Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Jaume I

About this trial

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:

1. 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. 2. 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. 3. 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. 4. The main barriers for the use of this technology are not technological, but rather attitudinal and they can be identified through qualitative studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive behavioral therapy with in vivo exposure

    Behavioral

    CBT will be used as the chosen approach for ADs. The main components will be psychoeducation and to help patients to challenge and change unhelpful cognitive distortions (e.g., thoughts, beliefs, and attitudes) and behaviors (e.g., avoidance), develop emotion regulation strategies (e.g., cognitive reappraisal), and learn coping strategies that target problem-solving. The practice is developed in several sessions that usually last between 10 and 20 sessions. Specifically, the exposure component will be considered as the first-line treatment. During the exposure component, patients will confront themselves over a long period of time, repetitively, with a feared stimulus until distress has decreased significantly by the exposure.In this condition participants will receive CBT treatment and be exposed to in vivo situations.

  • Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT

    Behavioral

    CBT will be used as the chosen approach for ADs. The main components will be psychoeducation and to help patients to challenge and change unhelpful cognitive distortions (e.g., thoughts, beliefs, and attitudes) and behaviors (e.g., avoidance), develop emotion regulation strategies (e.g., cognitive reappraisal), and learn coping strategies that target problem-solving. The practice is developed in several sessions that usually last between 10 and 20 sessions. Specifically, the exposure component will be considered as the first-line treatment. During the exposure component, patients will confront themselves over a long period of time, repetitively, with a feared stimulus until distress has decreased significantly by the exposure. In this condition participants will receive CBT treatment and be exposed to in vivo situations with the support of SYMPTOMS-JIT.

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: CBT Treatment with in vivo exposureActive comparator 1 intervention
Group B: CBT Treatment with in vivo exposure plus SYMPTOMS-JITExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)

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")

Time frame
Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
2

Fear and avoidance scales

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")

Time frame
Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

Secondary outcomes

1

Severity Measure for Specific Phobia - Adult

The SMSP-A is a 10-item measure that assesses the severity of specific phobia in adults during the last 7 days. Each item is rated on a 5-point scale, from 0 (never) to 4 (all of the time). Greater scores indicate more severe specific phobia, being the overall score 40.

Time frame
Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
2

Acrophobia Questionnaire

The AQ evaluates severity of anxiety and avoidance related to different situations that have to do with heights. It consists of 40 items divided into two subscales. On the one hand, there is an anxiety subscale where it is necessary to indicate the degree of anxiety, tension, or discomfort caused in the situations described, responding on a 0 to 6 point Likert-type scale ("no anxiety, calm and relaxed" - "extremely anxious"); and on the other hand, there is an avoidance subscale, where the response is coded on a 0 to 2 point Likert-type scale ("I would not try to avoid it" - "I would not bear it under any circumstances")

Time frame
Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
3

Claustrophoby Questionnaire

The CLQ consists of descriptions of 26 claustrophobic situations. Participants are asked about the degree to which they would feel anxious in these situations according to a 5-alternative Likert-type scale, where (0) is "not at all anxious" and (4) is "extremely anxious." The CLQ consists of two subscales: restriction of movement, ranging from items 1 to 12, and suffocation, ranging from items 13 to 26.

Time frame
Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
4

Fear of Flying Questionnaire II

This is a list of 30 situations related to flying that can cause discomfort or anxiety, divided into three subscales: in-flight situations, pre-flight situations, and vicarious situations. The items (each representing a situation) are rated on Likert scales from 1 (minimal discomfort) to 10 (maximum discomfort), and therefore the score ranges from 30 to 300.

Time frame
Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

Other outcomes

1

DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)

DSM-5 criteria will be considered

Time frame
Baseline, up to 12 weeks (average)
2

The Clinician Severity Scale

It uses a scale from 0 (absent/none) to 8 (very disturbing/disabling).

Time frame
Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
3

Item Short Form Health Survey (SF-12)

The SF-12 is a self-report that measures the impact of health on everyday life. It comprises 12 items and it is a valid and reliable measure. The internal consistency is great.

Time frame
Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
4

Quality of Life Inventory

It is a 10-item self-report that assesses various aspects of quality of life. These dimensions are rated on a 10-point Likert scale, ranging from 1 (poor) to 10 (excellent). The dimensions include physical well-being, psychological/emotional well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, social-emotional support, community and services support, personal fulfillment, spiritual fulfillment, and overall perception of quality of life. The total score is calculated as the average of all items and ranges from 1 to 10, with scores between 1 and 4.5 indicating a perception of quality of life below average, scores between 4.6 and 8.1 indicating an average perception, and scores between 8.2 and 10 indicating a perception above average. Test-retest reliability (0.89) and internal consistency (α = 0.89) are strong; discriminant validity is demonstrated in a sample of patients with mental illness.

Time frame
Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

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