Client-led Online Therapy for People Diagnosed With Bipolar Disorder

NCT04859647 | Completed

• 1 other identifier: 288776
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bipolar Spectrum Disorder

Keywords

Novel intervention; Psychological therapy; Online therapy; Client-led; Method of levels; Case Series

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Through study completion, up to 6 months

Secondary Outcomes (1)

• Working Alliance Inventory - Short Version Revised (WAI-SR; Paap & Dijkstra, 2017).

  During the Intervention, up to 26 weeks

Other Outcomes (2)

• The Active Involvement Scale (AIS) - A measure of client experience and key perceptions of therapy

  During the intervention, up to 6 months

• Perceived choice and control in therapy

  During the intervention, up to 3 months

Study Arms (1)

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.

Other: Method of Levels Therapy

Interventions

Method of Levels Therapy OTHER

MOL is a flexible, client-led psychological therapy that allows people to talk freely about important problems and life goals.

Also known as: Psychological Therapy, Talking Therapy, Psychotherapy

Therapy Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

The University of Manchester

Manchester, United Kingdom

Location

Related Publications (15)

• 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.

  PMID: 22104659 BACKGROUND

• Mansell 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.

  PMID: 25344393 BACKGROUND

• Gaffney 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.

  PMID: 31628789 BACKGROUND

• Griffiths 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.

  PMID: 30140445 BACKGROUND

• Davenport 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.

  PMID: 30175881 BACKGROUND

• Abu-Zidan FM, Abbas AK, Hefny AF. Clinical "case series": a concept analysis. Afr Health Sci. 2012 Dec;12(4):557-62.

  PMID: 23515566 BACKGROUND

• Carey, 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

• 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.

  PMID: 24616685 BACKGROUND

• Carey, T.A. (2008). Hold That Thought! Two Steps to Effective Counselling and Psycho- therapy with the Method of Levels. Behavioural and Cognitive Psychotherapy, 37, 311-324

  BACKGROUND

• Carey, 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28528592 BACKGROUND

• First, 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.

  BACKGROUND

• 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.

  PMID: 32206331 BACKGROUND

• Griffiths 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.

  PMID: 30701661 BACKGROUND

MeSH Terms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Kadie Roberts

  Trainee Clinical Psychologist, The University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 26, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)