Bipolar Spectrum DisorderNCT04859647
Client-led Online Therapy for People Diagnosed With Bipolar Disorder
A study testing Method of Levels Therapy in people with Bipolar Spectrum Disorder, run by University of Manchester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Spectrum Disorder
- What is being tested?
- Method of Levels Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2021to 31 Jan 2022
- Phase
- Interventional
- 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
Who may be able to join
- People aged 18 years and over
- Individuals with a diagnosis of Bipolar Spectrum Disorder.
- People accessing services or third sector agencies and/ or living in England.
- Access to personal use of technology is required for online therapy.
Who cannot join
- People presenting with extreme risk to self or others and engaging in active suicidal thoughts and/or behaviours.
- Problems of an organic nature, such as a brain injury or learning disability that might affect cognitive functioning.
- People already receiving a talking therapy for their difficulties
- People unable to speak/ understand sufficient English.
- Anyone already receiving talking therapy at the time of enrolment
- Anyone with a diagnosis of schizophrenia, schizoaffective disorder, primary substance misuse (mood swings caused purely by substance misuse), or psychosis outside of mood episodes or current episode of mania.
- People who do not have access to the internet and a video calling device.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Bipolar spectrum disorder (previously known as manic depression) is a diagnostic term used to describe experiences of extreme, and sometimes enduring, fluctuations in mood that interfere with a person's life or cause significant distress. Individuals diagnosed with bipolar disorder experience periods of depressed mood and periods of elevated or irritable mood. In many cases, this amounts to clinical depression, or mania that entails hospital admission. Periods of mood fluctuation usually involve extreme changes to usual thinking and behaviour. During a period of depression people might feel hopeless and suicidal, withdraw from social activities and have difficulty functioning, resulting in a neglect of self-care and basic needs. During mania people might experience delusional beliefs, become highly distractible and prone to engaging in high-risk activities such as excessive spending or drug-taking. Both mood states can result in significant impairment in work, social or daily functioning and may result in hospitalisation.
Many people with a diagnosis of a bipolar spectrum disorder experience multiple relapses, causing them significant long-term disability. Meeting the needs of this client group can pose a real challenge for services given the complexity of fluctuating mood states, high levels of impulsivity and associated risk, and additional difficulties that people can also experience (such as anxiety and trauma).
Current guidelines recommend that people who have received a diagnosis of a bipolar spectrum disorder are offered an evidence-based psychological intervention as well as medication. These interventions are typically time-limited and guided by a specific manual with emphasis on alleviating symptoms and relapse prevention. The quality of the evidence supporting such interventions has been questioned. There has also been doubt cast on the effectiveness of these interventions.
Treatment adherence is also considered suboptimal, with relatively high drop-out rates. Access to talking therapies for those with complex needs has been described as 'notoriously poor'. People diagnosed with a bipolar spectrum disorder often report reasons for distress other than symptoms and prioritise a fulfilling, purposeful life over remaining relapse-free. Talking freely to a caring, approachable therapist is valued, as are interventions that facilitate control over aspects of life beyond mood. Recovery is achievable when people are empowered to follow a self- determined path, take ownership and confront longstanding problems.
Recent advances in cognitive therapy have departed from traditional relapse prevention to offer a theory-based approach that helps people understand their individual experience of bipolar spectrum disorder and target current problems and control over life goals (rather than focusing on controlling swings). Although patients perceived the intervention to be beneficial, a trial did not find significant improvement compared to treatment as usual. Patients wanted more sessions and greater flexibility in scheduling, and many reported problems beyond their diagnosis.
More client-led approaches that are not tied to the specific diagnosis could better suit the therapeutic needs of people diagnosed with a bipolar spectrum disorder. One such approach is Method of Levels (MOL); an application of Perceptual Control Theory (PCT). PCT proposes that distress arises when people strive to achieve conflicting goals. People are typically able to resolve the conflict and re-establish control through a natural trial-and- error process. This process becomes disrupted when people remain unaware of the conflict. The questioning approach of MOL therefore aims to help people develop greater awareness of important goals and conflicts, and consider problems from new perspectives, thus generating their own solutions. For example, a client diagnosed with a bipolar spectrum disorder may work through their dilemma over whether to devote their life to their success as a creative writer, or to their relationship with their family; or they may be struggling between disclosing a past traumatic assault to the police to get justice, or to keep the experience to themselves for fear of reprisal or ridicule.
MOL has potential advantages over existing psychological approaches; it offers flexible, client-led appointment scheduling, it can be applied to a range of problems causing distress, treatment is tailored to individual needs, and it aims to provide people with more choice and control over the interventions they receive.
Perceived control, identified as a key mechanism of psychological change in MOL therapy, has been shown to contribute to decreased levels of overall distress. Perceived control has been linked to an increased awareness of the problem, an ability to talk freely and develop problem resolution. Client perceptions of control are closely related to their perceptions of helpfulness; both factors have been associated with effectiveness of therapy.
MOL has shown promising results in a variety of settings, including primary care, secondary care and inpatient hospital settings. It has been applied to a range of problems, including complex mental health problems such as psychosis.
Remote delivery of MOL via videoconferencing could further improve the level of flexibility and control offered to patients. There is promising evidence that video therapy can be clinically effective and acceptable to patients; when managed well it can also reduce costs for health services. Delivery via videoconferencing fits in with the flexible, client-led ethos of MOL, and is highly relevant given the current COVID-19 pandemic and associated restrictions on face to face therapy. MOL is interaction based, with no reliance on written information; it could be offered remotely from a practical perspective. It would seem that MOL has the potential to meet the needs of those who have received a diagnosis of a bipolar spectrum disorder, particularly when offered via videoconferencing.
To date, there have been no published studies evaluating MOL as a potential intervention for bipolar spectrum disorder. The feasibility and acceptability of offering MOL via videoconferencing has not yet been established. The proposed study therefore aims to evaluate the feasibility and acceptability of MOL, delivered via videoconferencing, as an intervention for people with a diagnosis of a bipolar spectrum disorder.
Given the importance of perceived control within therapy, the study also aims to provide an opportunity to explore the elements of therapy that people want choice over and the impact and importance of these elements. Considering the effectiveness of the intervention (in terms of reduction of distress and improvements in functioning and goal attainment) is a secondary aim of the study. An additional secondary aim is to determine whether there is a link between how much control over therapy participants perceive themselves to have and the degree to which they generate new perspectives, thoughts and insights.
The results of the study could help to inform future research into the clinical effectiveness of MOL for those with a diagnosis of a bipolar spectrum disorder, as well as the most effective methods of delivery for this therapy. It could also help inform developments in psychological therapies more broadly by considering the importance people place on perceiving themselves to have more choice and to feel in control during therapy and the impact this has on psychological change and overall wellbeing.
- Conditions
- Bipolar Spectrum Disorder
- Being tested
- Method of Levels Therapy
- Keywords
- Novel intervention, Psychological therapy, Online therapy, Client-led, Method of levels, Case Series
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method of Levels TherapyOther
Also called Psychological Therapy, Talking Therapy, Psychotherapy
MOL is a flexible, client-led psychological therapy that allows people to talk freely about important problems and life goals.
| Study group | Role | What they receive |
|---|---|---|
| Therapy Intervention | Other | Method of Levels Therapy Intervention - Clients will choose how many sessions to attend during the 6 months therapy window. Clients will also choose how often to attend sessions and the duration of each session. Receives: Other: Method of Levels Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Study through recruitment of participants
Feasibility will be measured by the proportion of eligible people recruited (based on the number of eligible referrals who chose to participate). These multiple measurements of feasibility will be combined to calculate an overall percentage of completion. Based on a recent trial with this client group, the percentage of eligible people needed to be recruited, remain in the study and complete the outcome measures to signal feasibility will be set conservatively at 50 percent. The number of sessions cancelled or terminated prematurely due to technical problems will also be considered.
Measured: Through study completion, up to 6 months
Feasibility of Study through retention of participants
Feasibility will be measured by participant retention rates (the number of people that remain in the study until the end of the study). These multiple measurements of feasibility will be combined to calculate an overall percentage of completion. Based on a recent trial with this client group, the percentage of eligible people needed to be recruited, remain in the study and complete the outcome measures to signal feasibility will be set conservatively at 50 percent. The number of sessions cancelled or terminated prematurely due to technical problems will also be considered.
