Development and Validation of an Online Treatment Program for Adjustment Disorders (TAO)

U

Universitat Jaume I

Status

Unknown

Conditions

Online Computerized Program Group
Waiting List Control Group

Treatments

Other: TAO

Study type

Interventional

Funder types

Other

Identifiers

NCT02758418
UJaumeI

Details and patient eligibility

About

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.

Full description

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.

Enrollment

68 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

68 participants in 2 patient groups

Online Computerized Program group.
Experimental group
Description:
Intervention group that uses "TAO" program.
Treatment:
Other: TAO
Waiting list control group.
No Intervention group
Description:
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).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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