Clinical trial NCT04768361: Behavioral Activation for Major Depression With and Without Mindfulness
Official title: Behavioral Activation for Major Depressive Disorder: Comparison Between Protocols With and Without Mindfulness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Behavioral Activation
Mindfulness
Major depressive disorder
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: Basilene
measure: Behavioral Activation
timeFrame: Basilene
measure: Depressive symptoms
timeFrame: 8 weeks
measure: Behavioral Activation
timeFrame: 8 weeks
measure: Depressive symptoms
timeFrame: 6 months follow up
measure: Behavioral Activation
timeFrame: 6 months follow up
Secondary outcomes:
measure: Automatic Thought Questionnarie (ATQ)
timeFrame: Basilene
measure: Daily Activity Record (RAD)
timeFrame: Basilene
Other outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Basilene
measure: Automatic Thought Questionnarie (ATQ)
timeFrame: 8 weeks
measure: Daily Activity Record (RAD)
timeFrame: 8 weeks
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 8 weeks
measure: Automatic Thought Questionnarie (ATQ)
timeFrame: 6 months follow up
measure: Daily Activity Record (RAD)
timeFrame: 6 months follow up
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 6 months follow up
Locations:
city: Zaragoza
country: Spain
facility: Department of Psychiatry. Miguel Servet University Hospital
Study officials:
affiliation: Miguel Servet Hospital and University os Zaragoza, Spain
name: Javier García-Campayo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.