Measured: Through study completion, up to 6 months
Feasibility of Study through data completion
Feasibility will be measured by the proportion of data completion (the number of outcome measures completed by participants during the study). These multiple measurements of feasibility will be combined to calculate an overall percentage of completion. Based on a recent trial with this client group, the percentage of eligible people needed to be recruited, remain in the study and complete the outcome measures to signal feasibility will be set conservatively at 50 percent. The number of sessions cancelled or terminated prematurely due to technical problems will also be considered.
Measured: Through study completion, up to 6 months
Acceptability of Intervention through written feedback
The key measure of acceptability will be a content analysis of written feedback comments. Feedback relating to quality of connection, audio, and video, and any impact of technological problems will also be considered. Descriptive statistics for the number of sessions attended, cancelled, not attended without prior notice, and the length of sessions will be provided. Where participants cancel or fail to attend a prearranged session, drop out of the study, or book few or no sessions, attempts will be made to ascertain the reasons. The collective data will determine whether the intervention would be considered acceptable by participants. A post-treatment retention rate of at least 75 percent would be considered to indicate acceptability in this study.
Measured: Through study completion, up to 6 months
Secondary outcomes (1)
Working Alliance Inventory - Short Version Revised (WAI-SR; Paap & Dijkstra, 2017).
Mean scores from the WAI-SR will also be presented as measures of acceptability. The 12-item self report scale aims to measure key aspects of therapeutic alliance; agreement regarding the goals of treatment, the tasks to achieve goals and the quality of the client-therapist bond. The higher the scores on the WAI-SR, the greater the degree of acceptability.
Measured: During the Intervention, up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Bipolar Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadie-Charelle Roberts, University of Manchester
- Investigators
- Kadie Roberts, Principal investigator, Trainee Clinical Psychologist, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859647
- Sponsor's protocol ID
- 288776
- Status last verified
- May 2022
- First submitted
- 7 Apr 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The findings of this study will be written up as a Doctorate level thesis, which will be available at the University of Manchester library. Articles will also be submitted for publication in peer reviewed scientific journals. The research team will offer to feedback the results of the study to the National Health Service (NHS) clinical teams and Charities that were involved in the recruitment of participants. This will be done via a written lay summary. Participants can also request a written summary or copy of any published articles. No identifiable personal data will be published when writing up the findings of this study. Individual participants will not be identifiable through the combination of data being published.
Publications
Searson R, Mansell W, Lowens I, Tai S. Think Effectively About Mood Swings (TEAMS): a case series of cognitive-behavioural therapy for bipolar disorders. J Behav Ther Exp Psychiatry. 2012 Jun;43(2):770-9. doi: 10.1016/j.jbtep.2011.10.001. Epub 2011 Oct 15.
PubMed 22104659Mansell W, Tai S, Clark A, Akgonul S, Dunn G, Davies L, Law H, Morriss R, Tinning N, Morrison AP. A novel cognitive behaviour therapy for bipolar disorders (Think Effectively About Mood Swings or TEAMS): study protocol for a randomized controlled trial. Trials. 2014 Oct 24;15:405. doi: 10.1186/1745-6215-15-405.
PubMed 25344393Gaffney H, Mansell W, Tai S. Conversational Agents in the Treatment of Mental Health Problems: Mixed-Method Systematic Review. JMIR Ment Health. 2019 Oct 18;6(10):e14166. doi: 10.2196/14166.
PubMed 31628789Griffiths R, Mansell W, Carey TA, Edge D, Emsley R, Tai SJ. Method of levels therapy for first-episode psychosis: rationale, design and baseline data for the feasibility randomised controlled Next Level study. BJPsych Open. 2018 Aug 14;4(5):339-345. doi: 10.1192/bjo.2018.44. eCollection 2018 Sep.
PubMed 30140445Davenport K, Hardy G, Tai S, Mansell W. Individual experiences of psychological-based interventions for bipolar disorder: A systematic review and thematic synthesis. Psychol Psychother. 2019 Dec;92(4):499-522. doi: 10.1111/papt.12197. Epub 2018 Sep 3.
