Clinical Trial: Development and Validation of an Online Treatment Program for Adjustment Disorders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

The purpose of this study is to determine the differential efficacy and effectiveness of a self-help treatment for adjustment disorders administered in two different formats: 1) computerized program applied over the Internet and 2) traditional bibliotherapy sent by e-mail. In addition, both treatment modalities included in the study will be compared with a waiting list control group.

It is expected that, on the one side, both intervention groups will improve significantly compared to the waiting list control group, and the computerized program applied over the Internet will be more effective than the treatment through traditional bibliotherapy sent by e-mail. On the other side, it is expected the self-applied online treatment program to have less drop-outs and be better accepted and valued by the patients than the bibliotherapy condition.

Detailed Summary:

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.

Current Primary Outcome:

• 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. [ Time Frame: Up to 12 months ]
  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.
• 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. [ Time Frame: Up to 12 months ]
  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).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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. [ Time Frame: Up to 12 months ]
  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
• Change in Posttraumatic Growth Inventory (PTGI) (Tedeschi & Calhoun, 1996) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups. [ Time Frame: Up to 12 months ]
  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.

Original Secondary Outcome: Same as current

Information By: Universitat Jaume I

Dates:
Date Received: April 25, 2016
Date Started: April 2016
Date Completion: July 2018
Last Updated: April 27, 2016
Last Verified: April 2016