Contact information
Type
Scientific
Primary contact
Dr Ladislav Timulak
ORCID ID
Contact details
199-200 Pearse Street
University of Dublin
Trinity College
Dublin
2
Ireland
+353 (0)879 343 678
Ladislav.timulak@tcd.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OTD
Study information
Scientific title
A randomised parallel group controlled trial of online delivered cognitive behavioural therapy treatment with an adult student population
Acronym
OTD
Study hypothesis
Online delivered cognitive behavioural therapy (CBT) treatments for depression are effective and the presence of a responsive therapeutic relationship to treatment adds value to the treatment delivered and consequently has the potential to influence a successful outcome.
Please note, as of 10/11/2011 the public title for this trial has been updated. The previous title was as follows:
Online Treatments for Depression: a randomised controlled trial on an adult student population
Ethics approval
University of Dublin, Ireland, 27 November 2007
Study design
Randomised parallel group 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
Mild to moderate depression
Intervention
The trial had two active treatment conditions, the first being cCBT (Computerised Cognitive Behaviour Therapy), self-administered by the user with no support. The second was eCBT (Email Cognitive Behaviour Therapy), delivered by a clinician. Both used the same CBT protocol. In addition the latter had the added element of the therapists free text writing as a response to the clients free text alongside the specific CBT aspects of treatment. No other condition was present such as waiting list. The duration of the treatment was 8 sessions over 8 weeks. Baseline measures were administered for screening purposes, they were the Beck Depression Inventory (BDI-II), Brief Symptom Inventory (BSI), Clinical Outcomes in Routine Evaluation - Outcome Measure - 10 items (CORE-OM-10), history collected data on previous experience of counselling and medication for depression, whether they had a previous diagnosis of a mental health disorder, alcohol and other drug use. Thereafter the principal measures were administered at Week 8, end of treatment, again at week 16 Follow-up and at week 32 Follow-up.
The online interventions included two CBT-based online treatments for depression. One consisted of therapist-led online counselling, the second was a self-administered software program called Beating the Blues, with minimal therapist contact. Beating the Blues is a cCBT (computerised cognitive behavioural therapy) program utilised to treat depression and anxiety. Each intervention includes 8 sessions of online treatment comprising cognitive-behavioural interventions, including psycho-education, written assignments, self monitoring, cognitive-restructuring, behavioural change, and relapse prevention strategies. In addition to the specific CBT aspects of the treatment, the online counselling condition included counsellors, through text, cultivating non-specific treatment factors that develop the therapeutic relationship including such generic skills as conveying of empathy, normalising, responding to the client's emotions, and validating successes. Treatment was delivered by trained and experienced professional therapist with additional training in online counselling.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Beck Depression Inventory (BDI)
Measured at baseline, week 8 (end of treatment), week 16 follow-up and week 32 follow-up
Secondary outcome measures
1. Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM-10) measured at baseline, week 8 (end of treatment), week 16 follow-up and week 32 follow-up
2. Working Alliance Inventory (WAI)-was administered at weeks 2, 4 and 6
3. Helpful Aspects of Therapy (HAT)-was administered from session 2 to session 8
4. Satisfaction with treatment measure was administered at week 8, end of treatment
Overall trial start date
01/08/2008
Overall trial end date
01/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Participant scores between 14 and 29 on the Beck Depression Inventory (BDI)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Below 14 or above 29 on BDI
2. Suicidal ideation and/or plans
3. Diagnosed organic mental health disorder
4. Recent medical illness diagnosis
5. Drug or alcohol dependence
6. On medication for depression less than 6 months
Recruitment start date
01/08/2008
Recruitment end date
01/06/2010
Locations
Countries of recruitment
Ireland
Trial participating centre
199-200 Pearse Street
Dublin
2
Ireland
Sponsor information
Organisation
University of Dublin (Ireland)
Sponsor details
c/o Dr. Derek Richards
School of Psychology
Trinity College Dublin
Dublin
2
Ireland
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
ESB Electric Aid (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
HSE Innovation Fund (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Office for Suicide Prevention (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