Posttraumatic Stress DisorderNCT05516277
Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
A study testing Behavioral Sleep Education Intervention in people with Posttraumatic Stress Disorder and Insomnia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Insomnia, Cardiovascular Diseases
- What is being tested?
- Behavioral Sleep Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 31 Mar 2028
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling Veterans aged 50 years and older
- Received care from a Veterans Health Administration (VHA) facility in the prior year
- Diagnosis of PTSD
- Diagnosis of insomnia disorder
- Lives within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center
Who cannot join
- Active substance use or in recovery with less than 90 days of sobriety
- Too ill to engage in the study procedures (e.g., unable to attend the in-person meetings)
- Unable to self-consent to participate
- Unstable housing (as this will impact the research team's ability to retrieve costly and difficult to replace monitoring equipment)
- Severe cardiovascular or respiratory disease (e.g., ventilatory failure, CHF)
- Unstable medical or psychiatric disorders (which are a contraindication for behavioral treatment of insomnia)
- Comorbid sleep disorders (i.e., central sleep apnea syndrome, diagnosed narcolepsy or circadian rhythm sleep-wake phase disorders) based on medical record review and baseline assessment data, or untreated, severe sleep disordered breathing (SDB) as assessed via WatchPAT or previous clinical evaluation (apnea-hypopnea index [AHI] ≥ 30; or AHI ≥ 15 plus Epworth Sleepiness Scale [ESS] score ≥ 10) that better explain sleep difficulties
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Greater Los Angeles Healthcare System
North Hills, California, 91343
Monica Kelly, PhD, 818-891-7711 ext. 36066, monica.kelly2@va.gov
Monica Kelly, PhD
About this study
This pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.
Read the detailed description
Both insomnia and Post Traumatic Stress Disorder (PTSD) are independent risk factors for cardiometabolic diseases; the leading causes of morbidity and mortality in the US for which the growing geriatric population is at elevated risk. PTSD and insomnia disorder frequently co-occur yet require unique treatments, as sleep difficulties are one of the most common residual symptoms that remain after completing an evidence-based PTSD treatment.
This pilot pre-post trial provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. Individuals over 50 years of age, who have received care at the VA Greater Los Angeles Healthcare System, and who have been exposed to a stressful or traumatic life event will be recruited for this study.
Participants will be asked to complete a baseline evaluation that involves (a) being asked questions about health, medications, personal information, quality of life, sleep patterns and habits, mood, and stressful/traumatic experiences; (b) wearing a blood pressure monitor at home for 24 hours; (c) wearing a continuous glucose monitor sensor that contains a small filament (a thread-sized needle) inserted into the upper arm or abdomen for 7 consecutive days; (d) wearing a wristwatch device that measures sleep/wake patterns for 7 consecutive days; and (e) completing a daily sleep diary for 7 consecutive days. Participants may also be screened for sleep apnea with a portable sleep apnea monitoring device with sensors worn on the wrist, index finger and chest for one night.
Information from the baseline evaluation and medical records will be reviewed by the research team to determine whether an individual is eligible and likely able to complete all future study activities. Participants will be contacted to be advised of their study eligibility status. If eligible after the baseline assessment, study staff will review future study activities and confirm the participant's interest in continuing in the study. All eligible and interested participants will then receive an evidence-based PTSD treatment (CPT; 12 sessions). Following completion of the PTSD treatment, participants will receive a sleep education program (CBT-I; 5 sessions). For eligible individuals, participation in this research will last about 11 months.
Main study outcomes assessments from the baseline evaluation will be repeated three times: (1) one week after completion of the PTSD treatment; (2) one week after completion of the sleep education program; and (3) 6-months after the sleep education program ends. Data will be analyzed using "intention to treat" principles, using appropriate statistical methods for pilot clinical trials.
The investigators hope to determine how these treatment programs affect health in older adults with PTSD and insomnia. Findings from this pilot study will expand our understanding of the relationships between evidence-based insomnia and trauma treatments and key outcomes of sleep, PTSD symptoms, cardiometabolic health and quality of life in older adults with PTSD and insomnia while informing future research.
- Being tested
- Behavioral Sleep Education Intervention
- Keywords
- Quality of Life
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders, Cardiovascular Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Sleep Education InterventionBehavioural
Also called Cognitive Behavioral Therapy for Insomnia
Manual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Sleep Education Intervention | Experimental | Manual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions. Receives: Behavioral: Behavioral Sleep Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus sleep diary questionnaire
Self-reported sleep quality assessed with the Consensus sleep diary, a brief patient questionnaire evaluating multiple aspects of sleep quality including sleep onset latency (time to fall asleep in minutes) and sleep efficiency percentage (time asleep in minutes/time in bed in minutes x 100).
