Plain English Summary
Background and study aims
Depression is a state of low mood and aversion to activity that can affect a person's thoughts, behavior, feelings and sense of well-being. The period after recovery from depression is thought to be an important time, as the risk that a person will relapse reduces during this time. The aim of this study is to test a new wellbeing course and see whether it is useful, and whether it should be offered to more people.
Who can participate?
Adults who have received treatment in Improving Access to Psychological Therapies (IAPT) services and have recovered from an episode of depression or low mood.
What does the study involve?
Participants are asked some questions about how they have been feeling in 3 months and again in 6 months from the end of their IAPT treatment. Half of the participants are randomly allocated to be offered a brief wellbeing course consisting of an introduction telephone call, a 2-hour group workshop, and a follow-up phone call. Participants also receive a booklet with tips and there are tasks to think about between sessions. To see whether the course is useful, the experience of the participants who try the course are compared to those who don't.
What are the possible benefits and risks of participating?
Participating will take up time for the follow-up phone calls, and potentially for the wellbeing course. We will do all we can to make sure the follow-ups are at a time convenient to participants. In previous studies we have found that participants often appreciate the opportunity to reflect on how they are doing during follow-up phone calls. Participants will also receive vouchers as a thank you for these calls. The aim of this study is to better understand and better assist people who have recovered from depression. Participants may contribute to helping someone who recovers from depression in the future. We don’t think this study will put participants at a significant risk.
Where is the study run from?
University College London (UCL), in partnership with clinicians in Camden and Islington Improving Access to Psychological Therapies (IAPT) services.
When is the study starting and how long is it expected to run for?
February 2015 to June 2017
Who is funding the study?
British Psychological Society (UK)
Who is the main contact?
Katherine Clarke
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15/0804
Study information
Scientific title
Protect after depression: a randomised pilot trial of a novel low-intensity intervention
Acronym
Study hypothesis
1. Could the ‘PRotect’ intervention help people to remain well after recovery from depression in an IAPT service?
2. How do service users and clinicians experience the ‘PRotect’ intervention?
Ethics approval
Camden and King's Cross NHS Ethics Committee, 14/06/2016, ref: 16/LO/0652
Study design
Single-centre pilot randomised controlled trial (individually randomised with 1:1 allocation and independent assignment, single-blind)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Wellbeing after recovery from depression
Intervention
A low-intensity (brief guided self-help style) intervention combining several well-being techniques. The wellbeing course consists of an introduction telephone call, a 2-hour group workshop, and a follow-up phone call. Participants will also receive a booklet with tips and there will be tasks to think about between sessions.
The control group will have no intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The presence or absence of relapses of depression up to 6 months after randomisation as measured using the depression section of the LIFE (Keller et al., 1987)
Secondary outcome measures
1. Scores on IAPT minimum dataset measures 3 and 6 months after randomisation
2. Self-reported use of wellbeing activities in everyday life
Overall trial start date
05/02/2015
Overall trial end date
04/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. IAPT service users who have experienced depression
2. Have received treatment and currently score below threshold for depression symptoms (they are well)
3. Are willing and able to provide informed consent
4. Are willing and able to participate in the intervention, including ability to speak English
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
130
Participant exclusion criteria
1. Has current suicidal thoughts
2. Is currently taking part in another piece of research within IAPT services
Recruitment start date
04/08/2016
Recruitment end date
04/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
iCope - Camden and Islington Psychological Therapies Services
Camden and Islington NHS Foundation Trust
211 King's Cross Road
London
WC1X 9DN
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Joint Research Office (part of the Research Support Centre)
Gower Street
London
WC1E 6BT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
British Psychological Society
Alternative name(s)
BPS
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
04/06/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list