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 designStratified, multi-centre, randomised controlled trial. 2 x 2 factorial design.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe 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) studiedDepression and anxiety
InterventionThe 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 typeOther
Primary outcome measureThe 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 measuresThe 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 date01/07/2007
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants400
Key inclusion criteriaCallers 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 criteriaIndividuals 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 enrolment01/07/2007
Date of final enrolment31/12/2008

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added 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