ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000313639

Ethics application status

Approved

Date submitted

9/03/2023

Date registered

22/03/2023

Date last updated

3/04/2024

Date data sharing statement initially provided

22/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Acceptability and Efficacy of Remote Treatment for Social Anxiety Disorder

Scientific title

A Randomised Controlled Trial of the Acceptability and Efficacy of Remote Cognitive Behavioural Therapy for Social Anxiety Disorder in Adults

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Social Anxiety Disorder

Condition category

Condition code

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Those in the immediate treatment condition will receive a manualised cognitive behaviour therapy (CBT) protocol that is informed by the Rapee and Heimberg (1997) model of social anxiety disorder. The treatment will be delivered by internet-videoconferencing. Treatment is delivered one-on-one in 50-minute sessions over an 8 week period. In total, participants will receive 8 sessions as one 50-minute per week. Participants will be asked to complete at-home activities between sessions such as symptom monitoring, problem solving using restructured thoughts, graded exposure. It is anticipated that participants will spend at least 10 minutes per day practicing cognitive restructuring and exposure techniques learned in session.

The treatment will comprise of five modules and will cover the following topics:
Module 1: Psychoeducation (week 1)
Module 2: Challenging automatic thoughts (weeks 2 - 3)
Module 3: Challenging core beliefs (week 4)
Module 4: Exposure (weeks 5 - 7)
Module 5: Relapse prevention/consolidation (week 8)

Treatment will be delivered by provisionally registered psychologists in their final year of a Master of Clinical Psychology degree or a clinical psychology registrar, under the supervision of an experienced clinical psychologist. All treating clinicians will be thoroughly trained in the administration of the treatment protocol by the project investigators and receive weekly supervision. All sessions will be recorded and at least 10% of sessions will be randomly selected for treatment fidelity.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

During the eight-week wait-list period, participants will be asked to refrain from seeking external psychological counselling. Following the eight-week wait-list period, participants in the wait-list control condition will be offered eight weekly, 50-minute sessions of imagery rescripting (ImR) for social anxiety disorder following the protocol established by Wild and Clark (2011). ImR is a collection of imagery techniques that alter negative meanings associated with autobiographical memories of distressing experiences. Treatment is delivered one-on-one in 50-minute sessions over an 8 week period. In total, participants will receive 8 sessions as one 50-minute per week. Participants will be asked to complete at-home activities between sessions such as symptom monitoring. It is anticipated that participants will spend at least 10 minutes per day practicing cognitive restructuring techniques learned in session.

ImR treatment will comprise of four modules and will cover the following topics:
Module 1: Psychoeducation (week 1)
Module 2: Identification and exploration of core beliefs (week 2)
Module 3: Imagery rescripting (weeks 3 - 7)
Module 4: Relapse prevention/consolidation (week 8)

Treatment will be delivered by provisionally registered psychologists in their final year of a Master of Clinical Psychology degree or a clinical psychology registrar, under the supervision of an experienced clinical psychologist. All treating clinicians will be thoroughly trained in the administration of the treatment protocol by the project investigators and receive weekly supervision. All sessions will be recorded and at least 10% of sessions will be randomly selected for treatment fidelity.

Control group

Active

Outcomes

Primary outcome [1]

Social anxiety disorder symptom severity will be measured with the Social Interaction Anxiety Scale-Short Form (SIAS-6) (Mattick & Clarke, 1998)

Timepoint [1]

Baseline
Mid-treatment (week 4)
Post treatment (week 9, primary endpoint)
3-month follow-up post treatment completion

Primary outcome [2]

Social anxiety disorder symptom severity will be measured with the Social Phobia Scale-Short Form (SPS) (Mattick & Clarke, 1998)

Timepoint [2]

Baseline
Mid-treatment (week 4)
Post treatment (week 9, primary endpoint)
3-month follow-up post treatment completion

Primary outcome [3]

Acceptability will be measured with the Client Satisfaction Questionnaire (CSQ) (Attkisson & Zwick, 1982)

Timepoint [3]

Mid-treatment (week 4)
Post treatment (week 9, primary endpoint)

Secondary outcome [1]

Social anxiety disorder symptom severity will be measured with the Social Anxiety Disorder Dimensional Scale (SAD-D) (LeBeau et al., 2012)

Timepoint [1]