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IMPROVE-1 Research Trial

Implementing Multifactorial Psychotherapy Research in Online Virtual Environments

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14333261
Enrollment
64
Registered
2013-09-23
Start date
2013-07-10
Completion date
Unknown
Last updated
2017-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe depression Mental and Behavioural Disorders Depressive episode, unspecified

Interventions

vignette examples of individuals with depression using the treatment (with some tailoring of examples based on participant gender)
All participants will be randomised to receive at least one module of the internet cognitive behavioral therapy (CBT) intervention. Within this fractional factorial design, there is not a no-treatment
questionnaires, rating scales, and online exercises and behavioral experiments including audio-recordings, which can be downloaded to be practiced in daily life. A number of questionnaires and exercis

Sponsors

University of Exeter (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Generalized anxiety disorder-7 (GAD7) questionnaire at baseline, 8 and 12 weeks

Countries

Australia, Canada, United Kingdom, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026