Condition category
Mental and Behavioural Disorders
Date applied
26/03/2018
Date assigned
10/04/2018
Last edited
05/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
This study aims to develop a new approach to help people with depression. Depression is a common mental health problem affecting one in four people at some point in their life. It can result in high levels of distress, increased suicide risk and a loss of interest in daily activities. Most people with depression find treatment helpful. However, for some people (about one in five), depression continues for more than two years, despite receiving mental health treatment. This is called chronic depression. Approaches for chronic depression are limited, and people often continue to have a poor quality of life. An intervention called DIALOG+ has been developed which helps patients with another serious mental illness called schizophrenia. DIALOG+ involved mental health staff using a tablet computer to ask patients about their satisfaction with different areas of life and then working together to find solutions to concerns raised. After using DIALOG+, patients were more satisfied with life and had fewer symptoms. Patients and staff found the approach helpful and it saved the NHS money. The aim of this research is to find out whether DIALOG+ can also help people with chronic depression. The researchers will see if DIALOG+ is acceptable by asking people with depression their opinions on the approach so they can adapt it to their needs. They will also be asking clinicians about their experience and views for adapting the intervention. Following this, they will conduct a study with nine staff members and 45 patients with depression to gain further experience with DIALOG+ and check whether a larger study testing it would be possible.

Who can participate?
Patients aged 18-80 who have had depression for at least 2 years

What does the study involve?
Clinicians are randomly allocated to the intervention group or the control group. Patients allocated to the intervention group use the ‘DIALOG+’ intervention on a tablet computer, together with their clinician, using the DIALOG+ scale to rate how satisfied they are with different areas of their life, and then choosing which areas need to be discussed in the meeting. The clinician applies a 4-step approach to these selected areas based on the principles of solution-focused therapy. Participants allocated to the control group have their routine meetings with their care coordinator as usual. At the end of the session they complete the DIALOG scale on a tablet computer to rate how satisfied they are with different areas of their life. They do this without any input from their clinician. Both interventions include 6 sessions delivered over a period of 6 months. Quality of life is assessed at baseline and 6 months (follow up).

What are the possible benefits and risks of participating?
It is not known whether participants will experience any direct benefits from taking part in this study, but it is hoped that they will enjoy and value their role in helping to test a new treatment and providing their thoughts on how it can be developed further to be a more effective treatment for long-term depression. Participants who complete the assessments will be reimbursed for their time and will be paid a fee of £20. It is believed that this study is safe and participants are not expected to suffer any harm or injury because of taking part. It is possible that some people may become distressed whilst taking part due to discussing sensitive issues. In the event of this happening the intervention session will be stopped and the individual will be asked if they want to continue. If they do wish to continue then they will be given time to recover. However, they may leave the session at any time and there will be a member of the participant’s healthcare team available to talk to them should they need to.

Where is the study run from?
The study is run from the Newham Centre for Mental Health, but is actively recruiting from three sites:
1. Enhanced Primary Care, East London NHS Foundation Trust
2. Haringey North East Locality Team, Barnet, Enfield and Haringey NHS Mental Health Trust
3. Chelmsford & Essex Centre (C&E) Centre, Essex Partnership University NHS Foundation Trust

When is the study starting and how long is it expected to run for?
April 2017 to June 2019

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Victoria Bird
v.j.bird@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Victoria Bird

ORCID ID

http://orcid.org/0000-0002-2053-7679

Contact details

Unit for Social and Community Psychiatry
Newham Centre for Mental Health
Cherry Tree Way
London
E13 8SP
United Kingdom
-
v.j.bird@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33823

Study information

Scientific title

Adapting and testing a technology supported and solution-focused intervention (DIALOG+) for people with chronic depression

Acronym

TACK

Study hypothesis

This research aims to develop a new approach to help people with depression. Depression is a common mental health problem affecting one in four people at some point in their life. It can result in high levels of distress, increased suicide risk and a loss of interest in daily activities. Most people with depression find treatment helpful. However for some people (about one in five), depression continues for more than two years, despite receiving mental health treatment. This is called chronic depression. Approaches for chronic depression are limited, and people often continue to have a poor quality of life.

In previous research we developed an intervention called DIALOG+ which helped patients with another serious mental illness called schizophrenia. DIALOG+ involved mental health staff using a tablet computer to ask patients about their satisfaction with different areas of life and then working together to find solutions to concerns raised. After using DIALOG+, patients were more satisfied with life and had fewer symptoms. Patients and staff found the approach helpful and it saved the NHS money.

The first phase of the TACK programme seeks to investigate whether DIALOG+ can also help people with chronic depression. We will see if DIALOG+ is acceptable by asking people with depression their opinions on the approach so we can adapt it to their needs. We will also be asking clinicians about their experience and views for adapting the intervention. Following this, we will conduct a study with nine staff members and 45 patients with depression to gain further experience with DIALOG+ and check whether a larger study testing it would be possible.

