MedTrace Logo

Behavioral Activation for Major Depression With and Without Mindfulness

NCT04768361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-03-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hospital Miguel Servet

    lead OTHER

Principal Investigators

  • Javier García-Campayo · Miguel Servet Hospital and University os Zaragoza, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2020-10-15
Completion
2021-04-27

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04768361 on ClinicalTrials.gov