Measured: Change from baseline to 1 week after completion of sleep intervention
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a self-report PTSD severity questionnaire evaluating multiple aspects of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A higher score indicates more severe PTSD symptoms.
Measured: Change from baseline to 1 week after completion of sleep intervention
24-hr ambulatory blood pressure monitoring (ABPM) blood pressure variability
ABPM is an assessment of hypertension, a cardiometabolic disease, and blood pressure patterns across the 24-hour period. We will assess within-subject blood pressure variability via standard deviation across 24-hours.
Measured: Change from baseline to 1 week after completion of sleep intervention
24-hr ambulatory blood pressure monitoring (ABPM) systolic/diastolic loads
ABPM is an assessment of hypertension, a cardiometabolic disease, and blood pressure patterns across the 24-hour period. We will assess systolic/diastolic loads via percentage of elevated values across 24-hours.
Measured: Change from baseline to 1 week after completion of sleep intervention
24-hr ambulatory blood pressure monitoring (ABPM) change in blood pressure day to night
ABPM is an assessment of hypertension, a cardiometabolic disease, and blood pressure patterns across the 24-hour period. We will assess change in blood pressure from day to night (day-night).
Measured: Change from baseline to 1 week after completion of sleep intervention
WHOQOL-BREF questionnaire
Self-reported quality of life assessed with a brief patient questionnaire evaluating aspects of quality of life across four domains: 1) Physical health, 2) Psychological, 3) Social relations, and 4) Environment. Mean scores for each domain range from 4-20, which are multiplied by 4 to transform the domain score into a scaled score that is comparable to the full WHOQOL-100 measure. A higher score indicated higher quality of life.
Measured: Change from baseline to 1 week after completion of sleep intervention
Secondary outcomes (6)
Homeostatic Model Assessment of Insulin Resistance (HOMA)
HOMA is an assessment of insulin resistance, a cardiometabolic disease risk factor
Measured: Change from baseline to 1 week after completion of sleep intervention
Hemoglobin A1c (HbA1c)
HbA1c is an assessment of hyperglycemia, a cardiometabolic disease.
Measured: Change from baseline to 6 months after completion of sleep intervention
Body Mass Index (BMI)
BMI is a measure body composition, a cardiometabolic disease risk factor.
Measured: Change from baseline to 1 week after completion of sleep intervention
Central adiposity
Hip-to-waist ratio is a measure of central adiposity, a cardiometabolic disease risk factor.
Measured: Change from baseline to 1 week after completion of sleep intervention
Actigraphy
Actigraphy is a wrist-watch style device with an imbedded accelerometer that measures movement to define sleep/wake patterns including sleep onset latency (time to fall asleep) and sleep efficiency (time asleep/time in bed x 100).
Measured: Change from baseline to 1 week after completion of sleep intervention
Dyslipidemia
Fasting serum lipids are measures of dyslipidemia, a cardiometabolic disease.
Measured: Change from baseline to 1 week after completion of sleep intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Apr 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible participants will receive the same treatments for PTSD and insomnia.
- Masking
- None (open label)
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Principal investigator, Monica R. Kelly, PhD, DBSM, University of California, Los Angeles
- Investigators
- Monica Kelly, PhD, Principal investigator, UCLA / VA Greater Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516277
- Sponsor's protocol ID
- 1K23HL157754-01A1
- Status last verified
- Apr 2026
- First submitted
- 16 Aug 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make individual participant data (IPD) available to other researchers as this is a pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT05516277
- Acronym / sponsor ID
- 1K23HL157754-01A1
- Keywords
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 25 Aug 2022 (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 pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.
Detailed description
Both insomnia and Post Traumatic Stress Disorder (PTSD) are independent risk factors for cardiometabolic diseases; the leading causes of morbidity and mortality in the US for which the growing geriatric population is at elevated risk. PTSD and insomnia disorder frequently co-occur yet require unique treatments, as sleep difficulties are one of the most common residual symptoms that remain after completing an evidence-based PTSD treatment.
This pilot pre-post trial provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. Individuals over 50 years of age, who have received care at the VA Greater Los Angeles Healthcare System, and who have been exposed to a stressful or traumatic life event will be recruited for this study.
