The wellbeing project: internet interventions to improve mental health and wellbeing

ISRCTN ISRCTN65657330
DOI https://doi.org/10.1186/ISRCTN65657330
Secondary identifying numbers N/A
Submission date
08/04/2008
Registration date
09/05/2008
Last edited
11/10/2016
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

Background and study aims
Depression is the primary cause of disability in Australia. As treatment many people prefer psychological and physical activity interventions and self-help modes of delivery. Support groups and internet support groups in particular are a popular form of self-help for depression. The aim of this study is to evaluate the effectiveness of an automated internet intervention and an internet support group for depression.

Who can participate?
People aged between 18 and 65 with evidence of psychological distress, determined through a screening questionnaire

What does the study involve?
The study involves two separate stages. First there is a survey of people aged between 18 and 65 to find out more about the emotional health of people living in the city as well as in rural areas. Then 500 people are chosen from among those who returned the survey and are willing to participate in the study. Participants are randomly allocated to one of four groups. The first group is given access to an automated internet intervention for depression consisting of depression information and an active self-help module. The second group is given access to an internet support group. The third group is given access to both of these interventions. The fourth group is given access to an internet intervention consisting of open-ended questions that probe health factors that might be related to depression (e.g. work habits and stress, nutrition). The study lasts 12 weeks and takes about half an hour of participants’ time each week. At the end of the 12 weeks participants are asked to complete a follow-up survey about the issues covered by the study. Participants are then contacted 6 months after the study and then again after 12 months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Australian National University (Australia)

When is the study starting and how long is it expected to run for?
May 2008 to March 2010

Who is funding the study?
National Health and Medical Research Council (Australia)

Who is the main contact?
Dr Kathy Griffiths
Kathy.Griffiths@anu.edu.au

Contact information

Dr Kathy Griffiths
Scientific

Centre for Mental Health Research
Australian National University
Canberra
0200
Australia

Phone +61 (0)2 6125 9723
Email Kathy.Griffiths@anu.edu.au

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleDo internet support groups and internet interventions improve mental health and wellbeing?
Study objectivesDepression is the primary cause of disability in Australia. It has been argued that a substantial percentage of the disease burden associated with depression could be averted with the delivery of evidence-based treatments. However, to succeed, such a program would need to develop feasible methods for delivery and to consider consumer treatment preferences. Many consumers prefer psychological and physical activity interventions and self-help modes of delivery. Peer-to-peer mutual support groups, and internet support groups (ISGs) in particular are a popular form of self help for depression. ISGs are highly accessible and consumers report they are helpful in reducing their depressive symptoms. However, the efficacy of ISGs has not been established. The current study seeks to evaluate the efficacy of an internet intervention for depression and an ISG both as independent interventions and in combination.

The study will evaluate the effect and relative effects of the D-couch (an automated internet intervention on depression) and Talking Point (an internet support group) interventions on depressive symptoms, social support, self-esteem, quality of life, depression literacy, stigma and help-seeking in people with depression.

The primary hypothesis is that:
D-couch and Talking Point will each be associated with a greater reduction in depression symptoms from baseline to post-intervention than the control.

Secondary hypotheses are that:
1. The magnitude of improvement in depression will be greater for:
1.1. The internet conditions combined (D-couch and Talking Point) than for either condition alone; and
1.2. D-couch compared to Talking Point
2. Talking Point participants will show a greater increase in perceived social support and self-esteem than non-Talking Point participants at post-test
3. D-couch and Talking Point will each be associated with improved quality of life, and decreased anxiety, disability and stigma. Both interventions will also be associated with improved depression literacy, but the effect will be greater for D-couch.
4. Both D-couch and Talking Point will be associated with an increase in empowerment but the effect of empowerment will be greater for Talking Point
5. Adherence will be greater among D-couch participants with access to Talking Point than for D-couch participants without access to the Internet support group
Ethics approval(s)Australian National University Human Research Ethics Committee, 15/12/2007, ref: 2007/2259
Health condition(s) or problem(s) studiedDepression
InterventionThis study involves two active interventions and an attention-matched placebo (control) described below:

1. Intervention group one:
D-couch: a multi-media internet application on depression comprising of a depression literacy module and an active self-help module. The depression literacy module contains information about the symptoms and types of depression and their diagnosis, sources of help, statistical information about the prevalence and disability burden associated with depression, depression risk factors, and evidence-based medical, psychological and lifestyle treatments for depression based on updated systematic reviews and clinical practice guidelines. The self help module comprises online versions of treatments amendable to delivery online and known to be effective in face-to-face therapy or as bibliotherapy. These include:
1.1. Cognitive behaviour therapy
1.2. Interpersonal therapy
1.3. Applied relaxation
1.4. Problem solving, and
1.5. Physical activity

2. Intervention group two:
Talking Point: an internet support group which uses a bulletin board format for discussions.

3. Control group:
HealthWatch: the control condition. An internet application comprising open ended questions that probe health factors that might be related to depression (e.g. work habits and stress, nutrition).

Participants receive one of the above conditions or a combination of D-couch and Talking Point. Each program is delivered over 12 weeks.
Intervention typeOther
Primary outcome measureDepressive symptoms: Centre for Epidemiology Studies - Depression (CES-D) 20-item self-report measure of depression severity. Measured at baseline, post-intervention (3 months), 6-month follow-up and 12-month follow-up.
Secondary outcome measures1. Anxiety symptoms: Penn State Worry Questionnaire (PSWQ)
2. Quality of life: EUROHIS-QOL - 8-item index
3. Disability: 'Days Out of Role' questions adapted from US National Comorbidity Survey
4. Depression knowledge:
4.1. D-Lit 21-item measure of depression literacy
4.2. An additional measure of depression treatment knowledge
5. Perceived social support:
5.1. Medical Outcomes Study Social Support Survey (MOS)
5.2. UCLA Loneliness Scale
6. Stigma: Depression Stigma Scale
7. Help seeking: purpose developed items
8. Self esteem: Rosenberg Self-esteem Scale
9. Empowerment:
9.1. Empowerment scale: Power-powerlessness subscale
9.2. Participation in healthcare measure
10. Satisfaction and user-perceived benefits

Outcomes will be measured at baseline, post-intervention (3 months), 6-month follow-up and 12-month follow-up.
Overall study start date12/05/2008
Completion date30/03/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants500
Key inclusion criteria1. Aged 18 - 65 years, either sex
2. Evidence of psychological distress determined through screening questionnaire
3. Access to the internet at home
4. Willingness to participate in the trial
Key exclusion criteria1. Current/prior participation in a project conducted by the Centre for Mental Health Research
2. Report that they are currently receiving treatment from a mental health professional or support group
Date of first enrolment12/05/2008
Date of final enrolment30/03/2010

Locations

Countries of recruitment

  • Australia

Study participating centre

Australian National University
Canberra
0200
Australia

Sponsor information

Australian National University
Hospital/treatment centre

Centre for Mental Health Research
Building 63
Canberra
0200
Australia

Phone +61 (0)2 6125 2741
Email cmhr@anu.edu.au
Website http://www.anu.edu.au
ROR logo "ROR" https://ror.org/019wvm592

Funders

Funder type

Research council

National Health and Medical Research Council
Government organisation / National government
Alternative name(s)
NHMRC
Location
Australia

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?
Protocol article protocol 08/03/2010 Yes No
Results article results 01/03/2012 Yes No
Results article results 08/01/2016 Yes No

Editorial Notes

11/10/2016: Plain English summary added.
11/01/2015: Publication reference added.