The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subclinical Symptoms

University at Buffalo (UB)

Status: Completed

Conditions: Depressive Symptoms; Major Depressive Disorder, Recurrent, in Remission

Treatments: Behavioral: Be Mindful

Study type: Interventional

Funder types: Other

Identifiers

NCT04740879

STUDY00005212

SU-20-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

Intervention

Experimental group

Description:

The Intervention condition will be provided with access to the 4-week online Mindfulness-Based Cognitive Therapy course "Be Mindful" immediately after randomization to group.

Treatment:

Behavioral: Be Mindful

Waitlist Control

Other group

Description:

The Waitlist Control condition will be provided with access to the 4-week online Mindfulness-Based Cognitive Therapy course "Be Mindful" approximately 4 months after randomization to group.

Treatment:

Behavioral: Be Mindful