- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04768361
Behavioral Activation for Major Depression With and Without Mindfulness
Behavioral Activation for Major Depressive Disorder: Comparison Between Protocols With and Without Mindfulness
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zaragoza, Spain, 50009
- Department of Psychiatry. Miguel Servet University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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 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 Activation with Mindfulness" includes functional analysis as key to defining out-of-session and activation strategies and mindfulness as central to mood change.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Basilene
|
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.
|
Basilene
|
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.
|
8 weeks
|
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.
|
8 weeks
|
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 months follow up
|
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.
|
6 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Basilene
|
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"
|
Basilene
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Basilene
|
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.
|
8 weeks
|
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"
|
8 weeks
|
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.
|
8 weeks
|
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 months follow up
|
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"
|
6 months follow up
|
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.
|
6 months follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Javier García-Campayo, Miguel Servet Hospital and University os Zaragoza, Spain
Publications and helpful links
General Publications
- 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.
- 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. doi: 10.1007/BF03392129.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BA11.2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Behavioral Activation without Mindfulness
-
Philipps University Marburg Medical CenterCompleted
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Duke UniversityCompletedAnhedoniaUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Duke UniversityCompletedAnhedoniaUnited States
-
Philipps University Marburg Medical CenterCompletedDepression Moderate | Depression MildGermany
-
Umeå UniversityUnknown
-
The Hong Kong Polytechnic UniversityRecruiting
-
Texas Tech UniversityNot yet recruitingGrief | Mental Health Issue | Burden, CaregiverUnited States
-
University Hospital, MontpellierC2careRecruiting
-
Karolinska InstitutetRecruitingDepression | Anxiety | Cancer SurvivorsSweden
-
Karolinska InstitutetNot yet recruitingDepression | Anxiety | Cancer Survivors