Condition category
Mental and Behavioural Disorders
Date applied
20/08/2009
Date assigned
09/11/2011
Last edited
10/11/2011
Prospective/Retrospective
Retrospectively 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

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

http://www.tcd.ie

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

Publication citations

Additional files

Editorial Notes