Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Internet-assisted therapy for adults with depressive symptoms: a randomised controlled trial for the effectiveness of interpersonal therapy (IPT) compared to cognitive behaviour therapy (CBT)
Acronym
Study hypothesis
1. To determine whether an internet-delivered module of interpersonal therapy (IPT) is as effective as a cognitive behaviour therapy (CBT) module in reducing symptoms of depression and anxiety
1.1. To determine which if any psychological variables mediate the effects on these outcomes, or predict adherence to the IPT intervention
1.2. To determine which if any psychological variables moderate the effects on these outcomes, or predict adherence to the IPT intervention
2. To determine whether the internet-delivered module of IPT is rated as feasible, acceptable and satisfactory as the CBT module
3. To determine whether the IPT and CBT modules produce comparable effects to the MoodGYM intervention
Ethics approval
Human Research Ethics Committee (HREC), Australian National University (ANU) Canberra, 14/09/2008, ref: 2008/269
Study design
Single-centre interventional automated online randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Depressive and anxiety disorders
Intervention
The conditions used in the study are:
Cognitive behaviour therapy (CBT):
The Internet-assisted CBT intervention was developed by the Centre for Mental Health Research (CMHR), Australian National University (ANU). This intervention is based on the principles of CBT. It was developed by the e-hub team and consists of three major sections each of which contains 10 or so exercises or sets of messages. The programme will be offered over 4 weeks. Each week an automated email will be used to remind participants of the availability of their new module.
Interpersonal psychotherapy (IPT):
IPT is a time-limited psychotherapy developed by Klerman et al. (1984) focusing on the onset of depression associated with interpersonal stress. IPT seeks to identify and link interpersonal stressors or conflicts to mood symptoms and to improve interpersonal functioning to reduce depressive symptoms. It has shown to be effective in reducing depressive symptoms among adults. The internet-assisted form of IPT, developed by the CMHR, ANU, consists of four modules. The material will be delivered over four weeks.
Standard CBT (MoodGYM) - control condition:
Participants in this condition will receive the standard online CBT package as delivered over 4 weeks by MoodGYM.
Follow-up: 6 months after end of intervention
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Symptoms of depression and anxiety as measured by the Goldberg Anxiety and Depression Questionnaires (0 'no depression/anxiety' - 9 'depression/anxiety') four times during the course (1 per week)
2. Symptoms of depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) (0 'no depressive symptoms' - 60 'severe depressive symptoms') measured at pre-test (baseline), post-test (after intervention) and follow-up (6 months)
Secondary outcome measures
1. Mental Health Literacy (to be developed by CMHR)
2. Stigma, as measured with the Depression Stigma Scale (DSS) - Personal: 9 items, 1 (high level of stigma) to 35 (low level of stigma)
3. Satisfaction with the intervention as measured with the Client Satisfaction Questionnaire (CSQ-8): score 1 (not satisfied) to 32 (very satisfied)
4. Dysfunctional thinking as measured with the Dysfunctional Attitudes Scale-Short Form (DAS-SF) (18 items, 1: low dysfunctional thinking to 126 high level of dysfunctional thinking)
5. Drop-out, measured by the drop-out survey developed by CMHR
6. Worrying, measured with the 7-item Generalised Anxiety Disorder Scale (GAD-7) (0 'no anxiety' - 21 'high level of anxiety')
7. Eurohisqol (8 item) to measure quality of life (1: poor quality of life - 40: high quality of life)
8. Days out of role to measure disability (0 days: no disability; 30 days: severe disability)
9. Mastery to measure perceived control, 7 items (1: low internal control; 28 high internal control)
10. Adherence to the intervention measured by sessions completed
All scales will be measured at pre-test (baseline), post-test (after intervention) and follow-up (6 months), except for the drop out survey (only when people drop out) and CSQ (only post-test).
Overall trial start date
01/11/2008
Overall trial end date
01/11/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All individuals (both males and females) will be included in the trial unless they are currently under 18 years of age or are currently receiving treatment for depression by a mental health specialist. Both people with and without depressive symptoms can participate in this trial, as the intervention aims to prevent depression as well as to treat the condition.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300 (data recruitment closed since December 2011)
Participant exclusion criteria
Individuals younger than 18 years or currently under treatment for depression by a mental health specialist
Recruitment start date
01/11/2008
Recruitment end date
01/11/2009
Locations
Countries of recruitment
Australia
Trial participating centre
Centre for Mental Health Research
Canberra
ACT 0200
Australia
Sponsor information
Organisation
Centre for Mental Health Research (CMHR) - The Australian National University (ANU) (Australia)
Sponsor details
Building 63
Eggleston Road
Canberra
0200 ACT
Australia
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Centre for Mental Health Research (CMHR) - The Australian National University (ANU) (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23669884
Publication citations
-
Results
Donker T, Bennett K, Bennett A, Mackinnon A, van Straten A, Cuijpers P, Christensen H, Griffiths KM, Internet-delivered interpersonal psychotherapy versus internet-delivered cognitive behavioral therapy for adults with depressive symptoms: randomized controlled noninferiority trial., J. Med. Internet Res., 2013, 15, 5, e82, doi: 10.2196/jmir.2307.