Internet treatment for social anxiety in IAPT

ISRCTN	ISRCTN72832736
DOI	https://doi.org/10.1186/ISRCTN72832736
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	286369
Protocol serial number	IRAS 286369, WT 200796/Z/16/Z
Sponsor	University of Oxford
Funder	Wellcome Trust

Submission date: 08/10/2021
Registration date: 15/11/2021
Last edited: 15/11/2021

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
Social anxiety disorder (SAD) is a common and disabling mental health problem. Cognitive therapy for SAD (CT-SAD) is an effective treatment for this condition. A therapist-assisted internet-delivered version of this treatment (iCT-SAD) has also been found to be acceptable to patients and effective in research studies as patients can complete online treatment modules that cover all components of CT-SAD at a time and place convenient to them. A therapist guides them remotely through the treatment and supports them through messages and phone/video calls.

The aim of this study is to investigate how effective iCT-SAD is in routine clinical care and who benefits from it. The clinical outcomes of patients treated with iCT-SAD will be assessed and compared with national targets for IAPT services and with the outcomes previously observed in the services.

Who can participate?
Adults with social anxiety disorder who are being seen at one of the participating Improving Access to Psychological Therapies (IAPT) NHS services and agree to participate in the study. About 30 therapists from participating IAPT NHS services will also be involved in the study.

What does the study involve?
For participating patients, the study involves completing the iCT-SAD treatment programme online with the support of messages and phone/ video calls with an IAPT therapist. It also involves completing questionnaires about symptoms, anxiety related thoughts & behaviours, and satisfaction with treatment.

Participating therapists will be trained to guide and support patients with SAD in completing the iCT-SAD treatment programme. They will then treat patients with SAD with iCT-SAD and receive supervision. At the end of the study, therapists complete a questionnaire and a focus group on their experience with delivering the treatment.

What are the possible benefits and risks of participating?
All participating patients will receive internet-based psychological therapy for social anxiety disorder with support from an IAPT therapist who has received specialist training and supervision. Undertaking treatment for social anxiety can be challenging. Like in-person therapy, iCT-SAD encourages participants to reflect on their difficulties in order to understand how social anxiety works, and supports participants in tackling situations that they may have previously avoided. While doing this may temporarily increase distress, facing these challenges is an important step towards overcoming social anxiety.

Where is the study run from?
The University of Oxford (UK)

When is the study starting and how long is it expected to run for?
April 2016 to July 2022

Who is funding the study?
The Wellcome Trust (UK)

Who is the main contact?
Sophie Grant
sophie.grant@psy.ox.ac.uk

Contact information

Prof David M. Clark
Scientific

Oxford Centre for Anxiety Disorders and Trauma
Department of Experimental Psychology
University of Oxford
The Old Rectory
Paradise Square
Oxford
OX1 1TW
United Kingdom

