Behavioral Activation for Major Depression With and Without Mindfulness

Sponsor

Hospital Miguel Servet (Other)

Overall Status

Completed

CT.gov ID

NCT04768361

Collaborator

(none)

150

Enrollment

Location

Arms

8.5

Actual Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Behavioral: Behavioral Activation without Mindfulness Behavioral: Behavioral Activation with Mindfulness	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 10, 2020

Actual Primary Completion Date :

Oct 15, 2020

Actual Study Completion Date :

Apr 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral Activation without Mindfulness 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.	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.
Experimental: Behavioral Activation with Mindfulness 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.	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.

Arm

Intervention/Treatment

Experimental: Behavioral Activation without Mindfulness

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.

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.

Experimental: Behavioral Activation with Mindfulness

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.

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.

Outcome Measures

Primary Outcome Measures

Depressive symptoms [Basilene]
Beck Depression Inventory (BDI-II): instrument of 21 fragmented items that assesses levels of depressive symptoms in adolescents and adults. Each statement is followed by four options that correspond to a number (0, 1, 2 and 3) so that the participant responds according to the option that best describes how they felt in the last two weeks, including the day of the application of the instrument. The score ranges from 0 to 63. The internal consistency (α) and the correlation (p) found in the original study was .93 and an investigation conducted in Spain the value of Alpha was .89.
Behavioral Activation [Basilene]
Behavioral Activation Scale for Depression - Long Form (BADS): instrument that identifies the levels of activation and avoidance with 25 elements which must be answered from a Likert scale of 0 ("disagree") to 6 ("Totally agree") considering the last week, including the day of application of the instrument. The internal consistency of the total scale obtained in a first study was .92 and with a population of Spanish obtained a similar value of .90.
Depressive symptoms [8 weeks]
Beck Depression Inventory (BDI-II): instrument of 21 fragmented items that assesses levels of depressive symptoms in adolescents and adults. Each statement is followed by four options that correspond to a number (0, 1, 2 and 3) so that the participant responds according to the option that best describes how they felt in the last two weeks, including the day of the application of the instrument. The score ranges from 0 to 63. The internal consistency (α) and the correlation (p) found in the original study was .93 and an investigation conducted in Spain the value of Alpha was .89.
Behavioral Activation [8 weeks]
Behavioral Activation Scale for Depression - Long Form (BADS): instrument that identifies the levels of activation and avoidance with 25 elements which must be answered from a Likert scale of 0 ("disagree") to 6 ("Totally agree") considering the last week, including the day of application of the instrument. The internal consistency of the total scale obtained in a first study was .92 and with a population of Spanish obtained a similar value of .90.
Depressive symptoms [6 months follow up]
Beck Depression Inventory (BDI-II): instrument of 21 fragmented items that assesses levels of depressive symptoms in adolescents and adults. Each statement is followed by four options that correspond to a number (0, 1, 2 and 3) so that the participant responds according to the option that best describes how they felt in the last two weeks, including the day of the application of the instrument. The score ranges from 0 to 63. The internal consistency (α) and the correlation (p) found in the original study was .93 and an investigation conducted in Spain the value of Alpha was .89.
Behavioral Activation [6 months follow up]
Behavioral Activation Scale for Depression - Long Form (BADS): instrument that identifies the levels of activation and avoidance with 25 elements which must be answered from a Likert scale of 0 ("disagree") to 6 ("Totally agree") considering the last week, including the day of application of the instrument. The internal consistency of the total scale obtained in a first study was .92 and with a population of Spanish obtained a similar value of .90.

Secondary Outcome Measures

Automatic Thought Questionnarie (ATQ) [Basilene]
Instrument consisting of 30 items that seeks to measure the frequency of negative thoughts related to depression. The participant must respond on the basis of the last week, including the day of application of instrument, the frequency of the thoughts using a Likert-type scale from 1 ("in absolute") to 5 ("al time"). The internal consistency found at the first validation was from .97 and the adaptation to Spanish found the values of .94 for negative self-concept, hopelessness .93, .87 for maladjustment and .85 for the self-disapproval.
Daily Activity Record (RAD) [Basilene]
Consists of a table for daily logging of activities performed by the individual, classifying the mood between 0 and 10. It may be 0 = "not depressed" and 10 "very depressed" or the other hand, 0 = "very depressed" and 10 = "not depressed"

Other Outcome Measures

Five Facet Mindfulness Questionnaire (FFMQ) [Basilene]
Instrument contains 39 fragmented items into five factors (observing, describing, acting with awareness, nojudging and nonreactivity) that are answered from a Likert scale of 1 ("never" or "very rarely true") to 5 ("very often" or "always true"). The internal consistency (α) and the correlation (p) found in a first study was: observing = .83, describing = .91, acting with awareness = .87, non-judging = 0.87. and nonreactivity = .75. In the Spanish language was found: observing = .81, describing = .91, acting with awareness = .89, nojudging = 0.91. y nonreactivity = .80.
Automatic Thought Questionnarie (ATQ) [8 weeks]
Instrument consisting of 30 items that seeks to measure the frequency of negative thoughts related to depression. The participant must respond on the basis of the last week, including the day of application of instrument, the frequency of the thoughts using a Likert-type scale from 1 ("in absolute") to 5 ("al time"). The internal consistency found at the first validation was from .97 and the adaptation to Spanish found the values of .94 for negative self-concept, hopelessness .93, .87 for maladjustment and .85 for the self-disapproval.
Daily Activity Record (RAD) [8 weeks]
Consists of a table for daily logging of activities performed by the individual, classifying the mood between 0 and 10. It may be 0 = "not depressed" and 10 "very depressed" or the other hand, 0 = "very depressed" and 10 = "not depressed"
Five Facet Mindfulness Questionnaire (FFMQ) [8 weeks]
Instrument contains 39 fragmented items into five factors (observing, describing, acting with awareness, nojudging and nonreactivity) that are answered from a Likert scale of 1 ("never" or "very rarely true") to 5 ("very often" or "always true"). The internal consistency (α) and the correlation (p) found in a first study was: observing = .83, describing = .91, acting with awareness = .87, non-judging = 0.87. and nonreactivity = .75. In the Spanish language was found: observing = .81, describing = .91, acting with awareness = .89, nojudging = 0.91. y nonreactivity = .80.
Automatic Thought Questionnarie (ATQ) [6 months follow up]
Instrument consisting of 30 items that seeks to measure the frequency of negative thoughts related to depression. The participant must respond on the basis of the last week, including the day of application of instrument, the frequency of the thoughts using a Likert-type scale from 1 ("in absolute") to 5 ("al time"). The internal consistency found at the first validation was from .97 and the adaptation to Spanish found the values of .94 for negative self-concept, hopelessness .93, .87 for maladjustment and .85 for the self-disapproval.
Daily Activity Record (RAD) [6 months follow up]
Consists of a table for daily logging of activities performed by the individual, classifying the mood between 0 and 10. It may be 0 = "not depressed" and 10 "very depressed" or the other hand, 0 = "very depressed" and 10 = "not depressed"
Five Facet Mindfulness Questionnaire (FFMQ) [6 months follow up]
Instrument contains 39 fragmented items into five factors (observing, describing, acting with awareness, nojudging and nonreactivity) that are answered from a Likert scale of 1 ("never" or "very rarely true") to 5 ("very often" or "always true"). The internal consistency (α) and the correlation (p) found in a first study was: observing = .83, describing = .91, acting with awareness = .87, non-judging = 0.87. and nonreactivity = .75. In the Spanish language was found: observing = .81, describing = .91, acting with awareness = .89, nojudging = 0.91. y nonreactivity = .80.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.