PEDAL: a group program with digital tools to help bipolar patients manage mood swings
Official title: The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder - a Randomised Controlled Trial
Run by Oslo University Hospital · NCT07239778 · Data updated 2026-11-12
A group-based program for people with bipolar disorder tests a psychoeducation approach enhanced with digital resources to help manage affective lability.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 4 sites (Drammen and 3 other locations) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | June 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07239778 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with bipolar I, II, or NOS who speak Scandinavian languages, own and use a smartphone, and can participate in group sessions.
✕Probably not a fit
Individuals who do not respond to group psychoeducation or who cannot engage with digital tools may experience limited benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
PEDAL combines traditional group psychoeducation for bipolar disorder with digital elements, including online materials and an app-based mood diary, to help patients learn strategies for affect regulation. The trial enrolls about 120 participants across five clinical sites in Oslo and Vestre Viken. It aims to determine whether adding these digital components improves management of rapid mood changes and overall functioning compared with standard group education. The study focuses on feasibility, potential efficacy, and cost-efficiency to support implementation in routine clinical care.
Why it matters
Potential benefit: If successful, PEDAL could improve mood regulation and quality of life for people with bipolar disorder and be scalable within standard clinical settings.
How similar studies have gone: Group psychoeducation with digital augmentation has shown promise in related mood-disorder interventions, though this specific combination targeting affective lability is novel/less tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bipolar I, II or not otherwise specified disorder * Understands Scandinavian language * Owns and will use smartphone as part of the intervention * Is considered eligible for group participation by treating clinician Exclusion Criteria: * Previous participation in group psychoeducation for bipolar disorder * Will move, is late in pregnancy or other situation that prevents competion of trial
Where it's running
-
Vestre Viken Hospital Trust (Drammen DPS)
Drammen, Norway Recruiting -
Oslo University Hospital (Nydalen DPS and Søndre Oslo DPS)
Oslo, Norway Recruiting -
Diakonhjemmet Hospital (Allmennpsykiatrisk poliklinikk)
Oslo, Norway Recruiting -
Lovisenberg Diaconal Hospital (Section for Group Treatment)
Oslo, Norway Recruiting
Study contacts
- Study coordinator: Trine V. Lagerberg, Professor
- Email: t.v.lagerberg@psykologi.uio.no
- Phone: +47 22 92 35 01
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.