Brain, Emotions, and Mind-Wandering

NCT05345392 | Recruiting DMC

• 2 other identifiers: STUDY21110115R01MH127021
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Mood lability is an important transdiagnostic problem that is associated with poor psychosocial function and suicidal thoughts, and is a predictor of mood disorder onset, especially in youth at familial risk. Thus, particularly in youth with a family history of mood disorder, an intervention to target mood lability during a key period of development could improve outcomes. This study will allow us to test neurobehavioral mechanisms of a mindfulness-based intervention to target mood lability in early adolescents at high risk for developing mood disorders. Through this randomized controlled trial, the investigators will better understand how and for whom mindfulness interventions work, which will lead to more targeted interventions to improve emotion regulation during this key developmental period.

Conditions

Mood Disorders

Keywords

mindfulness-based intervention; early intervention; prevention; adolescent

Outcome Measures

Primary Outcomes (3)

• PCC-FPCN rsFC: Seed-based

  During each visit, the investigators will collect 10 minutes of resting-state data (eyes open; 2 runs, 5 minutes each), using Framewise Integrated Real-time MRI Monitoring (FIRMM) to ensure high quality. Following preprocessing, the investigators will assess resting-state functional connectivity between the posterior cingulate cortex (PCC; 0,-62,24; 4mm radius) and the frontoparietal control network (FPCN). The investigators will use mixed models to assess changes over time in the MBI vs. HWI group.

  PCC-FPCN rsFC will be assessed up to 3 months after completing the MBI/HWI group.

• SART Accuracy

  Participants will complete a Sustained Attention to Response Task (SART). In this task, numbers 1-9 will be sequentially displayed on the screen. Participants will be asked to press the space bar for every number except for "3". Overall target discrimination (d') will be assessed by calculating and z-transforming the "false alarm rate" (% omission errors, i.e. failing to press the space bar when indicated) and subtracting it from the z-transformed "hit rate" (% correct omissions, i.e. accurately not pressing the space bar to "3"). The investigators will use mixed models to assess changes over time in the MBI vs. HWI group.

  SART accuracy will be assessed up to 3 months after completing the MBI/HWI group.

• SART: Mind-wandering Awareness Probe

  Participants will complete a Sustained Attention to Response Task (SART). In this task, numbers 1-9 will be sequentially displayed on the screen. Participants will be asked to press the space bar for every number except for "3". To assess mind-wandering awareness, following each block of 10, 14, 18, 22, or 26 trials, participants will be asked to rate on 5-point likert scales "Where was your attention focused just now?"; and "How aware were you of where your attention was?". Self-report probes will be classified as on-task (responses 1-2 on 5-point "on-task" scale); off-task aware (responses 3-5 on 5-point "on-task" scale + responses 1-2 on 5-point "aware" scale); or off-task unaware (responses 3-5 on 5-point "on-task" scale + responses 3-5 on 5-point "aware" scale). The investigators will use mixed models to assess changes over time in the MBI vs. HWI group.

  Mind-wandering during the SART will be assessed up to 3 months after completing the MBI/HWI group.

Secondary Outcomes (4)

• SART: Reaction Time Variability

  SART reaction time variability will be assessed before the MBI/HWI group.

• PCC-FPCN rsFC: Seed-based

  The investigators will test specifically for early differences (prior to the MBI/HWI group to immediately following the MBI/HWI group) and assess whether these differences are sustained (immediately following the MBI/HWI group to 3 month follow-up).

• SART Accuracy

  The investigators will test specifically for early differences (prior to the MBI/HWI group to immediately following the MBI/HWI group) and assess whether these differences are sustained (immediately following the MBI/HWI group to 3 month follow-up).

• SART: Mind-wandering Awareness Probe

  The investigators will test specifically for early differences (prior to the MBI/HWI group to immediately following the MBI/HWI group) and assess whether these differences are sustained (immediately following the MBI/HWI group to 3 month follow-up).

Study Arms (2)

Mindfulness-Based Intervention (MBI)

ACTIVE COMPARATOR

The MBI is based on mindfulness-based stress reduction and mindfulness-based cognitive therapy, borrowing publicly available materials from the Mindfulness in Schools Program and Acceptance and Commitment Therapy. The MBI consists of 8 weekly groups, 45-60 minutes in length, and include 3-8 youth. Group content will consist of brief, age-appropriate mindfulness practices, videos, and discussions to engage participants. Parents will be involved at the beginning of each session and will receive a handout detailing session content. Each week will focus on a different aspect of mindfulness: introduction to mindfulness, attention, being with internal experiences, the stories minds tell, watching thought traffic, waking up to now, flow, and wrap-up/mindfulness in daily life. A home practice given each week will be discussed at the next group. Groups will be taught by two trained instructors with an ongoing mindfulness practice, who have training and experience teaching mindfulness to youth.

