Condition category
Mental and Behavioural Disorders
Date applied
01/09/2005
Date assigned
09/09/2005
Last edited
01/03/2016
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 Christopher Williams

ORCID ID

Contact details

Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
+44 (0)141 2113912
chris.williams@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/S0701/77

Study information

Scientific title

A randomised controlled study of the effectiveness of a Cognitive Behaviour Therapy (CBT) CD Rom self-help treatment for depression compared with a widely-used Patient Information leaflet when offered to patients on a waiting list for a clinical psychology service

Acronym

Study hypothesis

1. Patients using the Overcoming Depression CBT CD Rom will:
1.1. Have improved mood measured on the Beck Depression Inventory (BDI-II)
1.2. Have improved symptoms and social functioning measured on the Clinical Outcome Measure in Routine evaluation - Outcome Measure (CORE-OM)
1.3. Have lower health care costs
1.4. Have improved knowledge of the causes and treatment of depression
1.5. Need less subsequent sessions of face to face specialist psychological treatment in the Psychology service compared to the control group receiving the Patient Information leaflet
2. The CD Rom self-help will be more acceptable to patients than the short information leaflet

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Depression

Intervention

1. In the Patient Information leaflet arm, a short information leaflet (Depression – by the British Association for Behavioural and Cognitive Psychotherapies) is given to the patient by the Support Nurse and the content is gone through in a face to face support session lasting 30-40 minutes. A second final support session lasting 20-30 will then be arranged about three weeks later.
2.. In the CBT CD Rom arm, 6 sessions of approximately 45 minutes are delivered by the CD rom. In addition a formal protocol is used to describe the three face to face support sessions that are offered. After the initial session the patient notes their unique user-name and can book in to use the package for up to an hour once a week. After the 3rd and final (session 6) treatment sessions on the computer, a brief review of progress (25-30 minutes) will be offered.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Comparison between the Beck Depression Inventory - II scores for the two randomised groups using a 2 sample 2-sided t-test at 2, 4 months and 12 months.
The 4 month outcome is the primary outcome measure.

Secondary outcome measures

Further analyses that adjust the treatment effect for a pre-specified set of baseline covariates thought to be of influence on the treatment effect such as use of antidepressants, other self-help materials, and the chronicity of depression using Normal Linear models, will be considered. Secondary analyses will examine the impact of treatment on the total and the four main CORE domains (well-being, symptoms, life functioning and risk), and also patient knowledge, and the cost implications of use, and patient and practitioner perspectives of the effectiveness and acceptability of the treatment approaches. The approach by Jacobson et al, (1991) to present change in the group under study at the level of the individual will also be used. Categorical data will be compared between the two groups using chi-squared tests and logistic regression to adjust for covariates.

Overall trial start date

01/01/2005

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients are offered the CD Rom and are eligible for the study when they have symptoms of depression (including depression and anxiety), and are willing and able to use the materials (i.e. have no visual or reading or hearing problems, learning difficulties and are able to read and understand the spoken English language).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

92 in each arm = 184 in total

Participant exclusion criteria

Patients who do not wish to use the CD Rom approach, or who have current drug/alcohol abuse/dependency will be excluded from the study. Patients with suicidal intent (score of 2 or more on the BDI-II suicidal thoughts item) and impaired concentration and motivation (as measured by a score of 7 or more on the combined BDI II items for energy, concentration difficulty and tiredness - items 15, 19 and 20 on the BDI-II) will be excluded from the study. In addition, patients with scores lower than 5 or higher than 19 on the Patient Health Questionnaire (PHQ) will not be offered the CD Rom self-help approach and will be excluded from the study.

Recruitment start date

01/01/2005

Recruitment end date

30/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychological Medicine
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow (UK)

Sponsor details

Research Manager
Research and Development Directorate
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
+44 (0)141 211 3661
brian.rae@gartnavel.glacomen.scot.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Internal NHS Greater Glasgow funding from the SPIRIT project (UK) (code 001 1837)

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

01/03/2016: No publications found, verifying study status with principal investigator.