Internet-assisted therapy for adults with depressive symptoms: a study for the effectiveness of interpersonal therapy (IPT) compared to cognitive behaviour therapy (CBT)

ISRCTN	ISRCTN69603913
DOI	https://doi.org/10.1186/ISRCTN69603913
Protocol serial number	N/A
Sponsor	Centre for Mental Health Research (CMHR) - The Australian National University (ANU) (Australia)
Funder	Centre for Mental Health Research (CMHR) - The Australian National University (ANU) (Australia)

Submission date: 10/10/2008
Registration date: 27/10/2008
Last edited: 10/07/2014

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
The Australian National University
Building 63
Canberra
ACT 0200
Australia

Study information

Primary study design	Interventional
Study design	Single-centre interventional automated online randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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)
Study objectives	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(s)	Human Research Ethics Committee (HREC), Australian National University (ANU) Canberra, 14/09/2008, ref: 2008/269
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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).
Completion date	01/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key 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.
Key exclusion criteria	Individuals younger than 18 years or currently under treatment for depression by a mental health specialist
Date of first enrolment	01/11/2008
Date of final enrolment	01/11/2009

Locations

Countries of recruitment

Australia

Study participating centre

Centre for Mental Health Research

Canberra
ACT 0200
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/05/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes