Internet-based cognitive therapy for social anxiety disorder

ISRCTN	ISRCTN95458747
DOI	https://doi.org/10.1186/ISRCTN95458747
Protocol serial number	Wellcome Trust 069777
Sponsor	Clinical Trials and Research Governance (UK)
Funder	Wellcome Trust grant ref: 069777

Submission date: 08/11/2012
Registration date: 12/11/2012
Last edited: 15/07/2022

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

Plain English summary of protocol

Background and study aims
Social anxiety disorder (social phobia) is a common and disabling disorder, which generally runs a chronic course in the absence of treatment . Many patients are currently unable to access effective treatments. It would thus be desirable to make effective treatments more easily available. Cognitive therapy (CT) for social anxiety disorder has been shown to be an effective treatment that compares favourably with other interventions. Across six studies in the UK, Germany and Sweden, CT has been shown to be superior to several psychological treatments and to medication. In its original form, the treatment involves 14 weekly face-to-face sessions with a therapist, each lasting 90 minutes. In a recent trial we developed a briefer (7 session) self-study assisted version of the treatment. In order to make the treatment even more efficient in terms of therapist time, as well as more widely accessible, we have now developed an internet-based version of cognitive therapy for social anxiety disorder (iCT). In particular, patients can access video demonstrations of key procedures before they try them themselves, they can also practice giving presentations to virtual audiences in preparation for real life work, and they can receive encouragement from a remote therapist using secure messaging. The main aim of the trial is to compare the effectiveness of iCT with our original CT. If the internet based treatment is as effective as the standard treatment programme, the savings in therapist time, along with the ease of access to the internet, will mean that it will be possible to make the treatment available to a larger number of patients in a wide range of settings.

Who can take part?
Participants with a diagnosis of Social Anxiety Disorder as their main presenting problem

What does the study involve?
Internet based CT for social anxiety disorder will be compared with the standard CT treatment and 14 week wait-list control. Patients with social anxiety disorder will be randomly allocated to either a 14-week wait-list, standard cognitive therapy for social anxiety disorder (14 weekly sessions of 90 minutes each), or internet based cognitive therapy for social anxiety disorder (14 weeks with email and phone support from a therapist). The wait-list group is included to determine whether internet-based CT is superior to no treatment. The standard CT condition is included to determine whether internet-based CT is as effective as standard CT. Patients allocated to the wait-list will receive one of the CT treatments at the end of the wait period. As social anxiety disorder is a chronic condition, it is important that treatments have a sustained effect. For this reason, the study includes a one-year follow-up after the end of treatment.
Main assessments will take place at baseline (pre-treatment/wait), mid-treatment/mid-wait (7 weeks), end of treatment/End-wait (14 weeks), 3 month post-treatment follow-up and 12 month post-treatment follow-up

What are the possible benefits and risks of participating?
Participants will receive cognitive therapy for social anxiety disorder from a team that specialises in treatment of the disorder. They will be followed for one year after the end of treatment so that any worsening in symptoms can be detected and referrals for further treatment can be made. Participants will be withdrawn from the treatment trial if their clinical condition is such that it requires other urgent treatment. This is an unlikely event. There is only one instance of this having happened in our previous three studies of cognitive therapy for social anxiety disorder.

Where is the study run from?
Oxford Centre for Anxiety Disorders and Trauma (UK)

When is the study starting and how long is it expected to run for?
January 2013 to December 2015

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Prof. David M Clark
david.clark@psy.ox.ac.uk

Contact information

Prof David M Clark
Scientific

Oxford Centre for Anxiety Disorders and Trauma
Department of Experimental Psychology
Tinbergen Building
9 South Parks Road
Oxford
OX1 3UD
United Kingdom

Study information

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial of internet-based cognitive therapy (iCT) and standard cognitive therapy (CT) for social anxiety disorder
Study objectives	1. Is internet-based cognitive therapy (iCT) an effective treatment for social anxiety disorder? 2. What is the mechanism by which iCT achieves its effects? 3. Can we predict who is particularly likely to benefit?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Social anxiety disorder (social phobia)
Intervention	Standard cognitive therapy for for social anxiety disorder. Patients will receive 14 weekly sessions of 90 minutes each, then three face to face follow-ups at monthly intervals post-treatment. Internet-based cognitive therapy for social anxiety disorder will cover all the main steps in therapy, incorporating the content of the self-study modules, which were found to be highly effective and acceptable to patients in our previous trial. Patients receive Internet treatment for 14 weeks, with the duration of all brief therapist contact recorded. During the 14 weeks, patients will have a 10-15 minute phone conversation with their therapist each week. In addition, they will receive encouragement and support via secure messaging (e-mail) within the internet programme. Following this, they will retain access to the site for 1 year without therapist contact. 14 week wait list control condition, after which patients will receive one of the two forms of cognitive therapy.
Intervention type	Other
Primary outcome measure(s)	Social phobia composite measure that is created by combining scores from six independent assessor and patient scales that are well validated measures of social anxiety disorder and related symptomatology. Scores on each scale are standardised (M = 0, SD = 1) across pre-treatment and post-treatment assessments by converting to Z-scores. The composite at each assessment occasion is the mean of the Z scores on that occasion. The procedure has been used in our last two social anxiety disorder trials (Clark et al., 2003) as well as in other trials in the field. The six scales that make up the social phobia composite are: 1. Anxiety Disorders Interview Schedule (Fear and Avoidance Scale) for DSM-IV (ADIS) (Brown, 1994) 2. Social Phobia Weekly Summary Scale (Clark et al., 2003) 3. Liebowitz Social Anxiety Scale (Liebowitz, 1987; Baker et al., 2002) 4. Fear of Negative Evaluation Scale (Watson & Friend, 1969) 5. Social Phobia Scale (Mattick and Clarke, 1998) 6. Social Interaction and Anxiety Scale (Mattick and Clarke, 1998) Other measures of social anxiety disorder will be: 1. Proportion of patients who continue to meet diagnostic criteria for social anxiety disorder at post-treatment/wait and 3 and 12 month post-treatment follow-up [assessed by the Anxiety Disorders Interview Schedule (ADIS)] 2. A behaviour test in which patients engage in two social interactions and subsequently complete a 14-item checklist covering their perception of how well they performed (e.g. whether they were embarrassed or boring or whether their voice was quivering or their hands were shaking). A mean checklist score is computed. The checklist has good internal consistency (Cronbachs alpha .85). This test is common in social anxiety trials and is essential in internet treatments trial, where there is a risk, if analyses are restricted to self-report questionnaires, that people might over report improvement. We used the proposed behaviour test in a previous trial (Clark et al., 2006) based in Oxford and London and found that it was acceptable to patients.
Key secondary outcome measure(s)	1. The proportion of patients who continue to meet diagnostic criteria for avoidant personality disorder at 12-month follow-up (assessed using the Structured Clinical Interview for DSM-IV) 2. General mood, as assessed by the Patient Health Questionnaire (PHQ-9; Kroenke & Spitzer, 2002) and the Generalised Anxiety Disorder 7 item scale (GAD-7; Spitzer et al, 2006) 3. Social anxiety disorder related disability assessed by the Sheehan Disability Scale (American Psychiatric Association, 1983) 4. Measures of possible mediators of therapeutic improvement are: 4.1. Social cognitions questionnaire (Clark et al., 2005) 4.2. Social behaviours questionnaire (Clark et al., 2005) 4.3. Social attitudes questionnaire (Clark et al., 2005) 5. Measures of possible predictors of improvement with cognitive therapy are: 5.1. Treatment credibility scale (Borkovec and Nau, 1972) 5.2. Working alliance inventory (Tracey & Kokotovic, 1989)
Completion date	01/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	102
Total final enrolment	102
Key inclusion criteria	1. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (American Psychiatric Association, 1994) criteria for social anxiety disorder as the main presenting problem. 2. Duration of social anxiety disorder for at least 6 months 3. Age 18 - 65 years 4. Can read and write in English & have a high-speed internet connection at home (or are willing to have one installed) 5. Willing to accept random allocation to weekly cognitive therapy (CT) or internet-based CT, either immediately or after a 14 week wait 6. No psychotropic medication, or on a stable dose for at least 2 months (without clinical improvement) and willing to keep dosage constant during the trial 7. Agree not to start any non-protocol mental health treatment during the trial 8. Live within the broad catchment area for London (within the M25) or Oxford (Oxfordshire, Buckinghamshire and Berkshire) so that patients can travel to the hub for assessments and face-to-face therapy
Key exclusion criteria	Participants who meet the inclusion criteria will be excluded if they also meet the following criteria: 1. Unable to attend weekly sessions 2. Previous CBT or exposure therapy for social anxiety disorder 3. Immediate suicide risk 4. Current substance dependence (abuse not dependency is acceptable) 5. Current or past psychosis 6. Meet criteria for borderline personality disorder
Date of first enrolment	01/01/2013
Date of final enrolment	01/12/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Oxford Centre for Anxiety Disorders and Trauma

Oxford
OX1 3UD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		15/07/2022	15/07/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/07/2022: Publication reference and total final enrolment added.
12/01/2018: No publications found, verifying study status with principal investigator.