Condition category
Mental and Behavioural Disorders
Date applied
02/08/2016
Date assigned
02/08/2016
Last edited
03/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Ms Katherine Clarke

ORCID ID

Contact details

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

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 measures

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

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

http://www.ucl.ac.uk/jro/

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

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes