New digital program aims to tame bipolar mood swings
NCT ID NCT07239778
First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study tests a new group program called PEDAL for people with bipolar disorder. It combines standard group education with digital tools like an app-based mood diary and online resources to help manage rapid mood swings. The trial will involve 120 participants across five sites in Norway. Researchers want to see if PEDAL reduces mood instability better than standard group education alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- group psychoeducation with digital tools and mood diary
- What this could lead to
- If it works, this could offer a more effective way to manage rapid mood swings in bipolar disorder, improving daily stability and quality of life.
- What could go wrong
- This is a Phase 2 trial with only 120 participants, so results may not apply to everyone. The added digital tools may not provide extra benefit over standard group education.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Diakonhjemmet Hospital (Allmennpsykiatrisk poliklinikk)
RECRUITINGOslo, 0373, Norway
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Lovisenberg Diaconal Hospital (Section for Group Treatment)
RECRUITINGOslo, 0440, Norway
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Oslo University Hospital (Nydalen DPS and Søndre Oslo DPS)
RECRUITINGOslo, 0351, Norway
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Vestre Viken Hospital Trust (Drammen DPS)
RECRUITINGDrammen, 3018, Norway
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Other studies related to the condition(s) this trial covers.
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