The second Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT-2) Trial

Not Applicable

Completed

Conditions: Recurrent depressive disorder
Depressive disorder
Mental and Behavioural Disorders

Registration Number: ISRCTN55310481

Lead Sponsor: niversity of York (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 350

Inclusion Criteria

1. Adult patients, aged 18 years and above
2. Depression defined as a score of greater than or equal to 10 on the PHQ9 depression severity instrument
3. Not currently in receipt of computerised CBT or specialist psychological therapy
4. Patients may be with or without either co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety
5. Both incident and prevalent cases
6. In line with the pragmatic nature of this trial, we will reflect usual GP care and participants will be eligible to participate whether they are in receipt of antidepressant medication or not
7. Patients with previous treatment experience of CBT will not be excluded

Exclusion Criteria

1. Actively suicidal
2. Suffering psychotic symptoms
3. Depressed in the post-natal period
4. Have recently suffered bereavement
5. Cases of psychotic depression; since computerised therapy is not recommended within NICE guidance.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression severity and symptomatology (PHQ-9 >=10), measured by a validated self-report measure (the Patient Health Questionnaire [PHQ-9]) depression score at four months.

Secondary Outcome Measures

Name	Time	Method
Outcome measures as of 01/04/2016:<br>1. Self-reported depression severity, measured by the 9-item Patient Health Questionnaire (PHQ-9) at four and 12 months as a continuous measure<br>2. Anxiety, measured using the Generalised Anxiety Disorder Assessment (GAD-7) at 4 and 12 months<br>3. Somatoform complaints, measured using the Patient Health Questionnaire 15 (PHQ-15) at 4 and 12 months<br>4. Health state utility, measured using EuroQol (EQ5D) at 4 and 12 months<br><br>Original secondary outcome measures:<br>1. PHQ-9 measured at 12 months <br>And the following outcome measures at both 4 and 12 months: <br>2. Anxiety, measured using the Generalised Anxiety Disorder Assessment (GAD-7)<br>3. Somatoform complaints, measured using the Patient Health Questionnaire 15 (PHQ-15)<br>4. Health-related quality of life, measured using the Short-Form 12 (SF-12)<br>5. Health state utility, measured using EuroQol (EQ5D) at 4, 12 and 24 months