The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder
ConditionBipolar Disorder (BD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous participation in group psychoeducation for bipolar disorder
Will move, is late in pregnancy or other situation that prevents competion of trial
Trial design
Design model
Parallel
Treatments tested in this trial
Traditional group psychoeducation for bipolar disorder
BehavioralPsychosocial intervention
Group psychoeducation with digital elements and focus on affective lability
BehavioralPsychosocial intervention
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: TAU: Traditional group psychoeducation for bipolar disorderActive comparator 1 intervention
Group B: PEDAL: Group psychoeducation with digital elements and focus on affective labilityExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)Secondary outcomes
1
Perceived Stress Scale (PSS-10)
The Perceived Stress Scale (PSS) is a validated self-report measure used to assess the degree to which a person perceives their life as stressful, unpredictable, and uncontrollable over the past month. The scale consists of 10 items rated on a 5-point Likert scale from 0 (never) to 4 (very often). Higher scores indicate higher levels of perceived stress. Change=follow-up 1 total score minus baseline total score.
Time frame
Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)2
Quick Inventory of Depressive Symptoms - self-report version (QIDS-SR)
The Quick Inventory of Depressive Symptoms - self-report version (QIDS-SR) is a validated self-report measure to screen for and measure the severity of depressive symptoms in the past 7 days. The scale consists of 16 items rated on a 4-point Likert scale ranging from 0 (not present) to 3 (severe), where a higher score indicates more severe depression. Change= follow-up 1 total score minus baseline total score.
Time frame
Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)3
The Bech-Rafelsen Mania Scale (BRMS)
The Bech-Rafelsen Mania Scale (BRMS) is an 11-item clinician-rated scale used to measure the severity of manic symptoms in patients with bipolar disorder over the past 3 days. A higher score indicates more severe symptoms, with 11 items scored from 0 (no/low level) to 4 (high level) corresponding to different levels of mania, such as mild, moderate, or severe. Change= follow-up 1 total score minus baseline total score.
Time frame
Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)4
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) is a validated 18-item self-report questionnaire used to measure difficulties in a person's capasity to regulate their emotions. The scale consists of 18 items rated on a 5-point Likert scale from 1 (almost never) to 5 (almost always), where higher scores indicate greater difficulties with emotion regulation. Change=follow-up 1 total score minus baseline total score.
Time frame
Baseline, week 13/15 (follow-up 1) and week 37/39 (follow-up 2)Other outcomes
1
electronic Case Report Form (eCRF)
Digital questionnaire developed by the study group which will be filled in by the participants' primary clinician. The questionnaire covers demographics, illness history, past and current suicidal behavior, past and current substance use and current treatment.
Time frame
Baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
Vestre Viken Hospital Trust
Collaborator
Diakonhjemmet Hospital
Collaborator
Lovisenberg Diakonale Hospital
Collaborator
Source ClinicalTrials.gov