NCT04768361

Behavioral Activation for Major Depression With and Without Mindfulness

Behavioral Activation for Major Depressive Disorder: Comparison Between Protocols With and Without Mindfulness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Hospital Miguel Servet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to compare, in individuals who meet the diagnostic criteria for major depression, the effects of Behavioral Activation (BA) strictly behavioral with a BA protocol that includes mindfulness practices. The secondary objectives are: a) to verify if the changes in the level of depressive symptoms found after the treatment will be kept during the follow-up in both groups; b) evaluate the possible moderating role of baseline depression levels on the effectiveness of interventions; c) evaluate relapse rates after treatment; and d) test a BA protocol as a single treatment. The primary hypothesis is that BA protocol with mindfulness practices is superior to BA without mindfulness practices.

Detailed description

Depression, according to the Word Health Organization, is the leading cause of disability in the world, often leading to a decrease in productivity and the departure from work activities, which generates economic impacts to the own health system. Between 2005 and 2015, an increase of almost 20% was identified in cases of depression worldwide. The impact of the disease on the world economy between 2011 and 2030 is expected at US $ 5,36 billion. Behavioral Activation (BA) and interventions with mindfulness are recognized as effective for depression. On the other hand, as currently the BA is complemented with strategies of the Third Generation Therapies, including mindfulness, no study has compared a protocol strictly behavioral with any treatment and there is also insufficient data to affirm if the BA has better benefits than interventions that include or are based on mindfulness or vice versa. The aim of this study is is to compare, in individuals who meet the diagnostic criteria for major depression, the effects of BA strictly behavioral with a BA protocol that includes mindfulness practices. The two intervention are face to face, in group (8 weeks), by a randomized controlled trial (RCT). Our main hypothesis is that la intervencion BA with mindfulness practices will be more efficacious to improve the symptomatology depressive, compared to a group with only BA the end of treatment. 150 participants diagnosed with depression will participate in the RCT.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Activation without Mindfulness	"Behavioral Activation without Mindfulness" includes functional analysis as key to defining out-of-session and activation strategies as central to mood change.
BEHAVIORAL	Behavioral Activation with Mindfulness	"Behavioral Activation with Mindfulness" includes functional analysis as key to defining out-of-session and activation strategies and mindfulness as central to mood change.

Timeline

• Start date: 2020-08-10
• Primary completion: 2020-10-15
• Completion: 2021-04-27
• First posted: 2021-02-24
• Last updated: 2022-03-25

Locations

1 site across 1 country: Spain