DepressionAIMSNCT06639477
Assessing Improvements in Mood and Sleep Trial
A study testing Treatment As Usual, Active Condition and Active Comparator in people with Depression and Suicidality, run by University of Pittsburgh at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Depression, Suicidality, Sleep
- What is being tested?
- Treatment As Usual, Active Condition and Active Comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 May 2025to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
William McCall, PhD, 716-721-6719, wmccall@augusta.edu
Jessica Britt-Thomas, PhD, 706-721-3141, jebritt@augusta.edu
- Recruiting
The Regents of the University of California, Los Angeles
Los Angeles, California, 90095
Michael Irwin, PhD, 310-825-8281, mirwin1@ucla.edu
Jennifer Kruse, PhD, 310-206-8095, jkruse@mednet.ucla.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Sara Sellars, M.A, 412-246-5963, alberts3@upmc.edu
Stephen F Smagula, PhD
About this study
Official title: 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.
Read the 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).
- Conditions
- Depression, Suicidality, Sleep
- Being tested
- Treatment As Usual, Active Condition, Active Comparator
- Keywords
- Older Adults, Depression
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment As UsualOther
In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.
Active ConditionBehavioural
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 ComparatorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment As Usual; Behavioral: Active Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months post-treatment
Secondary outcomes (2)
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.
Measured: from Enrollment to the end of treatment at 6-months post-intervention
Suicide Behavior Outcomes
Any suicidal behaviors over the six-month follow-up defined as escalating planning, suicide attempt, or suicide-related hospitalization.
Measured: from Enrollment to the end of treatment at 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 May 2025
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, University of California, Berkeley, University of California, Los Angeles, Augusta University, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephen Smagula, University of Pittsburgh
- Investigators
- Stephen F Smagula, Ph.D, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639477
- Sponsor's protocol ID
- STUDY24030049
- Other IDs
- R01MH137185
- Acronym
- AIMS
- Status last verified
- May 2026
- First submitted
- 10 Oct 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the main measures of this study as reported in publications after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults
- ClinicalTrials.gov ID
- NCT06639477
- Acronym / sponsor ID
- AIMS / STUDY24030049
- Conditions
- Depression, Suicidality, Sleep
- Keywords
- Older Adults, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Emory University, University of California, Berkeley, University of California, Los Angeles, Augusta University, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 20 May 2025 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concealed Control Intervention | Active comparator | Other: Treatment As Usual, Behavioral: Active ComparatorParticipants 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 | Experimental | Other: Treatment As Usual, Behavioral: Active ConditionParticipants 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment As UsualIn this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors. | Other | Active Condition, Concealed Control Intervention |
| Active ConditionParticipants 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. | Behavioural | Active Condition |
| Active ComparatorParticipants 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. | Behavioural | Concealed Control Intervention |
Primary outcome
Depression Symptom Response
Time frame: six months post-treatment
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.
2 secondary outcomes
Change in Suicide Ideation Severity
Time frame: from Enrollment to the end of treatment at 6-months post-intervention
Suicide Behavior Outcomes
Time frame: from Enrollment to the end of treatment at 6-months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the main measures of this study as reported in publications after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen F Smagula, Ph.D principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment As Usual, Active Condition and Active Comparator in people with Depression and Suicidality, run by University of Pittsburgh at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Sellars, M.A (412-246-5963, alberts3@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Symptom Response (time frame: six months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.