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NCT04859647
Client-led Online Therapy for People Diagnosed With Bipolar Disorder
NA trial testing Method of Levels Therapy in Bipolar Spectrum Disorder in 10 participants. Completed in 31 January 2022.
31 December 2021
Quick facts
| Lead sponsor | University of Manchester |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 June 2021 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 January 2022 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Method of Levels Therapy
Conditions studied
- Bipolar Spectrum Disorder — all drugs for Bipolar Spectrum Disorder →
Sponsor
University of Manchester
Who can join
18 and older, any sex, with Bipolar Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study aims to investigate the use of Method of Levels therapy (MOL) delivered online via videoconferencing for people who have received a diagnosis of a bipolar spectrum disorder. People are typically offered medication and talking therapies aimed at reducing symptoms and managing relapse. Research shows, however, that people tend to report reasons for distress other than symptoms and prioritise a fulfilling, purposeful life over remaining relapse- free. Having choice and control over treatment have been identified as important aspects of recovery in bipolar disorder. MOL is a flexible, client-led psychological therapy that allows people to talk freely about important problems and life goals. MOL has already been applied to a range of mental health difficulties with promising results. The aims of the study are to: * Investigate whether it is feasible to deliver MOL online to people with a bipolar spectrum disorder * Investigate whether MOL delivered online is an acceptable psychological intervention for people with a bipolar spectrum disorder * Identify the elements of therapy that people want choice over and the impact and importance of these elements * Determine whether there is a link between how much control over therapy people perceive themselves to have and the degree to which they generate new perspectives, thoughts and insights into their problems. The current study will aim to recruit a minimum of 12 participants with a diagnosis of Bipolar Spectrum Disorder to account for 30% attrition (a conservative estimate based on reported attrition rates for published studies evaluating Cognitive Behavioural Therapy (CBT) for Bipolar Disorder). Therefore, the study aims to retain 8 participants for completion of the study. This is considered feasible in the available timeframe as recruitment will adopt a broad strategy. Participants will be offered MOL sessions online for up to six months. Potential participants will choose how many sessions to have, when to attend and what to talk about. Investigators will consider how many participants chose to take part and remain in the study to the end. The investigators will also ask participants about their experiences of the intervention and any changes participants may have noticed via feedback questionnaires and an interview.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04859647
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Method of Levels Therapy
Trials testing the same drug.
- NCT05484518 — Method of Levels for People Using Community Crisis Services · NA · completed
Other recruiting trials for Bipolar Spectrum Disorder
Currently open trials in the same condition.
- NCT06920940 — Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents · NA · recruiting
Other University of Manchester trials
Trials by the same sponsor.
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- NCT07084090 — Using IF-THEN Plans to Support Patients in Raising Safety Concerns About Their Care · NA · not yet recruiting
- NCT07494760 — A Feasibility Randomised Control Trial to Evaluate Early Perinatal Bereavement Counselling for Parents Who Have Experien · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04859647 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Manchester
- Last refreshed: 19 May 2022
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/NCT04859647.
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