Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders: a Randomized Controlled Trial Using a Mixed Methods Approach
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
CBT Treatment with in vivo exposure
In this condition participants will receive CBT treatment and be exposed to in vivo situations.
Intervention: 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.
Intervention: Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT (Behavioral)
Outcomes
Primary Outcomes
Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)
Time Frame: 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
Time Frame: 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")
Secondary Outcomes
- 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))