Condition category
Mental and Behavioural Disorders
Date applied
18/07/2014
Date assigned
24/09/2014
Last edited
07/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 will complete some forms that will help us to know how effective the therapy is for them. Once treatment has finished, clients will be sent a questionnaire pack 6 months and 12 months after their entry into the study. We will also, with their agreement, contact them 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. This will help us understand why some people decide to leave treatment.

What are the possible benefits and risks of participating?
Participants will 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 will be continuing 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?
Professor Michael Barkham
m.barkham@sheffield.ac.uk

Trial website

http://www.shef.ac.uk/scharr/sections/hsr/mh/mhresearch/practiced/info

Contact information

Type

Scientific

Primary contact

Mr David Saxon

ORCID ID

Contact details

ScHARR
University of Sheffield
Regents Court
Regents Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 222 0718
d.saxon@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0001

Study information

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.

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

NRES Committee Yorkshire & The Humber - South Yorkshire, 27/03/2014, ref. 14/YH/0001

Study design

Non-inferiority randomised controlled trial embedded within a comprehensive cohort design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

Depression severity and symptomatology as 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. In addition we will collect healthcare utilisation by an adaptation of the Client Service Receipt Inventory
3. We will administer a patient satisfaction questionnaire, the Client Satisfaction Questionnaire (CSQ), at 6 months

Taken at baseline, 6 and 12 months

Overall trial start date

01/01/2014

Overall trial end date

30/08/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Participants must be 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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

550

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

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S1 4DA
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

CPSR
Health Services Research
The University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 222 0753
a.constantine@sheffield.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

The British Association for Counselling and Psychotherapy (BACP) Research Foundation (UK) (Ref: 0001)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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