D-Cycloserine and Virtual Reality Exposure Therapy Delivered on an iPad: Increasing Access to Treatment for Social Anxiety Disorder
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in behavioral avoidance
研究概览
简要总结
The proposed project aims to increase accessibility of exposure therapy, an evidence based treatment for social anxiety disorder, by adapting a therapist-assisted computer-based program to be delivered in a self-guided manner on an iPad. A significant problem with self-guided treatment delivered via computer is compliance. The vast majority of users do not complete treatment, so achieving therapeutic benefit as quickly as possible is essential. D-cycloserine is a drug found to augment response to therapist-guided exposure therapy for anxiety disorders, but has never been tested with self-guided exposure. This study uses a randomized, double-blind methodology to compare D-cycloserine (50 mg; DCS) to placebo in combination with self-guided virtual reality exposure therapy (VRE) delivered via iPad to treat social anxiety disorder. The proposed study tests the hypothesis that patients who receive DCS in combination with the self-guided VRE will show more improvement than those who receive placebo in combination with VRE. Outcome measures include self-reported symptoms of social anxiety, behavioral avoidance, and diagnostic remission. Participants (N=34) are adults with a primary diagnosis of social anxiety disorder. Participants will complete a structured diagnostic interview, standardized self-report measures of social anxiety, and a behavioral avoidance task (i.e., giving a speech) and will be assessed at pre-treatment, at post-treatment and at 3 month follow-up. Hierarchical linear regression and chi-square analyses will be used to test differences between those randomized to DCS versus placebo on the following outcomes: post-treatment scores of self-reported social phobia symptoms, willingness to and anxiety while giving a speech at post-treatment, and diagnostic remission at 3 month follow-up. The proposed project combines technological advances with translational research to develop an innovative and accessible treatment for those with social anxiety disorder. The pilot data generated from this study will be appealing to a variety of funding agencies, including the National Institute of Mental Health's call for exploratory clinical trials of novel interventions for mental illnesses, the Patient-Centered Outcomes Research Institute's call for effectiveness studies aimed to overcome barriers to treatment, and the National Science Foundation's call for innovation-technology translation research.
详细描述
Social Anxiety Disorder (social phobia) is the most common psychiatric disorder in the US. It negatively impacts health-related quality of life, educational and economic achievement, and it leads to attempted suicide in as many as 21% of affected individuals. A critical barrier to progress in reducing the negative impact of this disorder is that 75-92% of sufferers do not receive treatment. Social phobia self-help programs delivered via computer are designed to increase access to treatment and can be effective. Compliance and completion rates of such programs are, however, quite poor, greatly limiting their impact and accessibility. Furthermore, self-help programs for social phobia do not directly administer a critical component of treatment - exposure therapy. The direct administration of self-guided exposure therapy, using virtual reality is an innovation that would increase the accessibility and impact of computer delivered treatment.
Exposure therapy is based on well-researched fear extinction learning paradigms, where individuals confront what they fear in a therapeutic manner and learn that the feared outcome will not occur. Ressler et al's groundbreaking translational research showed that D-cycolserine (DCS), an analogue of D-alanine and a partial agonist at the NMDA receptor, facilitates the process of fear extinction. DCS is different from other pharmacological agents used to treat social phobia which are prescribed chronically (daily) over a period of months or years to maintain a therapeutic dose; one pill of DCS is taken immediately before exposure therapy sessions. This work sparked a flurry of research showing that DCS augments exposure therapy for a variety of anxiety disorders; people who take DCS show benefit from therapist-assisted exposure therapy more quickly than those who take placebo. Two randomized double-blind, placebo-controlled studies of social phobia conclude that the combination of DCS and therapist-assisted exposure therapy improves treatment response when participants complete fewer exposure sessions. The ability of DCS to speed up the response to exposure therapy is especially valuable for sufferers using self-guided treatment, because they are not generally compliant with the full exposure protocol. The combination of DCS and self-guided exposure therapy would increase access to effective treatment. The use of DCS with self-guided exposure, however, has never been tested.
Specific Aims
- Adapt an existing computer program to deliver self-guided VRE for social phobia via iPad, and
- Test the comparative efficacy of DCS vs placebo plus self-guided VRE.
Hypothesis: Participants who receive self-guided VRE plus DCS will show less self-reported social anxiety and less avoidance during a laboratory based behavioral test following a 5-week intervention than those who received self-guided VRE plus placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and provide written informed consent prior to conduct of any study procedures.
- •Be able to communicate in English with study personnel
- •Be able to manipulate the computer interface to interact with the program
- •If female, must have a negative pregnancy test prior to treatment and be maintained on an acceptable method of birth control during treatment
- •If using psychotropic medication, stable on medication and dosage for 3 months
排除标准
- •Participation in clinical trial within the past 12 months or treatment with DCS in a previous study
- •History of mania, schizophrenia, or other psychoses
- •Any unstable medical condition; Seizure disorders, with the exception of a childhood history of isolated, non-recurrent febrile seizures
- •Current or past substance (except nicotine, caffeine) or alcohol dependence based on DSM-V criteria within six months prior to screening
- •Liebowitz Social Anxiety Scale (LSAS) score of < 50 at baseline
研究组 & 干预措施
DCS
Participants will receive 50mg of Seromycin (aka D-cycloserine) in conjunction with virtual reality exposure therapy once a week for 4 weeks.
干预措施: Seromycin (Drug)
DCS
Participants will receive 50mg of Seromycin (aka D-cycloserine) in conjunction with virtual reality exposure therapy once a week for 4 weeks.
干预措施: Virtual Reality Exposure Therapy (Behavioral)
Placebo
Participants will receive a placebo in conjunction with virtual reality exposure therapy once a week for 4 weeks.
干预措施: Virtual Reality Exposure Therapy (Behavioral)
Placebo
Participants will receive a placebo in conjunction with virtual reality exposure therapy once a week for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in behavioral avoidance
时间窗: Week 1, week 7, and 17 weeks after the first session.
Complete Unstructured Conversation and Impromptu Speech Tasks. The assessments will be video recorded and the amount of eye contact - in seconds - will be rated by blind observers. The number of seconds of eye contact can then be compared across time points.
Change in scores on the Clinical Global Improvement Scale, Patient Report
时间窗: Week 7
Assesses diagnostic remission.
Change in scores on the Liebowitz Social Anxiety Scale-self report version (LSAS-SR)
时间窗: Participants will complete this measure once a week for 6 weeks and again at 17 weeks after the first visit.
Measures fear in and avoidance of 24 social situations.
次要结局
- Change in scores on the Patient Health Questionnaire(Week 1, week 7.)
- Change in scores on the Social Interaction Anxiety Scale(Participants will complete this measure once a week for 6 weeks and again at 17 weeks after the first visit.)
- Change in scores on the Sheehan Disability Scale(Week 1, week 7.)
- Change in scores on the Social Phobia Scale(Participants will complete this measure once a week for 6 weeks and again at 17 weeks after the first visit.)
- Change in scores on the Quality of Life Inventory(Week 1, week 7.)
研究者
Page Anderson
Associate Professor
Georgia State University