NCT03358056: MESI

Effects of Mindfulness Based Cognitive Therapy on Emotional Processing

Status unknown NA Last updated 30 November 2017

What this trial tests

NA trial testing Mindfulness-Based Cognitive Therapy in Unipolar Depression in 30 participants. Status unknown.

Timeline

1 September 2017

Primary endpoint
1 April 2018

1 April 2018

Quick facts

Lead sponsor	Parc de Salut Mar
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 September 2017
Primary completion	1 April 2018
Estimated completion	1 April 2018
Sites	1 location across Spain

Drugs / interventions tested

• Mindfulness-Based Cognitive Therapy

Conditions studied

• Unipolar Depression — all drugs for Unipolar Depression →
• Anxiety Disorders — all drugs for Anxiety Disorders →
• Adjustment Disorders — all drugs for Adjustment Disorders →
• Emotional Instability — all drugs for Emotional Instability →

Sponsor

Parc de Salut Mar — full company profile →

Who can join

Adults 18 to 65, any sex, with Unipolar Depression or Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: In the last 30 years mindfulness-based approaches have been extensively used for a variety of mental disorders, including affective disorders characterized by emotional instability. Mindfulness based cognitive therapy (MBCT) is an 8-week intervention that combines mindfulness practices with cognitive behavioural therapy. Although changes in emotional processing have been postulated as one of mindfulness mechanisms of action, the effects of mindfulness-based programs on objective tasks of emotional processing have been poorly studied.

Objective: To explore the effects of mindfulness-based cognitive therapy (MBCT) on emotional processing in a sample of individuals with emotional instability attended in a mental-health public service.

Methods: The sample (n = 30) will be recruited from public mental-health outpatient centers in Barcelona, Spain. Inclusion criteria: 1) high emotional instability defined as scores above 96 on the Difficulties in Emotion Regulation Scale (DERS), 2) age between 18 and 65 years, 4) no prior experience with mindfulness/meditation. Exclusion criteria: 1) risk of suicide (attempted suicide in the last year or current suicidal ideation). Psychotropic medication will be permitted, as long as there are no changes in dose/type during the study period.

Measures Diagnostic measures (MINI, DERS, CGI) and a complete medical register will be collected prior inclusion in the study. Additional measures on personality (ZKPQ) and temperament (Temps-A) will be collected as well.

Primary outcome:

Emotional processing task: Participants will complete the FERT task at two time points: baseline (pre-treatment) and 8 weeks (post-treatment).

Secondary outcomes:

In addition, participants will complete the following assessments (pre-and-post- treatment):

* Depressive Symptoms (QIDS-16)
* Anxiety Symptoms (STAI)
* Mindfulness (FFMQ and EQ).

Treatment Mindfulness-based cognitive therapy (MBCT) is a manualized, 8 weeks-group-based training derived from mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT). In MBCT participants are trained in how to be more aware of their bodily sensations, thoughts and feelings associated with negative emotional states. Mindfulness exercises and cognitive-behavioral skills are practiced both during the sessions and through homework assignments. The program is structured in 2.30 h group sessions over 8 consecutive weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.