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The iChill Project: can generalised anxiety disorder be prevented and treated using e-health interventions?

The effectiveness of online therapy for the prevention and treatment of generalised anxiety disorder: a multicentre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76298775
Enrollment
720
Registered
2010-01-04
Start date
2010-01-31
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Generalised anxiety disorder Mental and Behavioural Disorders Other anxiety disorders

Interventions

The intervention of interest to this study is ecouch for GAD. This is a 10-week, online, multimedia application that comprises of: 1. Psycho-education containing information on: 1.1. The definition of

Sponsors

Centre for Mental Health Research (CMHR) (Australia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 - 30 years, either sex 2. Access to the internet 3. Score 5 or higher for GAD (as assessed through GAD-7 scale) 4. Consent to participate 5. Provide active email address and phone number 6. Sufficient English language literacy

Exclusion criteria

Exclusion criteria: 1. For prevention arm: meet criteria for GAD on MINI (if criteria are met, retained for treatment arm) 2. Current or previous diagnoses of psychosis, schizophrenia or bipolar disorder 3. Prevention arm: meet criteria for social phobia, panic disorder, or PTSD on MINI; treatment arm: primary diagnosis of social phobia, panic disorder, PTSD, OCD, major depression or substance dependence on ADIS-IV 4. At risk of suicide/self-harm 5. Currently on psychiatric medications 6. Currently undergoing CBT or seeing a psychologist/psychiatrist Additional criteria for treatment arm: 7. Clinical diagnosis of GAD on ADIS-IV 8. Taking monoamine oxidase inhibitors (MAOIs) (+/- 14 days before or after treatment); concomitant pimozide 9. Treatment with sertraline in the past three months for a period of two or more weeks 10. Planning to become pregnant/pregnant/breastfeeding

Design outcomes

Primary

MeasureTime frame
GAD-7, a 7 item self-report scale measuring symptoms of GAD. In addition, for the Treatment trial any reductions in GAD diagnoses will be assessed using the Anxiety Disorders Interview Schedule-IV (ADIS-IV) (a clinician administered interview) which will be administered at assessment, post-intervention and 12 months post-intervention.

Secondary

MeasureTime frame
1. Fewer cases of GAD at six months post-intervention, as measured by a second administration of the MINI 2. Reduction in worry, measured by the Penn State Worry Questionnaire 3. Anxiety sensitivity, as measured by ASI 4. Reduction in depression symptoms assessed by the CES-D and PHQ-Depression 5. Alcohol use measured by AUDIT, disability, measured by the 'Days Out of Role' questions from the US National Comorbidity Survey and number of hours worked per day 6. Improvements in health knowledge using formats previously developed for depression and adapted for anxiety (Anxiety Literacy [A-Lit]) 7. Help-seeking using scales measuring actions taken to overcome anxiety adapted from parallel depression versions of these, perceived need for treatment assessed by the following item: "Was there ever a time in the last 12 months when you felt that you might need to see a health professional because of problems with your emotions or nerves?" 8. Adherence measured by survey return rates and website usage 9. Preferences for treatment type and expectations of the trial will be assessed using previously developed formats, and levels of psychological distress using the K10 Further outcome measures to be included in the assessments may also be potential risk factors and mediators of the effectiveness of the intervention. Personal and perceived stigma toward those with GAD will be assessed by a new scale currently under development - the Generalised Anxiety Stigma Scale, while participants' ability to identify mental illness will use measures using prototypes, and perceptions of personal health will be rated using a self-perceived emotional health item, symptoms of social phobia will be assessed using the Social Phobia Inventory and a new social phobia screener that is in development, whilst symptoms of panic will be measured using PHQ Panic and a new panic disorder screener that is in development. Availability of social support will be assessed using MOS Social Support, preferences

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026