PubMed 30175881Abu-Zidan FM, Abbas AK, Hefny AF. Clinical "case series": a concept analysis. Afr Health Sci. 2012 Dec;12(4):557-62.
PubMed 23515566Carey, T. A. (2008b). Perceptual control theory and the method of levels: Further contributions to a transdiagnostic perspective. International Journal of Cognitive Therapy, 1, 237-255.
Carey TA, Mansell W, Tai SJ. A biopsychosocial model based on negative feedback and control. Front Hum Neurosci. 2014 Feb 28;8:94. doi: 10.3389/fnhum.2014.00094. eCollection 2014.
PubMed 24616685Carey TA, Carey M, Mullan RJ, Spratt CG, Spratt MB. Assessing the statistical and personal significance of the method of levels. Behav Cogn Psychother. 2009 May;37(3):311-24. doi: 10.1017/S1352465809005232. Epub 2009 Apr 17.
PubMed 19371458Carey, T.A., Kelly, R.E., Mansell, W. & Tai, S. J. (2012). What's therapeutic about the therapeutic relationship? A hypothesis for practice informed by Perceptual Control Theory. The Cognitive Behaviour Therapist, 1-13.
Churchman, A., Mansell, W., & Tai, S. (2019). A school-based feasibility study of method of levels: a novel form of client-led counselling. Pastoral Care in Education, 37(4), 331-346
Cocklin AA, Mansell W, Emsley R, McEvoy P, Preston C, Comiskey J, Tai S. Client Perceptions of Helpfulness in Therapy: a Novel Video-Rating Methodology for Examining Process Variables at Brief Intervals During a Single Session. Behav Cogn Psychother. 2017 Nov;45(6):647-660. doi: 10.1017/S1352465817000273. Epub 2017 May 22.
PubMed 28528592First, M. B., Gibbon, M., Spitzer, R.L., & Williams, J. B. W. (2002). Structured Clinical interview for DSM-IV-TR axis 1 disorders (Research Version). New York: Biometrics Research Department, New York State Psychiatric Institute.
Gaffney H, Mansell W, Tai S. Agents of change: Understanding the therapeutic processes associated with the helpfulness of therapy for mental health problems with relational agent MYLO. Digit Health. 2020 Mar 16;6:2055207620911580. doi: 10.1177/2055207620911580. eCollection 2020 Jan-Dec.
PubMed 32206331Griffiths R, Mansell W, Edge D, Carey TA, Peel H, J Tai S. 'It was me answering my own questions': Experiences of method of levels therapy amongst people with first-episode psychosis. Int J Ment Health Nurs. 2019 Jun;28(3):721-734. doi: 10.1111/inm.12576. Epub 2019 Jan 31.
PubMed 30701661
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Client-led Online Therapy for People Diagnosed With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT04859647
- Acronym / sponsor ID
- 288776
- Conditions
- Bipolar Spectrum Disorder
- Keywords
- Novel intervention, Psychological therapy, Online therapy, Client-led, Method of levels, Case Series
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 26 Apr 2021 (actual)
- 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.
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.
Detailed description
Bipolar spectrum disorder (previously known as manic depression) is a diagnostic term used to describe experiences of extreme, and sometimes enduring, fluctuations in mood that interfere with a person's life or cause significant distress. Individuals diagnosed with bipolar disorder experience periods of depressed mood and periods of elevated or irritable mood. In many cases, this amounts to clinical depression, or mania that entails hospital admission. Periods of mood fluctuation usually involve extreme changes to usual thinking and behaviour. During a period of depression people might feel hopeless and suicidal, withdraw from social activities and have difficulty functioning, resulting in a neglect of self-care and basic needs. During mania people might experience delusional beliefs, become highly distractible and prone to engaging in high-risk activities such as excessive spending or drug-taking. Both mood states can result in significant impairment in work, social or daily functioning and may result in hospitalisation.
Many people with a diagnosis of a bipolar spectrum disorder experience multiple relapses, causing them significant long-term disability. Meeting the needs of this client group can pose a real challenge for services given the complexity of fluctuating mood states, high levels of impulsivity and associated risk, and additional difficulties that people can also experience (such as anxiety and trauma).
