None listed
Conditions
Brief summary
The primary aim of this study is to examine to acceptability and efficacy of an internet delivered VCBT for GAD. A secondary aim is to examine the acceptability and efficacy of a brief VCBT treatment for GAD. The aim of this study is to recruit and treat participants with generalized anxiety disorder using a cognitive behavioural treatment program administered remotely via internet videoconferencing. Participants in the treatment group will begin the program immediately, and their results will be compared with a waitlist control condition. Participants in Group 2 will receive access to a brief version of the program when Group 1 completes treatment (Week 10). Outcome measures will be administered at baseline, mid treatment, post treatment and 3 month follow-up. Based on the limited existing literature it is hypothesized that high intensity VCBT will 1) be acceptable to individuals with GAD; 2) result in significant reductions in symptoms, resulting in large within-group and between-group effect sizes at post-treatment and three-month follow up; and 3) brief VCBT will result in outcomes similar to those seen in standard face-to-face treatment.
Interventions
Treatment will follow a manualized videoconference delivered cognitive behavioural (VCBT) intervention which is informed by the Intolerance of Uncertainty Model of GAD (Dugas & Robichaud, 2007; Robichaud et al., 2019).
The modes of treatment for this study will be cognitive behavioural therapy delivered via an internet videoconferencing platform.
Those in the immediate treatment condition will receive 10 weekly (50 minute) treatment sessions to be conducted via Zoom (Zoom Video Communications I
Treatment will follow a manualized videoconference delivered cognitive behavioural (VCBT) intervention which is informed by the Intolerance of Uncertainty Model of GAD (Dugas & Robichaud, 2007; Robichaud et al., 2019). The modes of treatment for this study will be cognitive behavioural therapy delivered via an internet videoconferencing platform. Those in the immediate treatment condition will receive 10 weekly (50 minute) treatment sessions to be conducted via Zoom (Zoom Video Communications Inc., 2016). The treatment for this group will comprise six modules and will cover the following: Module 1: psychoeducation (week 1) Module 2: cognitive restructuring to challenge positive beliefs about worry (weeks 2-3) Module 3: behavioural experiments to develop a greater tolerance to uncertainty (weeks 4-5) Module 4: problem solving training to reduce negative problem orientation (week 6-7) Module 5: imaginal exposure to address cognitive avoidance (week 8-9) Module 6: relapse prevention (week 10) Participants will also be required to complete homework tasks between sessions. When the immediate treatment group concludes treatment the control group will receive a brief version of the same treatment taking place over 5 weeks (i.e., 5 weekly, 50 minute sessions). The same interventions will be covered however a smaller number of sessions will be dedicated to each intervention. Treatment will be delivered by provisionally registered or fully registered psychologist(s) under the supervision of an experienced clinical psychologist. All treating psychologists will be thoroughly trained in the administration of the treatment protocol by the project investigators. All sessions will be recorded and at least 10% of sessions will be randomly selected for treatment compliance and integrity checking. Treating clinicians will receive weekly supervision to review client progress and address clinical issues arising from sessions.
Sponsors
University of Technology Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Australian resident 2. Aged 18 or above 3. English as first language 4. Meet criteria for GAD as primary disorder and disorder is of at least ‘moderate severity’ (defined as a score of 4 on the DIAMOND module severity measure) 5. Medication free or on a stable dose of psychotropic medication 6. Not currently receiving regular psychological services for their GAD symptoms (defined as sessions at least once a week with a qualified mental health professional).
Exclusion criteria
1. Severe depressive symptoms as assessed by a score of 20 or above on the PHQ-9 2. Are at suicide risk as assessed by a score of ‘2’ (more than half the days) or higher on item 9 of the PHQ-9 on the screening questions or via clinician judgement during the telephone interview using the C-SSRS 3. Engage in daily alcohol use or daily illicit drug use 4. Presence of a schizophrenia spectrum disorder as assessed by the DIAMOND 5. Significant cognitive/intellectual impairment as assessed during diagnostic interview 6. Medical condition that may interfere with treatment 7. Do not have access to a computer with a camera and stable internet on a regular basis
Outcome results
None listed