ORCID ID	0000-0002-8173-6022
Phone	+441865818600
Email	david.clark@psy.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Interventional multicentre non-randomized implementation study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	A study of the implementation of internet-based cognitive therapy for Social Anxiety Disorder within NHS Improving Access to Psychological Therapies (IAPT) services (Overcome-SAD)
Study acronym	Overcome-SAD
Study objectives	The study aims to assess iCT-SAD clinical outcomes in comparison to National IAPT targets for the treatment of common mental health disorders (i.e. at least 50% of patients recover, with many others showing reliable improvement).
Ethics approval(s)	Approved 22/10/2020, North East - Tyne & Wear South Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; +44 (0)207 104 8052; tyneandwearsouth.rec@hra.nhs.uk), ref: 20/NE/0241
Health condition(s) or problem(s) studied	Social anxiety disorder
Intervention	Cognitive therapy for social anxiety disorder (CT-SAD) is a cognitive behavioural treatment for posttraumatic stress disorder recommended by NICE (2013) and international treatment guidelines. It is usually delivered in face-to-face sessions. A therapist-assisted internet-delivered version (iCT-SAD) has recently been found to be efficacious and acceptable to patients. Patients are guided through the online treatment programme by a therapist. Patients work through the therapy modules of iCT-SAD on a secure website, as well as completing treatment-related tasks and activities as part of their daily routine. The therapist releases the modules that are relevant to the patients and supports them through messages and phone/video calls. This study will evaluate the effectiveness of this treatment in IAPT services. IAPT therapists who consented to be part of the study, have been trained in iCT-SAD and are receiving supervision. The total duration of treatment is up to 7 months, with a 4-month main treatment phase with weekly calls and a 3-month booster phase with monthly calls.
Intervention type	Behavioural
Primary outcome measure(s)	Recovery (as defined in IAPT by cut-offs scores below the clinical cut-off) measured using the Social Phobia Inventory (SPIN) and Patient Health Questionnaire (PHQ-9) at baseline and 7 months
Key secondary outcome measure(s)	1. Social anxiety symptoms measured using the Social Anxiety Inventory (SPIN) and Liebowitz Social Anxiety Scale (LSAS-SR) collected by the internet programme each week between baseline and 4 months, and at 5, 6, and 7 months 2. Depression symptoms measured with the PHQ-9 completed at baseline, 4, and 7 months. The PHQ-9 is given weekly during the weekly therapy phase as is standard in IAPT services. 3. Anxiety symptoms measured with the Generalised Anxiety Disorder Questionnaire (GAD-7) completed at baseline, 4, and 7 months. The GAD-7 is given weekly during the weekly therapy phase as is standard in IAPT services. 4. Disability measured with the Work and Social Adjustment Scale (WSAS) completed at baseline, 4, and 7 months. The WSAS is given weekly during the weekly therapy phase as is standard in IAPT services. 5. Satisfaction with treatment assessed with the IAPT Patient Experience Questionnaire at 7 months Process measures: 1. Credibility of treatment measured with the Borkovec and Nau Credibility scale at 2 weeks. 2. Working alliance measured with the Working Alliance Scale completed by patients and therapists at 2 weeks 3. Key variables in the Clark & Wells (1995) cognitive model of SAD (social anxiety-related beliefs, safety behaviours, and focus of attention) are assessed repeatedly during treatment with relevant questionnaires 4. Patient activity on the online programme measured using data collected by the internet programme such as time spent on the programme and modules completed during treatment between baseline and 4 months 5. Therapist activity with the online programme measured using data collected by the internet programme such as number of calls and messages with patient during treatment between baseline and 4 months User experience with iCT-SAD: 1. Therapists’ experience with delivering iCT-SAD measured using the Therapist-Questionnaire and focus group discussion at the end of the study 2. Patients’ experience measured using ratings of helpfulness and free comments provided at the end of each module
Completion date	31/07/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	240
Key inclusion criteria	1. Social Anxiety Disorder is the main difficulty, and the client's priority to work on in therapy 2. Social Phobia Inventory (SPIN) score >25 at initial assessment 3. Regular, private access to internet-enabled device with webcam and reliable internet connection 4. Able to take phone calls from their therapist within normal IAPT clinic hours, and have enough time in their week to be able to log in and work on the programme regularly (i.e. at least 20 mins on 3-4 days each week) 5. Able to speak, read and write English 6. If on medication for mood/anxiety, the participant agrees not to change medication during the study 7. Aged 16 to 80 years
Key exclusion criteria	1. Marked clinical risk based on the service's intake assessment 2. Dependence on alcohol or substances. 3. Currently participating in another clinical research study 4. Current psychosis/bipolar affective disorder/emotionally unstable personality disorder (These conditions are not typically treated within IAPT services)
Date of first enrolment	24/10/2020
Date of final enrolment	31/12/2021

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Talking Space Plus, Oxford Health

Abell House
Slade Site
Horspath Driftway
Oxford
OX3 7JH
United Kingdom

Berkshire Talking Therapies IAPT Service

Fitzwilliam House
Skimped Hill Lane
Bracknell
RG12 1QB
United Kingdom

Healthy Minds - The Buckinghamshire IAPT Service

Floor 2, Prospect House
High Wycombe
HP13 6LA
United Kingdom

iCope Camden and iCope Islington Psychological Therapies Service

South Wing
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
United Kingdom

Lambeth Talking Therapies Service

Dalbury House
Ferndale Road
London
SW9 8AP
United Kingdom

Greenwich Time to Talk

135-143 Eltham High Street
London
SE9 1TJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/11/2021: Trial’s existence confirmed by North East - Tyne & Wear South Research Ethics Committee.