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

May 17, 2023 updated by: Meghan Bauer, State University of New York at Buffalo

The Effects of the "Be Mindful" Intervention in Previously Depressed College Students Currently Experiencing Subclinical Symptoms of Depression

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14260
        • State University of New York at Buffalo (SUNY at Buffalo)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
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.
Behavioral: Be Mindful
The online 4-week Be Mindful intervention was designed to follow the same outline as typical in-person 8-week MBCT courses. Week 1 and Week 2 introduce the topic of mindfulness and encourage its daily use, whereas Week 3 and Week 4 teach the individual to decenter from thoughts and utilize mindfulness when coping with stressors. Each week focuses on a separate mindfulness topic, which is initially presented to the individual in a short (under 5 minute) video containing didactic information and an overview of the experiential activities that will be introduced in subsequent videos. The intervention is provided entirely through audio, video, and text provided on the Be Mindful website (BeMindfulOnline.com).
Other: Waitlist Control
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.
Behavioral: Be Mindful
The online 4-week Be Mindful intervention was designed to follow the same outline as typical in-person 8-week MBCT courses. Week 1 and Week 2 introduce the topic of mindfulness and encourage its daily use, whereas Week 3 and Week 4 teach the individual to decenter from thoughts and utilize mindfulness when coping with stressors. Each week focuses on a separate mindfulness topic, which is initially presented to the individual in a short (under 5 minute) video containing didactic information and an overview of the experiential activities that will be introduced in subsequent videos. The intervention is provided entirely through audio, video, and text provided on the Be Mindful website (BeMindfulOnline.com).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 Post-Intervention
Time Frame: weekly during intervention, approximately 1-2 months
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
weekly during intervention, approximately 1-2 months
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up
Time Frame: at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in Mindfulness from Baseline as Measured by the Five Factor Mindfulness Questionnaire Short Form
Time Frame: through study completion, which can take up to 6 months
Participants are asked to rate items on a scale of 1 (never or rarely true) to 5 (very often or always true).
through study completion, which can take up to 6 months
Mean Change in Decentering from Baseline as Measured by the Toronto Mindfulness Scale
Time Frame: through study completion, which can take up to 6 months
Participants are asked to rate items on a scale of 0 (not at all) to 4 (very much).
through study completion, which can take up to 6 months
Mean Change in Rumination from Baseline as Measured by the Ruminative Response Questionnaire
Time Frame: through study completion, which can take up to 6 months
Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always).
through study completion, which can take up to 6 months
Mean Change in Worry from Baseline as Measured by the Penn State Worry Questionnaire
Time Frame: through study completion, which can take up to 6 months
Participants are asked to rate items on a scale of 1 (Not at all typical of me) to 5 (Very typical of me).
through study completion, which can take up to 6 months
Mean Change in Self-Compassion from Baseline as Measured by the Self-Compassion Scale Short Form
Time Frame: through study completion, which can take up to 6 months
Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always).
through study completion, which can take up to 6 months
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Dysfunctional Attitudes Scale (Short Form 1)
Time Frame: through study completion, which can take up to 6 months
Participants are asked to rate items on a scale of 1 (totally agree) to 4 (totally disagree).
through study completion, which can take up to 6 months
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Rosenberg Self-Esteem Scale
Time Frame: through study completion, which can take up to 6 months
Participants are asked to rate items on a scale of 0 (strongly disagree) to 3 (strongly agree).
through study completion, which can take up to 6 months
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Single-Item Self-Esteem Scale
Time Frame: through study completion, which can take up to 6 months
Participants are asked to rate items on a scale of 1 (Not Very True of Me) to 5 (Very True of Me).
through study completion, which can take up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meghan E Bauer, MA, State University of New York at Buffalo
  • Principal Investigator: John E Roberts, PhD, State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00005212
  • SU-20-01 (Other Grant/Funding Number: State University of New York at Buffalo)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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