Current guidelines recommend that people who have received a diagnosis of a bipolar spectrum disorder are offered an evidence-based psychological intervention as well as medication. These interventions are typically time-limited and guided by a specific manual with emphasis on alleviating symptoms and relapse prevention. The quality of the evidence supporting such interventions has been questioned. There has also been doubt cast on the effectiveness of these interventions.
Treatment adherence is also considered suboptimal, with relatively high drop-out rates. Access to talking therapies for those with complex needs has been described as 'notoriously poor'. People diagnosed with a bipolar spectrum disorder often report reasons for distress other than symptoms and prioritise a fulfilling, purposeful life over remaining relapse-free. Talking freely to a caring, approachable therapist is valued, as are interventions that facilitate control over aspects of life beyond mood. Recovery is achievable when people are empowered to follow a self- determined path, take ownership and confront longstanding problems.
Recent advances in cognitive therapy have departed from traditional relapse prevention to offer a theory-based approach that helps people understand their individual experience of bipolar spectrum disorder and target current problems and control over life goals (rather than focusing on controlling swings). Although patients perceived the intervention to be beneficial, a trial did not find significant improvement compared to treatment as usual. Patients wanted more sessions and greater flexibility in scheduling, and many reported problems beyond their diagnosis.
More client-led approaches that are not tied to the specific diagnosis could better suit the therapeutic needs of people diagnosed with a bipolar spectrum disorder. One such approach is Method of Levels (MOL); an application of Perceptual Control Theory (PCT). PCT proposes that distress arises when people strive to achieve conflicting goals. People are typically able to resolve the conflict and re-establish control through a natural trial-and- error process. This process becomes disrupted when people remain unaware of the conflict. The questioning approach of MOL therefore aims to help people develop greater awareness of important goals and conflicts, and consider problems from new perspectives, thus generating their own solutions. For example, a client diagnosed with a bipolar spectrum disorder may work through their dilemma over whether to devote their life to their success as a creative writer, or to their relationship with their family; or they may be struggling between disclosing a past traumatic assault to the police to get justice, or to keep the experience to themselves for fear of reprisal or ridicule.
MOL has potential advantages over existing psychological approaches; it offers flexible, client-led appointment scheduling, it can be applied to a range of problems causing distress, treatment is tailored to individual needs, and it aims to provide people with more choice and control over the interventions they receive.
Perceived control, identified as a key mechanism of psychological change in MOL therapy, has been shown to contribute to decreased levels of overall distress. Perceived control has been linked to an increased awareness of the problem, an ability to talk freely and develop problem resolution. Client perceptions of control are closely related to their perceptions of helpfulness; both factors have been associated with effectiveness of therapy.
MOL has shown promising results in a variety of settings, including primary care, secondary care and inpatient hospital settings. It has been applied to a range of problems, including complex mental health problems such as psychosis.
Remote delivery of MOL via videoconferencing could further improve the level of flexibility and control offered to patients. There is promising evidence that video therapy can be clinically effective and acceptable to patients; when managed well it can also reduce costs for health services. Delivery via videoconferencing fits in with the flexible, client-led ethos of MOL, and is highly relevant given the current COVID-19 pandemic and associated restrictions on face to face therapy. MOL is interaction based, with no reliance on written information; it could be offered remotely from a practical perspective. It would seem that MOL has the potential to meet the needs of those who have received a diagnosis of a bipolar spectrum disorder, particularly when offered via videoconferencing.
To date, there have been no published studies evaluating MOL as a potential intervention for bipolar spectrum disorder. The feasibility and acceptability of offering MOL via videoconferencing has not yet been established. The proposed study therefore aims to evaluate the feasibility and acceptability of MOL, delivered via videoconferencing, as an intervention for people with a diagnosis of a bipolar spectrum disorder.
Given the importance of perceived control within therapy, the study also aims to provide an opportunity to explore the elements of therapy that people want choice over and the impact and importance of these elements. Considering the effectiveness of the intervention (in terms of reduction of distress and improvements in functioning and goal attainment) is a secondary aim of the study. An additional secondary aim is to determine whether there is a link between how much control over therapy participants perceive themselves to have and the degree to which they generate new perspectives, thoughts and insights.
