NCT06176001 (R-Bipolar) is a NA clinical trial of psychoeducation in groups in Bipolar Disorder, sponsored by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital.

Who is sponsoring NCT06176001?

NCT06176001 is sponsored by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital.

What drugs are being tested in NCT06176001?

Interventions in NCT06176001: psychoeducation in groups.

What condition does NCT06176001 study?

NCT06176001 studies Bipolar Disorder.

Is NCT06176001 still recruiting?

NCT06176001 is currently completed. Last updated 26 September 2025.

Last reviewed 2025-09-26 · How we verify

NCT06176001: R-Bipolar

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder, a Randomized Controlled Trial

Completed NA Last updated 26 September 2025

What this trial tests

NA trial testing psychoeducation in groups in Bipolar Disorder in 206 participants. Completed in 1 June 2024.

Timeline

7 April 2022

Primary endpoint
1 June 2024

1 June 2024

Quick facts

Lead sponsor	Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	206
Start date	7 April 2022
Primary completion	1 June 2024
Estimated completion	1 June 2024
Sites	1 location across Denmark

Drugs / interventions tested

psychoeducation in groups

Conditions studied

Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Who can join

18 and older, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Relatives of patients with bipolar disorder (BD) often experience emotional burden with stress, and depressive symptoms that again increases the likelihood of destabilization and relapses in the patient. The effects of group-based psychoeducation have not been investigated in large-scale real-world settings. The investigators are currently conducting a large-scale real-world randomized controlled parallel group trial (RCT) to test whether group-based psychoeducation for relatives to patients with BD improves mood instability and other critical outcomes in relatives and the corresponding patients with BD. The trial is designed as a two-arm, parallel group randomized trial with a balanced randomization 1:1 to either group-based psychoeducation or a waiting list for approximately 4 months and subsequent group-based psychoeducation. the investigators plan to include 200 relatives. The group sizes for psychoeducation is between 20-40 relatives.The primary outcome measure is mood instability calculated based on daily smartphone-based mood self-assessment. Other relevant outcomes are measured, including patients' reported outcomes, assessing self-assessed burden, self-efficacy, and knowledge about BD.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Study protocol: group-based psychoeducation for relatives of patients with bipolar disorder-a large scale real-world randomized controlled parallel group trial, the R-bipolar RCT.
Stokholm JR, Vinberg M, Faurholt-Jepsen M, Kessing LV. · · 2024 · cited 2× · PMID 38783322 · DOI 10.1186/s13063-024-08172-z
Becoming diplomats with boundaries - a thematic analysis of relatives' experiences with group-based psychoeducation about bipolar disorder.
Stokholm JR, Waldemar AK, Kessing LV. · · 2025 · PMID 40890647 · DOI 10.1186/s12888-025-07219-y

Verify or expand the search:

Other recruiting trials for Bipolar Disorder

Currently open trials in the same condition.

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Other Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital trials

Trials by the same sponsor.

NCT07404085 — Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations · NA · recruiting
NCT07302165 — PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be · NA · enrolling by invitation
NCT06919133 — The Effect of Digital Markers in the Self-management of Depressive Symptoms · NA · enrolling by invitation
NCT06755710 — Patient Engagement in PTSD Treatment (PEP) · NA · recruiting
NCT06993831 — ENGAGE: Virtual Reality-based Psychotherapy for Negative Symptoms in Schizophrenia · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06176001 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Last refreshed: 26 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06176001.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing