1. Introduction
Social Anxiety Disorder (SAD), previously named social phobia, was first introduced as a mental health illness in the Diagnostic and Statistical Manual of Mental Disorders (DSM), 3rd Edition in 1980 (American Psychiatric Association [APA], 1980). Upon the recent completion of the DSM 5th Edition (APA, 2013; DSM-5), SAD has remained a dominant disorder and has quickly become considered as one of the most prevalent anxiety disorders, with lifetime prevalence rates estimated at approximately 13% (Kessler et al., 2004; Kessler et al., 2005; Kringlen, Torgersen & Cramer, 2001). SAD is categorised by substantial fears in social and interpersonal situations, including fears of negative evaluation or judgment by others when being observed by, presenting to, and/or conversing with others (APA, 2013). SAD is characterised by an early onset and chronic course and can create much distress and impairment in many areas of life including occupationally, educationally and socially (APA, 2013), particularly if left untreated (DeWit et al., 1999).
Several trials have identified effective psychosocial treatments for SAD (Rodebaugh et al., 2004). Cognitive Behavioural Therapy (CBT) has been shown to be most effective for SAD (Clark & Wells, 1995; Hiemberg, 2002; Hoifman & Smits, 2008), and is the recommended first line treatment choice in clinical guidelines for SAD (NICE, X; Pilling et al., 2013). However, access to such treatment is low (Issakidis & Andrews, 2002) and a minority of patients receive evidence-based interventions (Salomonsson et al., 2017). Lack of resources, shortage of qualified therapists, long waiting lists and high costs have been highlighted as important contributing factors (Layard & Clark, 2014; Kohn et al., 2004; Shafran et al., 2009). Consequently, a challenge is to increase the accessibility of evidence-based psychological treatment (Carlbring et al., 2007).
The UK’s Improving Access to Psychological Therapies (IAPT) programme is part of the National Health Service (NHS) designed to provide stepped care approach to treating people with anxiety and depressive disorders (Clarke, 2011). Stepped care models match treatment intensity to client needs (Richards et al., 2018), which allows for the effective management of resources (Bennett-Levy, Richards & Farrand, 2010). Step 2 of IAPT allows access to evidence-based treatments by delivering low-intensity psychological support to patients presenting with mild-to-moderate symptoms of depression and anxiety (Richards et al., 2018). Furthermore, patients can receive benefit from a low-intensity CBT-based intervention (LI-CBT) while they wait for higher intensity treatment options become available, if needed.
Self-help treatments are available in various formats, including books, also referred to as bibliotherapy, and computer or online programmes. Self-help treatments can be utilised as an alternative to, or in conjunction with, traditional therapy. For example, Menchola, Arkowitx and Burke (2007) found that over 80% of psychologists report recommending some form of self-help interventions to their patients in addition to traditional face-to-face treatment. Self-help treatments can be utilised with, or without, the guidance and contact of a mental health practitioner, also referred to as guided or unguided self-help, respectively. Therapeutic contact can come in various forms including in-person, phone, email or video messaging and in various durations including weekly, monthly or an as needed basis.
The National Institute for Health and Care Excellence ([NICE] 2006, 2009) recommends the use of computerised Cognitive Behavioural Therapy (cCBT), currently offered by IAPT as a low-intensity, Step 2 intervention. cCBT helps to overcome the common barriers to accessing mental health treatment, such as costs and long waiting lists (Richards et al., 2018). A substantial body of research supports the efficacy of online delivered CBT for depression and anxiety disorders (Anderson & Cuijpers, 2009; Richards et al., 2015; Wells et al., in press) and findings have been transferred into clinical practice, however little is currently known about its efficacy for social anxiety.
Emerging evidence suggests that text-based self-help manuals presented via the internet and supported by therapist feedback can yield reliable improvements in a variety of mental disorders (Furmark et al., 2009). A crucial question is how the treatment would work when presented as pure bibliotherapy i.e. as self-help book without additional therapist guidance. The research literature on bibliotherapy for SAD is relatively minimal. Of the few research studies published, a few studies showed only limited efficacy of pure self-help for SAD (Titov et al., 2008; Rapee et al., 2007). A recent study conducted by Nordgreen et al. (2011) found that those receiving access to bibliotherapy had greater reductions in social phobia compared to those in the waitlist control condition.
Many other studies have not included a comparison treatment, so specificity of findings remain unassured. To current knowledge, there has been no previous study investigating the efficacy of cCBT, unguided self-help and guided self-help altogether as low-intensity CBT for SAD in primary care. The current utility of these LI-CBT interventions for SAD within primary care is currently known.
2. Study Objectives and Design
2.1 Study Objectives
The purpose of this study is to evaluate the long-term effectiveness of Guided Self-Help (GSH), computerised CBT (cCBT) and Unguided Self-Help (USH) as Low-Intensity CBT (LI-CBT) interventions for patients with SAD.
- Primary Objectives: Primary outcome measures will assess social anxiety and depressive symptoms to explore the efficacy of GSH, USH and cCBT compared to a waiting-list (WL) control group in reducing (i) SAD and (ii) depression symptoms.
- Secondary Objectives: Secondary outcome measures allow for the evaluation of long-term outcomes on dependent measures, including generalised anxiety, phobia and general functioning from baseline to post-intervention and from baseline to follow-up.
- Hypotheses of Efficacy: The following hypotheses are proposed: (a) GSH in comparison to cCBT and USH will lead to greater reductions in SAD symptom severity from baseline to post-intervention and (b) all low-intensity delivery modes will be superior to an active waiting-list control group at post-intervention and six-months follow-up.
- Primary end point: Responders/non-responders to LI-CBT for SAD. Response is operationalised as having scored below the clinical cut-offs on both the SPIN and PHQ-9 between assessment and discharge or between discharge and 6-month follow-up.
- Secondary end point: Scores on the GAD-7, IAPT Phobia Scale and WSAS.
2.2 Study Design & Flowchart
This will be a prospective, parallel groups, interventional RCT with 1:1:1:1 allocation to four arms, taking place in the Southwark IAPT service. Measures of social anxiety, depression, generalised anxiety, phobia and general functioning are taken prospectively at assessment, discharge, and longitudinally at two different time points within a sample of patients meeting criterion for SAD. Levels of SAD will be tested against response/non-response to treatment of SAD and analysed using the intention-to-treat principle. In addition, the study includes qualitative evaluation of participants’ experiences of treatment, with a focus of better understanding barriers and facilitators to engaging in self-help interventions in IAPT.
Fig. 1 Participant flow for each stage of LISA-D
3. Sample Size, Statistics, Selection and Withdrawal of Subjects
3.1 Sample Size
Sample size was determined using the software program G-Power (Faul et al., 2007) and based on a moderate between group effect size of d = 0.5 with a power of 80%, and an alpha error of 0.05, and a 1:1:1:1 randomisation procedure. This calculation returned a total sample of 180 participants, distributed evenly to the three groups. To ameliorate against attrition, a 20% uplift was added, resulting in a total sample of 216. Therefore, this number translates to a ratio of n = 54 in the GSH treatment group, n ¬= 54 in the USH treatment group, n = 54 in the cCBT treatment group and n = 54 in the waiting list control group.
Recruitment will begin in June 2019 and will continue for 12 months until the numbers are reached or exceeded. Patients will be recruited via self-referral or GP referral to the Southwark IAPT service and screened for eligibility by a clinician at initial assessment.
3.2 Participants
Inclusion Criteria
Participants will meet the following criteria: (a) meet diagnostic criteria on the Structured Clinical Interview for DSM-5 disorders (SCID-5-RV) for a primary diagnosis of social anxiety disorder; (b) scoring ≥ 19 on the SPIN; (c) if prescribed psychiatric medication, the participant must have been taking the medication for at least 3 months and the dosage had to be kept constant throughout the study; (d) aged 18 years or over; (e) users of the Southwark IAPT service; (f) have sufficient literacy skills to understand the self-help materials; (g) have regular access to a computer or smartphone with internet connection.
Exclusion Criteria
Participants meeting the following criteria will be deemed ineligible to participate: (a) active suicidality: score of ≥ 2 on PHQ-9 suicidality scale (to prevent the inclusion of individuals in strong need of specialist consultation); (b) currently receiving psychological treatment during the study period; (c) currently meeting diagnostic criteria for psychosis, substance abuse or another disorder that could influence the outcome of the study; (d) previous completion of CBT course for SAD; (e) express of a strong treatment preference (5/5) on the TPA.
Criteria for Premature Withdrawal
Participants can leave the study at any time by providing written notice to a member of the research team, using the contact details provided on the Participant Information Sheet. At the time of withdrawal, the participant should inform the research team if they will allow for the continued collection and use of their health information by the researchers. If withdrawal occurs before discharge, follow-up measures will not be administered.
3.3 Clinicians
LI-CBT interventions are delivered by Psychological Wellbeing Practitioners (PWPs), who are predominately graduate psychologists with further training in delivering LI-CBT interventions (Clarke, 2011). All PWPs within Southwark IAPT are eligible to participate in the trial. PWPs will be invited to a 2-day information session where the trial and objectives will be fully described. They will be introduced to the workbook and cCBT interventions and be provided with protocols for each intervention. PWPs are invited to participate as both clinical supporters and research participants. PWPs will provide electronically signed informed consent and receive ongoing supervision throughout the study. At each supervision meeting, they will complete a checklist of the congruence between the content of the PWP’s online/face-to-face reviews and the CBT module that the patient is progressing through to ensure that patients receive the appropriate evidence-based intervention and that each patient receives a similar standard of intervention, augmenting the reproducibility of the study.
4. Study Procedures
4.1 Informed Consent Procedure
Written informed consent is obtained from each participant prior to any study specific procedures. Subjects are given a Participant Information Sheet explaining the purpose, procedures, nature and extent of patient involvement and potential benefits and hazards of the study. Patients are given ample time to consider giving their consent for the study. Participants are also informed that they are free to withdraw their consent at any point during the study and their treatment as a service user with Southwark IAPT remains unaffected.
4.2 Screening Procedure
All potential participants will complete a routine IAPT telephone screening assessment upon referral to Southwark IAPT service. The assessment will determine if an individual meets eligibility criterion, and an initial indication of social anxiety disorder will be advised by the clinician. Potential participants are described the trial and requested for consent to take part in the baseline assessment. Potential participants not meeting eligibility criteria are not offered the study and are offered usual care by the IAPT service.
Participants fulfilling the inclusion criteria are contacted via telephone by a research assistant. They will also receive an email to give consent to the full trial online (including randomisation, treatment and follow-up assessments), by means of digital signature. Upon receipt of consent, participants complete the primary and secondary outcomes and are interviewed using the research edition of the Structured Clinical Interview for DSM-5 Disorders ([SCID]; X) over the phone (Rohde, Lewinsohn & Seeley, 1997) to confirm the SAD diagnosis. Participants will also complete the TPA to determine strong treatment preference. Higher scores indicate that the participant views the treatment as effective and if randomised to the non-preferred intervention they may likely drop out of the intervention. Participants meeting the eligibility criteria are randomised to the treatment or waiting-list group and informed of the outcome during the interview and informed of the withdrawal process. Participants not meeting eligibility criteria are referred back to the clinician for advice on where to seek more appropriate help or received treatment as usual.
At the posttreatment/postwait assessment, participants will also complete a brief clinical interview with an independent assessor who is blinded to their group allocation, as a partial effort to reduce bias.
4.3 Randomisation Procedure
There will be effective (concealed) randomisation of the subjects to the intervention/control groups (to eliminate selection bias and minimise confounding variables). Participants are randomly allocated using the Sealed Envelope online service (www.sealedenvelope.com). The team statistician uses Sealed Envelope to set up and test the randomisation procedure incorporating stratification by SPIN severity category (mild or moderate) using random block length and 1:1:1:1 allocation. The research assistant randomises participants by completing the online form with participant’s details, which immediately shows whether the participant is assigned to the GSH, USH, cCBT or WL arm.
4.4 Intervention Procedure
Upon randomisation to study arms, participants either begin treatment immediately (groups 1, 2 and 3) or placed on a waiting list (group 4). Each participant will be assigned to a PWP who will monitor their progress throughout the trial.
