Behavioral Activation for Major Depression With and Without Mindfulness

University Hospital Miguel Servet

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: Behavioral Activation with Mindfulness; Behavioral: Behavioral Activation without Mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT04768361

BA11.2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be older than 18 years of age,
• To meet current DSM-5 criteria for major depression
• Be willing to participate in the study
• Be able to understand and read Spanish.

Exclusion criteria

• Not being able to read and write;
• Psychiatric conditions present that may affect study participation: schizophrenia, substance abuse, bipolar disorder, eating disorders, obsessive-compulsive disorder, social phobia, self-injurious behavior without suicidal intent;
• Be in psychotherapy;
• Have participated in three sessions of behavioral therapy and / or cognitive therapy;
• Have regular practice in any type of meditation;
• Disagreement in maintaining the dose of psychotropic medications without changes during the session period, if in use.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Behavioral Activation without Mindfulness

Experimental group

Description:

Program with 8 face to face sessions (115 minutes/session) in groups of 15-18 people. This program was adapted from BA proponents and excludes terms and interventions from Third Generation Therapies.

Treatment:

Behavioral: Behavioral Activation without Mindfulness

Behavioral Activation with Mindfulness

Experimental group

Description:

Program with 8 face to face sessions (115 minutes/session) in groups of 15-18 people. This program was adapted from BA proponents and include mindfulness practices.

Treatment:

Behavioral: Behavioral Activation with Mindfulness