Bipolar DisorderNCT02637401
Group Dialectical Behavioural Therapy for Mood Instability Within Bipolar Disorder: An Open Trial
An observational study of Bipolar Disorder, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Bipolar Disorders (BD) typically involve repeated episodes of both depression and excessively high mood or irritability (hypomania or mania). BD presents considerable challenges for the individual, his or her supporters, and society more generally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Dialectical Behaviour Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with frequent bipolar mood swings.
Inclusion criteria for patient participants are: i) aged 18 or over; i) meets DSMV criteria for Bipolar Spectrum Disorder; iii) current bipolar mood instability (over the past two years numerous periods with hypomanic symptoms that do not meet criteria for a hypomanic episode and numerous periods with depressive symptoms that do not meet criteria for a depressive episode, continuing into the past month); iv) client wishes to engage in psychological therapy that focusses primarily on ongoing mood instability and its consequences.
Exclusion criteria are: i) current substance dependence disorder; ii) currently receiving other psychological therapy; iii) the patient is currently actively suicidal; iv) presenting difficulties that are characteristic of Borderline Personality Disorder rather than Bipolar Disorder and that would be an early treatment target in standard DBT (frequent and serious deliberate selfharm, marked disturbance in ability to form or maintain interpersonal relationships); v) presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example panic disorder with agoraphobia, Post Traumatic Stress Disorder); vi) the information available suggests that the person may present a significant risk to other group members (such as aggression, likelihood of carrying out sexual or other exploitation); vii) the person lacks capacity to consent to treatment or research participation; viii) currently experiencing an episode of mania.
Trial locations and contacts
1 site in 1 country.
About this study
Bipolar Disorders (BD) typically involve repeated episodes of both depression and excessively high mood or irritability (hypomania or mania). BD presents considerable challenges for the individual, his or her supporters, and society more generally. Medication is generally considered to be the mainstay treatment, however a substantial number of individuals with BD continue to experience episodes despite use of medication. Furthermore, ongoing mood instability either outside of episodes, or as the main feature of their BD, is a significant difficulty experienced by many. Whilst studies suggest that certain psychological therapies can be helpful for people experiencing full bipolar episodes, or to reduce risk of future episodes, there are no evidencebased psychological therapies available for individuals experiencing ongoing mood instability. Dialectical Behaviour Therapy (DBT) was developed several decades ago as an approach for people with Borderline Personality Disorder. DBT aims to give individuals who experience rapid and intense shifts in affect skills for managing this. Despite the many similarities in the symptoms experienced by individuals with Borderline Personality Disorder and those with Bipolar Disorder only a small number of studies have tested DBT for BD, and no studies to date have specifically investigated DBT as a means to help individuals with ongoing mood instability. We have developed a version of groupbased DBT that draws upon our own research to adapt standard DBT for this client group (DBTBD).
The group is designed to be delivered efficiently within the U.K. healthcare system whilst meeting the needs of individual participants through use of additional individual sessions and a mobile phone application. The current study investigates how acceptable DBTBD is to clinicians and patients, and whether - for the small number of individuals in the study -changes in symptoms and key ways of thinking and behaving appear to take place across the period of treatment.
- Conditions
- Bipolar Disorder
- Being tested
- Dialectical Behaviour Therapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behaviour TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Therapy group | Dialectical behaviour therapy: a psychological therpay involving 16 group sessions plus approximately 5 individual meetings over 4 months. Receives: Behavioral: Dialectical Behaviour Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the therapy (% completing treatment)
Measured: 10 months
Acceptability of the therapy and study procedures
Qualitiative feedback from participants
Measured: 10 months
Feasibility of the study procedures
recruitment rate; feedback from referrers and clincians / researchers
Measured: 10 months
Secondary outcomes (2)
Clinical effectiveness
symptoms, quality of life, recovery status. Analysis focuses upon the sensitvity of these measures to change, and pre-post correlations.
Measured: 15 months
Process measures
self report measures of key psychological processes hypothesised to be changed by therapy. Analysis focuses upon the sensitvity of these measures to change, and pre-post correlations.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637401
- Sponsor's protocol ID
- 1415/002
- Status last verified
- May 2018
- First submitted
- 17 Dec 2015
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data would potentially be shared on Open Repository Exeter (University of Exeter's open data repository)
Publications
Wright K, Palmer G, Javaid M, Mostazir M, Lynch T. Psychological therapy for mood instability within bipolar spectrum disorder: a single-arm feasibility study of a dialectical behaviour therapy-informed approach. Pilot Feasibility Stud. 2020 Apr 15;6:46. doi: 10.1186/s40814-020-00586-1. eCollection 2020.
PubMed 32318271
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Dialectical Behavioural Therapy for Mood Instability Within Bipolar Disorder: An Open Trial
- ClinicalTrials.gov ID
- NCT02637401
- Acronym / sponsor ID
- 1415/002
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bipolar Disorders (BD) typically involve repeated episodes of both depression and excessively high mood or irritability (hypomania or mania). BD presents considerable challenges for the individual, his or her supporters, and society more generally. Medication is generally considered to be the mainstay treatment, however a substantial number of individuals with BD continue to experience episodes despite use of medication. Furthermore, ongoing mood instability either outside of episodes, or as the main feature of their BD, is a significant difficulty experienced by many. Whilst studies suggest that certain psychological therapies can be helpful for people experiencing full bipolar episodes, or to reduce risk of future episodes, there are no evidencebased psychological therapies available for individuals experiencing ongoing mood instability. Dialectical Behaviour Therapy (DBT) was developed several decades ago as an approach for people with Borderline Personality Disorder. DBT aims to give individuals who experience rapid and intense shifts in affect skills for managing this. Despite the many similarities in the symptoms experienced by individuals with Borderline Personality Disorder and those with Bipolar Disorder only a small number of studies have tested DBT for BD, and no studies to date have specifically investigated DBT as a means to help individuals with ongoing mood instability. We have developed a version of groupbased DBT that draws upon our own research to adapt standard DBT for this client group (DBTBD).
The group is designed to be delivered efficiently within the U.K. healthcare system whilst meeting the needs of individual participants through use of additional individual sessions and a mobile phone application. The current study investigates how acceptable DBTBD is to clinicians and patients, and whether - for the small number of individuals in the study -changes in symptoms and key ways of thinking and behaving appear to take place across the period of treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy group | – | Behavioral: Dialectical Behaviour TherapyDialectical behaviour therapy: a psychological therpay involving 16 group sessions plus approximately 5 individual meetings over 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with frequent bipolar mood swings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behaviour Therapy | Behavioural | Therapy group |
Primary outcome
Acceptability of the therapy (% completing treatment)
Time frame: 10 months
Acceptability of the therapy and study procedures
Time frame: 10 months
Qualitiative feedback from participants
Feasibility of the study procedures
Time frame: 10 months
recruitment rate; feedback from referrers and clincians / researchers
2 secondary outcomes
Clinical effectiveness
Time frame: 15 months
Process measures
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Derived from this study: PubMed 32318271Wright K, Palmer G, Javaid M, Mostazir M, Lynch T. Psychological therapy for mood instability within bipolar spectrum disorder: a single-arm feasibility study of a dialectical behaviour therapy-informed approach. Pilot Feasibility Stud. 2020 Apr 15;6:46. doi: 10.1186/s40814-020-00586-1. eCollection 2020.
- Individual participant dataSharing planned: Undecided. Data would potentially be shared on Open Repository Exeter (University of Exeter's open data repository)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the therapy (% completing treatment) (time frame: 10 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.