The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder

PEDAL is a group-based intervention for patients with bipolar disorder that builds on the traditional group psychoeducational program (GPP) by adding digital tools and specific strategies to help manage rapid fluctuations between affective states, known as affective lability. The program's goal is to help patients learn and develop new ways to better manage their condition, with particular attention to affective lability and other difficulties with affect regulation- challenges which are not typically addressed in current treatments. The PEDAL trial will run at five clinical sites around Oslo and Vestre Viken, aiming to recruit 120 participants with bipolar disorder. The program combines existing group sessions from GPP with new components: additional group sessions focusing on strategies for improving affect regulation such as mindfulness and distress tolerance, an online platform with all course materials including instructional videos and other resources, and an app-based mood diary. This framework maintains the benefits of regular group meetings while adding digital support tools to make the intervention more personalized and accessible. The main aim of PEDAL is to see if the new program reduces affective lability more effectively than GPP (treatment-as-usual; TAU), and both intervention groups will be compared on the level of affective lability before and after the intervention. Several secondary outcomes like mood symptoms, suicidal thoughts, perceived stress, and quality of life will also be assessed. In terms of study design, all study sites will run the PEDAL and TAU groups in parallel, and participants will be randomly assigned to either PEDAL or TAU. To qualify for the study, participants must be aged 18-65, diagnosed with bipolar disorder, able to participate in a group intervention, capable of providing informed consent, and have a smartphone or computer. People who have previously completed group psychoeducation, who are unable to complete the study period due to pregnancy or other factors, or those who cannot use the required technology are excluded. In summary, PEDAL is a novel study that modernizes the existing group psychoeducational program for bipolar disorder by targeting affective lability through skills training and digital tools, while also evaluating its reception and effects in a controlled clinical trial.

NCT Number	NCT07239778
Lead Sponsor	Oslo University Hospital Collaborators: Vestre Viken Hospital Trust, Diakonhjemmet Hospital, Lovisenberg Diakonale Hospital
Conditions	Bipolar Disorder (BD)
Enrollment	120 participants
Start Date	2025-11-25
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-11-25