Is Betwixt App Effective and Acceptable?

NCT06958887 | Completed

• 1 other identifier: 23064
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression - Major Depressive Disorder; ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)

Keywords

Mental health; Smartphone application; Effectiveness; Acceptability; Emotion regulation

Outcome Measures

Primary Outcomes (3)

• Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)

  Measure of emotion regulation. 18 items, 5-point Likert scale. Higher scores indicate more difficulty in emotion regulation. Total score ranges from 18 to 90.

  Every second day from enrolment to the end of study (6 or 7 weeks per participant).

• Patient Health Questionnaire-2 (PHQ-2)

  Measure of low mood/psychological distress. Two items, 4-point Likert scale. Higher scores indicate more severe depression symptoms. Total score ranges from zero to six, where three or above indicates depression.

  Every second day from enrolment to the end of study (6 or 7 weeks per participant).

• Generalised Anxiety Disorder-2 (GAD-2)

  Measure of generalised anxiety/psychological distress. Two items, 4-point Likert scale. Higher scores indicate more severe generalised anxiety symptoms. Total score ranges from zero to six, where three or above indicates anxiety.

  Every second day from enrolment to the end of study (6 or 7 weeks per participant).

Secondary Outcomes (6)

• Cognitive Emotion Regulation Questionnaire - Short (CERQ-short)

  Every second day from enrolment to the end of study (6 or 7 weeks per participant).

• Self-Compassion Scale - Short Form (SCS-SF)

  Every second day from enrolment to the end of study (6 or 7 weeks per participant).

• Patient Health Questionnaire-9 (PHQ-9)

  Every second day from enrolment to the end of study (6 or 7 weeks per participant).

• Generalised Anxiety Disorder-7 (GAD-7)

  Every second day from enrolment to the end of study (6 or 7 weeks per participant).

• Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS)

  Every second day from enrolment to the end of study (6 or 7 weeks per participant).

Study Arms (1)

Betwixt app intervention

EXPERIMENTAL

Betwixt app intervention

Other: Betwixt app intervention

Interventions

Betwixt app intervention OTHER

Narrative gaming smartphone app

Betwixt app intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nottingham: lead
• Lincolnshire Partnership NHS Foundation Trust: collaborator

Study Sites (1)

Lincolnshire Partnership Foundation Trust

Lincoln, UK, LN1 1FS, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders; Phobic Disorders; Psychological Well-Being; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior; Self-Control; Social Behavior

Study Officials

• Jacob Andrews

  University of Nottingham

  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: SPONSOR

Model Details: Mixed-methods Single-Case Experimental Design (SCED) series

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 6, 2025
• Study Start: April 8, 2024
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)