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

Not Applicable

Completed

• Conditions: Major depressive disorder (a depressive disorder); Generalised anxiety disorder (an anxiety disorder); Panic disorder (with or without agoraphobia) (both anxiety disorders); Social phobia (an anxiety disorder); Mental Health - Depression; Mental Health - Anxiety

• Registration Number: ACTRN12610001058066
• Lead Sponsor: Centre for Emotional Health, Department of Psychology, Macquarie University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of depression and anxiety are measured by the Depression and Anxiety Stress Scales 21 item (DASS-21)[Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education];Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)[Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education];Symptoms and severity of anxiety are by the Generalized Anxiety Disorder-7 Item (GAD-7)[Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education]