Behavioral Activation for Major Depression With and Without Mindfulness

NCT04768361 | Completed DMC

• 1 other identifier: BA11.2019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Behavioral Activation; Mindfulness; Major depressive disorder

Outcome Measures

Primary Outcomes (6)

• Depressive symptoms

  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

  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

  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

  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

  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

  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 Outcomes (2)

• Automatic Thought Questionnarie (ATQ)

  Basilene

• Daily Activity Record (RAD)

  Basilene

Other Outcomes (7)

• Five Facet Mindfulness Questionnaire (FFMQ)

  Basilene

• Automatic Thought Questionnarie (ATQ)

  8 weeks

• Daily Activity Record (RAD)

  8 weeks

Study Arms (2)

Behavioral Activation without Mindfulness

EXPERIMENTAL

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 with Mindfulness

EXPERIMENTAL

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

Interventions

Behavioral Activation without Mindfulness BEHAVIORAL

"Behavioral Activation without Mindfulness" includes functional analysis as key to defining out-of-session and activation strategies as central to mood change.

Behavioral Activation without Mindfulness

Behavioral Activation with Mindfulness BEHAVIORAL

"Behavioral Activation with Mindfulness" includes functional analysis as key to defining out-of-session and activation strategies and mindfulness as central to mood change.

Behavioral Activation with Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Miguel Servet: lead

Study Sites (1)

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, 50009, Spain

Location

Related Publications (5)

• 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.

  PMID: 28408544 BACKGROUND

• 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.

  PMID: 29649708 BACKGROUND

• 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.

  PMID: 22478462 BACKGROUND

• 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.

  PMID: 27486150 BACKGROUND

• 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.

  PMID: 24763812 BACKGROUND

Related Links

• Mindful Nation UK (2015). Report by the Mindfulness All-Party Parliamentary Group (MAPPG)
• UN health agency reports depression now 'leading cause of disability worldwide'

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Javier García-Campayo

  Miguel Servet Hospital and University os Zaragoza, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: February 24, 2021
• Study Start: August 10, 2020
• Primary Completion: October 15, 2020
• Study Completion: April 27, 2021
• Last Updated: March 25, 2022

Record last verified: 2022-03

Locations

ES (1)