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Pilot Trial of a Transdiagnostic Blended Care Group for Anxiety in Adults

Pilot Trial of the Effect of a Transdiagnostic Blended Care Group for Anxiety in Adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000637448
Enrollment
5
Registered
2025-06-17
Start date
2025-12-05
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

None listed

Brief summary

This pilot trial will explore the acceptability, feasibility and outcomes of a blended care group program which combines 8 group therapy sessions with a smartphone app, called MyNewWay. The purpose is to evaluate the short-term outcomes of this new blended care intervention for adults with anxiety disorders.

Interventions

The transdiagnostic blended care group program will comprise of 8 sessions across 8 weeks, delivered via telehealth, by psychologists. The program is derived by cognitive behavioural therapy and includes psychoeducation about anxiety and management of physical symptoms of anxiety, graded exposure to overcome avoidance, behavioural experiments to test maladaptive beliefs, thought challenging to address unhelpful thoughts, communication skills to address assertiveness, distress tolerance, mindfuln

The transdiagnostic blended care group program will comprise of 8 sessions across 8 weeks, delivered via telehealth, by psychologists. The program is derived by cognitive behavioural therapy and includes psychoeducation about anxiety and management of physical symptoms of anxiety, graded exposure to overcome avoidance, behavioural experiments to test maladaptive beliefs, thought challenging to address unhelpful thoughts, communication skills to address assertiveness, distress tolerance, mindfulness and acceptance, and relapse prevention. Each week a new module will be presented during the group session and each session will take approximately 90 minutes. Participants will also have access to a smartphone application, myNewWay, and the group sessions have been designed to refer to activities and exercises in myNewWay for the participants to use the app in their own time between sessions. Participants will be encouraged to use the app between sessions to consolidate learning and practice new skills introduced during the group sessions. Participants will complete a measure of anxiety prior to the first weekly session, during week 4, and at the completion of the 8 weeks. Participants will also complete measures of social anxiety, panic, illness anxiety, depression, work and social functioning, and self-efficacy prior to the first week, during week 4, and at the completion of the 8 weeks. A group session rating scale and a measure of psychological distress will be completed each week by participants. These weekly scores will be monitored by clinicians and if a participant has an elevated score of distress, if it is clinically justified, the clinician may communicate with the participant to determine if additional support is needed. Strategies used to improve adherence to the intervention procedures include: automated email reminders, and verbal check-ins at each group session.

Sponsors

UNSW Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Key Inclusion Criteria 1. Aged 18 years or over 2. Australian resident 3. Proficient in English language 4. Have access to the internet 5. Have access to a smartphone with a supported operating system (Apple: iOS 13 released 1999 or newer; Android: 7.0 released 2016 or newer). 6. Have elevated scores on the General Anxiety Disorder 7-item Scale (total of 10 or above) 7. Meet criteria for generalised anxiety disorder, social anxiety disorder, panic disorder and/or illness anxiety disorder 8. Willing to provide demographic information (name, age, gender, address, phone number), details of an emergency contact and their GP.

Exclusion criteria

1. Under the age of 18 years 2. General Anxiety Disorder 7-item Scale score of 9 or below 3. Self-reported diagnosis of schizophrenia, bipolar disorder, or current psychotic symptoms 4. Current frequent suicidal ideation (score of 3 on Item 9 of the PHQ-9) or acutely suicidal (current suicide plan or intent) 5. Self-reported substance use issues as measured by the CAGE-AID screener (total score of 2 or above) 6. Very severe depression (PHQ-9 scores of 24 and above) 7. Commencement of a new mental health medication or change in dose of existing medication in the two months prior to application 8. Currently engaged in Cognitive behavioural therapy for anxiety

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 14, 2026