Condition category
Mental and Behavioural Disorders
Date applied
15/12/2017
Date assigned
05/01/2018
Last edited
05/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Post-traumatic stress disorder (PTSD) is an anxiety disorder caused by very stressful, frightening or distressing events. Research shows that PTSD can be treated effectively with psychological treatments. However, many patients with PTSD are currently unable to access effective psychological treatments for a range of reasons, such as shortage of therapists, living too far away from treatment centres, or being unable to attend therapy during usual working hours. Given the large number of people suffering from PTSD, it is desirable to develop more efficient forms of treatment delivery that can be widely accessed, and online treatment delivery appears to be a promising alternative to face-to-face therapy. There is already some evidence that therapist-assisted online psychological treatments are effective in PTSD. The aim of this study is to compare two forms of therapist-supported internet-based psychological therapy for PTSD. The online therapies are based on effective face-to-face therapies (cognitive therapy, stress management therapy). Both treatments are compared with a wait-list to control for the natural recovery that is sometimes seen in PTSD.

Who can participate?
Patients aged 18 or above who suffer from PTSD resulting from traumatic events experienced in adulthood

What does the study involve?
Participants’ symptoms of PTSD, depression, anxiety and functioning are assessed and they are randomly allocated to receive either one of the two internet-delivered psychological therapies immediately or after a delay of 13 weeks. The assessments are repeated at 6 weeks, the end of therapy/waiting, and 3, 6 and 12 months after the end of therapy. Therapy involves completing therapy modules online and assignments over 3 months, with guidance via messages and weekly phone calls with an experienced psychological therapist. An evaluation of the process of how symptoms change is treatment is also undertaken by collecting weekly questionnaires and by interviewing participants regarding their experiences.

What are the possible benefits and risks of participating?
All participants receive internet-delivered psychological therapy with support from a therapist for their PTSD. A team that specialises in the treatment of this disorder delivers the treatment and closely monitors progress. There is a 14% chance that participants are randomly selected to wait for 13 weeks before starting treatment. Some people may experience a temporary increase in distress as a result of remembering the trauma during treatment, but this is usually short-lived.

Where is the study run from?
1. University of Oxford (UK)
2. Institute for Psychiatry, Psychology and Neuroscience, King's College London (UK)
3. Oxford Health NHS Foundation Trust (UK)
4. South London and Maudsley NHS Foundation Trust (UK)
5. Sussex Partnership NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2017 to December 2021

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Maxie Scheske
maxie.scheske@psy.ox.ac.uk

Trial website

https://www.psy.ox.ac.uk/research/oxford-centre-for-anxiety-disorders-and-trauma/anxiety-disorders/post-traumatic-stress-disorder

Contact information

Type

Public

Primary contact

Miss Maxie Scheske

ORCID ID

Contact details

Oxford Centre for Anxiety Disorders and Trauma
University of Oxford
Paradise Square
Oxford
OX1 1TW
United Kingdom
+44 (0)1865 281867
maxie.scheske@psy.ox.ac.uk

Type

Scientific

Additional contact

Prof Anke Ehlers

ORCID ID

http://orcid.org/0000-0002-8742-0192

Contact details

Oxford Centre for Anxiety Disorders and Trauma
University of Oxford
Paradise Square
Oxford
OX1 1TW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REC: 13041, IRAS: 224759, Protocol Version 1, 9th November 2017

Study information

Scientific title

A randomiSed controlled Trial of therapist-assisted Online Psychological therapies for Post-Traumatic Stress Disorder

Acronym

STOP-PTSD

Study hypothesis

Is internet-delivered cognitive therapy for PTSD more efficacious than internet-delivered stress-management for PTSD, i.e. does it lead to greater improvement in PTSD symptoms?

Ethics approval

West Midlands - Black Country Research Ethics Committee, 17/WM/0441

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Post-traumatic stress disorder

Intervention

Participants’ symptoms of PTSD, depression, anxiety and functioning are assessed and they are randomised (minimisation with a random component) at a 3:3:1 ratio to either:
1. Internet-delivered cognitive therapy for PTSD (iCT-PTSD)
2. Internet-delivered stress-management for PTSD (iStress)
3. 13-week waitlist

The assessments are repeated at 6 weeks, the end of therapy/waiting, and 3, 6 and 12 months after the end of therapy. Therapy involves completing therapy modules online and assignments over 3 months, with guidance via messages and weekly phone calls with an experienced psychological therapists. An evaluation of the process of how symptoms change is treatment is also undertaken by collecting weekly questionnaires and by interviewing participants regarding their experiences.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

PTSD symptoms measured with PTSD Symptom Checklist 5 at baseline, 6, 13 weeks after random allocation (with follow-ups at 26, 39 and 65 weeks), and weekly during treatment

Secondary outcome measures

1. Assessor ratings of PTSD symptoms, assessed with the Clinician Administered PTSD Scale for DSM 5 (CAPS-5) at baseline and 13 weeks after random allocation (with follow-ups at 26, 39 and 65 weeks).
2. Other symptom measures assessed at baseline, 6, 13 weeks after random allocation (with follow-ups at 26, 39 and 65 weeks), and weekly during treatment:
2.1. Depression, assessed with the Patient Health Questionnaire (PHQ-9)
2.2. Anxiety, assessed with the Generalized Anxiety Disorder Scale 7-items (GAD-7)
2.3. Disability, assessed with the Work and Social Adjustment Scale (WSAS)
2.4. Sleep problems, assessed with the Insomnia Sleep Index (ISI)
3. Health economics measures (Euroqol EQ-5D-5L12, iMTA Productivity Cost Questionnaire (PCQ), Endicott Quality of Life Scale (QoL), Client Service Receipt Inventory (CSRI), employment status and state benefits), assessed at baseline, 13, 26 and 39 weeks
4. Process measures assessed at baseline, 6, 13, 26, 39 weeks after random allocation (and some weekly during treatment):
4.1. Excessively negative appraisals, assessed with the Posttraumatic Cognitions Inventory (PTCI), short version
4.2. Disjointed memories, assessed with the Trauma Memory Questionnaire (MQ), short version
4.3. Unhelpful strategies to deal with intrusive memories, assessed with the Response to Intrusion Questionnaire (RIQ)
4.4. Safety behaviours, assessed with the short version Safety Behaviours Questionnaire (SBQ)
4.5. Dissociation, assessed with the short version State-Trait Dissociation Questionnaire (TSDQ)
4.6. Self-efficacy, assessed with the short version Generalized Self Efficacy Scale (GSES)

Other process measures:
1. Therapeutic alliance, assessed using the Working Alliance Inventory (WAI) at weeks 2 and 6
2. Patient satisfaction and comments on their experience with online therapy, assessed using Online Treatment Experience Interview at week 13

Overall trial start date

01/01/2017

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 and above
2. Diagnosis of Posttraumatic Stress Disorder (as assessed with the Structured Clinical Interview for DSM-5)
3. The current reexperiencing symptoms are linked to one or two discrete traumatic events experienced in adulthood
4. PTSD is the main psychological problem needing treatment
5. Willing and able to provide informed consent
6. Able to read and write in English
7. Access to internet
8. Willing to be randomly allocated to one of the psychological treatments or wait
9. If taking psychotropic medication, the dose must be stable for at least 1 month before randomisation
10. If currently receiving psychological therapy for PTSD, this treatment must have ended before randomisation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

175

Participant exclusion criteria

1. History of psychosis
2. Current substance dependence
3. Current borderline personality disorder
4. Acute serious suicide risk

Recruitment start date

15/01/2018

Recruitment end date

30/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Centre for Anxiety Disorders and Trauma Paradise Square
Oxford
OX1 1TW
United Kingdom

Trial participating centre

Institute for Psychiatry, Psychology and Neuroscience, King's College London
De Crespigny Park
London
SE5 8AF
United Kingdom

Trial participating centre

Oxford Health NHS Foundation Trust
Oxford
OX3 7JX
United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
BR3 3BX

Trial participating centre

Sussex Partnership NHS Foundation Trust
BN13 3EP

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Goverance
Joint Research Office
Block 60
Churchill Hospital
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Wellcome Trust

Alternative name(s)

Wellcome

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results will be published in peer-reviewed scientific journals with open access, as per Wellcome Trust policy

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

Intention to publish date

31/12/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes