Individual MBCT vs. CBT in Major Depression: A Pilot Study.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

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.
    

Detailed description: 
      The trial is a parallel, two-arm, randomised pilot trial (Ottawa, Ontario, Canada).
      Participants will be recruited from the Mood and Anxiety Program of the Royal Ottawa Mental
      Health Centre, which is a specialized tertiary care centre, and from two psychiatrists
      working in community.

      Procedure Participants will be referred to the study by the treating psychiatrist, then
      screened in a telephone interview by the research coordinator; the eligibility criteria will
      be finally assessed by a psychiatrist involved in the study and by the research coordinator.
      The psychiatrist will administer the Structured Clinical Interview (SCID) for DSM-IV-TR
      (First et al. 2002) and collect the information related to clinical variables: previous
      hospitalizations, history of suicide attempts, comorbidity with a current anxiety disorder,
      age at onset of the mood disorder, number of previous major depressive episodes, duration of
      the current episode, severity of the current depressive episode, use of alcohol or street
      drugs, family history of affective disorders, and number of chronic medical conditions. The
      research coordinator will assess the severity of depression using the HAMD-17. If the
      criteria of eligibility to the study were satisfied, participants will be asked to sign an
      informed written consent. Individuals meeting study criteria will be randomly assigned by
      computer-generated numbers to treatment with either I-MBCT or CBT (1:1). Participants
      included in the trial will be followed by the referring clinician. Concurrent use of
      psychotropics will be allowed. Concomitant treatment with any form of structured "bona fide"
      psychotherapy is not permitted during the study.

      Participants randomized to I-MBCT 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.

      Participants randomized to 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.

      Data Analyses The statistical analysis will be performed on the overall sample of patients
      who will start the treatment. As this was a feasibility study, a formal sample size
      calculation was not required. We applied the "rule of thumb" recommended by Julious (2005),
      suggesting a minimum of 12 participants per treatment arm, which optimizes the gain in
      precision around the mean. Pre-treatment demographic and clinical characteristics will be
      compared between I-MBCT and CBT treatment using univariate analyses (t-test for continuous
      variables and Fisher test for categorical variables).

      The primary outcome will be the HAM-D. The changes in depressive and anxiety symptoms,
      rumination, emotion dysregulation, and negative automatic thoughts during MBCT and at
      follow-up will be tested through linear mixed-effects models (LMM, SPSS Mixed procedure).
      Interaction between time and treatment will be use to compare the changes during MBCT and
      CBT. Multiple regression analyses will be used to test the value of clinical variables in
      predicting the changes in severity of depressive symptoms during psychotherapy, adjusting for
      age, gender and baseline depressive severity .

      To evaluate the strength of the changes in outcome variables (depressive and anxiety
      symptoms, rumination, emotion dysregulation, and negative automatic thoughts) during I-MBCT
      and CBT, within-group effect sizes of the change pre- and post-treatment using Cohen's delta
      for repeated measures will be used.
    

Intervention name(s): Individual Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Psychotherapy using meditation, yoga, through being in the present moment a non judgmental way and open minded
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel, two-arm, randomised pilot trial comparing Individual MBCT with Individual CBT
Masking: None (Open Label)
Primary purpose: Treatment