Evaluation of the Effects of Post-Session Administration of D-cycloserine On Exposure Therapy Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acrophobia Questionnaire With Avoidance (AAVQ)
研究概览
简要总结
The purpose of this study is to investigate the utility of post-session administration of D-cycloserine to enhance fear extinction in a sample of people with acrophobia who will be treated with CBT.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females 18-65 years of age with a psychiatric diagnosis of acrophobia defined by DSM-IV criteria.
- •Willingness and ability to comply with the requirements of the study protocol.
排除标准
- •A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance (amphetamines, benzodiazepines, barbiturates, cocaine metabolites, marijuana, narcotics, and sedative hypnotics) abuse or dependence or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
- •Patients with posttraumatic stress disorder and panic disorder within the past 6 months are excluded. Entry of patients with other mood or anxiety disorders will be permitted in order to increase accrual of a clinically relevant sample. Patients with significant suicidal ideation (MADRS item 10 score > 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- •Patients must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.
- •Significant personality dysfunction likely to interfere with study participation.
- •Serious medical illness or instability for which hospitalization may be likely within the next year.
- •Patients with a current or past history of seizures.
- •Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
- •Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of acrophobia is excluded. Prohibited psychotherapy includes CBT therapy focusing on exploring specific, dynamic causes of the phobic symptomatology and provides management skills. General supportive therapy initiated > 3 months prior is acceptable.
- •Prior non-response to adequately delivered exposure (i.e., as defined by the patient's report of receiving specific and regular exposure assignments as part of a previous treatment) will exclude participants from the study.
- •Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
- •Patients receiving isoniazid.
- •Patients unable to understand study procedures and participate in the informed consent process.
研究组 & 干预措施
Sugar Pill
Participants will receive placebo augmented cognitive behavioral therapy
干预措施: Individual Cognitive Behavioral Therapy (CBT) (Behavioral)
Sugar Pill
Participants will receive placebo augmented cognitive behavioral therapy
干预措施: Placebo (Drug)
D-Cycloserine
Participants will receive D-Cycloserine augmented cognitive behavioral therapy
干预措施: Individual Cognitive Behavioral Therapy (CBT) (Behavioral)
D-Cycloserine
Participants will receive D-Cycloserine augmented cognitive behavioral therapy
干预措施: D-Cycloserine (Drug)
结局指标
主要结局
Acrophobia Questionnaire With Avoidance (AAVQ)
时间窗: 2 months
Self-report measure that assesses fear and avoidance of a variety of heights situations. This questionnaire (Cohen, 1977) describes 20 situations and assesses levels of avoidance (0-3) and anxiety (0-6). These scales widely used measure of acrophobia with adequate retest reliability (r = .82-.86) and validity (Baker et al., 1973). Higher scores indicate higher levels of avoidance/anxiety (i.e., worse outcome). All subscales are summed for a total score. AAVQ will be assessed at each visit throughout the 2 month protocol. The minimum score is 0, the maximum is 90.
次要结局
- Attitudes Towards Heights Questionnaire (ATHQ)(2 months)
- Clinical Global Improvement Scale (CGI)(2 months)
- Behavioral Avoidance Test (BAT)(2 months)
研究者
Jasper Smits, Ph.D.
Principal Investigator
Southern Methodist University