Pragmatic, randomised controlled trial assessing the non-Inferiority of counselling and its effectiveness for depression
| ISRCTN | ISRCTN06461651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06461651 |
| Secondary identifying numbers | 0001 |
- Submission date
- 18/07/2014
- Registration date
- 24/09/2014
- Last edited
- 18/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
There is good evidence showing that a talking therapy called Cognitive Behaviour Therapy (CBT) can and does help many people. However, it does not help everyone all the time. For people experiencing moderate or severe depression there is an alternative treatment called counselling for depression (CfD). CfD is as effective as CBT but we need to test whether this is really the case by conducting a scientifically rigorous study. This is the purpose of the study and the findings may help to inform patient choice in the future.
Who can participate?
Adults from the Sheffield Health and Social Care NHS Foundation Trust's Improving Access to Psychological Therapies (IAPT) service who have been referred for step 3 treatment and who have a primary diagnosis of moderate or severe depression.
What does the study involve?
Participants are randomly allocated to either Counselling for Depression (CfD) or Cognitive Behaviour Therapy (CBT). Once people are screened and accepted into the study, they complete some forms about how effective the therapy is for them. Once treatment has finished, clients are sent a questionnaire pack 6 and 12 months after their entry into the study. With their agreement, they are also contacted by telephone to carry out a short interview on their experience of treatment, whether they have terminated treatment with the agreement of their practitioner or by their own decision.
What are the possible benefits and risks of participating?
Participants stand an equal chance of receiving either CBT or CfD, and there is currently little evidence to suggest that one treatment is better than the other for depression. There is little or no risk to participants who are part of the study. This is because they continue with their treatment as they would normally.
Where is the study run from?
Sheffield Health and Social Care NHS Foundation Trust (UK) - Improving Access to Psychological Therapies (IAPT) service
When is the study starting and how long is it expected to run for?
Recruitment began in August 2014 and will recruit for a period of around 18 months
Who is funding the study?
The British Association for Counselling and Psychotherapy (BACP) Research Foundation (UK)
Who is the main contact?
Prof. Michael Barkham
m.barkham@sheffield.ac.uk
Contact information
Scientific
ScHARR
University of Sheffield
Regents Court
Regents Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 222 0718 |
|---|---|
| d.saxon@sheffield.ac.uk |
Study information
| Study design | Non-inferiority randomised controlled trial embedded within a comprehensive cohort design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A pragmatic non-inferiority randomised trial of the clinical and cost-effectiveness of counselling for depression versus cognitive-behaviour therapy, for clients in primary care meeting a diagnosis of moderate or severe depression |
| Study acronym | PRaCTICED |
| Study hypothesis | Determining the clinical and cost-effectiveness of counselling for depression (CfD) compared with cognitive behaviour therapy (CBT) as delivered in primary care for clients with moderate or severe depression. |
| Ethics approval(s) | NRES Committee Yorkshire & The Humber - South Yorkshire, 27/03/2014, ref: 14/YH/0001 |
| Condition | Moderate and severe depression |
| Intervention | Participants are randomised to two arms: 1. Counselling for Depression (CfD): the intervention being evaluated is Counselling for Depression (CfD). CfD is a form of Person-Centred/Experiential (PCE) therapy derived from the competences required to deliver effective humanistic psychological therapies. CfD is drawn from those humanistic approaches with the strongest evidence for efficacy, based on outcomes of controlled trials. CfD is specifically designed to address depression and is delivered within IAPT and related programmes. The comparator intervention will be high-intensity Beckian CBT as delivered within the Sheffield IAPT service. Both interventions will offer up to 20 sessions for participants. 2. Cognitive Behavioural Therapy (CBT) |
| Intervention type | Other |
| Primary outcome measure | Depression severity and symptomatology measured by the PHQ-9 at 6 months and at 12-month follow-up. |
| Secondary outcome measures | 1. CORE-OM, BDI-II, EQ-5D-5L, WSAS and GAD-7 2. Healthcare utilisation, measured using an adaptation of the Client Service Receipt Inventory 3. Patient satisfaction, measured using the Client Satisfaction Questionnaire (CSQ), at 6 months Taken at baseline, 6 and 12 months |
| Overall study start date | 01/01/2014 |
| Overall study end date | 30/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 550 |
| Total final enrolment | 510 |
| Participant inclusion criteria | Aged 18 or over Stage 1: 1. An initial indication by the client that depression is a major focus (ascertained by the PWP during initial assessment of presenting issues) 2. Weekly PHQ-9 scores are greater or equal to 12 at the 3rd or 4th appointment with the PWP 3. Client states no strong objection to either treatment sufficient for them to be unwilling to enter the trial should they be allocated to the alternate treatment Stage 2: 4. Client meets an ICD-10 diagnosis of moderate or severe depression using the Clinical Interview Schedule-Revised (CIS-R) carried out by an independent assessor |
| Participant exclusion criteria | Stage 1: 1. Presence of prior diagnosis of personality disorder, bipolar disorder, schizophrenia as indicated in the IAPT Outcomes Toolkit within the service data or from GP referral notes to the service 2. Organic origin of presentation (e.g., dementia) as indicated on referral to the service by the GP 3. Long-term physical condition as denoted in service notes Stage 2: 4. Elevated risk of suicide: if active thoughts of suicide are indicated from the CIS-R, we will implement a risk protocol to inform the PWP or identified practitioner 5. Alcohol or substance dependency: these will be determined by Questions 1 and 2 from Section I (Alcohol) and Section II (Drug) of the Mini-International Neuropsychiatric Interview (M.I.N.I.), which yield diagnoses of current alcohol or drug dependency |
| Recruitment start date | 16/10/2014 |
| Recruitment end date | 30/08/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
S1 4DA
United Kingdom
Sponsor information
University/education
CPSR
Health Services Research
The University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
England
United Kingdom
| Phone | +44 (0)114 222 0753 |
|---|---|
| a.constantine@sheffield.ac.uk | |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/05/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. December 2016: Protocol paper submit to Trials Journal 2. September 2019: Primary outcome paper (Clinical & Cost effectiveness) Other planned papers at later date: 1. On patient drop-out 2. Patient experience of treatment 3. Comparison between trial patients & similar non-trial patients seen routinely by the service, 4) treatment adherence |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/03/2017 | Yes | No | |
| Results article | 01/06/2021 | 18/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
18/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
18/02/2021: The intention to publish date was changed from 30/08/2020 to 01/05/2021.
08/10/2018: The intention to publish date was added
03/03/2017: Publication reference added.
07/11/2016: Changed overall start date from 15/08/2014 to 01/01/2014. Changed overall end date from 31/12/2016 to 30/08/2019. Changed recruitment start date from 15/08/2014 to 16/10/2014. Changed recruitment end date from 15/02/2016 to 30/08/2018. Added publication plan
03/11/2016: Changed contact details
