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Clinical Trials/NCT03159715
NCT03159715
Unknown
Not Applicable

Internet-based Depression Treatment. Differential Efficacy of Different Specific Therapeutic Components: Behavioral Activation and Positive Psychology.

Universitat Jaume I1 site in 1 country192 target enrollmentMay 1, 2017
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Universitat Jaume I
Enrollment
192
Locations
1
Primary Endpoint
Change in the Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996) at pre, post intervention and at 3 and 12 months follow-ups.
Last Updated
5 years ago

Overview

Brief Summary

The objective of the present project is to study the differential effectiveness of three brief self-applied via the Internet interventions for mild to moderate depression: a global protocol composed of several therapeutic components (psychoeducation, cognitive restructuring, behavioral activation, positive psychology, and relapse prevention), a protocol just based on behavioral activation (BA), and a protocol just based on positive psychology (PP). The purpose is to know the specific contribution of each therapeutic components in the treatment of depression.

Detailed Description

Depression is one of the most important health problems worldwide, which generates important costs, both from the economic point of view as from the social and personal one. If not properly treated, it may become chronic and therefore interferes significantly in all areas of operation. Hence, one of the most important challenges within this scope is the design of new ways to apply treatments in a way that maximizes its therapeutic efficiency. Information and Communication Technologies (ICTs) have proven their utility as they are very useful in order to provide help to all those in need. It is a field of study very novel which will become more important in the short term. Several internationally renowned research groups have launched self-applied treatment programs through the Internet in order to address this issue. Results obtained so far are consistent and promising, and show these treatments as effective. However, these treatments have different therapeutic components and it is important to identify the specific contribution of each of them. Therefore, the objective of the present project is to study the differential effectiveness of three brief self-applied via the Internet interventions for mild to moderate depression: a global protocol composed of several therapeutic components (psychoeducation, cognitive restructuring, behavioral activation, positive psychology, and relapse prevention), a protocol just based on behavioral activation (BA), and a protocol just based on positive psychology (PP). A minimum of 192 participants diagnosed with mild to moderate depression symptoms will be randomly assigned to one of the three experimental conditions: an Internet-based global protocol composed of several therapeutic components (n=64); a Internet-based protocol based on BA (n=64), and an Internet-based program based on PP (n=64). Our hypothesis is that it is possible to progress and improve in the treatment of depression through intervention strategies applied through the Internet.

Registry
clinicaltrials.gov
Start Date
May 1, 2017
End Date
November 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universitat Jaume I
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18-65 years old.
  • Having mild to moderate depression symptoms.
  • Providing written, informed consent.
  • Being able to understand and read Spanish.
  • Having daily access to the Internet in their natural environment.

Exclusion Criteria

  • Being diagnosed a severe mental disorder (people with the following mental disorders will be excluded from the study: schizophrenia, bipolar disorder and personality disorders from clusters A and B).
  • Being diagnosed an alcohol and/or substance dependence disorder.
  • The presence of high suicidal risk.
  • A medical disease or condition which prevent the participant from carry out the psychological treatment.
  • Receiving another psychological treatment while the study is still ongoing.
  • The increase and/or changes in the medication of participants receiving pharmacological treatment during the study.

Outcomes

Primary Outcomes

Change in the Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996) at pre, post intervention and at 3 and 12 months follow-ups.

Time Frame: Up to 12 months

The BDI-II is one of the most widely used questionnaires to evaluate the severity of depression in pharmacological and psychotherapy trials. It consists of 21 items about the different symptoms characterizing the major depression disorder, summed to obtain the total score, which 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.

Secondary Outcomes

  • The Positive and Negative Affect Schedule (PANAS) (Watson, Clark y Tellegen, 1988; Sandín et al., 1999) at pre, post intervention and at 3 and 12 months follow-ups.(Up to 12 months)
  • Overall Depression Severity and Impairment Scale (ODSIS) at pre, post intervention and at 3 and 12 months follow-ups.(Up to 12 months)
  • Multicultural Quality of Life Index (MQLI) at pre, post intervention and at 3 and 12 months follow-ups.(Up to 12 months)
  • Overall Anxiety Severity and Impairment Scale (OASIS) Overall Depression Severity and Impairment Scale (ODSIS) at pre, post intervention and at 3 and 12 months follow-ups.(Up to 12 months)

Study Sites (1)

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