Efficacy and implementation of an Internet psychoeducational program for teens with type 1 diabetes.

OBJECTIVE: The purpose of the study was to evaluate the participation and preliminary efficacy of an Internet psychoeducational program (Teens.Connect) shown to be efficacious under controlled conditions compared with an open-access diabetes website for youth (Planet D) on the primary outcomes of A1C and quality of life (QoL), and secondary outcomes of psychosocial and behavioral factors. RESEARCH DESIGN AND METHODS: Teens with type 1 diabetes (n = 124, 11-14 yr) from two clinical sites were randomly prescribed one of the programs and completed baseline, 3-month and 6-month data. A1C was obtained from clinic records. Participation data included number of log ins, posts to the discussion board, and lessons completed (Teens.Connect only). Descriptive and mixed model analyses were used. RESULTS: Eighty-five percent (85%) of consented teens registered for their prescribed program. Satisfaction and log ins were similar between groups (satisfaction ranged 3.3-3.5/5; mean log ins = 14/teen). Posts to the discussion forum were higher in Planet D (mean = 28 vs. 19). Participation in the Teens.Connect lessons was low, with only 69% of teens completing any lesson. After 6 months there were no significant differences in A1C, QoL or secondary outcomes between groups. Teens in the Teens.Connect group reported lower perceived stress over time (p < 0.01). CONCLUSIONS: Teens do not actively participate in an Internet psychoeducational program when they do not have frequent reminders, which may have contributed to a lack of treatment effect. Teens have many competing demands. Strategic implementation that includes targeted reminders and family support may be necessary to assure participation and improvement in health outcomes.

Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study.

OBJECTIVES: Intravenous micronutrient therapy (IVMT), and specifically the Myers' Cocktail, is a popular approach for treating fibromyalgia syndrome (FMS) among complementary and alternative medicine practitioners, but its efficacy is uncertain. This trial assessed the feasibility, safety, and provided insights into the efficacy of this therapy. DESIGN: This was a randomized, double-blind, placebo-controlled pilot study. LOCATIONS: The study locations were an academic research center, teaching hospital, and affiliated Integrative Medicine Center in Derby, CT. SUBJECTS: The subjects were 34 adults with American College of Rheumatology (ACR)-defined FMS. INTERVENTION: Subjects were randomly assigned either to treatment (weekly infusions of IVMT) or to placebo (weekly infusions of lactated Ringer's solution) for 8 weeks. OUTCOME MEASURES: Primary outcome was change in the Tender Point Index, assessed 8 and 12 weeks after initiation. Secondary measures included a Visual Analog Scale to assess global pain, and validated measures of physical function (Fibromyalgia Impact Questionnaire), mood (Beck Depression Index), and quality of life (Health Status Questionnaire 2.0). RESULTS: Clinically significant improvements were noted (of a magnitude similar to other effective interventions). However, in part because of the high placebo response and the small sample size, no statistically significant differences were seen between groups, in any outcome measure, at 8 and 16 weeks. Statistically significant within-group differences were seen in both the intervention and placebo groups, demonstrating a treatment effect for both IVMT and placebo. At 8 weeks, the IVMT group experienced significantly improved tender points, pain, depression, and quality of life directly following treatment (all p < or = 0.02), while the placebo group experienced significantly improved tender points only (p < or = 0.05). The treatment effects of IVMT persisted at 4 weeks postintervention for tender points, pain, and quality of life, while placebo effects persisted only for tender points. A single minor adverse event was noted in one subject in the intervention group. CONCLUSIONS: This first controlled pilot study established the safety and feasibility of treating FMS with IVMT. Most subjects experienced relief as compared to baseline, but no statistically significant differences were seen between IVMT and placebo. The efficacy of IVMT for fibromyalgia, relative to placebo, is as yet uncertain.