Abstract
Background
Addressing the enhancement of ill health self-management skills in adults diagnosed with bipolar disorder may be considered an important intervention for health care systems worldwide.
Objective
This protocol describes the study “Management of my Bipolarity” (MoB), which aims to develop an educational intervention for adults with bipolar disorder and assess its effectiveness. The objectives include (a) a literature review on bipolar disorder educational interventions; (b) a qualitative exploration of the educational needs of people with bipolar disorder; (c) development of an educational intervention based on objectives (a) and (b) (ie, the MoB educational intervention); and (d) exploration of the effectiveness of the intervention regarding participants’ knowledge of their mental health condition and enhancement of their ill health self-management skills. The MoB educational intervention will consist of an in-person and a web-based intervention in the form of a digital platform.
Methods
The proposed interventional study is a combination of a qualitative and a quantitative design (mixed methods study). A focus group and content analysis will be implemented for the qualitative assessment of the educational needs of adults with bipolar disorder. The intervention will be developed based on the qualitative data of the study and relevant literature. The effectiveness of the acquired knowledge and self-management skills will be assessed according to (a) substance use behavior, (b) health locus of control, (c) impulse control, (d) adherence to pharmacotherapy, (e) relapse prevention, (f) improvement of quality of life, and (g) bipolar disorder knowledge level via structured instruments in the quantitative part of the study using descriptive and inferential statistics (SPSS version 24.0).
Results
A total of 13 patients with bipolar disorder have been interviewed (8 women, 5 men) to identify educational needs to be covered through the intervention. Moreover, a literature review on bipolar disorder educational interventions has been completed. These data have been incorporated in the design of the MoB in-person intervention and the digital platform. The digital platform is live, and the development of the MoB in-person intervention was completed at the end of 2020. The recruitment of the participants for the intervention (40 patients) and the control group (40 patients) began during the first semester of 2021. Moreover, by tracking the platform for 1.5 years, we have recorded that 2180 users have visited the platform with an average session duration of almost 2 minutes. Mobile and tablet devices are being used by 70% of the visitors.
Conclusions
Since new parameters regarding educational interventions will be explored, these findings are expected to provide evidence that participation in structured educational interventions offers patients the opportunity to improve adherence to pharmacotherapy and increase their quality of life.
Trial Registration
ClinicalTrials.gov NCT04643210; https://clinicaltrials.gov/ct2/show/NCT04643210
International Registered Report Identifier (IRRID)
DERR1-10.2196/25168