NCT06958887Completed
Is Betwixt App Effective and Acceptable?
Is the Betwixt Application Effective and Acceptable in Improving Emotion Regulation for an Adult Clinical Population?
Source: ClinicalTrials.gov · Last updated 6 May 2025
Brief summary (registry, in English)
Title Is the Betwixt application effective and acceptable in improving emotion regulation for an adult clinical population? Short title Betwixt: Effective/acceptable clinical population emotion regulation? Chief Investigator Jacob Andrews Aims A: Evaluate the effectiveness of the Betwixt intervention on emotion regulation, self-compassion, and cognitive reappraisal in a clinical population. B: Investigate whether changes in processes targeted by Betwixt result in improvements in clinical outcomes. C: Explore the acceptability, and putative processes of Betwixt within a clinical context. Trial configuration Single Case Experimental Design (SCED) series and acceptability and change interviews Setting Lincolnshire Partnership Foundation Trust Sample size estimate Minimum of three cases recommended Number of participants Eight (with replacement participants if they do not contribute sufficient data to the intervention phase) Eligibility criteria Inclusion criteria for IAPT services: Adult, on the waiting list for the service, experiencing an anxiety disorder or depression, own a mobile phone, and comfortable using a phone for an extended period. Able to give informed consent. Exclusion criteria: Insufficient English reading ability and not available for the length of the intervention. Description of interventions The intervention is an interactive game called Betwixt, which is delivered to participants via an app. Betwixt is a theory-driven app with foundations in emotion regulation, cognitive behavioural therapy, and mindfulness. Each participant will have access to the app for four weeks and will be asked to use it every two days. Duration of study Overall: 24 months Per participant: Seven weeks Outcome measures CER-Q, DERS-SF, GAD-2, GAD-7, PHQ-2, PHQ-9, SCS, SWEMWBS and WSAS Analytical methods Structured visual analysis; Kendall's Tau-U; Reliable Change and Clinically Significant Change analysis; Simulation Modelling Analysis; and Framework Analysis.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 14 Apr 2025
- Start date
- 8 Apr 2024
- Primary completion date
- 11 Oct 2024
- Lead sponsor
- University of Nottingham
- Diseases
- Depression
- NCT number
- NCT06958887
What you commit to
- Study type: Interventional
- Participants enrolled: 7
- From 8 Apr 2024 to the primary completion date, 11 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Sufficient English reading ability, due to the narrative nature of Betwixt. This will be ascertained by ensuring that the participant can read and understand the PIS, and information outlining the narrative nature of Betwixt will also be included.
- Available for up to seven weeks whilst on the IAPT waiting list. There is flexibility, for example, if a participant has a planned holiday whilst on the IAPT waiting list, the study can be delayed for two weeks (if the waiting time allows).
Who the study is looking for
- Adults (aged 18 years and above).
- Currently on the waiting list for a specific IAPT service.
- Experiencing an anxiety disorder and/or depression (scoring 10 or above on the Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 2001) measure for depression or scoring eight or above on the Generalised Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) measure for anxiety) (The National Collaborating Centre for Mental Health, 2021), when assessed by the IAPT service.
- Own a mobile phone they can use Betwixt on.
- Comfortable with using a phone for extended periods of time.
- Able to give informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lincolnshire Partnership Foundation Trust Coordinator of this site? Confirm its status | Lincoln | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.