Assessing Improvements in Mood and Sleep Trial

NCT06639477 | Recruiting DMC

• 2 other identifiers: STUDY24030049R01MH137185
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multi-site randomized control trial involving people age 55+ years who have current depression symptoms plus another suicide risk indicator (either current suicidal ideation or a past history of attempt). Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping, bad moods, and any suicidality. Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.

Conditions

Depression; Suicidality; Sleep

Keywords

Older Adults; Depression

Outcome Measures

Primary Outcomes (1)

• Depression Symptom Response

  The outcome is the rate of clinically significant depression symptom responses six-months post treatment, defined as having ≥50% reduction in pre-treatment depression severity six-months posttreatment. Depression severity will be assessed as total scores from the 14 non-sleep items of the clinician rated GRID Hamilton Depression Rating Scale. Lower scores on the GRID Hamilton would indicate a reduction in depression symptoms.

  six months post-treatment

Secondary Outcomes (2)

• Change in Suicide Ideation Severity

  from Enrollment to the end of treatment at 6-months post-intervention

• Suicide Behavior Outcomes

  from Enrollment to the end of treatment at 6-months post-intervention

Study Arms (2)

Concealed Control Intervention

ACTIVE COMPARATOR

Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.

Other: Treatment As Usual; Behavioral: Active Comparator

Active Condition

EXPERIMENTAL

Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.

Other: Treatment As Usual; Behavioral: Active Condition

Interventions

Treatment As Usual OTHER

In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.

Active Condition; Concealed Control Intervention

Active Condition BEHAVIORAL

Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.

Active Condition

Active Comparator BEHAVIORAL

Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.

Concealed Control Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 Years and older
• Patient Health Questionnaire -9 score of 10 or higher
• Past month Scale for Suicide Ideation score of 3 or higher OR any history of suicide attempt
• PROMIS Sleep Disturbance or impairment scale t-scores of 55 or higher
• Pharmacotherapy for depression meeting minimum adequate dose level as defined by FDA approval documents for at least 4 weeks.

You may not qualify if:

• Active suicide planning with intent or clinical judgement that suicide risk is too high for outpatient treatment OR being currently treated at an inpatient unit.
• Bipolar disorder
• Psychotic disorder
• Borderline personality disorder.
• Active Cognitive/Behavioral Therapy (e.g., CBT-I), current or upcoming esketamine (ketamine) treatment, or active phase of ECT/TMS treatment course.
• Illness with life expectancy of less than 1 year or plans to leave the study area
• Incapacity to consent/dementia diagnosis
• Active substance use disorder of at least moderate severity
• Active night-shift work

Sponsors & Collaborators

• University of Pittsburgh: lead
• Emory University: collaborator
• University of California, Berkeley: collaborator
• University of California, Los Angeles: collaborator
• Augusta University: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

The Regents of the University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Depression; Suicidal Ideation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Study Officials

• Stephen F Smagula, Ph.D

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Sellars, M.A

CONTACT

412-246-5963; alberts3@upmc.edu

Stephen Smagula, Ph.D

CONTACT

412-246-6674; smagulasf@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: May 20, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 5 years after article publication
• Access Criteria: Researchers who provide methodologically sound proposal

Locations

US (3)