Plain English Summary
Background and study aims
Depression is a major public health issue. Persistent depressive symptoms below the threshold criteria for major depression is a chronic condition with a prolonged course and high risk of relapse or progression to major depressive episodes. Hence, it is important to establish which treatments for persistent sub-threshold depressive symptoms and mild depression are cost-effective and should therefore be provided in the National Health Service (NHS) in the UK. We are carrying out an initial study comparing the results of two different psychological therapies for depression: counselling and low-intensity cognitive behavioural therapy. This study will provide a number of estimates that are necessary for the design of the main study and will help to identify any potential problems that will need to be addressed before the main study.
Who can participate?
We aim to recruit 50 patients at five general practices in Glasgow with the diagnosis of persistent sub-threshold depressive symptoms and mild depression.
What does the study involve?
Patients will be randomly allocated to either eight weekly sessions of person-centred counselling or eight weeks of self-help cognitive-behavioural resources with telephone support. Person-centred counselling (PCC) is the most common psychological intervention offered in community settings in the UK. PCC focuses on the provision of an empathic, accepting, and genuine therapeutic relationship, which aims to foster patients' inner capacities and resources, promoting positive change. Guided self-help cognitive-behavioural therapy (CBT) is a recommended intervention for mild to moderate depression. It is termed a low intensity treatment because the amount of doctor time is limited compared to traditional high intensity expert-led treatments. Guided self-help CBT will be delivered through booklets and online resources.
What are the possible benefits and risks of participating?
Participants will receive either a course of eight sessions of person-centred counselling or eight telephone support sessions for guided self-help CBT. Access to psychological therapies in primary care is limited, so access to such treatments may be seen as a benefit for those participating in the trial. These treatments are widely used within primary care in the NHS. Any potential risks are therefore minimal. All participants will continue to be under the care of their GP for the duration of the trial and GP will be able to monitor any adverse effects.
Where is the study run from?
The study is organised by the University of Aberdeen, in collaboration with the University of Glasgow and University of Strathclyde.
When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in November 2012. Participants will be enrolled on the study for a period of 8 months. The overall duration of this project will be 15 months.
Who is funding the study?
The CLICD study is funded by a grant from the Chief Scientist Office, which is part of the Scottish Government Health and Social Care Directorates.
Who is the main contact?
Dr Elizabeth Freire
e.freire@abdn.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CZH/4/723
Study information
Scientific title
Counselling versus Low-Intensity Cognitive Behavioural Therapy for persistent subthreshold and mild Depression (CLICD): a pilot/feasibility randomised controlled trial
Acronym
CLICD
Study hypothesis
This study will test the feasibility of a randomised controlled trial of the clinical and cost effectiveness of Low Intensity Cognitive Behaviour Therapy (LI-CBT) and Person-Centred Counselling (PCC) for patients with persistent subthreshold depressive symptoms and mild depression. This study will provide estimates for the recruitment, adherence, and retention rates, as well as estimates of the variability of outcome measures to inform power calculations for a definitive trial. Estimates of comparative intervention effects will be produced, but this study is not designed to have sufficient power to detect differences, nor to demonstrate non-inferiority between interventions. The pilot will test the feasibility of attaining adequate recruitment and retention, as well as identifying a range of moderator variables. Finally, this study will help to identify any potential problems that will need to be addressed before a definitive trial.
On 29/10/2012 the following changes were made to the record:
1. The public title was updated. Previously it was "Comparing Counselling and Low-Intensity Cognitive behavioural therapy for Depression"
2. The overall trial start date was updated from 01/09/2012 to 01/10/2012
3. The overall trial end date was updated from 31/11/2013 to 31/12/2013
As of 13/01/2014, the overall trial end date was changed from 30/12/2013 to 30/06/2014. Recruitment to the trial is now closed, but follow-up assessments with participants continue.
Ethics approval
West of Scotland Research Ethics Committee 3, 03/09/2012, ref: 12/WS/0173
Study design
Two-arm parallel-group randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Depression
Intervention
Patients will be randomised to either eight weekly sessions of person-centred counselling or eight weeks of cognitive-behavioural self-help resources with telephone support.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Recruitment, adherence and retention rates at six months from baseline
Secondary outcome measures
1. Changes at 6 months on depressive symptoms (as measured by GRID-HAMD-17 and PHQ-9)
2. Recovery from, or prevention of, depression according to DSM-IV diagnosis at 6 months
3. Changes at 6 months on impairment in functioning (as measured by Work and Social Adjustment Scale - WSAS)
4. Changes at 6 months on health status (as measured by EQ5D and SF12)
Overall trial start date
01/10/2012
Overall trial end date
30/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 14/01/2014; this change was applied to patients screened from 16/04/2013 onward:
1. Aged ≥ 16
2. Scoring 5-18 on the Patient Health Questionnaire (PHQ-9) (i.e. mild or moderate low mood)
3. Screened positive for persistent (i.e., > 6 months) subthreshold depressive symptoms or mild depression (SCID)
4. Capable of taking part in research procedures
Previous inclusion criteria:
1. Aged ≥ 16
2. Scoring 5-14 on the Patient Health Questionnaire (PHQ-9) (i.e. mild or moderate low mood)
3. Screened positive for persistent (i.e., > 6 months) subthreshold depressive symptoms or mild depression (SCID)
4. Capable of taking part in research procedures
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Alcohol/substance dependence
2. Receiving other psychological intervention
3. Bipolar disorder
4. Bereavement as presenting issue
5. Post-traumatic Stress Disorder (PTSD)
6. Cognitive impairment
7. Unable to understand, speak, read or write in English
8. Terminal illness
9. Unable to take part in any of the interventions.
Recruitment start date
01/11/2012
Recruitment end date
30/06/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Aberdeen
Aberdeen
AB24 5UA
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
University Office
King's College
Regent Walk
Aberdeen
AB24 3FX
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (CSO), Scotland (UK) (ref. CZH/4/723)
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25392813
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26275718
Publication citations
-
Protocol
Freire E, Morrison J, Williams C, Cooper M, Elliott R, McConnachie A, Walker A, Heard D, Counselling versus Low-Intensity Cognitive Behavioural Therapy for persistent sub-threshold and mild Depression (CLICD): study protocol for a pilot/feasibility randomised controlled trial., Springerplus, 2014, 3, 654, doi: 10.1186/2193-1801-3-654.
-
Results
Freire E, Williams C, Messow CM, Cooper M, Elliott R, McConnachie A, Walker A, Heard D, Morrison J, Counselling versus low-intensity cognitive behavioural therapy for persistent sub-threshold and mild depression (CLICD): a pilot/feasibility randomised controlled trial, BMC Psychiatry, 2015, 15, 1, 197, doi: 10.1186/s12888-015-0582-y.