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A randomized controlled trial of the effects of different levels of graded support on symptoms of anxiety and depression in adults using the Internet-based Wellbeing Course

Randomized controlled trial of the effects of two levels of graded support on symptoms of anxiety and depression using an Internet-based education program for anxiety and depression

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610001058066
Enrollment
253
Registered
2010-12-02
Start date
2011-07-20
Completion date
2011-10-01
Last updated
2020-01-13

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 project is part of a research program funded by the NHMRC (No. 630560) to develop and evaluate Internet based transdiagnostic education and treatment programs for people with anxiety and depression. This project examines the efficacy of a 5-lesson education course for people with depression, social phobia and/or panic disorder (with or without agoraphobia) and/or generalized anxiety disorder. It also explores the relative effect of different types of reminders (none vs. automatic email reminders) on outcomes and acceptability to consumers. We expect that differences will be observed between groups in symptoms of anxiety and depression (Groups 3>2>1) and in acceptability to consumers (Groups 3>2>1) and in completion rates (Groups 3>2>1).

Interventions

Participants will be randomly assigned to one of three groups: Group 1: Waitlist Control (who will begin the program 9 weeks after the other Groups). This group will receive the same intervention as Group 3. Group 2: Self-Guided Group. This group will receive access to all the program materials including access to the 5 online lessons and homework assignments, to stories written by previous participants with symptoms of anxiety and depression, and access to additional written resources. Group 3:

Participants will be randomly assigned to one of three groups: Group 1: Waitlist Control (who will begin the program 9 weeks after the other Groups). This group will receive the same intervention as Group 3. Group 2: Self-Guided Group. This group will receive access to all the program materials including access to the 5 online lessons and homework assignments, to stories written by previous participants with symptoms of anxiety and depression, and access to additional written resources. Group 3: Self-Guided + Automatic Email Group. This group will receive access to all the materials provided to Group 2, but will also receive regular automatic emails to inform participants about new materials, upcoming lessons, and reminders to complete lessons. All participants will receive online access to 5 lessons of Internet based education about management of symptoms of depression and anxiety. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to homework assignments/summaries of each lesson, and will read anonymous stories about other people with anxiety and depression, taking a further 10 minutes per week. The duration of the program is 8 weeks. Participants in Groups 2 and 3 will be contacted 3 months and 12 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-education, post-education, 3-months post-education and 12 months post-education. These will take about 20-30 minutes to complete. The education materials are based on evidence-based cognitive behavioural techniques for managing symptoms of anxiety and depression.

Sponsors

Centre for Emotional Health, Department of Psychology, Macquarie University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

1. Elevated symptoms of depression or anxiety as indicated by: Total scores on at least one of the following measures: PHQ-9 > 9; GAD-7 > 7; Mini SPIN > 5; ANSQ > 1. Scores above these cut-offs indicate likelihood of meeting diagnostic criteria for at least one of: depression, generalized anxiety disorder, social phobia, panic disorder, respectively. 2. Self-identifying as having difficulties with either depression, social phobia, panic disorder, or generalized anxiety disorder. Note that meeting diagnostic criteria for a formal anxiety disorder or depression is NOT an inclusion criteria – instead, participants need to have elevated symptoms of anxiety or depression as indicated in (1), above. 3. No current participation in cognitive behavioural treatment. 4. No change in medications in the period 1 month prior to this study, and no change in medications during the study. 5. Access to the Internet and a printer. 6. 18 years to 64 years old. 7. Resident of Australia. 8. Prepared to provide name, phone number and address, and to provide the name and address of a local general practitioner 9. Prepared to provide written informed consent.

Exclusion criteria

1. Severe depression (score of 23 or greater on PHQ-9) 2. Suicidal intent or plan (either reporting suicidal intent or responding >2 to Question 9 [suicidal ideation] on the PHQ-9) 3. Scoring below cut-offs on the measures of anxiety and depression 4. Current substance abuse 5. Psychosis 6. Primary presenting problem not depression, generalized anxiety disorder, social phobia, or panic disorder.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 10, 2026