Improving accessibility of a digital body-based therapy for anxiety

HeartRater:Clinical. Optimizing ADIE therapy for the treatment of anxiety in underserved populations

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11108223

Enrollment

100

Registered

2024-06-21

Start date

2024-10-15

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Mental and Behavioural Disorders

Interventions

Stage 1. Recruitment Stage 2: Trial entry a. Randomization The Brighton & Sussex Clinical Trials Unit (BSCTU) will randomize each participant to either receive therapist- or self-guided ADIE therapy.

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. Primary feasibility outcomes are: 1. Recruitment to target (N=100 in 24 months) 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) 3. Retention (i.e., proportion of consenting participants who are retained after four sessions, six sessions, and at end-point assessment per trial arm) 4. Adherence (i.e., proportion of participants per trial arm completing at least four out of six therapy sessions)	—

Measure

Time frame

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. Primary feasibility outcomes are: 1. Recruitment to target (N=100 in 24 months) 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) 3. Retention (i.e., proportion of consenting participants who are retained after four sessions, six sessions, and at end-point assessment per trial arm) 4. Adherence (i.e., proportion of participants per trial arm completing at least four out of six therapy sessions)

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Secondary

Measure	Time frame
1. Whether a therapist needs to be present for delivering ADIE therapy 2. Establishing the appropriate primary outcome for a full-scale clinical trial. Candidate primary standardized clinical outcome measures for a full-scale RCT: 2.1. 7-item Generalized Anxiety Disorders Assessment (GAD7) 2.2. Beck Anxiety Inventory (BAI) 2.3. Spielberger State-Trait Anxiety Inventory (STAI) 2.4. Secondary clinical outcome measures: 2.5. Anxiety sensitivity 2.6. Quality of life 2.7. Alexithymia 2.8. General body perception 2.9. Interoceptive abilities 3. Health economic outcome measures: 3.1. EuroQoL 5 dimensions, 5 levels health survey (EQ-5D-5L) 3.2. Client Service Receipt Inventory (CSRI)	—

Measure

Time frame

1. Whether a therapist needs to be present for delivering ADIE therapy 2. Establishing the appropriate primary outcome for a full-scale clinical trial. Candidate primary standardized clinical outcome measures for a full-scale RCT: 2.1. 7-item Generalized Anxiety Disorders Assessment (GAD7) 2.2. Beck Anxiety Inventory (BAI) 2.3. Spielberger State-Trait Anxiety Inventory (STAI) 2.4. Secondary clinical outcome measures: 2.5. Anxiety sensitivity 2.6. Quality of life 2.7. Alexithymia 2.8. General body perception 2.9. Interoceptive abilities 3. Health economic outcome measures: 3.1. EuroQoL 5 dimensions, 5 levels health survey (EQ-5D-5L) 3.2. Client Service Receipt Inventory (CSRI)

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026