The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder - a Randomised Controlled Trial
The PEDAL trial, sponsored by Oslo University Hospital, aims to evaluate a novel group-based intervention for bipolar disorder that integrates digital tools to address affective lability, a significant unmet need in current treatment paradigms. With an estimated recruitment of 120 participants across five clinical sites in Norway, the trial seeks to demonstrate superior efficacy of the PEDAL intervention over traditional group psychoeducation (TAU). If successful, the intervention could enhance treatment options for bipolar disorder, potentially leading to broader adoption in clinical practice both nationally and internationally. The focus on digital tools may also align with increasing trends towards telehealth and personalized medicine, positioning the PEDAL intervention favorably in a competitive landscape that includes existing psychoeducational programs and digital mental health solutions.
Indication: Bipolar Disorder (BD)
Modality: behavioral intervention
Target: Affective lability and emotion regulation in bipolar disorder
Sponsor: Oslo University Hospital
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jun 25, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Affective lability and emotion regulation in bipolar disorder
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Condition raw: Bipolar Disorder (BD)
Condition normalized: Bipolar Disorder (BD)
Modality raw: behavioral intervention
Modality normalized: behavioral intervention
Target raw: Affective lability and emotion regulation in bipolar disorder
Target normalized: Affective lability and emotion regulation in bipolar disorder