Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders: a Randomized Controlled Trial Using a Mixed Methods Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)
研究概览
简要总结
The aim of this study is to develop and test the efficacy of first-of-its-kind, fully instrumented sensor-based smartphone-guided in-vivo exposure therapy using a just-in-time intervention for anxiety disorder. The main hypotheses are:
- Both treatment conditions (CBT treatment with IVE and CBT treatment with IVE+SYMPTOMS-JIT) will show efficacy and no statistically significant differences will be found between them. The efficacy will be determined for the differences in pre-post treatment in the used outcome measures.
- The therapeutic gains obtained in both treatment conditions (IVE and (IVE+SYMPTOMS-JIT) will be maintained at 1-, 6-, and 12-month follow-up periods.
- Both treatment conditions will be efficient, that is, they will be well-valued by patients and therapists. However, IVE+SYMPTOMS-JIT will be preferred and perceived as less aversive than IVE.
- The main barriers for the use of this technology are not technological, but rather attitudinal and they can be identified through qualitative studies.
详细描述
Anxiety Disorders are one of the most prevalent psychological problems around the world and if not treated they tend to become chronic. Cognitive Behavioral Therapy (CBT) is the treatment of choice, being the component of in vivo exposure (IVE) the central feature. Despite its efficacy it is still a hard component to implement for the patients. Information and Communication Technologies (ICT) can help assisting and/or applying psychological interventions. The proposed study will fill the existing gap in this sense as it will assess the efficacy of a fully configurable, sensor-guided and location-based (GPS) app for the in vivo exposure component. It will also address the shortage of clinical validation studies of mHealth apps thanks to the proposed RCT. The study will expand our knowledge about the use of technologies in mental health problems and help improve the effectiveness of exposure therapy.
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
- None
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
- •Being at least 18 years or older.
- •Meeting DSM-5 diagnostic criteria (APA, 2013) for anxiety disorder, specifically specific phobia, agoraphobia, panic disorder and social phobia.
- •Being willing to follow the study conditions.
- •Sign the consent form.
排除标准
- •Having another psychological problem that requires immediate attention.
- •Having current alcohol or drug dependence or abuse, psychosis or severe organic illness.
- •Currently being treated in a similar treatment program.
- •Taking anxiolytics during the study (or in the case of taking them, changing drug or dose during the study).
研究组 & 干预措施
CBT Treatment with in vivo exposure
In this condition participants will receive CBT treatment and be exposed to in vivo situations.
干预措施: Cognitive behavioral therapy with in vivo exposure (Behavioral)
CBT Treatment with in vivo exposure plus SYMPTOMS-JIT
In this condition participants will receive CBT treatment and be exposed to in vivo situations with the support of SYMPTOMS-JIT.
干预措施: Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT (Behavioral)
结局指标
主要结局
Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)
时间窗: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
It is a specific diagnostic semistructured interview for the diagnosis of anxiety disorders. Phobias, Agoraphobia and Social Phobia Sections will be used. For the majority of anxiety disorders, this interview has demonstrated appropriate psychometric qualities and good to exceptional reliability (Orsillo \& Roemer, 2001). This instrument includes relevant clinical measures such as interference and distress as perceived by the participant on a scale from 0 to 8 (wherein 0 = "Not at all" and 8 = "Very severe")
Fear and avoidance scales
时间窗: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
The participants and therapists identify the situations and physical sensations that cause the participants the most fear and distress, as well as the negative thoughts associated with them. Next, they assess, on a scale of 0-10, the degree of fear (0="no fear"; 10="extreme fear") and avoidance (0="never avoid"; 10="always avoid") for each feared situation and sensation. In addition, the degree of belief in the negative thoughts related with the target behaviors and sensations are also assessed, using a scale ranging from 0 ("I do not believe the content of the thought at all") to 10 ("I believe the thought is totally true")
次要结局
- Acrophobia Questionnaire(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Fear Questionnaire (FQ)(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Social Interaction Anxiety Inventory (SIAS)(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Fear of negative evaluation scale(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Social avoidance and distress scale(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Panic Disorder Severity Scale (PDSS-SR)(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Severity Measure for Specific Phobia - Adult(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Claustrophoby Questionnaire(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Fear of Flying Questionnaire II(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Anxiety Sensitivity Inventory(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Agoraphobia Inventory(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Overall Depression Severity and Impairment Scale(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Overall Anxiety Severity and Impairment Scale(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))
- Behavioral Avoidance Test(Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months))