Internet-based cognitive therapy for social anxiety disorder

A randomised controlled trial of internet-based cognitive therapy (iCT) and standard cognitive therapy (CT) for social anxiety disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95458747

Enrollment

102

Registered

2012-11-12

Start date

2013-01-01

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social anxiety disorder (social phobia) Mental and Behavioural Disorders Social phobias

Interventions

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. Inter

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 (Cronbach?s 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 O	—

Measure

Time frame

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 (Cronbach?s 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 O

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Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026