Mild-moderate Unipolar Depression; Persistent Negative Affect
Conditions
Brief summary
This study addresses NCCAM's request for research that investigates the neuropsychological mechanisms underlying mind-body therapies, and for precise criteria and better delineation of meditation practices. The purpose of this study is to assess the clinical efficacy and mechanism of action of 2 component practices of mindfulness meditation, i.e. focused awareness (FA) and open monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based Cognitive Therapy (MBCT).
Detailed description
Meditation, particularly mindfulness meditation, is one of the most popular Complementary and Alternative Medicine (CAM) therapies for alleviating emotional stress, depression and anxiety. While standardized meditation-based treatment packages like Mindfulness Based Stress Reduction (MBSR) and Mindfulness-based Cognitive Therapy (MBCT) have reliably shown sustained improvements in emotional disturbances and wellbeing, they contain so many different components and practices that the active ingredient cannot be ascertained. What is commonly called Mindfulness meditation is actually comprised of two separate practices: 1) focused awareness practice (FA), and 2) open-monitoring practice (OM). This project aims to create separate 8 week programs for FA and OM meditations, compare their clinical efficacy and investigate their separate mechanisms of action in individuals with clinically significant levels of persistent negative affect and depression. The clinical benefit and mechanism of action of focused awareness (FA) vs open-monitoring (OM) vs MBCT will be examined with a 3-armed randomized control trial of these 8 week interventions. Outcome variables include negative affect (depression, anxiety, stress) and wellbeing. Hypothesized mediating processes include objectively measured attention, emotion regulation and the basic wakefulness on which they depend.
Interventions
BEHAVIORALMindfulness-Based Cognitive Therapy
BEHAVIORALFocused Attention (FA)
BEHAVIORALOpen- Monitoring
Sponsors
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* English-speaking * ages 18-65 * mild-severe levels of depression or high level of negative affect
Exclusion criteria
* Current: * age \<18 or \>65 * inability to read and write in English * Extremely severe levels of depression * active suicidal ideation * presence of Axis I personality disorder * panic disorder * post-traumatic stress disorder * obsessive-compulsive disorder * eating disorder, or substance abuse/dependence * current psychotherapy * change in antidepressant medication type or dosage in the last 8 weeks. Lifetime history exclusions: * bipolar disorder * psychotic disorders * persistent antisocial behavior or repeated self-harm, * borderline personality disorder, * organic brain damage * regular meditation practice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Wellbeing Scale (WBS) | baseline, 8 weeks, 20 weeks | 73-item self-report questionnaire of psychological wellbeing |
| change in Depression, Anxiety Stress Scale (DASS) | baseline, week 2,4,6,8, 20 | 42-item self-report questionnaire on depression, anxiety and stress symptoms |
| Change in Inventory of Depressive Symptomatology | baseline, 8 weeks, 20 weeks | 30-item clinician administered interview about unipolar depression symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Attention to response Task (SART) | baseline, 8 weeks | 40 minuted sustained attention, go-no-go task |
| Difficulties in Emotion Regulation Scale (DERS) | baseline, 8 weeks, 20 weeks | 36-item self report of emotion regulation |
| Attention Control Questionnaire (Derryberry & Reed, 2002) | baseline, 8 weeks, 20 weeks | 20-item self report measure of attentional abilities |
| Change in alpha-theta EEG power from baseline to 8 weeks | baseline and 8 weeks | Resting/spontaneous EEG power in 5-9 Hz range |
| Change in Facial EMG power from baseline to 8 weeks | baseline and 8 weeks | Facial EMG response to emotional (IAPS) photos (reactivity + regulation) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Affect Scale (PANAS) | week 1,2,3,4,5,6,7,8 | 60-item self report of emotional states |
| Self-Compassion Scale (Neff 2003) | baseline, 8 weeks, 20 weeks | 26-item self report of attitudes towards oneself |
| Five Facet Mindfulness Questionnaire (FFMQ) | baseline, week 3,5,7,8,20 | 39-item self-report questionnaire of mindfulness skill acquisition (attention, non-reactivity) |
Countries
United States
Outcome results
None listed