Interventions
Guided Self-Help
GSH is delivered via a disorder-specific self-help book and face-to-face guidance with a PWP. The Shyness & Social Anxiety Workbook, Third Edition (Antony & Swinson, 2017) is an eleven-chapter self-help book, based on CBT principles with a focus on psychoeducation, cognitive principles, such as acknowledging faulty cognitions, mindfulness practice and behavioural principles, such as in vivo exposure tasks. For the purpose of the study, the workbook will be divided into eight modules to be completed over the course of one week. Previous research has demonstrated the effectiveness, ease and benefits of reading one module a week of a self-help manual for those suffering from mental health disorders (Palumbo, 2015). PWPs provide four fortnightly face-to-face sessions, lasting 30-45 minutes each, over 8 weeks. In the first session, patients receive the self-help book and instructions to work with the program. PWPs encourage patients to schedule their therapy at home with weekly sessions of reading and planning, as well as daily registrations and experiments.
Unguided Self-Help
Participants in the USH condition will receive the Shyness & Social Anxiety Workbook (Antony & Swinson, 2017) by post with a copy of the treatment protocol. The treatment protocol provides participants with a weekly overview of the chapter(s) they would be assigned to read, the page numbers of the chapter(s) in the text, the content within the chapter(s) and the designated assignments within the chapter(s). Each week, the participants will receive an email with the assigned module, and tasks to be completed. No therapeutic support is provided throughout the intervention.
Computerised CBT
The online intervention ‘Space from Social Anxiety’ is a 7-module online CBT-based intervention for social anxiety, provided by Silvercloud Health (www.silvercloudhealth.com). Each module takes roughly 1h to complete, and it is recommended one module to be completed per week. The structure and content of the programme modules follow established evidence-based principles of CBT for the treatment of social anxiety disorder, including attention control and personal stories from individuals experiencing social anxiety. At their first login the participant receives a message from their PWP to highlight aspects of the programme. Over the course of the 8-week supported intervention, PWPs will login 4 times fortnightly for 10-15 minutes per session, to review participants progress and leave feedback.
Waiting List Control Group
Participants in the WL control group receive no treatment for the first 8-weeks. At week 8, they will complete the primary and secondary outcome measures. For ethical reasons, participants in the control group will begin treatment with support from a PWP.
The trial involves two participating centres run by Southwark IAPT in the North (Munro Centre, 66 Snowfields, London, SE1 3SS) and South (Middle House, Maudsley Hospital, London, SE5 8RZ) of the borough.
4.5 Measures
Relevant measures will be administered to participants during baseline (assessment), pre-treatment/prewait, post-treatment/postwait, 6- and 12-month follow up. Participants complete relevant measures for each time point online (with a postal option). The study measures and assessment times are summarised in Table 1.
Primary Outcome Measures
The latest version of the IAPT Data Handbook (Department of Health, 2011) recommends that for SAD the combination of the SPIN and the PHQ-9 should be used to define clinical caseness at pre-treatment and recovery at posttreatment. In particular, individuals should be classed as SAD cases at pre-treatment if they score above the clinical cut-off on the SPIN (irrespective of PHQ-9 score) and should be subsequently recovered if they score below the clinical cut-offs on both the SPIN and PHQ-9 at post-treatment.
SAD. Assessed using the Social Phobia Inventory ([SPIN]; Connor et al., 2000). The SPIN is a scale designed to assess the three important dimensions (fear, avoidance, physiological arousal) of SAD in a brief format. The SPIN’s 17-items are rated on a scale (0= “not at all” to 4 = “extremely”). Scores are then totalled to produce a value that is representative of symptom severity on a continuum from none to very severe. The SPIN range of scores is 0 to 68; a cut-off score ≥ 19 indicates caseness threshold (Connor et al., 2000).
Depression. Assessed using the Patient Health Questionnaire ([PHQ-9]; Kroenke et al., 2010). The PHQ-9 is routinely used in IAPT services and based on the diagnostic criteria for major depressive disorders in DSM 4th Edition (APA, 2000). The PHQ9 range of scores is 0 to 27; a cut-off score ≥ 10 indicates caseness threshold.
Secondary Outcome Measures
Diagnostic Status. Diagnosis of SAD for research purposes will be established using the F module of the Structured Clinical Interview for DSM-5 Disorders ([SCID]; X), research edition. Diagnosticians are independent assessors blind to treatment condition, at the posttreatment/postwait assessment point. In the event where a clear diagnosis is not available, the assessors and CI, will decide on the diagnosis based on the outcome from the SCID and clinical knowledge from the initial assessment (scores on the PHQ-9, GAD-7).
