The purpose of the current study was to develop a manualized treatment for fibromyalgia syndrome (FM) and to examine the efficacy of the treatment in a randomized controlled clinical trial. FM is a chronic musculoskeletal pain disorder characterized by tender points and generalized pain. Depression, chronic fatigue, and sleep disturbance are common. A biopsychosocial model served as a framework for understanding FM by integrating psychological, social, and physical factors. Cognitive-behavioural therapy (CBT), an empirically validated treatment for arthritis, has also been used with FM patients in an attempt to improve pain control, reduce disability, and increase self-efficacy. Overall, the attention/placebo controlled studies employing CBT as a treatment for FM show that it is not superior to a credible attention placebo. The current study attempted to combine the necessary components of CBT with interpersonal therapy to address relational patterns and personality characteristics that can affect ability to cope with chronic pain. One hundred and five women diagnosed with FM by a rheumatologist were randomly assigned to the CBT-interpersonal treatment condition or an attention-control condition. There were 8 treatment groups with a mean of 6-7 participants in each. The treatment consisted of weekly 2-hour sessions over 8 consecutive weeks. Outcome measures included: FM impact, pain, health care utilization, depression, coping, and self-efficacy. An intention-to-treat analysis was conducted. Results showed that the impact of FM symptoms was reduced following treatment compared to the control group and this was statistically and clinically significant, but was not maintained at 3-month follow-up. Significant improvements were also observed in coping strategies, some of which were maintained at follow-up. Importantly, self-efficacy improved significantly following treatment compared to the control group. Self-efficacy beliefs have been related to pain, coping efforts, disability, and psychological functioning. Directions for future research may include a focus on long-term maintenance of treatment gains that may be mediated by improvements in self-efficacy. There is strong evidence that changes in self-efficacy are enduring and affect changes in health behaviours and health status.

The purpose of the current study was to develop a manualized treatment for fibromyalgia syndrome (FM) and to examine the efficacy of the treatment in a randomized controlled clinical trial. FM is a chronic musculoskeletal pain disorder characterized by tender points and generalized pain. Depression, chronic fatigue, and sleep disturbance are common. A biopsychosocial model served as a framework for understanding FM by integrating psychological, social, and physical factors. Cognitive-behavioural therapy (CBT), an empirically validated treatment for arthritis, has also been used with FM patients in an attempt to improve pain control, reduce disability, and increase self-efficacy. Overall, the attention/placebo controlled studies employing CBT as a treatment for FM show that it is not superior to a credible attention placebo. The current study attempted to combine the necessary components of CBT with interpersonal therapy to address relational patterns and personality characteristics that can affect ability to cope with chronic pain. One hundred and five women diagnosed with FM by a rheumatologist were randomly assigned to the CBT-interpersonal treatment condition or an attention-control condition. There were 8 treatment groups with a mean of 6-7 participants in each. The treatment consisted of weekly 2-hour sessions over 8 consecutive weeks. Outcome measures included: FM impact, pain, health care utilization, depression, coping, and self-efficacy. An intention-to-treat analysis was conducted. Results showed that the impact of FM symptoms was reduced following treatment compared to the control group and this was statistically and clinically significant, but was not maintained at 3-month follow-up. Significant improvements were also observed in coping strategies, some of which were maintained at follow-up. Importantly, self-efficacy improved significantly following treatment compared to the control group. Self-efficacy beliefs have been related to pain, coping efforts, disability, and psychological functioning. Directions for future research may include a focus on long-term maintenance of treatment gains that may be mediated by improvements in self-efficacy. There is strong evidence that changes in self-efficacy are enduring and affect changes in health behaviours and health status.

