Assessing Improvements in Mood and Sleep Trial (AIMS)

Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Sleep; Suicidality
• Intervention / Treatment: Other: Treatment As Usual; Behavioral: Active Comparator; Behavioral: Active Condition

Detailed Description

The main purpose of the study is to compare the effects of two approaches on sleep and mood including any symptoms of depression and suicidality. There will be 420 people invited to participate across three sites in the United States (University of Pittsburgh, UCLA, Augusta).

Participants will be randomized to receive one of two evidence-based programs that are designed to help improve outcomes. Each group will contain 210 participants. Researchers will enroll a total of 140 participants (70 in each group) at the University of Pittsburgh. Both groups will meet with a study therapist once a week to complete the assigned 8-week program. To determine which (if any) program has beneficial effect over time, researchers will ask participants to complete assessments of their sleep, mood, and health before and after the therapy. Certain information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.

There are three main study visits where participants will complete assessments about their sleep, mood, cognition and health. These would be:

• Before the therapy program begins
• Right after it ends
• Six months later

Around the time of each visit, researchers will ask participants to wear an actigraphy watch on their wrist 24/7 for a week while completing a sleep diary. The actigraphy watch is a wrist-watch like device that measures movement so that researchers can estimate the participant's activity and sleep levels.

After the first main visit is complete, participants will be randomly assigned to one of two programs that include meeting with a study clinician for 30-50 minutes each week for 8 weeks (8 sessions total). Both groups will receive educational information and, depending on the group the participants are assigned to, may include guided discussions, activities, and/or support addressing any stressors participants face, sleep problems, and/or depression.

During the therapy period, researchers would ask participants to continue wearing the actigraphy watch. Researchers would also ask participants to answer questions on the phone with study staff every other week, starting at week 2 (that would take about 30-40 minutes a week).

After the participant's last therapy session, researchers would repeat the phone assessments once a month until the last main visit occurs (six-months after therapy ends). Participants will have one more call at about 6 months after the last main visit (12 months after the therapy ended) to repeat some phone assessments done during the bi-weekly and monthly calls).

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Smagula, Ph.D; Phone Number: 412-246-6674; Email: smagulasf@upmc.edu
• Study Contact Backup: Name: Sara Sellars, M.A; Phone Number: 412-246-5963; Email: alberts3@upmc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • The Regents of the University of California, Los Angeles
      • Contact: Michael Irwin, PhD; Phone Number: 310-825-8281; Email: mirwin1@ucla.edu
      • Contact: Jennifer Kruse, PhD; Phone Number: 310-206-8095; Email: jkruse@mednet.ucla.edu
      • Principal Investigator: Michael Iriwn, PhD
      • Sub-Investigator: Jennifer Kruse, PhD
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University
      • Contact: William McCall, PhD; Phone Number: 716-721-6719; Email: wmccall@augusta.edu
      • Contact: Jessica Britt-Thomas, PhD; Phone Number: 706-721-3141; Email: jebritt@augusta.edu
      • Principal Investigator: William McCall, PhD
      • Sub-Investigator: Jessica Britt-Thomas, PhD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Principal Investigator: Stephen F Smagula, PhD
      • Sub-Investigator: Daniel J Buysse, MD
      • Contact: Sara Sellars, M.A; Phone Number: 412-246-5963; Email: alberts3@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Any physical, mental, or neurological condition that would make participation in the study, including either treatment arm, unsafe or infeasible.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Concealed Control Intervention; 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; In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.; Behavioral: 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.
Experimental: Active Condition; 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; In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.; Behavioral: Active Condition; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide Behavior Outcomes	Any suicidal behaviors over the six-month follow-up defined as escalating planning, suicide attempt, or suicide-related hospitalization.	from Enrollment to the end of treatment at 6-months post-intervention
Change in Suicide Ideation Severity	Measuring rates of clinically significant past-month active SI at the six-month follow-up defined as Columbia Suicide Severity Rating Scale (CSSR) ideation dimension scores ≥ 3. This level on the CSSR, equivalent to having at least SI with a method, was identified as an optimal cut-off for predicting future suicide death. Lower scores on the Columbia Suicide Severity Rating Scale would indicate lower levels of suicide ideation.	from Enrollment to the end of treatment at 6-months post-intervention

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH); University of California, Berkeley; University of California, Los Angeles; Emory University; National Institutes of Health (NIH); Augusta University
• Investigators: Principal Investigator: Stephen F Smagula, Ph.D, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Older Adults
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Suicidal Ideation; Depression; Therapeutics
• Other Study ID Numbers: STUDY24030049; R01MH137185 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the main measures of this study as reported in publications after de-identification.
• IPD Sharing Time Frame: Beginning 6 months and ending 5 years after article publication
• IPD Sharing Access Criteria: Researchers who provide methodologically sound proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

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