Development and Validation of an Online Treatment Program for Adjustment Disorders

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and effectiveness of a self-help treatment for adjustment disorders administered through a computerized program applied over the Internet. This treatment modality will be compared with a waiting list control group. It is expected that, on the one side, the intervention group will improve significantly compared to the waiting list control group. On the other side, it is expected the self-applied online treatment program to be well accepted and valued by the patient.

Detailed Description
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Adjustment Disorder (AD) is a highly prevalent health problem that causes a great suffering and can result in suicidal thinking and/or behavior. However, unlike mood and anxiety disorders, AD has received little attention from scientific community and very few studies have been carried out to develop evidence-based treatments (EBT) for this problem. Besides, although a cognitive behavioral therapy (CBT) protocol is currently available for the treatment of AD, many patients with this diagnosis remain untreated. There is therefore an evident need to design strategies that guarantee the patients receive adequate treatment. A feasible solution might be self-administered computerized CBT (cCBT). A growing body of research has found that cCBT is highly effective for anxiety and depressive disorders, achieving clinical improvements similar to those obtained with traditional face-to-face interventions. The use of internet to administer EBT allows reducing the contact time between the patient and the therapist and this way reach people who otherwise would not receive treatment. Therefore, the development of a cCBT for AD will mean an improvement in the delivery and dissemination of the current treatment programs. This is especially relevant for this problem considering the scarce attention received by the scientific community and the high interference caused in the patients' life. As far as we know, there is no cCBT program specifically designed for the treatment of AD. As a consequence, further research in this area is needed.

Official Title
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Efficacy of an Internet-based CBT Program for Adjustment Disorders: A Randomized Controlled Trial

Conditions
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Online Computerized Program Group, Waiting List Control Group

Intervention / Treatment
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* Other: TAO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between 18 and 65 years of age. Meet DSM-V (APA, 2013) criteria for Adjustment Disorder. Be able to understand and read Spanish. Be able to use a computer and have an Internet connection at home. Have an e-mail address. If having any medication, not change the drug or the dose during the treatment period. Exclusion Criteria: Be receiving other psychological treatment. Meet criteria for other severe mental disorder on Axis I: abuse or dependence of alcohol or other substances, psychotic disorder, dementia or bipolar disorder. Meet criteria for a severe personality disorder or illness. Presence of risk of suicide or self-destructive behaviors.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Computerized Program group.<br>Intervention group that uses TAO program. | Other: TAO<br>* TAO is a self-applied online treatment program and consists on the computerized version of the traditional CBT protocol for Adjustment Disorders. The treatment protocol comprises different therapeutic components (see section Intervention) which are presented to the patients through 7 modules (one of them introductory). The Internet platform allows audiovisual resources (videos, illustrations, music and exercises that provide quick feedback) to be included, that makes the program more interactive.<br>* Other names: Internet-based CBT for Adjustment Disorders;|
| No Intervention: Waiting list control group.<br>Participants of this group are able to access the treatment program after 7 weeks of waiting period. After this waiting period of 7 weeks, those participants still interested in receiving assistance are randomly assigned to one of two intervention conditions (Online Computerized Program group or Bibliotherapy group). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beck Depression Inventory - Second Edition (BDI-II) (Beck, Steer, & Brown, 1996; validated in Spanish population by Sanz, Navarro, & Vázquez, 2003) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups. | BDI-II is a self-report inventory that measures characteristic attitudes and symptoms of depression. The total score is obtained adding the 21 items which constitute the instrument and can be a maximum of 63 points. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and a test-retest reliability of around 0.8. | Up to 12 months | 
| Change in Beck Anxiety Inventory (BAI) (Beck & Steer, 1990; validated in Spanish population by Magán, Sanz, & García-Vera, 2008) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups. | BAI measures the severity of both physiological and cognitive symptoms of anxiety. The 21 items are rated on a 4-point Likert-type scale (from 0 to 3) and the total score, which oscillates between 0 and 63, is obtained after directly adding the score of each item. Psychometric analysis carried out so far show excellent internal consistency (Cronbach's alpha ≥ 0.85). | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Inventory of Stress and Loss (Mor, Molés, Rachyla, & Quero, 2015) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups. | This inventory is an adaptation of the Complicated Grief Inventory (CGI; Prigerson et al., 1995). It consists of 17 first-person statements regarding the degree to which the lost person/situation interferes in the individual's life. There are 5 response options, ranging from 0 (Never) to 4 (Always). The instrument has excellent internal consistency (Cronbach's alpha .86) and a test-retest reliability of around 0.90 | Up to 12 months | 
| Change in Posttraumatic Growth Inventory (PTGI) (Tedeschi & Calhoun, 1996) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups. | PTGI is a 21-item instrument which assesses positive outcomes reported by persons who have experienced traumatic events. A 6-point Likert response format is used, so that each statement is rated from I did not experience this change as a result of my crisis (scored 0), to I experienced this change to a very great degree as a result of my crisis (scored 5). The instrument has an excellent internal consistency (Cronbach's alpha of 0.90) and acceptable test-retest reliability of around 0.71. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjustment disorders online, Psychological Treatments, Information and Communication Technologies, Internet