Most individuals who die by suicide have contact with a physician in the year before their death. There are no randomized trials that have evaluated suicide intervention training for medical students or physicians. The objective of this study was to determine the effectiveness of a gatekeeper training program on suicide intervention behavior using Objective Structured Clinical Examinations (OSCEs) in medical students. A randomized controlled trial design was used. Participants were 112 undergraduate medical students at the University of Manitoba. The 2-day Applied Suicide Intervention Skills Training (ASIST) program was completed by half of the participants, according to a stratified block randomization design. Scores on OSCEs and scores on the Suicide Intervention Response Inventory (SIRI-2) were used as objective measures of intervention behaviors. There was a a significant Group-by-Time interaction on OSCE data, demonstrating that medical students who received ASIST performed significantly better than medical students who received training as usual (p<.001). The two groups did not differ significantly from each other on the SIRI-2 (p=.78). ASIST training improved the ability of medical students to detect and intervene with a standardized suicidal patient as assessed by OSCEs, compared to medical school training as usual. This study provides support for ASIST training for medical students to develop skills in recognition and management of suicidal patients. / October 2015

Despite the rapid development of palliative care teams, evidence for their effectiveness in oncology care is lacking. This thesis reviews and contributes towards this evidence, focusing on the randomized controlled trial as a research method. We conducted a systematic review of 22 trials reviewed that measured effectiveness of specialized palliative care. Family satisfaction with care improved in seven of 10 studies, but only four of 13 trials assessing quality of life and one of 14 assessing symptoms showed a benefit of the intervention. Conclusions were limited by methodologic problems in all of the trials. We conducted a phase II study of the efficacy of a palliative care team for symptom control and satisfaction of 150 patients with advanced cancer. Symptom severity (Edmonton Symptom Assessment System Distress Score) improved at one week and one month, as did patient satisfaction (all p<0.0001). We investigated factors associated with symptom severity and response for patients enrolled in the phase II study. Symptoms at baseline were worse for women and those with worse performance status (both p<0.005); female gender and worse baseline symptom severity independently predicted symptom improvement (both p<0.05). We planned and initiated an RCT of the effectiveness of an early palliative care intervention for improvement of health-related quality of life (HRQL) and satisfaction with care. Using baseline data from this RCT, we examined factors associated with HRQL in patients with advanced cancer. The strongest determinants of overall HRQL (combined FACT-G total score and FACIT-Sp Meaning and Peace subscore) were increased age (p<0.001), good performance status (p<0.001) and survival time >6 months (p=0.001). Compared to patients receiving cancer treatment, those awaiting new treatment had worse emotional well-being (p<0.001) while those on surveillance or whose treatment had been stopped had worse existential well-being (p=0.03). Male gender predicted better emotional and physical well-being and lower income predicted worse social well-being. Lastly, we developed recommendations for those planning an RCT in a palliative care population, incorporating information from the studies presented. Although such RCTs are challenging to conduct, they are feasible and necessary to improve the evidence base for the treatment of patients with advanced cancer.

Despite the rapid development of palliative care teams, evidence for their effectiveness in oncology care is lacking. This thesis reviews and contributes towards this evidence, focusing on the randomized controlled trial as a research method. We conducted a systematic review of 22 trials reviewed that measured effectiveness of specialized palliative care. Family satisfaction with care improved in seven of 10 studies, but only four of 13 trials assessing quality of life and one of 14 assessing symptoms showed a benefit of the intervention. Conclusions were limited by methodologic problems in all of the trials. We conducted a phase II study of the efficacy of a palliative care team for symptom control and satisfaction of 150 patients with advanced cancer. Symptom severity (Edmonton Symptom Assessment System Distress Score) improved at one week and one month, as did patient satisfaction (all p<0.0001). We investigated factors associated with symptom severity and response for patients enrolled in the phase II study. Symptoms at baseline were worse for women and those with worse performance status (both p<0.005); female gender and worse baseline symptom severity independently predicted symptom improvement (both p<0.05). We planned and initiated an RCT of the effectiveness of an early palliative care intervention for improvement of health-related quality of life (HRQL) and satisfaction with care. Using baseline data from this RCT, we examined factors associated with HRQL in patients with advanced cancer. The strongest determinants of overall HRQL (combined FACT-G total score and FACIT-Sp Meaning and Peace subscore) were increased age (p<0.001), good performance status (p<0.001) and survival time >6 months (p=0.001). Compared to patients receiving cancer treatment, those awaiting new treatment had worse emotional well-being (p<0.001) while those on surveillance or whose treatment had been stopped had worse existential well-being (p=0.03). Male gender predicted better emotional and physical well-being and lower income predicted worse social well-being. Lastly, we developed recommendations for those planning an RCT in a palliative care population, incorporating information from the studies presented. Although such RCTs are challenging to conduct, they are feasible and necessary to improve the evidence base for the treatment of patients with advanced cancer.

