|
ISRCTN
|
ISRCTN63094649
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A comparison of two online cognitive-behavioural interventions for symptoms of depression in a student population: the role of therapist responsiveness
|
|
Scientific title
|
A randomised parallel group controlled trial of online delivered cognitive behavioural therapy treatment with an adult student population
|
|
Acronym
|
OTD
|
|
Serial number at source
|
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
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
University of Dublin, Ireland, 27 November 2007
|
|
Study design
|
Randomised parallel group controlled trial
|
|
Countries of recruitment
|
Ireland
|
|
Disease/condition/study domain
|
Mild to moderate depression
|
|
Participants - inclusion criteria
|
Participant scores between 14 and 29 on the Beck Depression Inventory (BDI)
|
|
Participants - 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
|
|
Anticipated start date
|
01/08/2008
|
|
Anticipated end date
|
01/06/2010
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
120
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Beck Depression Inventory (BDI)
Measured at baseline, week 8 (end of treatment), week 16 follow-up and week 32 follow-up
|
|
Secondary outcome measure(s)
|
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
|
|
Sources of funding
|
1. ESB Electric Aid (Ireland)
2. HSE Innovation Fund (Ireland)
3. National Office for Suicide Prevention (Ireland)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Ladislav
Timulak
|
|
Address
|
199-200 Pearse Street
University of Dublin
Trinity College
|
|
City/town
|
Dublin
|
|
Zip/Postcode
|
2
|
|
Country
|
Ireland
|
|
Tel
|
+353 (0)879 343 678
|
|
Email
|
Ladislav.timulak@tcd.ie
|
|
Sponsor
|
University of Dublin (Ireland)
|
|
Address
|
c/o Dr. Derek Richards
School of Psychology
Trinity College Dublin
|
|
City/town
|
Dublin
|
|
Zip/Postcode
|
2
|
|
Country
|
Ireland
|
|
Sponsor website:
|
http://www.tcd.ie
|
|
Date applied
|
20/08/2009
|
|
Last edited
|
10/11/2011
|
|
Date ISRCTN assigned
|
09/11/2011
|
