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Healthlines Randomised Controlled Trial - Depression

Effectiveness and cost-effectiveness of an NHS Direct-delivered telehealth intervention to support the management of long term conditions: a pragmatic randomised controlled trial for patients with depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14172341
Enrollment
640
Registered
2012-06-26
Start date
2012-07-06
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Topic: Primary Care Research Network for England

Interventions

Current interventions as of 26/04/2013: Usual Care: Care provided by GP or nurse at usual general practice as required. Usual Care plus NHS Direct Healthlines: Usual Care, plus extra support provided

Sponsors

University of Bristol (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Target Gender: Male & Female; Upper Age Limit 100 years; Lower Age Limit 18 years (on date of invitation to participate) 2. Confirmed diagnosis of depression using the Clinical Interview Schedule 3. Revised (CIS-R) and PHQ-9 = 10 4. Access to a telephone (landline or mobile), the Internet and an e-mail address for personal use

Exclusion criteria

Exclusion criteria: 1. Currently receiving case management from a specialist mental health worker 2. Currently receiving face-to-face, telephone or computerised CBT or similar psychotherapy 3. Have given birth in the previous 12 months 4. Bipolar disorder 5. Psychotic illness 6. Dementia or substantial cognitive impairment 7. Severe learning disability 8. Substance dependency 9. Receiving palliative care 10. Significant suicidal risk 11. GP determines that participation would cause distress (e.g. due to recent bereavement) 12. Inability to communicate verbally in English sufficiently to receive telephone-based support delivered in English. Patients who can communicate verbally in English but are unable to read English will be eligible provided they have a family member or friend who is willing and able to translate written materials (such as information sheets, consent forms and online material) for them.

Design outcomes

Primary

MeasureTime frame
Current primary outcome measures as of 26/04/2013: 1. Patient Health Questionnaire (PHQ)-9 Depression Score <10 AND an absolute reduction in PHQ-9 of at least 5 points after 4 months 2. (Sub-study only) The number of patients consenting to participate in the Healthlines Trials. Previous primary outcome measures until 26/04/2013: Patient Health Questionnaire (PHQ)-9 Depression Score <10 AND an absolute reduction in PHQ-9 of at least 5 points after 4 months

Secondary

MeasureTime frame
Current secondary outcome measures as of 26/04/2013: 1. PHQ-9 score as continuous variable 2. Quality of life (EQ-5D-5L) 3. Patient satisfaction 4. Patient perceived access to care 5. Exercise behaviour 6. Use of telehealth interventions 7. Self management skills 8. Self efficacy 9. Medication adherence 10. Health literacy; anxiety 11. Care coordination 12. (Sub-study only) Retention in the Healthlines studies. We will keep a record of all patients who were identified as potential participants and which intervention group they were in. Previous secondary outcome measures until 26/04/2013: 1. PHQ-9 score as continuous variable 2. Quality of life (EQ-5D-5L) 3. Patient satisfaction 4. Patient perceived access to care 5. Exercise behaviour 6. Use of telehealth interventions 7. Self management skills 8. Self efficacy 9. Medication adherence 10. Health literacy; anxiety 11. Care coordination

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026