Maternal and child undernutrition are a significant problem in the developing world, with serious consequences for human health and socio-economic development. In Cambodia, 55% of children, 43% of women of reproductive age, and 50% of pregnant women are anemic. Current prevention and control practices rely on supplementation with iron pills or large-scale food fortification, neither of which are affordable or feasible in rural Cambodia. In the study areas, 97% of women did not meet their daily iron requirements. The current research focuses on the design and evaluation of an innovative iron supplementation technique. A culturally acceptable, inexpensive and lightweight iron ingot was designed to resemble a fish species considered lucky in Khmer culture. The ingot, referred to as ‘try sabay’ or ‘happy fish’, was designed to supply iron at a slow, steady rate. Iron leaching was observed in water and soup samples prepared with the iron fish when used concurrently with an acidifier. More than 75% of daily iron requirements can be met with regular use. Its use in the common pot of soup or boiled water provides supplementation to the entire family. The effectiveness of the iron fish was investigated in a randomized community trial involving 310 women in rural Cambodia. Blood samples were taken at baseline and every three months thereafter, over a 12-month trial period. Significant increases in hemoglobin concentrations were observed in women allocated an iron fish when compared to controls throughout the study, with an endline difference of 11.6 g/L. Significant improvements in serum ferritin concentration were observed at 9 months (6.9 ng/mL) and endline (30.8 ng/mL) in women who used an iron fish regularly when compared to the control group. Overall, use of the iron fish led to a two-fold reduction in the prevalence of anemia. The supplement was used daily by 94% of the households at the end of the trial. The study highlights the acceptability and effectiveness of a fish-shaped iron ingot as a means of improving dietary iron content. It offers a promising, simple solution to iron deficiency anemia if the project can be scaled-up for use throughout the country. / Canadian Institutes of Health Research; International Development Research Centre; University of Guelph

Breastfeeding is recommended as the optimal source of nutrition for newborns for the first 6 months of life and beyond with the addition of complementary foods. While breastfeeding initiation rates have been increasing, duration rates remain a concern as many women prematurely discontinue due to difficulties encountered rather than maternal choice. In addition, there is a sizable gap between rates of exclusive breastfeeding and current recommendations. Targeting modifiable variables that may be amenable to intervention is one strategy to improve breastfeeding outcomes. One such modifiable variable is breastfeeding self-efficacy. Although research has clearly shown that breastfeeding self-efficacy is predictive of breastfeeding duration and exclusivity, it is unknown whether it can be enhanced to improve breastfeeding outcomes. The purpose of this pilot randomized controlled trial was to examine the feasibility and compliance of a newly developed trial protocol and the acceptability of an intervention to increase breastfeeding self-efficacy in the immediate postpartum period. Secondary outcomes included determining whether there were any trends between groups related to breastfeeding self-efficacy, duration, and exclusivity. Participants included 150 primiparous mothers who were breastfeeding their healthy, full-term infants. Eligible and consenting mothers were randomized to either a control group (standard postpartum care) or an intervention group (standard postpartum care plus the self-efficacy intervention). Participants allocated to the intervention group received three individualized, self-efficacy enhancing sessions with the researcher; two sessions were conducted in hospital, and one was administered via telephone 1 week following hospital discharge. A research assistant blinded to group allocation collected outcome data at 4 and 8 weeks postpartum. The results suggested that the administration of the intervention was feasible and that there was a high degree of protocol compliance; the majority of participants reported that the intervention was beneficial. Secondary outcomes identified that there was a trend among participants in the intervention group to have improved breastfeeding outcomes, including higher rates of breastfeeding self-efficacy, duration, and exclusivity at 4 and 8 weeks postpartum. Preliminary evidence also suggested that the self-efficacy intervention may have assisted to decrease perceptions of insufficient milk supply among the intervention group participants. Overall, the findings from this pilot trial indicated that a larger trial is warranted.

