ISRCTN ISRCTN23278208
DOI https://doi.org/10.1186/ISRCTN23278208
Secondary identifying numbers 36210
Submission date
20/11/2017
Registration date
28/11/2017
Last edited
22/10/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Cassandra Kenning
Public

The University of Manchester
6th floor, Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCiD logoORCID ID 0000-0001-6041-4051
Phone +44 161 275 7610
Email cassandra.kenning@manchester.ac.uk

Study information

Study designRandomised; Interventional; Design type: Prevention, Psychological & Behavioural
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN23278208_PIS_V2_31Oct17.pdf
Scientific titlePreventing depression in the community by voluntary sector providers
Study acronymPERSUADE
Study objectivesThe 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(s)North West- Greater Manchester East REC, 23/11/2017, ref: 17/NW/0604
Health condition(s) or problem(s) studiedSpecialty: Primary care, Primary sub-specialty: Mental Health; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders
InterventionParticipants 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 typeOther
Primary outcome measureFeasibility 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 measures1. 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 study start date01/07/2017
Completion date30/09/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 64; UK Sample Size: 64
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2018
Date of final enrolment30/06/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor information

The University of Manchester
Hospital/treatment centre

Oxford Road
Manchester
M13 9PL
England
United Kingdom

ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planA 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 planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V2 31/10/2017 28/11/2017 No Yes
Protocol article protocol 03/10/2019 22/10/2020 Yes No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN23278208_PIS_V2_31Oct17.pdf
Uploaded 28/11/2017

Editorial Notes

22/10/2020: Publication reference added.
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.