A Blended Intervention for Adjustment Disorder.

Study Overview
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Brief Summary
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The aim of this study is to evaluate the feasibility (including usability and satisfaction) and preliminary effectiveness of a blended intervention for Adjustment Disorder. This intervention combines a self-applied Internet-based program (TAO) with face-to-face sessions with a therapist via videoconference.

Detailed Description
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Adjustment disorder (AjD) is one of the most commonly diagnosed disorders in clinical practice. However, although there is still no evidence-based treatment for this problem, Cognitive Behavioral Therapy (CBT) is the most studied. Internet-based treatments emerge as an alternative to reach more people in need while reducing intervention costs. However, high drop-out rates in this format highlight the need to develop new ways of delivering treatments. The present study aims to test a blended treatment for AjD that combines a self-applied CBT programme online (TAO: Adjustment Disorder Online) with face-to-face sessions with a therapist via videoconference every 10-12 days. Only one treatment group has been included and patients will be evaluated at pre-treatment, post-treatment and follow-up (3 and 12 months). The study will be conducted following the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement for pilot and feasibility studies (Eldridge et al., 2016), the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and online TeleHealth guidelines (Eysenbach, 2011), and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (Chan et al., 2013a; 2013b). Specific objectives of the study include: (1) To analyse the feasibility of different recruitment and data collection methods (e.g., how broad or restrictive are the eligibility criteria, how willing are patients to participate, time needed to collect data), (2) To explore reasons for non-participation and drop-outs from treatment, (3) To assess patient satisfaction and acceptance of treatment (both quantitatively and qualitatively), (4) In addition, as a secondary objective to explore the potential effectiveness of the treatment at post-treatment and follow-up.

Official Title
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A Blended Intervention for Adjustment Disorder: Feasibility Trial and Preliminary Effectiveness.

Conditions
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Adjustment Disorders

Intervention / Treatment
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* Behavioral: • Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Meeting diagnostic criteria for Adjustment Disorder based on the International Classification of Diseases 11 edition (ICD-11). Exceed the cut-off point of 47.5 on the Adjustment Disorder New Module-20 scale (ADNM-20; Lorenz et al., 2016). Sign an informed consent. Ability to understand and read Spanish. Ability to use a computer and having access to the Internet. Having an e-mail address. Exclusion Criteria: Presence of risk of suicide or self-destructive behaviors. Presence of another severe mental disorder (substance abuse or dependence, psychotic disorder, dementia, bipolar disorder or personality disorder). Receiving other psychological treatment during the study for AjD. An increase and/or change in the medication during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will be assessed for eligibility and if they meet the inclusion criteria they will be assigned to the single treatment group (single arm). All patients will receive the same blended intervention that combines the self-applied online TAO program with videoconferencing sessions with a therapist.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blended intervention for AjD.<br>Blended intervention for AjD. Main components: psychoeducation, techniques for regulating emotions, exposure, problem-solving techniques, Mindfulness, acceptance and elaboration of the stressful event, positive psychology strategies and relapse prevention. | Behavioral: • Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference.<br>* The self-applied Internet-based program called TAO is accessible online from the platform https://psicologiaytecnologia.labpsitec.es. It is organised into 7 sequential modules of approximately 60 minutes. The patient will do a treatment module every 10-12 days, plus an individual session via videoconference with a therapist (approximately 20-30 minutes long). During these sessions, the therapist will explain the main contents of each module, resolve doubts and motivate the patient to continue with the therapy. It takes about 12 weeks to complete the intervention. TAO is the optimised version of the original intervention protocol for AjD developed by Botella et al. by Botella et al. (2008) and includes the following therapeutic components: psychoeducation, emotion regulation techniques, exposure, problem-solving techniques, Mindfulness, acceptance and elaboration of the stressful event, positive psychology strategies and relapse prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' adherence to the intervention. | Drop-outs rates (and reasons), number of modules completed, number of times participants enter treatment, time spent in treatment and whether they do reviews. | At post-treatment (approximately 12 weeks from the beginning). | 
| Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972). | This questionnaire consists of two different scales. Both include 6 items with a response scale ranging from 0 (not at all) to 10 (completely). One of the scales refers to the expectations about the treatment and it is administered before starting the treatment once an explanation about it has been carried out. The other scale refers to the patients' opinion once they have finished the intervention. | At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months). | 
| Opinion Questionnaire about the intervention | It assesses participants' opinion about TAO online program, the videoconference sessions with the therapist and the blended format. The questions refer to the satisfaction and usefulness of these components using a response scale from 0 to 10 and open-ended opinion questions. | At post-treatment (approximately 12 weeks from the beginning). | 
| Working Alliance Inventory for guided Internet Interventions (WAI-I) adapted from Horvath and Greenberg (1989). | The WAI-I scale assesses the different components of therapeutic alliance according to Bordin (1979). This version is adapted for internet-based treatments and consists of 12 items with a response scale from 1 (never) to 7 (always). | At post-treatment (approximately 12 weeks from the beginning). | 
| Usability System Scale (SUS; Bangor et al., 2008; Brooke,1996). | This scale assesses the usability of a service or product and the acceptance by the users. It consists of 10 items with a response scale ranging from 1 (strongly disagree) to 5 (strongly agree). | At post-treatment (approximately 12 weeks from the beginning). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adjustment Disorder New Module-20 (ADNM-20; Einsle et al., 2010). | Self-report based on ICD-11 diagnostic criteria for AjD. It includes a list of stressful events and another of symptoms. Patients' symptomatology is evaluated in reference to the stressful event that they consider most interferes with them. It uses a response scale from 1 (never) to 4 (frequently). Higher scores indicate greater symptomatology. Lorenz et al. (2016) suggest that a cut off at 47.5 can differentiate between people with low and high risk of AjD. | At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months). | 
| Change in the Loss and Stress Inventory (IEP) (Quero et al., 2019). | The IEP consists of 17 items that assess the intensity with which a situation or person lost as a result of the stressful event interferes with the patient's life. It uses a response scale from 0 (never) to 4 (always). | At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months). | 
| Change in the Positive and Negative Affect Scale (PANAS trait) (Watson et al., 1988; Díaz-García et al., 2020). | The PANAS assesses two dimensions of mood (positive affect and negative affect). It consists of 20 items describing different emotions or feelings. The patient must respond to the extent to which he or she usually feels the way each expression, using a response scale from 1 (not at all or hardly at all) to 5 (very much). | At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months). | 
| Change in the Posttraumatic Growth Inventory (PTGI) (Tadeschi and Calhoun,1996; Weiss et al., 2006). | This measure includes 21 items that assess positive psychological change following an adverse or traumatic experience. It uses a response scale ranging from 0 (I did not experience this change as a result of the crisis) to 5 (I experienced this change to a great extent). | At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months). | 
| Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Norman et al., 2006; González-Robles et al., 2018). | The OASIS measures the frequency and severity of anxiety symptoms, as well as the degree of avoidance and interference. It consists of 5 items with a response scale from 0 to 4. Higher scores indicate greater severity or frequency of symptomatology. | At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months). | 
| Change in the Overall Depression Severity and Impairment Scale (ODSIS; Norman et al., 2006; Mira et al., 2019). | The ODSIS measures the frequency and severity of depressive symptoms, as well as the degree of avoidance and interference. It consists of 5 items with a response scale from 0 to 4. One additional item has been included to assess suicide ideation. Higher scores indicate greater severity or frequency of symptomatology. | At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjustment Disorders, Internet-based treatment, Blended intervention, Feasibility, Videoconferencing