Improving accessibility of a digital body-based therapy for anxiety

Not Applicable

• Conditions: Anxiety; Mental and Behavioural Disorders

• Registration Number: ISRCTN11108223
• Lead Sponsor: niversity of Sussex

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-21
• Last Update Posted: 2 September 2024
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Aged over 18 years
2. Meets M.I.N.I (7.0.2) criteria for generalized anxiety disorder, social anxiety disorder, or panic disorder
3. Access to stable internet connection in home
4. Access to personal device (smartphone, tablet, (laptop) computer) with video chat function

Exclusion Criteria

1. Age under 18 years
2. Currently pregnant
3. Current medication for cardiac arrhythmia
4. Health anxiety related to cardiac events
5. Participation in previous trials using ADIE therapy
6. Current severe depression (PHQ9 score >=20)
7. Current risk of suicide
8. Co-occurring Post Traumatic Stress Disorder (PTSD)
9. Co-occurring Obsessive Compulsive Disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whether it is feasible to conduct a full randomized controlled trial on ADIE therapy delivered through HeartRater:Clinical within the IAPT/Talking Therapies NHS services.<br>Primary feasibility outcomes are:<br>1. Recruitment to target (N=100 in 24 months)<br>2. Uptake (Patient’s willingness to enter the study as an alternative to IAPT/TT offers; i.e., proportion of participant screened who are eligible and participants who consent)<br>3. Retention (i.e., proportion of consenting participants who are retained after four sessions, six sessions, and at end-point assessment per trial arm)<br>4. Adherence (i.e., proportion of participants per trial arm completing at least four out of six therapy sessions)

Secondary Outcome Measures

Name	Time	Method
1. Whether a therapist needs to be present for delivering ADIE therapy<br>2. Establishing the appropriate primary outcome for a full-scale clinical trial.<br>Candidate primary standardized clinical outcome measures for a full-scale RCT:<br>2.1.7-item Generalized Anxiety Disorders Assessment (GAD7)<br>2.2.Beck Anxiety Inventory (BAI)<br>2.3.Spielberger State-Trait Anxiety Inventory (STAI)<br>2.4.Secondary clinical outcome measures:<br>2.5.Anxiety sensitivity<br>2.6.Quality of life<br>2.7.Alexithymia<br>2.8.General body perception<br>2.9.Interoceptive abilities<br>3. Health economic outcome measures:<br>3.1.EuroQoL 5 dimensions, 5 levels health survey (EQ-5D-5L)<br>3.2.Client Service Receipt Inventory (CSRI)