Ethics approval

Wales NHS Research Ethics Committee 5, 19/03/2017, ref: 17/WA/0085

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Complex Intervention

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Mental health, Primary sub-specialty: Depression; UKCRC code/ Disease: Mental Health/ Mood [affective] disorders

Intervention

Randomisation will be performed by an independent statistician from the Pragmatic Clinical Trials Unit (PCTU) who is not part of the trial team. The feasibility trial will be cluster randomised, with the clinician as unit of randomisation. As soon as five eligible patients (or all eligible and willing patients on the clinician’s caseload where this is less than five) have been recruited, informed consent obtained and the baseline assessment completed, the clinician will be randomised to either the intervention or control arm. Clinicians will be randomised on a 2:1 basis with 6 allocated to the intervention arm and three included in the control arm.

Participants allocated to the intervention are will use the ‘DIALOG+’ intervention on a tablet computer, together with their clinician. The will include using the DIALOG+ scale to rate how satisfied they are with different areas of their life, and then choosing which areas need to be discussed in the meeting. The clinician will apply a 4-step therapeutic approach to these selected areas based on the principles of solution-focused therapy.

Participants allocated to the control arm will have their routine meetings with their care coordinator as usual. At the end of the session they will complete the ‘DIALOG scale’ on a tablet computer to rate how satisfied they are with different areas of their life. They will do this without any input from their clinician.

Both interventions will include 6 sessions delivered over a period of 6 months. Outcome measures to be taken at baseline and 6 months (follow up).

Intervention type

Other

Phase

Phase I

Drug names

Primary outcome measure

Quality of life, measured using the Manchester Short Assessment of Quality of Life (MANSA) at baseline and 6 months

Secondary outcome measures

Measured at baseline and 6 months:
1. Depression symptoms, measured by two scales, the Montgomery–Samberg Depression Rating Scale (MADRS; observer rated) and Beck Depression Inventory (BDI-II; self-report)
2. General mental health symptoms, observer rated by the Health of the Nation Outcome Scale (Honos)
3. Physical health satisfaction, measured by the SF-36
4. Economic evaluation through completion of the ICECAP-A (a measure of capability for the general adult population)
5. Satisfaction with care, measured using the Client Satisfaction Questionnaire (CSQ-8)
6. Health-related quality of life, measured using the Europol 5 dimension (EQ-5D-35L)
7. Social functioning, observer rated on the Global Assessment of Functioning (GAF)
8. Data on health service usage in the past 6 months by the participant, collected via an amended version of the Client Service Receipt Inventory (CSRI)
9. The experience of receiving the DIALOG+ intervention, assessed using a bespoke questionnaire developed in partnership with the TACK Lived Experience Advisory Panel (only participants allocated to the intervention arm will complete this) at 6 month follow up

Overall trial start date

06/04/2017

Overall trial end date

30/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18-80 years old
2. Clinical diagnosis of depression with a duration of illness of at least 2 years
3. Using NHS mental health services for the treatment of depression with regular contact with clinicians
4. Capacity to provide informed consent
5. Ability to speak and understand English
6. Low quality of life (as indicated by a score of <5 on the MANSA)
7. Evidence of current depression symptoms (score of >=10 on the MADRS)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

Patients:
1. Does not meet inclusion criteria
2. A mean score of 5 or more on the MANSA
3. A total score of less than 10 on the MADRS
4. Primary problem of current substance misuse
5. No capacity to provide informed consent
6. An inpatient on a psychiatric ward at the time of recruitment

Clinicians:
1. Does not meet inclusion criteria
2. Does not have any clinical contact with patients with depression

Recruitment start date

01/04/2018

Recruitment end date

30/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Enhanced Primary Care
East London NHS Foundation Trust 86 Old Montague Street
London
E1 5NN
United Kingdom

Trial participating centre

Haringey North East Locality Team
Barnet, Enfield and Haringey NHS Mental Health Trust St. Ann's Hospital St. Ann's Road Tottenham
London
N15 3TH
United Kingdom

Trial participating centre

Chelmsford & Essex Centre (C&E) Centre
Essex Partnership University NHS Foundation Trust
Chelmsford
CM2 0QH
United Kingdom

Sponsor information

Organisation

East London NHS Foundation Trust

Sponsor details

20-24 Commercial Street
London
E1 6LP
United Kingdom
-
sponsor.noclor@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0615-20010

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study documentation is available on request from Dr Victoria Bird (v.j.bird@qmul.ac.uk). Dissemination activities will run throughout the whole programme of research. The Lived Experience Advisory Panel (LEAP) will take an active role in dissemination to ensure findings are accessible and meaningful to service users, carers and the general public. Dissemination will target different stakeholders including mental health service commissioners, clinicians, patients, carers and academics.

Results of the feasibility trial are planned to be published in a high impact, open access journal within one year of the overall trial end date.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/06/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/10/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 30/08/2018 to 30/12/2018. 2. The overall trial end date was changed from 30/03/2019 to 30/06/2019. 3. The intention to publish date was changed from 30/03/2020 to 30/06/2020. 4. The trial participating centres were updated.