Behavioral Activation for Major Depression With and Without Mindfulness

• ClinicalTrials.gov Identifier: NCT04768361
• Recruitment Status: Active, not recruiting
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Sponsor: Hospital Miguel Servet
• Information provided by (Responsible Party): Javier Garcia Campayo, Hospital Miguel Servet

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 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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Behavioral: Behavioral Activation without Mindfulness; Behavioral: Behavioral Activation with Mindfulness	Not Applicable

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 (Clinical Trial)
• 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: August 10, 2020
• Actual Primary Completion Date: September 9, 2020
• Estimated Study Completion Date: May 30, 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.

Outcome Measures

Primary Outcome Measures :

1. Depressive symptoms [ Time Frame: 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.
2. Behavioral Activation [ Time Frame: 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.
3. Depressive symptoms [ Time Frame: 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.
4. Behavioral Activation [ Time Frame: 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.
5. Depressive symptoms [ Time Frame: 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.
6. Behavioral Activation [ Time Frame: 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 :

1. Automatic Thought Questionnarie (ATQ) [ Time Frame: 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.
2. Daily Activity Record (RAD) [ Time Frame: 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:

1. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 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.
2. Automatic Thought Questionnarie (ATQ) [ Time Frame: 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.
3. Daily Activity Record (RAD) [ Time Frame: 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"
4. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 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.
5. Automatic Thought Questionnarie (ATQ) [ Time Frame: 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.
6. Daily Activity Record (RAD) [ Time Frame: 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"
7. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Spain

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, Spain, 50009

Sponsors and Collaborators

Hospital Miguel Servet

Investigators

• Principal Investigator: Javier García-Campayo; Miguel Servet Hospital and University os Zaragoza, Spain

More Information

Additional Information:

Mindful Nation UK (2015). Report by the Mindfulness All-Party Parliamentary Group (MAPPG) 

UN health agency reports depression now 'leading cause of disability worldwide' 

Publications:

Finning K, Richards DA, Moore L, Ekers D, McMillan D, Farrand PA, O'Mahen HA, Watkins ER, Wright KA, Fletcher E, Rhodes S, Woodhouse R, Wray F. Cost and outcome of behavioural activation versus cognitive behavioural therapy for depression (COBRA): a qualitative process evaluation. BMJ Open. 2017 Apr 13;7(4):e014161. doi: 10.1136/bmjopen-2016-014161.

Huguet A, Miller A, Kisely S, Rao S, Saadat N, McGrath PJ. A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. J Affect Disord. 2018 Aug 1;235:27-38. doi: 10.1016/j.jad.2018.02.073. Epub 2018 Mar 8.

Kanter JW, Baruch DE, Gaynor ST. Acceptance and commitment therapy and behavioral activation for the treatment of depression: description and comparison. Behav Anal. 2006 Fall;29(2):161-85.

Parikh SV, Quilty LC, Ravitz P, Rosenbluth M, Pavlova B, Grigoriadis S, Velyvis V, Kennedy SH, Lam RW, MacQueen GM, Milev RV, Ravindran AV, Uher R; CANMAT Depression Work Group. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 2. Psychological Treatments. Can J Psychiatry. 2016 Sep;61(9):524-39. doi: 10.1177/0706743716659418. Epub 2016 Aug 2. Review.

Strauss C, Cavanagh K, Oliver A, Pettman D. Mindfulness-based interventions for people diagnosed with a current episode of an anxiety or depressive disorder: a meta-analysis of randomised controlled trials. PLoS One. 2014 Apr 24;9(4):e96110. doi: 10.1371/journal.pone.0096110. eCollection 2014.

• Responsible Party: Javier Garcia Campayo, Principal investigator, Hospital Miguel Servet
• ClinicalTrials.gov Identifier: NCT04768361
• Other Study ID Numbers: BA11.2019
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier Garcia Campayo, Hospital Miguel Servet:

Behavioral Activation; Mindfulness; Major depressive disorder

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms