SuspendedNot Applicable

Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression

Stopped: Difficulties recruiting

Sweden54 participantsStarted 2022-10-26

Plain-language summary

Hypothesis: the hypothesis of the study is that aerobic physical exercise (PE) performed with the method Braining accelerates recovery from bipolar depression as well as improves psychiatric and somatic health in individuals with bipolar depression Method: a randomized controlled trial with 54 patients with bipolar depression are randomized to 6 weeks of either 1) supervised aerobic PE 3 times/week, 2) supervised relaxation/stretching 3 times/week or 3) information about PE but no supervised activity.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients at Psychiatry Southwest, Karolinska University Hospital Region Stockholm Sweden. * Bipolar disorder * Ongoing depression, defined as a PHQ-9 score of 9 or higher at any occasion 2 weeks before inclusion. Exclusion Criteria: * Severe psychiatric disorder such as mania and psychosis * Medical conditions such as heart- and lung diseases where PE is contraindicated. * Unable to understand written and spoken Swedish language.

What they're measuring

PHQ-9 (Patient Health Questionnaire - 9 items)

Timeframe: Change from inclusion to follow up 6 weeks after inclusion

PHQ-9 (Patient Health Questionnaire - 9 items)

Timeframe: At follow up 12 months after intervention.

PHQ-9 (Patient Health Questionnaire - 9 items)

Timeframe: At follow up 24 months after intervention.

PHQ-9 (Patient Health Questionnaire - 9 items)

Timeframe: At follow up 36 months after intervention.

Trial details

NCT IDNCT05340686

SponsorRegion Stockholm

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Bipolar Disorder trials