Individualised patient support as an adjunct to computerised selfhelp for depression: factorial randomised controlled trial of brief vs. extended support given by clinicians vs. assistants

Phase 4

Completed

• Conditions: Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Depression, Not Assigned; Disease: Depression; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN98677176
• Lead Sponsor: HS Norfolk (UK)

Brief Summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22925596

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-26
• Study Completion: 2012-09-30
• Last Update Posted: 22 October 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

The main criterion for patients to be included in the study is that their primary problem is:
1. Nonsuicidal, nonpsychotic, unipolar mood disorder, such as depression or dysthymia: the key features are low mood, loss of interest/pleasure and/or increased fatigue/low energy for more than 2 weeks. Secondary features can be: feelings of guilt and self-reproach, emotional blunting, loss of confidence, psychomotor retardation or agitation, problems with memory or concentration, changes in weight & appetite, sleep problems, irritability, loss of libido
2. Mixed anxiety and depressive disorder: this condition is very common in primary care and shares key features of both depression (as above) and generalised anxiety (key features: 6 months of tension, worry, apprehension paniclike physical symptoms) but neither cluster of symptoms is clearly predominant and present to the extent that justifies separate diagnoses of a depressive episode or generalised anxiety disorder.
3. Additional inclusion criteria that need to be met so that patients can participate in the study are:
3.1. Signing a written consent form for screening & treatment
3.2. Having a general practitioner (GP) within NHS Norfolk (which does not include Great Yarmouth & Waveney) or being cared for by a service/facility commissioned by NHS Norfolk. In case of University of East Anglia (UEA) students, they would need to have a temporary GP within NHS Norfolk.
3.3. Being 18 years old or above.; Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. High current risk of suicide (current suicide plans and intent to harm oneself). In this case, referral to a community mental health or crisis team should be a priority
2. Current psychotic symptoms (due to schizophrenia or bipolar affective disorder or severe depression with psychotic features)
3. Current substance abuse/misuse (alcohol, illicit drugs, tranquilisers) which needs to be addressed as a priority
4. Cognitive impairment which makes difficult the use of a computer, doing homework, etc
5. Any other primary problem (e.g. posttraumaticstress disorder, obsessive compulsive disorder) which needs to be treated as a priority but which may have depression as a comorbid feature

Study & Design

• Study Type: Interventional
• Study Design: Not specified