abstract: The present study applied latent class analysis to a family-centered prevention trial in early childhood to identify subgroups of families with differential responsiveness to the Family Check-up (FCU) intervention. The sample included 731 families of 2-year- olds randomized to the FCU or control and followed through age five with yearly follow up assessments (Dishion et al., 2014; Shaw et al., 2015). A two-step mixture model was used to examine whether specific constellations of family characteristics at age 2 (baseline) were related to intervention response at age 3, 4, and 5. The first step empirically identified latent classes of families based on a variety of demographic and adjustment variables selected on the basis of previous research on predictors of response to the FCU and parent training in general, as well as on the clinical observations of FCU implementers. The second step modeled the effect of the FCU on longitudinal change in children's problem behavior in each of the empirically derived latent classes. Results suggested a five-class solution, where a significant intervention effect of moderate-to- large size was observed in one of the five classes. The families within the responsive class were characterized by child neglect, legal problems, and mental health issues. Pairwise comparisons revealed that the intervention effect was significantly greater in this class of families than in two other classes that were generally less at risk for the development of disruptive behavior problems, and post hoc analyses partially supported these results. Thus, results indicated that the FCU was most successful in reducing child problem behavior in the highly distressed group of families. We conclude by discussing the potential practical utility of these results and emphasizing the need for future research to evaluate this approach's predictive accuracy. / Dissertation/Thesis / Masters Thesis Psychology 2016

Background: A pilot study can be an important step in the assessment of an intervention by providing information to design the future definitive trial. Pilot studies can be used to estimate the recruitment and retention rates and population variance and to provide preliminary evidence of efficacy potential. However, estimation is poor because pilot studies are small, so sensitivity analyses for the main trial's sample size calculations should be undertaken. Methods: We demonstrate how to carry out easy-to-perform sensitivity analysis for designing trials based on pilot data using an example. Furthermore, we introduce rules of thumb for the size of the pilot study so that the overall sample size, for both pilot and main trials, is minimized. Results: The example illustrates how sample size estimates for the main trial can alter dramatically by plausibly varying assumptions. Required sample size for 90% power varied from 392 to 692 depending on assumptions. Some scenarios were not feasible based on the pilot study recruitment and retention rates. Conclusion: Pilot studies can be used to help design the main trial, but caution should be exercised. We recommend the use of sensitivity analyses to assess the robustness of the design assumptions for a main trial.

Background: With usual supplementation practices, most children are Vitamin D Deficient (VDD) following Congenital Heart Disease (CHD) surgery and alternative regimens need consideration. Methods/Results: i) A systematic review identified 88 pediatric trials of high dose vitamin D. Studies evaluating the Institute of Medicine (IOM) Tolerable Upper Intake Level (UL) did not rapidly normalize levels, while loading therapy (≥ 40000 IU) did so within 3 days. Hypercalcemia occurred more often with doses above 400000 IU. ii) A double blind RCT was designed to determine whether pre-operative administration of the IOM UL can prevent post-operative VDD. Results after the first 30 participants completed study procedures demonstrated it was possible to recruit (1.8 patients per month) and complete study procedures (i.e. blood collection). Unfortunately few participants (45%) received more than 30 doses of study drug. Conclusion: Prevention of post-operative VDD in the majority of CHD patients will require alternatives to the IOM recommendations.