13-17.

Kabat-Zinn, J. (1982). An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: Theoretical considerations and preliminary results. General Hospital Psychiatry, 4(1), 33-47.

Kabat-Zinn, J. (1994). Wherever you go, there you are: Mindfulness meditation in everyday life. New York: Hyperion.

Kabat-Zinn, J., & Hanh, T. N. (2009). Full catastrophe living: Using the wisdom of your body and mind to face stress, pain, and illness. New York, N.Y: Delta Trade Paperbacks.

Katz, D., & Toner, B. (2013). A systematic review of gender differences in the effectiveness of mindfulness-based treatments for substance use disorders. Mindfulness, 4(4), 318-331.

Marlatt, G., & Gordon, J. (1985). Relapse prevention: Maintenance strategies in the treatment of addictive behaviors Guilford. New York: Guilford Press.

Meltzer, E. C., Rybin, D., Saitz, R., Samet, J. H., Schwartz, S. L., Butler, S. F., & Liebschutz, J. M. (2011). Identifying prescription opioid use disorder in primary care: Diagnostic characteristics of the current opioid misuse measure (COMM). Pain, 152(2), 397-402.

Meltzer, E. C., Rybin, D., Meshesha, L. Z., Saitz, R., Samet, J. H., Rubens, S. L., & Liebschutz, J. M. (2012). Aberrant Drug‐Related behaviors: Unsystematic documentation does not identify prescription drug use disorder. Pain Medicine, 13(11), 1436-1443.

O’Donnell, J. K., Halpin, J., Mattson, C. L., Goldberger, B. A., & Gladden, M. R. (2017).

Deaths involving fentanyl, fentanyl analogs, and U-47700—10 states, July– December 2016. Morbidity and Mortality Weekly Report (MMWR), 66, 1197-1202.

Park, P. W., Dryer, R. D., Hegeman‐Dingle, R., Mardekian, J., Zlateva, G., Wolff, G. G., & Lamerato, L. E. (2016). Cost burden of chronic pain patients in a large integrated delivery system in the United States. Pain Practice, 16(8), 1001-1011.

Paulozzi, L., Jones, C., & Mack, K. (2015). Vitals Signs: Overdoses of Prescription Opioid Pain relievers—United States, 1998-2008.Atlanta, GA: Centers for Disease Control and Prevention, 2011,

Phillips, J. K., Ford, M. A., Bonnie, R. J., & National Academies of Sciences, Engineering, and Medicine (Eds.). (2017). Trends in opioid use, harms, and treatment. Washington, DC: National Academies Press (US).

Rasu, R. S., Sohraby, R., Cunningham, L., & Knell, M. E. (2013). Assessing chronic pain treatment practices and evaluating adherence to chronic pain clinical guidelines in outpatient practices in the United States. The Journal of Pain, 14(6), 568-578.

Rudd, R. A., Aleshire, N., Zibbell, J. E., & Matthew Gladden, R. (2016). Increases in drug and opioid overdose deaths—United states, 2000–2014. American Journal of Transplantation, 16(4), 1323-1327.

Sadhasivam, S., & Chidambaran, V. (2012). Pharmacogenomics of opioids and perioperative pain management. Pharmacogenomics, 13(15), 1719-1740.

Stumbo, S. P., Yarborough, B. J. H., McCarty, D., Weisner, C., & Green, C. A. (2017).

Patient-reported pathways to opioid use disorders and pain-related barriers to treatment engagement. Journal of Substance Abuse Treatment, 73, 47-54.

Substance abuse and mental health services administration. (2009). Substance abuse and psychiatric services administration. (2009). national survey of substance abuse treatment services (N-SSATS): 2008. data on substance abuse treatment facilities (DAIS series: S-49, DHHS publication no. SMA 09-4451). Rockville, MD: Substance Abuse and Mental Health Services.

United Nations Office on Drugs and Crime. (2017). World drug report 2017. (). United Nations Office on Drugs and Crime, Vienna Austria: United Nations. Retrieved from

Vowles, K. E., McEntee, M. L., Julnes, P. S., Frohe, T., Ney, J. P., & van der Goes, D. N. (2015). Rates of opioid misuse, abuse, and addiction in chronic pain: A systematic review and data synthesis. Pain, 156(4), 569-576.

Zgierska, A., Rabago, D., Chawla, N., Kushner, K., Koehler, R., & Marlatt, A. (2009).

Mindfulness meditation for substance use disorders: A systematic review. Substance Abuse, 30(4), 266-294.

Zgierska, A., Rabago, D., Zuelsdorff, M., Coe, C., Miller, M., & Fleming, M. (2008). Mindfulness meditation for alcohol relapse prevention: A feasibility pilot study. Journal of Addiction Medicine, 2(3), 165-173.

Grading Rubric

Use these criteria as a guide for writing your proposal, since this is the criteria by which your assignment will be assessed

Criteria	Points Possible
· Introduction and Background	5
· Literature Review	15
· Objective(s)/Research question(s)/hypothesis(es)	10
· Methodology	50
· Implications	5
· Overall Quality · APA style throughout the paper · Organization of paper · Clarity of writing and statements · Formatting and submission guidelines followed	15
TOTAL	100