Clinical trial NCT04740879: The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subclinical Symptoms
Official title: The Effects of the "Be Mindful" Intervention in Previously Depressed College Students Currently Experiencing Subclinical Symptoms of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Major Depressive Disorder, Recurrent, in Remission
Keywords: Mindfulness Based Cognitive Therapy
Be Mindful Intervention
Past Major Depressive Disorder
Major Depressive Disorder
Depressive Symptoms
Mechanisms of Change
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to help individuals cope with their current depressive symptoms by providing them access to a 4-week online Mindfulness-Based Cognitive Therapy: Be Mindful. Research has shown that completion of the Be Mindful intervention can reduce depressive symptoms in a community sample, and this study aims to evaluate if it can also help reduce depressive symptoms in individuals with a confirmed history of depression. Participants will either receive the intervention at the start of the study or four months after the start of the study (i.e., at 3-month follow-up), which will allow research staff to assess if reductions in depression are due to the intervention or something else. Research staff will also evaluate if the reduction in depressive symptoms lasts over the three months following intervention, and will investigate possible reasons for the change in depression (i.e., why the intervention produces change).

Detailed description: Participant outcome variables will be assessed weekly for the first month after baseline. This will include the primary dependent variable (i.e., depressive symptoms), but will also include variables that will be explored as potential mechanisms of change (i.e., mindfulness, decentering, rumination, worry, self-compassion, and dysfunctional attitudes). The final weekly assessment will represent the Post-Intervention assessment.

Brief follow-up assessments of the primary dependent variable will be given 1-month and 2-months after the final weekly questionnaire. There will be a 3-month assessment that measures potential mechanisms of change in addition to the primary dependent variable.

After the 3-month follow-up, the Waitlist Control condition will be given access to the intervention. All participants (i.e., in both conditions) will be asked to complete another month of weekly questionnaires. These questionnaires will be identical to the first set of weekly questionnaires, and will allow mechanisms of change to be evaluated in the Waitlist Control condition.

Eligibility criteria: Inclusion Criteria:

* currently experiencing mild to moderate depressive symptoms (Patient Health Questionnaire 9 Current scores between 5 and 14)
* meet Diagnostic and Statistical Manual of Mental Disorders (fifth edition; DSM-5) criteria for Past Major Depressive Disorder (determined by clinical interview)

Exclusion Criteria:

* responses suggest they have never experienced a Major Depressive Episode
* responses suggest they are not currently experiencing sub-threshold symptoms of depression
* they state they are not open to learning mindfulness or meditation techniques
* they indicate they are currently receiving therapeutic treatment for depression or stress management elsewhere
* they indicate their age is not between 18 and 65
* they state they do not currently live in New York State

Primary outcomes:
measure: Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 Post-Intervention
timeFrame: weekly during intervention, approximately 1-2 months
measure: Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up
timeFrame: at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)
Secondary outcomes:
measure: Mean Change in Mindfulness from Baseline as Measured by the Five Factor Mindfulness Questionnaire Short Form
timeFrame: through study completion, which can take up to 6 months
measure: Mean Change in Decentering from Baseline as Measured by the Toronto Mindfulness Scale
timeFrame: through study completion, which can take up to 6 months
measure: Mean Change in Rumination from Baseline as Measured by the Ruminative Response Questionnaire
timeFrame: through study completion, which can take up to 6 months
measure: Mean Change in Worry from Baseline as Measured by the Penn State Worry Questionnaire
timeFrame: through study completion, which can take up to 6 months
measure: Mean Change in Self-Compassion from Baseline as Measured by the Self-Compassion Scale Short Form
timeFrame: through study completion, which can take up to 6 months
measure: Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Dysfunctional Attitudes Scale (Short Form 1)
timeFrame: through study completion, which can take up to 6 months
measure: Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Rosenberg Self-Esteem Scale
timeFrame: through study completion, which can take up to 6 months
measure: Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Single-Item Self-Esteem Scale
timeFrame: through study completion, which can take up to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University of New York at Buffalo (SUNY at Buffalo)
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Meghan E Bauer, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York at Buffalo
name: John E Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References: