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

Primary Purpose

Depressive Symptoms, Major Depressive Disorder, Recurrent, in Remission

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Be Mindful
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Mindfulness Based Cognitive Therapy, Be Mindful Intervention, Past Major Depressive Disorder, Major Depressive Disorder, Depressive Symptoms, Mechanisms of Change

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • State University of New York at Buffalo (SUNY at Buffalo)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Waitlist Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 Post-Intervention
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).

Secondary Outcome Measures

Mean Change in Mindfulness from Baseline as Measured by the Five Factor Mindfulness Questionnaire Short Form
Participants are asked to rate items on a scale of 1 (never or rarely true) to 5 (very often or always true).
Mean Change in Decentering from Baseline as Measured by the Toronto Mindfulness Scale
Participants are asked to rate items on a scale of 0 (not at all) to 4 (very much).
Mean Change in Rumination from Baseline as Measured by the Ruminative Response Questionnaire
Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always).
Mean Change in Worry from Baseline as Measured by the Penn State Worry Questionnaire
Participants are asked to rate items on a scale of 1 (Not at all typical of me) to 5 (Very typical of me).
Mean Change in Self-Compassion from Baseline as Measured by the Self-Compassion Scale Short Form
Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always).
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Dysfunctional Attitudes Scale (Short Form 1)
Participants are asked to rate items on a scale of 1 (totally agree) to 4 (totally disagree).
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Rosenberg Self-Esteem Scale
Participants are asked to rate items on a scale of 0 (strongly disagree) to 3 (strongly agree).
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Single-Item Self-Esteem Scale
Participants are asked to rate items on a scale of 1 (Not Very True of Me) to 5 (Very True of Me).

Full Information

First Posted
February 1, 2021
Last Updated
May 17, 2023
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT04740879
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Waitlist Control
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Be Mindful
Intervention Description
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).
Primary Outcome Measure Information:
Title
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 Post-Intervention
Description
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
Time Frame
weekly during intervention, approximately 1-2 months
Title
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up
Description
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
Time Frame
at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)
Secondary Outcome Measure Information:
Title
Mean Change in Mindfulness from Baseline as Measured by the Five Factor Mindfulness Questionnaire Short Form
Description
Participants are asked to rate items on a scale of 1 (never or rarely true) to 5 (very often or always true).
Time Frame
through study completion, which can take up to 6 months
Title
Mean Change in Decentering from Baseline as Measured by the Toronto Mindfulness Scale
Description
Participants are asked to rate items on a scale of 0 (not at all) to 4 (very much).
Time Frame
through study completion, which can take up to 6 months
Title
Mean Change in Rumination from Baseline as Measured by the Ruminative Response Questionnaire
Description
Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always).
Time Frame
through study completion, which can take up to 6 months
Title
Mean Change in Worry from Baseline as Measured by the Penn State Worry Questionnaire
Description
Participants are asked to rate items on a scale of 1 (Not at all typical of me) to 5 (Very typical of me).
Time Frame
through study completion, which can take up to 6 months
Title
Mean Change in Self-Compassion from Baseline as Measured by the Self-Compassion Scale Short Form
Description
Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always).
Time Frame
through study completion, which can take up to 6 months
Title
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Dysfunctional Attitudes Scale (Short Form 1)
Description
Participants are asked to rate items on a scale of 1 (totally agree) to 4 (totally disagree).
Time Frame
through study completion, which can take up to 6 months
Title
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Rosenberg Self-Esteem Scale
Description
Participants are asked to rate items on a scale of 0 (strongly disagree) to 3 (strongly agree).
Time Frame
through study completion, which can take up to 6 months
Title
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Single-Item Self-Esteem Scale
Description
Participants are asked to rate items on a scale of 1 (Not Very True of Me) to 5 (Very True of Me).
Time Frame
through study completion, which can take up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan E Bauer, MA
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John E Roberts, PhD
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University of New York at Buffalo (SUNY at Buffalo)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14260
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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