Condition category
Mental and Behavioural Disorders
Date applied
21/12/2016
Date assigned
21/12/2016
Last edited
13/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Post-traumatic stress disorder (PTSD) is a common, often disabling mental disorder that can occur following major traumatic events such as abuse, assaults and accidents. Typical symptoms include: distressing reliving in the form of nightmares or intrusive thoughts; avoidance of reminders; distorted thoughts such as feeling shame for being abused; and hyperarousal, for example through increased irritability and jumpiness. Recent news stories highlight the devastating impact that PTSD can have (e.g. the Savile Effect) and how the absence of timely intervention can lead to long-term suffering. They have also increased public awareness of PTSD and, potentially, the likelihood of presentation for help. The first choice treatments for PTSD are individual talking treatments (such as individual trauma-focused cognitive behavioural therapy, TFCBT) of 12-16 hours duration. Unfortunately, the limited number of therapists available and length of treatment means that there are long NHS waiting lists of up to 18 months. PTSD sufferers may also have difficulty committing to weekly appointments, especially if they are working, have childcare commitments or are scared to go out alone or to new places. If equally effective treatments could be developed that take less time and can be largely undertaken in a flexible manner at home, this would improve accessibility, reduce waiting times and hence the burden of disease. GSH has the potential to address this gap. The aim of this study is to find out whether trauma-focused guided self-help (GSH) using a web-based programme is an effective treatment for PTSD compared to TFCBT.

Who can participate?
Adults with PTSD following a single traumatic event

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in an eight week programme of the online guided self-help (GSH) programme using a web and app-based programme, with up to three hours contact with a therapist either in person, via internet video link or telephone. Those in the second group will receive a 12 week programme of TFCBT, which involves weekly face-to-face sessions with a trained therapist. At the start of the study and then again after 16 and 52 weeks, participants in both groups complete a range of questionnaires to assess their mental wellbeing in order to establish the effectiveness of the treatments in treating their PTSD.

What are the possible benefits and risks of participating?
By taking part in the study, it is likely that participants will benefit from quicker access to therapy than on the NHS. Their involvement will also help the researchers to find out if GSH is a suitable and accessible treatment for people in the future, which may help to reduce waiting times for treatment and benefit patients in the future. A potential risk to taking part is an increase in psychological distress due to exposure to the trauma. However, this applies to any trauma focused therapy and the pilot (initial) study did not find any harms from the GSH intervention and none are expected in this study.

Where is the study run from?
Cardiff University (UK)

When is the study starting and how long is it expected to run for?
October 2016 to March 2020

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

Who is the main contact?
Ms Katy Addison
rapid@cardiff.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Katy Addison

ORCID ID

Contact details

Centre for Trials Research
College of Biomedical and Life Sciences
7th Floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 (0)2920 687 522
rapid@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPON 1545-16

Study information

Scientific title

Pragmatic randomised controlled trial of a trauma-focused guided self help programme versus individual trauma-focused cognitive behavioural therapy for post traumatic stress disorder

Acronym

RAPID

Study hypothesis

Current hypothesis as of 13/09/2017:
The aim of this study is to determine whether, for patients with PTSD, an internet Trauma Focused Cognitive Behavioural Therapy (TFCBT) based Guided Self Help (GSH) programme is not inferior to individual TFCBT, as judged by reduced symptoms of PTSD at 16 weeks post-randomisation.

Previous hypothesis:
The aim of this study is to determine whether, for patients with PTSD, an internet Trauma Focused Cognitive Behavioural Therapy (TFCBT) based Guided Self Help (GSH) programme is not inferior to individual TFCBT, as judged by reduced symptoms of PTSD at 52 weeks post-randomisation.

Ethics approval

Wales REC 3, 23/02/2017, ref: 17/WA/0008

Study design

Phase III pragmatic assessor-blind individually-randomised controlled non-inferiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files

Condition

Post-traumatic stress disorder following a single traumatic event

Intervention

Participants are randomised to one of two groups.

Intervention group: Participants receive Online Guided Self Help based on Trauma Focused Cognitive Behavioural Therapy (8 weeks)

Control group: Participants receive Face-to-face individual Trauma Focused Cognitive Behavioural Therapy (up to 12 weeks)

Participants in both groups are followed up 16 and 52 weeks post-randomisation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Change in PTSD symtoms Clinician Administered PTSD Scale for DSM5 (CAPS-5) at 16 weeks.

Secondary outcome measures

1. PTSD symptoms, as measured using the Clinician-Administered PTSD Scale (CAPS-5) at 52 weeks post randomisation and Impact of Events Scale - Revised (IES-R) at 16 weeks and 52 weeks post-randomisation. IES-R is also completed at each therapy session.
2. Quality of life is measured using the EQ-5D-5L questionnaire at baseline, 16 and 52 weeks
3. Functional impairment is measured using the Work and Social Adjustment Scale (WSAS) at baseline, 16 and 52 weeks
4. Depression is measured using the Patient Health Questionnaire (PHQ-9) at baseline, 16 and 52 weeks
5. Anxiety symptoms are measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale at baseline, 16 and 52 weeks
6. Alcohol use is measured using the AUDIT-O questionnaire at baseline, 16 and 52 weeks
7. Social Support is measured using the Multidimensional Scale of Perceived Social Support (MSPSS) at baseline, 16 and 52 weeks
8. Insomnia is measured using the Insomnia Severity Index (ISI) at baseline, 16 and 52 weeks
9. Self-efficacy is measured using the General Self-Efficacy Scale (GSES) at baseline, 16 and 52 weeks
10. Cognition is measured using the Posttraumatic Cognitions Inventory (PTCI) at baseline, 16 and 52 weeks
11. Health care usage using an adapted version of the CSSRI-EU at baseline, 16 and 52 weeks

Overall trial start date

01/10/2016

Overall trial end date

31/03/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Screen positive for PTSD on the Traumatic Screening Questionnaire (TSQ) following a single traumatic event experienced at any age
3. Regular access to the internet in order to complete the modules and homework required by the Guided Self Help (GSH) programme
4. Provide informed consent
5. After a two week monitoring period, continue to meet Clinician Administered PTSD Scale (CAPS-5) criteria for mild to moderate PTSD (less than 50 on the CAPS-5)
6. PTSD is the primary diagnosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

192

Participant exclusion criteria

1. Inability to read and write fluently in English
2. Previous completion of a course of Trauma-focused Cognitive Behavioural Therapy (TFCBT) for PTSD
3. Currently engaged in a psychological therapy
4. Change in psychotropic medication in last four weeks
5. Psychosis
6. Substance dependence
7. Active suicide risk

Recruitment start date

29/08/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiff University
Cardiff
CF10 3AT
United Kingdom

Sponsor information

Organisation

Cardiff University

Sponsor details

-
Cardiff
CF10 3AT
United Kingdom
+44 (0)2920 879 277
falconerhe@cardiff.ac.uk

Sponsor type

University/education

Website

http://www.cardiff.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Promotion of the trial will occur throughout the study through study webpages, social media, local and national media. The results will be presented to the participants through an end of study report and published in high quality, open access journals.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/03/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/09/2017: The following changes were made to the trial record: 1. Ethics approval details added. 2. The recruitment start date was changed from 01/04/2017 to 29/08/2017. 3. Participant information sheet added.