The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder

NCT07239778 | Not Yet Recruiting Phase 2

• 2 other identifiers: 875821340534
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Bipolar Disorder (BD)

Keywords

Affective lability; Bipolar disorder; Psychoeducation; Group intervention; Emotion regulation; Digital tools; eHealth

Outcome Measures

Primary Outcomes (1)

• Change from baseline to follow-up 1 (week 13 in TAU and week 15 in PEDAL) on the 18 item Affective Lability Scale - short form (ALS-SF)

  The Affective Lability Scale is a validated self-report instrument assessing the typical pattern and level of affective lability, from 0 (not very descriptive of me) to 3 (very descriptive of me). Change = Follow-up 1 total score minus baseline total score.

  Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)

Secondary Outcomes (7)

• Perceived Stress Scale (PSS-10)

  Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)

• Quick Inventory of Depressive Symptoms - self-report version (QIDS-SR)

  Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)

• The Bech-Rafelsen Mania Scale (BRMS)

  Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)

• Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)

  Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)

• WHO-5 Well-Being Index

  Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)

Other Outcomes (1)

• electronic Case Report Form (eCRF)

  Baseline.

Study Arms (2)

TAU: Traditional group psychoeducation for bipolar disorder

ACTIVE COMPARATOR

Traditional GPP for bipolar disorder consists of 11 group sessions led by one or two trained therapists. The sessions comprise predefined topics such as the characteristics of BD, theories about etiology, managing depression and mania, psychopharmacological treatment, and lifestyle advice to enhance illness stabilization. Each session has an introductory lecture on the topic held by the therapist, small-group discussions based on the participants' experiences in this area, and plenary discussions led by the therapist. The program also provides written material for the participants to read and prepare for the relevant session, provided in a booklet. It contains the educational parts, a toolkit with a mood diary, an overview of potential "warning signs" for relapse, and an emergency plan. The toolkit is used to engage the participants in self-management of the disorder.

Behavioral: Traditional group psychoeducation for bipolar disorder

PEDAL: Group psychoeducation with digital elements and focus on affective lability

EXPERIMENTAL

The PEDAL arm provides the 11 group sessions as described for the comparator arm, and two additional sessions that have been developed for the trial to cover topics related to affective lability and emotion regulation. Thus, in this arm there will be 13 group sessions. The format of the sessions is the same as for the TAU arm. In addition, participants in this arm will have access to an online platform with the following content: All written course material, three video tutorials for emotion regulation skills training, and an app-based mood diary that provides a dashboard where participants can monitor their mood and sleep patterns.

Behavioral: Group psychoeducation with digital elements and focus on affective lability

Interventions

Traditional group psychoeducation for bipolar disorder BEHAVIORAL

Psychosocial intervention

TAU: Traditional group psychoeducation for bipolar disorder

Group psychoeducation with digital elements and focus on affective lability BEHAVIORAL

Psychosocial intervention

Also known as: The PEDAL intervention

PEDAL: Group psychoeducation with digital elements and focus on affective lability

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous participation in group psychoeducation for bipolar disorder
• Will move, is late in pregnancy or other situation that prevents competion of trial

Sponsors & Collaborators

• Oslo University Hospital: lead
• Vestre Viken Hospital Trust: collaborator
• Diakonhjemmet Hospital: collaborator
• Lovisenberg Diakonale Hospital: collaborator

Study Sites (4)

Vestre Viken Hospital Trust (Drammen DPS)

Drammen, 3018, Norway

Location

Oslo University Hospital (Nydalen DPS and Søndre Oslo DPS)

Oslo, 0351, Norway

Location

Diakonhjemmet Hospital (Allmennpsykiatrisk poliklinikk)

Oslo, 0373, Norway

Location

Lovisenberg Diaconal Hospital (Section for Group Treatment)

Oslo, 0440, Norway

Location

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Related Links

• Information about the study on sponsors website

MeSH Terms

Conditions

Bipolar Disorder; Emotional Regulation

Interventions

MD1

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Central Study Contacts

Trine V. Lagerberg, Professor

CONTACT

+47 22 92 35 01; t.v.lagerberg@psykologi.uio.no

Margrethe C. Høegh, PhD

CONTACT

+47 23 02 73 30; machoe@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistical analysts
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4)