The results of the study could help to inform future research into the clinical effectiveness of MOL for those with a diagnosis of a bipolar spectrum disorder, as well as the most effective methods of delivery for this therapy. It could also help inform developments in psychological therapies more broadly by considering the importance people place on perceiving themselves to have more choice and to feel in control during therapy and the impact this has on psychological change and overall wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy Intervention | Other | Other: Method of Levels TherapyMethod of Levels Therapy Intervention - Clients will choose how many sessions to attend during the 6 months therapy window. Clients will also choose how often to attend sessions and the duration of each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People aged 18 years and over
- Individuals with a diagnosis of Bipolar Spectrum Disorder.
- People accessing services or third sector agencies and/ or living in England.
- Access to personal use of technology is required for online therapy.
Key exclusion criteria (7 listed)
- People presenting with extreme risk to self or others and engaging in active suicidal thoughts and/or behaviours.
- Problems of an organic nature, such as a brain injury or learning disability that might affect cognitive functioning.
- People already receiving a talking therapy for their difficulties
- People unable to speak/ understand sufficient English.
- Anyone already receiving talking therapy at the time of enrolment
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 |
|---|---|---|
| Method of Levels TherapyAlso: Psychological Therapy, Talking Therapy, PsychotherapyMOL is a flexible, client-led psychological therapy that allows people to talk freely about important problems and life goals. | Other | Therapy Intervention |
Primary outcome
Feasibility of Study through recruitment of participants
Time frame: Through study completion, up to 6 months
Feasibility will be measured by the proportion of eligible people recruited (based on the number of eligible referrals who chose to participate). These multiple measurements of feasibility will be combined to calculate an overall percentage of completion. Based on a recent trial with this client group, the percentage of eligible people needed to be recruited, remain in the study and complete the outcome measures to signal feasibility will be set conservatively at 50 percent. The number of sessions cancelled or terminated prematurely due to technical problems will also be considered.
Feasibility of Study through retention of participants
Time frame: Through study completion, up to 6 months
Feasibility will be measured by participant retention rates (the number of people that remain in the study until the end of the study). These multiple measurements of feasibility will be combined to calculate an overall percentage of completion. Based on a recent trial with this client group, the percentage of eligible people needed to be recruited, remain in the study and complete the outcome measures to signal feasibility will be set conservatively at 50 percent. The number of sessions cancelled or terminated prematurely due to technical problems will also be considered.
Feasibility of Study through data completion
Time frame: Through study completion, up to 6 months
Feasibility will be measured by the proportion of data completion (the number of outcome measures completed by participants during the study). These multiple measurements of feasibility will be combined to calculate an overall percentage of completion. Based on a recent trial with this client group, the percentage of eligible people needed to be recruited, remain in the study and complete the outcome measures to signal feasibility will be set conservatively at 50 percent. The number of sessions cancelled or terminated prematurely due to technical problems will also be considered.
Acceptability of Intervention through written feedback
Time frame: Through study completion, up to 6 months
The key measure of acceptability will be a content analysis of written feedback comments. Feedback relating to quality of connection, audio, and video, and any impact of technological problems will also be considered. Descriptive statistics for the number of sessions attended, cancelled, not attended without prior notice, and the length of sessions will be provided. Where participants cancel or fail to attend a prearranged session, drop out of the study, or book few or no sessions, attempts will be made to ascertain the reasons. The collective data will determine whether the intervention would be considered acceptable by participants. A post-treatment retention rate of at least 75 percent would be considered to indicate acceptability in this study.
1 secondary outcome
Working Alliance Inventory - Short Version Revised (WAI-SR; Paap & Dijkstra, 2017).
Time frame: During the Intervention, up to 26 weeks
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 19 May 2022.
- Background: PubMed 22104659Searson R, Mansell W, Lowens I, Tai S. Think Effectively About Mood Swings (TEAMS): a case series of cognitive-behavioural therapy for bipolar disorders. J Behav Ther Exp Psychiatry. 2012 Jun;43(2):770-9. doi: 10.1016/j.jbtep.2011.10.001. Epub 2011 Oct 15.
