The Wellbeing6 Program for Anxiety and Depression - A Randomised Controlled Trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611001055998
• Date of registration: 10/10/2011
• Prospective Registration: Yes
• Primary sponsor: St Vincent's Hospital, Sydney
• Public title: The Wellbeing6 Program for Anxiety and Depression - A Randomised Controlled Trial
• Scientific title: A randomised controlled trial comparing clinician-assisted Internet based treatment for Generalised Anxiety Disorder (GAD) and/or depression vs. a waitlist control condition on severity of symptoms of GAD and depression.
• Date of first enrolment: 10/10/2011
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12611001055998.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Professor Gavin Andrews

• Name: Prof Professor Gavin Andrews

Key inclusion & exclusion criteria

Inclusion criteria: Meet Diagnostic and Statistical Manual of the American Psychiatric Association-4th Edition (DSM-IV) criteria for Generalised Anxiety Disorder and/or Major Depressive Disorder, Internet access + printer access, Australian citizen.
Exclusion criteria: Current substance abuse/dependence, Psychotic mental illness (Bipolar or Schizophrenia), Current or planned psychological treatment during study duration, Change in medications during last 1 month or intended change during study duration, use of Benzodiazepines, Suicidal.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Anxiety

Major Depressive Disorder;Generalised Anxiety Disorder;
Major Depressive Disorder
Generalised Anxiety Disorder

Mental Health - Depression

Intervention(s)

Participants will be randomly assigned to one of two groups: 1) Treatment with clinician-assisted Internet based Cognitive Behavioural Therapy for Generalised Anxiety Disorder (GAD) and/or depression, or 2) Waitlist control. All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for GAD and/or Major Depressive Disorder. All group 1 participants will separately complete 6 lessons of Internet based treatment about the management of symptoms of GAD and depression. One lesson will be completed every 7 to 14 days (it will become available after the preceding lesson has been completed, with a minimum of 7 days between lessons and a maximum of 14 days). Each lesson will take about 15 minutes to complete. Group 1 participants will have access to summaries of each lesson, homework exercises, extra resources, weekly reminder emails, and one-on-one contact with the Clinician (Clinical Psychologist) by telephone or email in the first 2 weeks, then as required. The duration of the program is 8-10 weeks, but participants will be contacted 3 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-treatment, mid-treatment, post-treatment, at 3 months post-treatment, and the K10 pre-each lesson. These will take about 20 minutes to complete. The treatment materials are based on cognitive behavioural techniques.

Primary Outcome(s)

Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9).[Administered at application, pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.]

Generalised Anxiety Disorder is measured by the Generalized Anxiety Disorder - 7 Item (GAD-7) questionnaire.[Administered at application, pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.]

Secondary Outcome(s)

Disability is measured by the WHO Disability Assessment Scale (WHODASS-II).[Administered at pre-treatment and post-treatment.]

Psychological distress is measured by the Kessler-10 (K-10).[Administered before each lesson, at pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.]

Symptoms and severity of depression is measured by the Beck Depression Inventory - II (BDI-II).[Administered at pre-treatment and post-treatment.]

Adherence to lessons and homework.[Pre- each lesson (lesson must be completed and homework downloaded before patient advances to next lesson).

The slides of a lesson must be clicked through from start to finish before the homework for that lesson can be downloaded, and the next lesson will not become available until the homework has been downloaded. Our admin system will notify us whether or not the homework has been downloaded.]

Temperament is measured by the NEO-Five Factor Inventory, Neuroticism scale (NEO-FF-I, N scale).[Administered at pre-treatment and post-treatment.]

Patient satisfaction questionnaire.[Administered at pre-treatment and post-treatment.]

Anxiety is also measured by the Penn State Worry Questionnaire (PSWQ).[Administered at pre-treatment and post-treatment.]

Rumination (or repetitive thinking) is measured by the Repetitive Thinking Questionnaire (RTF) and the Positive Beliefs about Rumination Scale-Adapted Version (PSRS-A).[Administered at pre-treatment and post-treatment.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

St Vincent's Hospital, Sydney

Ethics review

Status: Approved
Approval date:
Contact:

St Vincent's Hospital Human Research Ethics Committee (HREC)