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

Not Applicable

Completed

• Conditions: Depression; Mental and Behavioural Disorders; Depressive episode

• Registration Number: ISRCTN23491839
• Lead Sponsor: HS Greater Glasgow (UK)

Brief Summary

2006 results in https://www.cambridge.org/core/journals/behavioural-and-cognitive-psychotherapy/article/the-impact-of-a-novel-computerized-cbt-cd-rom-overcoming-depression-offered-to-patients-referred-to-clinical-psychology/D33B7D209991ABF0D237178B6C08F8FB

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-09
• Study Completion: 2007-06-30
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 184

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).

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>The 4 month outcome is the primary outcome measure.

Secondary Outcome Measures

Name	Time	Method
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.