Protect after depression: a randomised pilot trial of a new wellbeing course

ISRCTN	ISRCTN17371456
DOI	https://doi.org/10.1186/ISRCTN17371456
Secondary identifying numbers	15/0804

Submission date: 02/08/2016
Registration date: 02/08/2016
Last edited: 18/10/2017

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
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

Contact information

Ms Katherine Clarke
Public

Centre for Outcomes Research and Effectiveness
1- 19 Torrington Place
London
WC1E 7HB
United Kingdom

Study information

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
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Protect after depression: a randomised pilot trial of a novel low-intensity intervention
Study objectives	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(s)	Camden and King's Cross NHS Ethics Committee, 14/06/2016, ref: 16/LO/0652
Health condition(s) or problem(s) studied	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
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 study start date	05/02/2015
Completion date	04/06/2017

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	130
Key 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
Key exclusion criteria	1. Has current suicidal thoughts 2. Is currently taking part in another piece of research within IAPT services
Date of first enrolment	04/08/2016
Date of final enrolment	04/12/2016

Locations

Countries of recruitment

England
United Kingdom

Study 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

University College London (UK)
University/education

Joint Research Office (part of the Research Support Centre)
Gower Street
London
WC1E 6BT
England
United Kingdom

Website	http://www.ucl.ac.uk/jro/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Other

British Psychological Society
Private sector organisation / Associations and societies (private and public)

Alternative name(s): BPS
Location: United Kingdom

Results and Publications

Intention to publish date	04/06/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

18/10/2017: Internal review.