Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Client-led Online Therapy for People Diagnosed With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04859647
Recruitment Status : Completed
First Posted : April 26, 2021
Last Update Posted : May 19, 2022
Sponsor:
Information provided by (Responsible Party):
Kadie-Charelle Roberts, University of Manchester

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.


Condition or disease Intervention/treatment Phase
Bipolar Spectrum Disorder Other: Method of Levels Therapy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Client-led Online Therapy for People Diagnosed With Bipolar Disorder
Actual Study Start Date : June 1, 2021
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Therapy Intervention
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
MOL is a flexible, client-led psychological therapy that allows people to talk freely about important problems and life goals.
Other Names:
  • Psychological Therapy
  • Talking Therapy
  • Psychotherapy




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Working Alliance Inventory - Short Version Revised (WAI-SR; Paap & Dijkstra, 2017). [ Time Frame: During the Intervention, up to 26 weeks ]
    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.


Other Outcome Measures:
  1. The Active Involvement Scale (AIS) - A measure of client experience and key perceptions of therapy [ Time Frame: During the intervention, up to 6 months ]
    The Active Involvement Scale (AIS) - a 5 item feedback questionnaire devised specifically to capture and focus on the participant's experience of the therapy session; their ability to talk openly about their problem and their perception of what they believe to be the key elements of the therapy, and how these are experienced. Each item scale ranges from 0-10, with 10 being the highest score, and therefore indicates a high level of perceived control and choice. It is anticipated that 50 percent of scores above 5 on the AIS would indicate perceived control during therapy and reflect changes in perceived distress during the course of treatment. Total scores range from 0-40.

  2. Perceived choice and control in therapy [ Time Frame: During the intervention, up to 3 months ]
    Qualitative interviews will be the most significant indicator of perceived choice and control during therapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04859647


Locations
Layout table for location information
United Kingdom
The University of Manchester
Manchester, United Kingdom
Sponsors and Collaborators
University of Manchester
Investigators
Layout table for investigator information
Principal Investigator: Kadie Roberts Trainee Clinical Psychologist, The University of Manchester
Publications:
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.
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.
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
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.

Layout table for additonal information
Responsible Party: Kadie-Charelle Roberts, Trainee Clinical Psychologist, University of Manchester
ClinicalTrials.gov Identifier: NCT04859647    
Other Study ID Numbers: 288776
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kadie-Charelle Roberts, University of Manchester:
Novel intervention
Psychological therapy
Online therapy
Client-led
Method of levels
Case Series
Additional relevant MeSH terms:
Layout table for MeSH terms
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders