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Efficacy of cognitive behavioural therapy for social anxiety disorder, and the use of stress and sex hormones for predicting response to treatment

Efficacy of cognitive behavioural therapy for social anxiety disorder, and the use of stress and sex hormones for predicting response to treatment

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000929505
Enrollment
15
Registered
2015-09-07
Start date
2015-09-08
Completion date
2016-12-01
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The main aims of the current study are to: (a) investigate the efficacy of intensive individual cognitive behavioural therapy (CBT) for social anxiety disorder (SAD) and (b) examine the capacity of the stress hormone cortisol to predict treatment response to intensive CBT in individuals with SAD. This project will test these aims in a preliminary, single group open trial design. Treatment will consist of three 60-minute sessions of CBT each week over four weeks, (12 hours in total). Saliva samples will be collected at 3 of these 12 sessions in order to measure cortisol levels in response to exposure therapy.

Interventions

Participants will complete three sessions of cognitive-behaviour therapy (CBT) per week over four weeks (12 sessions in total). Each session will involve the participant and the therapist meeting in an individual treatment format to reduce the factors maintaining the participant's anxiety (i.e., unhelpful thoughts and unhelpful behaviours). To reduce the unhelpful thoughts, cognitive interventions are used and to reduce the unhelpful behaviours exposure therapy is used. Exposure therapy involves

Participants will complete three sessions of cognitive-behaviour therapy (CBT) per week over four weeks (12 sessions in total). Each session will involve the participant and the therapist meeting in an individual treatment format to reduce the factors maintaining the participant's anxiety (i.e., unhelpful thoughts and unhelpful behaviours). To reduce the unhelpful thoughts, cognitive interventions are used and to reduce the unhelpful behaviours exposure therapy is used. Exposure therapy involves gradually confronting feared stimuli in a controlled and systematic way. The sessions involve: Session 1 - Psychoeducation Session 2 - Introduction to cognitive distortions and challenging unhelpful cognitions Session 3 - Challenging unhelpful cognitions Session 4 - Advanced cognitive strategies - challenging core beliefs Session 5 - Introduction to exposure therapy and the development of an exposure hierarchy Session 6 - Exposure I (saliva sample collection) Session 7 - Exposure II Session 8 - Exposure III (saliva sample collection) Session 9 - Exposure IV Session 10 - Exposure V (saliva sample collection) Session 11 - Exposure VI Session 12 - Relapse prevention. Participants will provide a saliva sample (10ml saliva) via the passive drool method immediately before and 30 minutes after exposure therapy in sessions 6, 8, and 10 in order to examine the endogenous cortisol response to exposure therapy. Therapy sessions will be delivered individually with either a provisional or registered psychologist. The duration of sessions will be 60 minutes. The treatment is manualised and the content of sessions will include psycho-education, cognitive restructuring and in-vivo exposure. Adherence to the treatment will be measured by monitoring session attendance. Between session adherence will be measured based on homework compliance (a rating on a scale of 0-4 is given to each participant at each session based on the homework compliance).

Sponsors

University of Tasmania
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

- Primary diagnosis of SAD - Aged 18 and 65 years - Able to read and write English fluently - Able to attend treatment sessions 3 times per week.

Exclusion criteria

- Pregnant (due to hormonal/cortisol changes) - Severe depression, suicidality or psychosis - History of abnormal menstrual cycles, hormonal disorder or endometriosis - Intellectual or cognitive impairment that interferes with ability to provide informed consent or to engage in CBT - History of brain injury or neurological disorder.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026