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The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder

RecruitingPhase 2Ages 18 Years - 65 YearsAllOslo University Hospital
NCT07239778 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Traditional group psychoeducation for bipolar disorder
  • Group psychoeducation with digital elements and focus on affective lability
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Where

4 sites
Vestre Viken Hospital Trust (Drammen DPS)
Drammen, Norway
Oslo University Hospital (Nydalen DPS and Søndre Oslo DPS)
Oslo, Norway
Diakonhjemmet Hospital (Allmennpsykiatrisk poliklinikk)
Oslo, Norway
Lovisenberg Diaconal Hospital (Section for Group Treatment)
Oslo, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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