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

ISRCTN	ISRCTN23491839
DOI	https://doi.org/10.1186/ISRCTN23491839
Secondary identifying numbers	04/S0701/77

Submission date: 01/09/2005
Registration date: 09/09/2005
Last edited: 25/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Christopher Williams
Scientific

Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Phone	+44 (0)141 2113912
Email	chris.williams@clinmed.gla.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
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(s)	Not provided at time of registration
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
Primary outcome measure	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 study start date	01/01/2005
Overall study end date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	92 in each arm = 184 in total
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 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

Scotland
United Kingdom

Study participating centre

Psychological Medicine

Glasgow
G12 0XH
United Kingdom

Sponsor information

NHS Greater Glasgow (UK)
Government

Research Manager
Research and Development Directorate
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Phone	+44 (0)141 211 3661
Email	brian.rae@gartnavel.glacomen.scot.nhs.uk
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2006		Yes	No

Editorial Notes

24/05/2018: Publication reference added.
01/03/2016: No publications found, verifying study status with principal investigator.