Behavioral: Mindfulness-Based Intervention (MBI)

Health and Wellness Intervention (HWI)

ACTIVE COMPARATOR

The control intervention, Health and Wellness Intervention (HWI), is a manualized intervention that's inspired by the Health Enhancement Program that has been adapted for youth 11-14 years old, using brief, engaging, and age-appropriate activities to address topics related to physical and mental health. HWI consists of 8 weekly groups, 45-60 minutes in length, and include 3-8 youth. Parents will be involved at the beginning of each session and will receive a handout detailing session content. HWI will include the following modules: stress management, social support, strengths and values, sleep health, nutrition, and exercise. As with the MBI, a home practice given each week will be discussed at the next group. Groups will be taught by two trained instructors without extensive mindfulness practice or training. The intervention will be matched on time and social interaction, but the HWI will not contain any mindfulness or cognitive behavioral therapy (CBT) components.

Behavioral: Health and Wellness Intervention (HWI)

Interventions

Mindfulness-Based Intervention (MBI) BEHAVIORAL

The mindfulness-based intervention is based on mindfulness-based stress reduction and mindfulness-based cognitive therapy, borrowing publicly available materials from the Mindfulness in Schools Program and Acceptance and Commitment Therapy. The MBI consists of 8 weekly groups, 45-60 minutes in length, and include 3-8 youth.

Mindfulness-Based Intervention (MBI)

Health and Wellness Intervention (HWI) BEHAVIORAL

The control intervention is inspired by the Health Enhancement Program that has been adapted for youth 11-14 years old, using brief, engaging, and age-appropriate activities to address topics related to physical and mental health. HWI consists of 8 weekly groups, 45-60 minutes in length, and include 3-8 youth.

Health and Wellness Intervention (HWI)

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females between the ages of 11-14 years
• Parent or full biological sibling with major depressive disorder and/or bipolar I/II disorder
• Elevated mood lability, which is defined as \>10 on the Children's Affective Lability Scale (averaging the child and parent score).

You may not qualify if:

• IQ\<70 or significant learning disability (which will make it difficult to participate in study procedures)
• Current or previous diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or autism spectrum disorder
• Current diagnosis of major depressive disorder
• Contraindications to scanning, including metal in the body (e.g. has braces or planning to get braces within the next 8 months)
• Suicidal or homicidal ideation within the past month
• Changed medications or medication doses (including psychotropic medications and/or hormonal contraceptives), or have started a new therapy, within the past two months.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Western Psychiatric Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (1)

• Hafeman DM, Ostroff AN, Feldman J, Hickey MB, Phillips ML, Creswell D, Birmaher B, Goldstein TR. Mindfulness-based intervention to decrease mood lability in at-risk youth: Preliminary evidence for changes in resting state functional connectivity. J Affect Disord. 2020 Nov 1;276:23-29. doi: 10.1016/j.jad.2020.06.042. Epub 2020 Jul 14.

  PMID: 32697703 BACKGROUND

MeSH Terms

Conditions

Mood Disorders

Interventions

Health

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Danella Hafeman, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danella Hafeman, MD, PhD

CONTACT

412-246-5820; hafemand@upmc.edu

Ashley Harbaugh, BS

CONTACT

412-628-8885; harbaughaj2@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The final study visit will include a Kiddie Schedule for Affective Disorders and Schizophrenia: Present and Lifetime (KSADS-PL) administered by an assessor who will be blind to group assignment. Consensus will also occur with a psychiatrist/psychologist who is blind to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of Pittsburgh Department of Psychiatry

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 25, 2022
• Study Start: September 23, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for addressing other research questions (i.e., those that are not described in funding/pending grants) as soon as the data have been checked for accuracy (a period that will be no later than 1 year after the completion of each assessment). After the award has ended, the study team will continue to test the stated aims but will continue to solicit collaborations with outside researchers and to consider data requests in a timely manner.
• Access Criteria: When all prerequisites have been met, access to data will be provided through the NDCT Data Access Committee (DAC). Only Investigators and Institutions who have met security measures and have submitted a Data Use Certification co-signed by the PI and the designated Institutional Official at the NIH-recognized sponsoring institution with a current Federal Wide Assurance will be given access. Outside Investigators will be asked to acknowledge the grant that supported the data collection and management in all publications and presentations.

Locations

US (1)