The PEDAL study: Group Psychoeducation with Digital Elements and Focus on Affective Lability
The PEDAL study investigates whether a digital and updated version of the psychoeducation program for bipolar disorder can provide better support for individuals with the diagnosis. By combining the established framework of the traditional program with digital tools and new content on affect regulation, we hope to strengthen the effect on symptoms, functioning, and quality of life.
About the Project
Many people with bipolar disorder experience significant challenges with affect regulation such as affective lability and other residual symptoms outside of the distinct episodes of hypomania/mania and depression. This may lead to a more severe course of illness and/or a higher risk of additional difficulties such as anxiety, substance use, and suicidal behaviour.
In the PEDAL study, we will test an expanded and modernized version of the well-established psychoeducation program for bipolar disorder (often referred to as the "bipolar course"). The traditional program involves lectures by health professionals and the opportunity to share experiences with others in the same situation. The course consists of lectures, small-group discussions, the use of a paper-based mood diary, as well as homework exercises, and is associated with beneficial effects in several areas, including the prevention of new illness episodes.
In the PEDAL version of the program, we maintain the original structure but digitize much of the content and add elements focusing on affect regulation, as well as a digital mood diary (app). We aim to test whether the PEDAL version can improve difficulties with affect regulation and other common symptoms of bipolar disorder compared to the traditional course, in addition to having better effects on functioning and quality of life.
Method and Design
The PEDAL study is a randomized controlled trial in which participants will be randomly assigned to either the traditional program or the PEDAL version. The study is relevant for people with bipolar disorder (I, II, or unspecified) who are otherwise considered suitable for the psychoeducational program according to standard procedures. At least 120 participants will be recruited from five clinical units at Oslo University Hospital, Lovisenberg Diakonale Hospital, Diakonhjemmet Hospital, and Vestre Viken Hospital Trust.
The traditional program and the PEDAL program will run in parallel at all five study sites, with weekly two-hour sessions. Participants will be asked to complete questionnaires before the programs start, immediately after the programs end, and again after six months.
Status
The project is in an active planning and development phase and is currently recruiting participants. The intervention period with weekly sessions will run from February to June 2026.
Contact
PEDAL study phone 47 76 52 75
Principal investigator: Trine Vik Lagerberg, uxlagt@ous-hf.no
Project coordinator: Margrethe Collier Høegh, machoe@ous-hf.no