Condition category
Mental and Behavioural Disorders
Date applied
19/06/2013
Date assigned
16/07/2013
Last edited
14/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In Ireland the prevalence of depression has been reported to be 15.1% (8.9% from urban areas and 6.2% from rural areas). Worldwide, a large percentage of affected individuals do not have a medical diagnosis and do not seek treatment. Depression can be treated and Cognitive Behavior Therapy (CBT) is a recommended treatment option. Many in Ireland with depression find it difficult to access CBT. This is due to several factors, including personal barriers such as stigma and costs. However, in Ireland the shortage of trained professionals alongside the underdevelopment of services makes it difficult to access treatments. One type of low-intensity intervention that has been developed and has shown effectiveness are tailored treatment programs for specific disorders using the internet, both with and without the guidance of a clinician. Some initial research has been conducted in Ireland and large-scale studies are now needed. The objective of the current study is to introduce and evaluate the effectiveness of an internet-delivered low-intensity treatment for depression in an Irish adult community.

Who can participate?
Subjects aged 18-65 years with symptoms of depression can participate. All participants will be recruited from community users of the charity Aware in Ireland. Aware is a charity that aims to create a society where those with depression or related mood disorders and their families are understood and supported, are free from stigma and have access to a broad range of support options.

What does the study involve?
Students will be randomly allocated to one of the two groups:
1. Active treatment group: a computerized cognitive behavior program for the treatment of depression. The programme consists of seven sessions. Users will be supported in their use of the programme.
2. Waiting list control group: the participants in this group will receive computerized cognitive behavior program eight weeks after the active treatment group.
All participants will receive the same treatment.

What are the possible benefits and risks of participating?
There may be improvements in depression symptoms and health status.

Where is the study run from?
We will aim to recruit a sample of 100 participants. All participants will be recruited from community users of the charity Aware in Ireland.

When is the study starting and how long is it expected to run for?
We hope to begin recruitment in October 2013 and thereafter the trial will run until April 2014. The first eight weeks will be with an active treatment group and a waiting list control. Thereafter the waiting list control participants will begin treatment.

Who is funding the study?
SilverCloud Health Ltd and Aware Charity, Ireland.

Who is the main contact?
Dr Derek Richards,
derek.richards@tcd.ie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Derek Richards

ORCID ID

Contact details

7-9 South Leinster Street
3rd Floor
University of Dublin
Trinity College
Dublin
2
Ireland
-
derek.richards@tcd.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression: protocol for a randomized controlled trial

Acronym

IDTD

Study hypothesis

Depression is a high prevalence disorder, displaying high rates of lifetime incidence, early age onset, high chronicity, and role impairment. In Ireland prevalence of depression has been reported to be 15.1%, with a difference in reported rates for urban (8.9%) and rural areas (6.2%). Worldwide, a large percentage of affected individuals have no medical diagnosis nor seek treatment. Depression can be treated and Cognitive Behavior Therapy (CBT) has established itself as an option for the treatment of depression. Many in Ireland with depression find it difficult to access evidence-based CBT, this is due to several factors, some of which are personal barriers such as stigma and costs. However, in Ireland systematic factors including the shortage of trained professionals alongside the relative underdevelopment of services makes it difficult to access treatments.
Similar to what has occurred in the UK with the development of a stepped-care model that includes both low- and high-intensity interventions needs to take root in Ireland. Collaborative and stepped-care has been approved as best practice by the National Institute for Clinical Excellence. One type of low-intensity interventions that has been developed and has demonstrated effectiveness are tailored treatment programs for specific disorders using the internet, both clinican-guided and stand-alone. While some preliminary research has come from Ireland what is now needed are some large scale studies on efficacy and effectiveness. Thus the objective of the current study is to implement and evaluate the potential of an internet-delivered low intensity treatment for depression in an Irish adult community sample.

Ethics approval

School of Psychology, Trinity College Dublin - approval pending

Study design

Randomized 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

Depression

Intervention

internet intervention for symptoms of depression in the community

1. An active treatment group
Mind Balance is a seven-module online CBT-based intervention for depression, delivered on a Web 2.0 platform using media-rich interactive content. The structure and content of the programme modules follow evidence-based principles of a traditional CBT programme, incorporating ideas from Mindfulness. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.
The active condition consists of 7 modules of computerised Cognitive Behavioural Therapy (cCBT), over 8 weeks, with support providing weekly feedback on progress and exercises. The intervention teaches the principles of CBT and also different cognitive and behavioral strategies that participants can learn to help manage their depression.

2. A waiting list control.
Participants in the waiting-list control group receive no treatment for the duration of the first 8 weeks. At week 8 waiting-list participants will complete the primary and secondary outcome measures (BDI-II, Sociodemographic & History, GAD-7, WHOQOL, and CEQ) and will be given access to the program for 8 weeks with support from a trained volunteer at Aware.
The study seeks to observe and evaluate the effect of the treatment on changes in depressive symptoms in participants. Data will be collected at baseline and at the end of treatment, week 8 and at follow-up, week 12 (3-months) and week 24 (6-months).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Beck Depression Inventory (BDI-II) measured at baseline and at the end of treatment, week 8 and at follow-up, week 12 (3-months) and week 24 (6-months).

Secondary outcome measures

1. General Anxiety Disorder – 7 (GAD-7)
2. Work and Social Adjustment Scale (WSAS)
3. Credibility and Expectancy for treatment (CEQ)
4. Helpful Aspects of Therapy Form (HAT)
5. Satisfaction with Treatment (SAT)
6. Reasons for dropout

All above outcomes measured at baseline and at the end of treatment, week 8 and at follow-up, week 12 (3-months) and week 24 (6-months).

Overall trial start date

01/10/2013

Overall trial end date

01/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. At least 18 years of age, either sex
2. Mild to Moderate depressive symptoms (BDI-II 14-29 range)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Suicidal intent/ideation: score >2 on BDI-II question 9
2. Currently in CBT treatment for depression
3. Psychotic illness
4. Alcohol or drug misuse
5. On medication for less than 1 month
6. Previous diagnosis of an organic mental health disorder
7. Depression preceding or coinciding a diagnosed medical condition

Recruitment start date

01/10/2013

Recruitment end date

01/04/2014

Locations

Countries of recruitment

Ireland

Trial participating centre

Trinity College Dublin
Dublin
2
Ireland

Sponsor information

Organisation

University of Dublin (Ireland)

Sponsor details

c/o Ladislav Timulak
School of Psychology
Trintiy College
Dublin
2
Ireland
+353 (0)1 896 2431
TimulakL@tcd.ie

Sponsor type

University/education

Website

http://www.tcd.ie/

Funders

Funder type

Industry

Funder name

SilverCloud Health Ltd. (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Aware Charity (Ireland)

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

2014 protocol in http://www.ncbi.nlm.nih.gov/pubmed/24886179
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26523885

Publication citations

  1. Protocol

    Richards D, Timulak L, Doherty G, Sharry J, Colla A, Joyce C, Hayes C, Internet-delivered treatment: its potential as a low-intensity community intervention for adults with symptoms of depression: protocol for a randomized controlled trial., BMC Psychiatry, 2014, 14, 147, doi: 10.1186/1471-244X-14-147.

  2. Results

    Richards D, Timulak L, O'Brien E, Hayes C, Vigano N, Sharry J, Doherty G, A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression, Behav Res Ther, 2015, 75, 20-31, doi: 10.1016/j.brat.2015.10.005.

Additional files

Editorial Notes

14/01/2016: Publication reference added.