A randomised controlled trial of the feasibility and effectiveness of Internet-based interventions for depression in a telephone counselling setting

ISRCTN	ISRCTN93903959
DOI	https://doi.org/10.1186/ISRCTN93903959
Secondary identifying numbers	N/A

Submission date: 10/04/2008
Registration date: 22/04/2008
Last edited: 19/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Helen Christensen
Scientific

Centre for Mental Health Research
Building 63
Eggleston Road
The Australian National University
Canberra, ACT
0200
Australia

Email	helen.christensen@anu.edu.au

Study information

Study design	Stratified, multi-centre, randomised controlled trial. 2 x 2 factorial design.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	The aim of this research is to evaluate the effectiveness of Internet-based tools (MoodGYM [http://www.moodgym.anu.edu.au] and BluePages [http://www.bluepages.anu.edu.au]) in the treatment of depression and anxiety among callers to a large, national telephone counselling centre. This project will use a randomised controlled trial to assess 1) whether self-administered online cognitive behaviour therapy and psychoeducation are effective in reducing symptoms of depression and anxiety and 2) whether regular contact from a telephone counsellor optimises the effectiveness of these programs.
Ethics approval(s)	Australian National University Human Ethics Committee. Date of approval: 14/03/2007 (ref: 2007/12)
Health condition(s) or problem(s) studied	Depression and anxiety
Intervention	The participants will be randomly allocated to the following four arms: Arm 1: MoodGYM, an evidence based depression prevention website based on cognitive behavioural therapy, and BluePages, a website providing evidenced based information on depression. Arm 2: MoodGYM and BluePages plus weekly telephone contact from a support person. Arm 3: Attention control condition, in which participants receive weekly telephone contact from a support person to discuss factors associated with depression. Arm 4: "Treatment as usual" control condition, in which participants access telephone counselling as usual. Duration of interventions: 6 weeks
Intervention type	Other
Primary outcome measure	The following will be assessed at pre-intervention, post-intervention, and 6 and 12 months post-intervention: 1. Depression, as measured by the Centre for Epidemiological Studies Depression Scale 2. Anxiety, as measured by the Depression Anxiety and Stress Scales
Secondary outcome measures	The following will be assessed at pre-intervention, post-intervention, and 6 and 12 months post-intervention: 1. Dysfunctional thoughts (Automatic Thoughts Questionnaire) 2. Personal stigma, assessed by a scale developed by the researchers of this study 3. Beliefs about the Internet, assessed by the items developed by the researchers of this study 4. Mental health literacy, assessed by the items developed by the researchers of this study 5. Help-seeking, assessed by the items developed by the researchers of this study 6. Depression literacy, assessed by the items developed by the researchers of this study 7. Cognitive behaviour therapy literacy, assessed by the items developed by the researchers of this study 8. Alcohol use, measured by the Alcohol Use Disorders Identification Test 9. Quality of life, assessed by the European Health Interview Survey 8 (EUROHIS-8) 10. Suicidal ideation, assessed using four items from the 28-item General Health Questionnaire (GHQ-28)
Overall study start date	01/07/2007
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	400
Key inclusion criteria	Callers to a national telephone counselling service who: 1. Are aged 18 years or older, both men and women 2. Consent to participate 3. Are English-speaking 4. Have access to the Internet at least once a week 5. Obtain a score of 22 or above on the Kessler Psychological Distress Scale (K-10)
Key exclusion criteria	Individuals who: 1. Report a history of schizophrenia, psychosis or bipolar disorder 2. Are currently receiving cognitive behavioural therapy 3. Have a reading impairment
Date of first enrolment	01/07/2007
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Australia

Study participating centre

Centre for Mental Health Research

Canberra, ACT
0200
Australia

Sponsor information

The Australian National University (Australia)
University/education

Centre for Mental Health Research
Building 63
Eggleston Road
Canberra, ACT
0200
Australia

Website	http://www.anu.edu.au
"ROR"	https://ror.org/019wvm592

Funders

Funder type

Government

Australian Research Council, Linkage Grant (ref: LP0667970)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Other publications	evaluation of recruitment challenges	01/12/2010	Yes	No
Other publications	effectiveness of internet-based interventions	01/12/2011	Yes	No
Results article	secondary outcomes results	27/06/2012	Yes	No