Anxiety Disorders Clinical Trial
— MESIOfficial title:
Effects of Mindfulness Based Cognitive Therapy on Emotional Processing
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | April 1, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - high emotional instability defined as scores above 96 on the Difficulties in Emotion Regulation Scale (DERS) - diagnosis of unipolar affective disorders - age between 18 and 65 years - no prior experience with mindfulness/meditation Exclusion Criteria: - risk of suicide (attempted suicide in the last year or current suicidal ideation. |
Country | Name | City | State |
---|---|---|---|
Spain | Parc de Salut Mar | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Facial Emotion Recognition Task | Computarized facial emotion recognition task | 8 past weeks | |
Secondary | Quick Depression Inventory | Inventory for assessing depressive symptoms | 1 past week |
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