Condition category
Mental and Behavioural Disorders
Date applied
20/11/2017
Date assigned
28/11/2017
Last edited
18/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The number of people with depression is increasing across the world; depression is set to become the leading cause of disability worldwide by 2030. Treatments for depression have limited usefulness and have only led to a 35% reduction of cases of depression, as compared to those receiving no treatment. People with untreated depression symptoms are at an increased risk of persistent depression with poor outcomes. There is a need to develop treatments that can be delivered at the very early stage of the illness thus preventing progression into full blown symptoms of depression. One of the major risk factors for depression is sub-threshold depression. Sub-threshold depression is a condition where the person has developed some of the symptoms of stress and low mood but the number of symptoms, and their severity, is lower than the threshold that we would use to diagnose someone with depression. In routine clinical practice we use a score of 10 or above on a depression questionnaire (Personal Health Questionnaire PHQ 9) to diagnose depression. This study uses a score of between 5 and 9 on the PHQ 9 to indicate sub-threshold depression. Experience tells us that it can be difficult to engage people with mild depression into preventive treatments that may require ongoing commitment. So, we plan to use user involvement to adapt and evaluate a psychological therapy program which is acceptable. It will be based on Cognitive Behaviour Therapy (CBT) principles. The aim of this study is to reduce depression symptom scores and prevent development of depression in people with sub-threshold depression defined as PHQ score 5-9.

Who can participate?
Adults aged 18 to 60 who have score between a 5 to 9 on the PHQ 9 scale.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive a specially developed CBT based intervention manual and will be required to attend a one full-day or two half-day workshops to support the manual. Those in the second group receive the usual care (no treatment). All participants are asked to complete a short questionnaire three months after the study to assess their symptoms. Some participants in the treatment group are also invited to take part in an interview over the telephone, to talk about their experiences during the study.

What are the possible benefits and risks of participating?
The model being used in the intervention has been used in many previous studies and shown effectiveness in helping people to manage their mood better. We do not anticipate the self-help intervention to pose a risk to participants and it does not prevent them accessing other more traditional health care through their GP if needed.

Where is the study run from?
The University of Manchester (UK)

When is the study starting and how long is it expected to run for?
July 2017 to June 2018

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

Who is the main contact?
Dr Cassandra Kenning
cassandra.kenning@manchester.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Cassandra Kenning

ORCID ID

http://orcid.org/0000-0001-6041-4051

Contact details

The University of Manchester
6th floor
Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 275 7610
cassandra.kenning@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36210

Study information

Scientific title

Preventing depression in the community by voluntary sector providers

Acronym

PERSUADE

Study hypothesis

The primary aim is to reduce depression symptom scores and prevent development of depression in people with sub-threshold depression defined as PHQ score 5-9.

The objectives of the study are:
1. To adapt a low intensity community based depression prevention intervention based upon Cognitive Behaviour Therapy (CBT) model for adults with sub-threshold depression deliverable by voluntary sector organisations
2. To establish the acceptability and uptake of this model by adults with sub-threshold depression
3. To test the feasibility of conducting a successful trial of community based depression prevention intervention for adults with sub-threshold depression

Ethics approval

North West- Greater Manchester East REC, 23/11/2017, ref: 17/NW/0604

Study design

Randomised; Interventional; Design type: Prevention, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Primary care, Primary sub-specialty: Mental Health; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders

Intervention

Participants are randomised to either the intervention group or to usual care (no treatment). Participants in the intervention group receive a specially developed CBT based intervention manual and are required to attend a one full-day (or 2 half-days) workshop to support the manual. Motivational techniques are incorporated at the beginning of the workshop to help engage participants, based on previous research and our own experience of conducting social groups. Group exercises, role-play demonstrations and discussions of case vignettes will be participatory to maintain participant’s interest and motivation.

All participants are followed up 3 months post randomisation.

Engagement, attendance of workshops and retention to the study are recorded.

Phone or face-to-face interviews are conducted with a sample of the participants in the intervention group (n=15) on completion of the intervention, looking at acceptability. Interviews are also be carried out with the specially trained facilitators at the end of the study to assess training, support and intervention delivery.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility and acceptability are assessed using:
1. Recruitment methods - a number of different recruitment strategies are tried and assessed to see how much time each takes and the yields.
2. Engagement, attendance of workshops and retention to the study
3. Phone or face-to-face interviews are conducted with a sample of the participants in the intervention group
4. Interviews are carried out with the specially trained facilitators at the end of the study to assess training, support and intervention delivery

Secondary outcome measures

1. Depression is measured using PHQ-9 at baseline and 3 months.
2. Health status is measured using EQ-5D-3L at baseline and 3 months
3. Healthcare utilisation is measured using (CSRI) at baseline and 3 months
4. Client Satisfaction is measured using Client Satisfaction Questionnaire (CSQ-8) at baseline and 3 months

Overall trial start date

01/07/2017

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients from primary care or the general community
2. Male and female
3. Aged between 18 years and 60 years of age
4. Score between 5-9 on the PHQ 9

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 64; UK Sample Size: 64

Participant exclusion criteria

1. Depression (score higher than 9 on PHQ-9, or formal diagnosis of depression)
2. Psychosis
3. Drug or alcohol use as primary diagnosis
4. Suicidal ideations
5. Non-English language speakers

Recruitment start date

01/01/2018

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

The University of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A protocol paper has been written and will be submitted once ethical approval has been confirmed.
This will be followed by a process evaluation paper and a results paper at the end of the study in 2019.

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

31/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/05/2018: The following changes have been made: 1. The recruitment start date has been changed from 01/12/2017 to 01/01/2018. 2. The recruitment start date has been changed from 31/01/2018 to 30/06/2018. 3. The overall trial end date has been changed from 30/06/2018 to 30/09/2018.