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

NCT04740879 | Completed

• 2 other identifiers: STUDY00005212SU-20-01
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  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 Outcomes (8)

• Mean Change in Mindfulness from Baseline as Measured by the Five Factor Mindfulness Questionnaire Short Form

  through study completion, which can take up to 6 months

• Mean Change in Decentering from Baseline as Measured by the Toronto Mindfulness Scale

  through study completion, which can take up to 6 months

• Mean Change in Rumination from Baseline as Measured by the Ruminative Response Questionnaire

  through study completion, which can take up to 6 months

• Mean Change in Worry from Baseline as Measured by the Penn State Worry Questionnaire

  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

  through study completion, which can take up to 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Waitlist Control

OTHER

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

Interventions

Be Mindful BEHAVIORAL

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).

Intervention; Waitlist Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

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

Buffalo, New York, 14260, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Recurrence

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meghan E Bauer, MA

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

• John E Roberts, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: March 30, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

US (1)