Individual MBCT vs. CBT in Major Depression: A Pilot Study.

NCT05108701 | Completed

• 1 other identifier: G6302357
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Depression is a highly recurrent disorder, which often requires lifelong treatment. Psychotherapy has an important role in the treatment of depression, both in the treatment of the acute phase and in prevention of relapses. Mindfulness-based therapies have become popular in the last decade. Mindfulness-based Cognitive Therapy (MBCT) is an established treatment for relapse prevention in Major Depressive Disorder (MDD) and there is preliminary evidence of its efficacy in treating acute symptoms. Several studies have highlighted the benefits of MBCT in reducing the severity of depressive symptoms in patients diagnosed with a current Major Depressive Episode, as indicated by some meta-analyses showing that MBCT is more effective than treatment as usual in decreasing depressive symptoms and equivalent to active treatments. However, the results at follow-up were less conclusive, due to the limited number of studies and moderate-to-large heterogeneity within the subgroups. A number of studies have examined the effects of MBCT on a larger spectrum of factors that can affect the severity of depression. In patients with MDD, MBCT was more effective than treatment as usual in decreasing rumination, worry, negative affect and dysfunctional attitudes, increasing mindfulness skills and positive affect and improving sleep and quality of life. However, data comparing the specific effect of MBCT with other active treatments (for example Cognitive Behavioural Therapy, CBT) are lacking. Most trials exploring the efficacy of MBCT have been conducted with group MBCT, but there is less evidence about the use of individual MBCT (I-MBCT). Individual MBCT may have some advantages, compared with group therapy, such as better attendance and higher efficacy in major depression, when compared with group therapy. Furthermore, the individual format can often be better tailored to a specific patient, with a slower progression and a longer number of sessions, if needed. Objective: The primary objective of this pilot trial was to test the feasibility of a larger randomized trial examining the changes in depressive and anxiety symptoms, rumination, mindfulness, emotion regulation, behavioral activation and negative automatic thoughts during I-MBCT and cognitive behavioural therapy (CBT). Further objectives were: (a) replicating studies evaluating the efficacy of I-MBCT to improve depression, in particularly in patients diagnosed with a major depressive disorder; (b) assessing the persistence of benefits of I-MBCT after the end of treatment; (c) comparing the effects of I-MBCT with CBT, not only on depressive symptoms, but also on factors which are specifically targeted by MBCT, such as rumination and mindfulness; explore possible predictors of outcome of MBCT. Hypotheses: We make the following hypotheses: a) a larger trial comparing I-MBCT with CBT examining the changes of depressive and anxiety symptoms, rumination, mindfulness, emotion regulation, behavioral activation and negative automatic thoughts is feasible, with recruitment rates and drop-off rates consistent with those usually observed among participants with current major depression; b) the levels of depressive and anxiety symptoms, rumination, emotion dysregulation, and negative automatic thoughts will decrease during I-MBCT, while the levels of mindfulness and behavioral activation will increase, with effect sizes similar to those observed in CBT; c) the changes in depressive and anxiety symptoms, rumination, emotion dysregulation, negative automatic thoughts, mindfulness and behavioral activation will be maintained at follow-up; d) the changes in mindfulness and rumination dimensions are expected to be larger during MBCT than CBT; these analyses will be exploratory, given the state of knowledge; d) we will explore the role of predictors of clinical variables, such as earlier age at onset of the mood disorder; longer and more severe current episode; presence of current comorbidity with anxiety disorders, initial levels of anxiety, behavioral activation, emotion dysregulation and of the history of severe childhood maltreatment in predicting the outcome to MBCT and CBT.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton for Depression - 17 items

  clinician-rated scale measure of depression severity

  10 minutes

Secondary Outcomes (7)

• Beck Depression Inventory - Depression

  3 minutes

• Five Facet Mindfulness Questionnaire

  3 minutes

• Reflection Rumination Questionnaire - Rumination subscale (RRQ)

  3 minutes

• Difficulties in Emotion Regulation Scale

  3 minutes

• Automatic Thoughts Questionnaire

  3 minutes

Study Arms (2)

I-MBCT

EXPERIMENTAL

Participants randomized to I-MBCT (Mindfulness-Based Cognitive Therapy) receive 12 weekly 60- minute sessions of I-MBCT according to the protocol of Segal et al. (2002), integrated with the "theme, rationale, intention and practice" skills (TRIP) protocol (Woods et al. 2016, 2019). The original MBCT protocol, created for eight group sessions lasting two hours, is adapted to twelve individual sessions.

Behavioral: Individual Psychotherapy

CBT

ACTIVE COMPARATOR

Participants randomized to Individual Cognitive Behavioural Therapy (CBT) receive 12 weekly 60-minute individual sessions of standard CBT strategies following Beck et al. (1979). Participants receive a copy of Greenberger and Padesky's Mind over Mood (The Guilford Press, 1995) for use during the intervention.

Behavioral: Individual Psychotherapy

Interventions

Individual Psychotherapy BEHAVIORAL

Psychotherapy using meditation, yoga, through being in the present moment a non judgmental way and open minded

CBT; I-MBCT

Eligibility Criteria

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

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

Related Publications (3)

• Tovote KA, Fleer J, Snippe E, Peeters AC, Emmelkamp PM, Sanderman R, Links TP, Schroevers MJ. Individual mindfulness-based cognitive therapy and cognitive behavior therapy for treating depressive symptoms in patients with diabetes: results of a randomized controlled trial. Diabetes Care. 2014 Sep;37(9):2427-34. doi: 10.2337/dc13-2918. Epub 2014 Jun 4.

  PMID: 24898301 BACKGROUND

• Chiesa A, Serretti A. Mindfulness based cognitive therapy for psychiatric disorders: a systematic review and meta-analysis. Psychiatry Res. 2011 May 30;187(3):441-53. doi: 10.1016/j.psychres.2010.08.011. Epub 2010 Sep 16.

  PMID: 20846726 BACKGROUND

• Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Kearney DJ, Simpson TL. Mindfulness-based cognitive therapy for the treatment of current depressive symptoms: a meta-analysis. Cogn Behav Ther. 2019 Nov;48(6):445-462. doi: 10.1080/16506073.2018.1556330. Epub 2019 Feb 8.

  PMID: 30732534 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel, two-arm, randomised pilot trial comparing Individual MBCT with Individual CBT

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: November 2, 2015
• Primary Completion: January 15, 2017
• Study Completion: January 15, 2018
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share