Condition category
Mental and Behavioural Disorders
Date applied
10/10/2008
Date assigned
27/10/2008
Last edited
10/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Helen Christensen

ORCID ID

Contact details

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

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 measures

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

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

http://cmhr.anu.edu.au

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23669884

Publication citations

  1. 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.

Additional files

Editorial Notes