- Background: PubMed 25344393Mansell W, Tai S, Clark A, Akgonul S, Dunn G, Davies L, Law H, Morriss R, Tinning N, Morrison AP. A novel cognitive behaviour therapy for bipolar disorders (Think Effectively About Mood Swings or TEAMS): study protocol for a randomized controlled trial. Trials. 2014 Oct 24;15:405. doi: 10.1186/1745-6215-15-405.
- Background: PubMed 31628789Gaffney H, Mansell W, Tai S. Conversational Agents in the Treatment of Mental Health Problems: Mixed-Method Systematic Review. JMIR Ment Health. 2019 Oct 18;6(10):e14166. doi: 10.2196/14166.
- Background: PubMed 30140445Griffiths R, Mansell W, Carey TA, Edge D, Emsley R, Tai SJ. Method of levels therapy for first-episode psychosis: rationale, design and baseline data for the feasibility randomised controlled Next Level study. BJPsych Open. 2018 Aug 14;4(5):339-345. doi: 10.1192/bjo.2018.44. eCollection 2018 Sep.
- Background: PubMed 30175881Davenport K, Hardy G, Tai S, Mansell W. Individual experiences of psychological-based interventions for bipolar disorder: A systematic review and thematic synthesis. Psychol Psychother. 2019 Dec;92(4):499-522. doi: 10.1111/papt.12197. Epub 2018 Sep 3.
- Background: PubMed 23515566Abu-Zidan FM, Abbas AK, Hefny AF. Clinical "case series": a concept analysis. Afr Health Sci. 2012 Dec;12(4):557-62.
- BackgroundCarey, T. A. (2008b). Perceptual control theory and the method of levels: Further contributions to a transdiagnostic perspective. International Journal of Cognitive Therapy, 1, 237-255.
- Background: PubMed 24616685Carey TA, Mansell W, Tai SJ. A biopsychosocial model based on negative feedback and control. Front Hum Neurosci. 2014 Feb 28;8:94. doi: 10.3389/fnhum.2014.00094. eCollection 2014.
- Background: PubMed 19371458Carey TA, Carey M, Mullan RJ, Spratt CG, Spratt MB. Assessing the statistical and personal significance of the method of levels. Behav Cogn Psychother. 2009 May;37(3):311-24. doi: 10.1017/S1352465809005232. Epub 2009 Apr 17.
- BackgroundCarey, T.A., Kelly, R.E., Mansell, W. & Tai, S. J. (2012). What's therapeutic about the therapeutic relationship? A hypothesis for practice informed by Perceptual Control Theory. The Cognitive Behaviour Therapist, 1-13.
- BackgroundChurchman, A., Mansell, W., & Tai, S. (2019). A school-based feasibility study of method of levels: a novel form of client-led counselling. Pastoral Care in Education, 37(4), 331-346
- Background: PubMed 28528592Cocklin AA, Mansell W, Emsley R, McEvoy P, Preston C, Comiskey J, Tai S. Client Perceptions of Helpfulness in Therapy: a Novel Video-Rating Methodology for Examining Process Variables at Brief Intervals During a Single Session. Behav Cogn Psychother. 2017 Nov;45(6):647-660. doi: 10.1017/S1352465817000273. Epub 2017 May 22.
- Individual participant dataSharing planned: No. The findings of this study will be written up as a Doctorate level thesis, which will be available at the University of Manchester library. Articles will also be submitted for publication in peer reviewed scientific journals. The research team will offer to feedback the results of the study to the National Health Service (NHS) clinical teams and Charities that were involved in the recruitment of participants. This will be done via a written lay summary. Participants can also request a written summary or copy of any published articles. No identifiable personal data will be published when writing up the findings of this study. Individual participants will not be identifiable through the combination of data being published.
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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.
Kadie Roberts principal investigator
Trainee Clinical Psychologist, The University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Method of Levels Therapy in people with Bipolar Spectrum Disorder, run by University of Manchester 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?
The sponsor lists 4 inclusion and 7 exclusion criteria. 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 19 May 2022. 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?
Feasibility of Study through recruitment of participants (time frame: Through study completion, up to 6 months). The study lists 4 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 NCT04859647, which also lists 15 linked publications.
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 19 May 2022.