IMPROVE-1 Research Trial

Not Applicable

Completed

• Conditions: Moderate to severe depression; Depressive episode, unspecified; Mental and Behavioural Disorders

• Registration Number: ISRCTN14333261
• Lead Sponsor: niversity of Exeter (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-23
• Last Update Posted: 24 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Aged 18 or older as reported on mood screener
2. Access to internet and an email account that will be maintained and regularly checked for at least 12 weeks
3. Competent at reading and writing in English
4. Meeting caseness for major depression, as indexed by meeting standard cut-off scores on the Patient Health Questionnaire-9 (PHQ-9) (Kroenke, Spitzer & Williams, 2001) as follows:
4.1. A score of 2 or more (more than half the days) on one or both of the first two items measuring ?little pleasure in doing things? or ?feeling down depressed or hopeless?
4.2. A score of 2 or more on at least 5 of the PHQ9 items 1 to 9
4.3. A score of 2 or more on (very difficult) follow-up question 10 (how difficult have these problems made it for you to do your work, take care of things at home, or get along with people?)

Exclusion Criteria

1. Co-morbid diagnoses of current and significant substance abuse or dependence, current psychosis, bipolar disorder. These are assessed by well-established screening questions within the internet mood screener followed up by relevant questions as necessary from the researcher
2. Persistent self-injury requiring clinical management/therapy
3. Unable to engage with internet treatment for physical, practical or other reasons (e.g., very disabling physical or mental health problem, unable to comprehend materials, poor reading)
4. Formal concurrent face-to-face psychotherapy/counselling including computer-based CBT; IAPT treatments
5. Elevated levels of suicide risk as indicated by reporting suicidal ideation and some intentions/plans for suicide

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Rate of recruitment and patient flow <br>2. Retention and attrition through the treatment modules and number/percentage of participants retained through to follow-up assessment<br>3. Patient Health Questionnaire (PHQ-9) at baseline, 8 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Generalized anxiety disorder-7 (GAD7) questionnaire at baseline, 8 and 12 weeks