Generalised Anxiety Disorder. Generalised anxiety is measured using the GAD-7 (Spitzer et al., 2006) which is a 7-item clinical measure for the assessment of generalised anxiety disorder in primary care (Spitzer et al., 2006) routinely used in IAPT services. The GAD7 range of scores is 0 to 21; a cut-off score ≥ 8 indicates caseness threshold.
Phobia. Phobia symptom severity is measured using the IAPT Phobia scales, which have been designed to capture patients who may score below the clinical cut-off on the PHQ-9 and GAD-7 but whose lives may be significantly impaired by the presence of social anxiety, agoraphobia and specific phobias (National Health Service [NHS], 2011).
General Functioning. Functioning will be measured using the Work and Social Adjustment Scale (WSAS), which is a 5-item self-report measure that provides an experiential impact of the disorder from a patient’s point of view (Mundt et al., 2002). It looks at how the disorder impairs the patient’s ability to function day to day on five dimensions: work, home life, social life, private life and close relationships.
Treatment Preference. Preference to treatment will be measured at screening using the Treatment Preference Assessment (Sidani et al., 2009). The participant rates each treatment on effectiveness, acceptability/logicality, suitability/appropriateness and convenience.
Patient Experience. Patient’s experience and satisfaction is measured using the Patient Experience Questionnaire ([PEQ]; NHS, 2011). The PEQ contains several quantitative questions and open-ended questions that are used to assess participant’s views and satisfaction with service provision.
Table 1
Study measures and assessment times
Measure Assessment Time of assessment
SCID Diagnosis BL, Post-T, 6-FU
SPIN Social Anxiety Disorder BL, Pre-T, Post-T, FU
PHQ-9 Depression BL, contin, Pre-T, Post-T, FU
GAD-7 Anxiety BL, contin, Pre-T, Post-T, FU
IAPT Phobia Scale Specific Phobia BL, contin, Pre-T, Post-T, FU
WSAS General Functioning BL, contin, Pre-T, Post-T, FU
TPA Treatment Preference BL
PEQ Patient Experience Post-T
BL Baseline; Pre-T Pre-Treatment or Pre-Wait; Post-T Post-Treatment or Post-Wait; FU All follow-ups; 6-FU 6-month follow-up; 12-FU 12-month follow-up; contin continuous; SCID Structured Clinical Interview for DSM-5 Disorders; SPIN Social Phobia Inventory; PHQ-9 Patient Health Questionnaire-9; GAD-7 Generalised Anxiety Disorder-7; WSAS Work and Social Adjustment; TPA Treatment Preference Assessment; PEQ Patient Experience Questionnaire.
4.6 Follow-Up Procedures
Follow-ups will occur at 6 and 12 months after treatment completion to assess long-term outcomes. These are completed via a 30-minute telephone call for the clinician-rated measures and via email (or post) for the self-rated measures. Hard copies of the self-rated measures will be available by hard copy to be returned via post. There will be no follow-up assessment of those in the waiting list condition (control group).
4. 7 Statistical Analyses
Statistical analyses are conducted using SPSS 25.0 (IBM, Chicago) based on the intention-to-treat principle. Continuous data are analysed using mixed effects models or t-tests. Independent-sample t-tests are used to test group differences pre-treatment scores and post-treatment scores, and to compare the treatment group and the wait-list control group with regard to initial differences at pre-treatment. Treatment effects are analysed with mixed between-within analyses of variance (ANOVAs) and appropriate post-hoc tests to compare all the treated participants over the four-time frames (pre-treatment, post-treatment, 6- and 12-month follow-up). Effect sizes are calculated based on the pooled standard deviation and expressed as Cohen’s d (Cohen, 1988). As an addition to the primary outcome, a reliable change index (Jacobson & Truax, 1991) is used to determine the number of participants who have made reliable change and significant change on the SAD and depression measures at post-treatment, 6- and 12-month follow-up.
4.8 Risk/Burdens
There are few risks involved in participating. As the clinical measures in the study cover symptoms related to mental health problems, individuals may find participation distressing. Furthermore, participants might experience negative thoughts and feelings through engaging in therapy, as some of the modules or chapters increase awareness of current and past experiences. Participants are informed by their PWP that in CBT it is common to become more aware of experiences that may include unpleasant, difficult experiences. Adverse events/effects will be monitored throughout treatment and at follow-up points. Participants will have the opportunity to discuss their experiences of their allocated intervention and the PWP will be supervised by the study lead who is a consultant psychiatrist working in mental health care settings. PWP will also have allocated supervisors within Southwark IAPT to discuss clinical issues with and guide clinical decisions. In the event of a participant experiencing a high degree of distress, the research team would follow good practice and ensure that the participant is referred on to an appropriate source of support.
4.9 End of Study Definition
The date the last participant completes the 12-month follow-up pack marks the end of this study. The REC will be notified of its conclusion, in writing, using the ‘Declaration of the End of a Study’ form.
5. Assessment of Safety
At assessment, clients are assessed for risk in line with routine clinical practice. This includes an assessment of whether patients can maintain their safety whilst on the waiting list. Those who exceed a clinically determined cut-off for ‘low risk’ in terms of suicide and/or self-harm on the screening questions will not be eligible to participate in the study and, if deemed necessary, will be referred for urgent crisis support with the South Southwark Assessment & Liaison Team (SSALT).
Integrated risk measures in the Silvercloud programme allow for monitoring by supporters of any changes in risk for patients throughout the programme. If required. An alert will be sent through to their clinician, which can be escalated appropriately within the established clinical governance structure. Silvercloud will not be presented to patients as a programme capable of providing crisis support, and this will be further emphasised through informed consent and the user contract.
During the study, in the possibility that patients’ level of risk increases, or their symptoms deteriorate during the course of the study, the measures taken as part of this research will be used to monitor participants’ clinical status and risk management will be considered during each contact with participants. Any concerns raised will be shared and discussed with participants for any further steps to be taken.
Upon completion of the intervention, shared decision-making between the patient, PWP and their supervisor, together with outcomes on the SPIN, PHQ-9 and GAD-7, will determine whether patients will be appropriately discharged or referred on for further treatment within Southwark IAPT service or specialist support (such as, Centre for Anxiety Disorders & Trauma or Southwark Integrated Psychological Therapy Team).
6. Study Oversight Arrangements
The CI will be responsible for monitoring the data, safety and managing any directing of the study protocol. A progress report will be submitted to the main Research Ethics Committee, who will oversee the maintenance of the study’s safety.
7. Ethics & Regulatory Approvals
Name: London – South East Research Ethics Committee
Address: Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH
Telephone: 02071048014
Email Address: NRESCommittee.London-SouthEast@nhs.net
8. Data Handling
Confidentiality
Identifiable information collected from the participants includes names, dates of birth, personal history and other sensitive demographic information. Dropout from the study or treatment at any point after randomisation, will also be recorded along with reason for discontinuation or termination. Only those involved in handling the data will have access to the information as they are required to extract it from patient files located on IAPTus (www.iaptus.co.uk) to be entered into the database for subsequent analysis. Information about the study subjects are stored anonymously, kept confidential and managed according to the requirements of Data Protection Act, NHS Caldicott Guardian, The Research Governance Framework for Health and Social
Care and Research Ethics Committee Approval.
Case Report Form
Data will be recorded on Case Report Forms (CRFs). These will be collected and recorded by the research team. The CRFs will be checked for completeness and legibility by the CI before being entered onto the trial database.
Record Retention and Archiving
Patient files will be kept in locked cupboards in a secure room at all times. Data from the interviews and self-report questionnaires will be stored in a password protected database at which stage, identifying information, such as the patient’s name will be omitted.
Compliance
The CI will ensure that the trial is conducted in compliance with the principles of the Declaration of Helsinki (1996), the CONSORT statement (Shulz, Altman & Moher, 2010), the SPIRIT guidelines (Chan et al., 2013) and in accordance with all applicable regulatory requirements including but not limited to the Research Governance Framework, Trust and Research Office policies and procedures and any subsequent amendments.
9. Finance and Publication Policy
This research will be funded by The National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) King’s College London.
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