Participants will be asked to complete a baseline evaluation that involves (a) being asked questions about health, medications, personal information, quality of life, sleep patterns and habits, mood, and stressful/traumatic experiences; (b) wearing a blood pressure monitor at home for 24 hours; (c) wearing a continuous glucose monitor sensor that contains a small filament (a thread-sized needle) inserted into the upper arm or abdomen for 7 consecutive days; (d) wearing a wristwatch device that measures sleep/wake patterns for 7 consecutive days; and (e) completing a daily sleep diary for 7 consecutive days. Participants may also be screened for sleep apnea with a portable sleep apnea monitoring device with sensors worn on the wrist, index finger and chest for one night.
Information from the baseline evaluation and medical records will be reviewed by the research team to determine whether an individual is eligible and likely able to complete all future study activities. Participants will be contacted to be advised of their study eligibility status. If eligible after the baseline assessment, study staff will review future study activities and confirm the participant's interest in continuing in the study. All eligible and interested participants will then receive an evidence-based PTSD treatment (CPT; 12 sessions). Following completion of the PTSD treatment, participants will receive a sleep education program (CBT-I; 5 sessions). For eligible individuals, participation in this research will last about 11 months.
Main study outcomes assessments from the baseline evaluation will be repeated three times: (1) one week after completion of the PTSD treatment; (2) one week after completion of the sleep education program; and (3) 6-months after the sleep education program ends. Data will be analyzed using "intention to treat" principles, using appropriate statistical methods for pilot clinical trials.
The investigators hope to determine how these treatment programs affect health in older adults with PTSD and insomnia. Findings from this pilot study will expand our understanding of the relationships between evidence-based insomnia and trauma treatments and key outcomes of sleep, PTSD symptoms, cardiometabolic health and quality of life in older adults with PTSD and insomnia while informing future research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible participants will receive the same treatments for PTSD and insomnia.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Sleep Education Intervention | Experimental | Behavioral: Behavioral Sleep Education InterventionManual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Community-dwelling Veterans aged 50 years and older
- Received care from a Veterans Health Administration (VHA) facility in the prior year
- Diagnosis of PTSD
- Diagnosis of insomnia disorder
- Lives within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center
Key exclusion criteria (7 listed)
- Active substance use or in recovery with less than 90 days of sobriety
- Too ill to engage in the study procedures (e.g., unable to attend the in-person meetings)
- Unable to self-consent to participate
- Unstable housing (as this will impact the research team's ability to retrieve costly and difficult to replace monitoring equipment)
- Severe cardiovascular or respiratory disease (e.g., ventilatory failure, CHF)
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 |
|---|---|---|
| Behavioral Sleep Education InterventionAlso: Cognitive Behavioral Therapy for InsomniaManual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions. | Behavioural | Behavioral Sleep Education Intervention |
Primary outcome
Consensus sleep diary questionnaire
Time frame: Change from baseline to 1 week after completion of sleep intervention
Self-reported sleep quality assessed with the Consensus sleep diary, a brief patient questionnaire evaluating multiple aspects of sleep quality including sleep onset latency (time to fall asleep in minutes) and sleep efficiency percentage (time asleep in minutes/time in bed in minutes x 100).
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Change from baseline to 1 week after completion of sleep intervention
The PCL-5 is a self-report PTSD severity questionnaire evaluating multiple aspects of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A higher score indicates more severe PTSD symptoms.
24-hr ambulatory blood pressure monitoring (ABPM) blood pressure variability
Time frame: Change from baseline to 1 week after completion of sleep intervention
ABPM is an assessment of hypertension, a cardiometabolic disease, and blood pressure patterns across the 24-hour period. We will assess within-subject blood pressure variability via standard deviation across 24-hours.
24-hr ambulatory blood pressure monitoring (ABPM) systolic/diastolic loads
Time frame: Change from baseline to 1 week after completion of sleep intervention
ABPM is an assessment of hypertension, a cardiometabolic disease, and blood pressure patterns across the 24-hour period. We will assess systolic/diastolic loads via percentage of elevated values across 24-hours.
24-hr ambulatory blood pressure monitoring (ABPM) change in blood pressure day to night
Time frame: Change from baseline to 1 week after completion of sleep intervention
ABPM is an assessment of hypertension, a cardiometabolic disease, and blood pressure patterns across the 24-hour period. We will assess change in blood pressure from day to night (day-night).
WHOQOL-BREF questionnaire
Time frame: Change from baseline to 1 week after completion of sleep intervention
Self-reported quality of life assessed with a brief patient questionnaire evaluating aspects of quality of life across four domains: 1) Physical health, 2) Psychological, 3) Social relations, and 4) Environment. Mean scores for each domain range from 4-20, which are multiplied by 4 to transform the domain score into a scaled score that is comparable to the full WHOQOL-100 measure. A higher score indicated higher quality of life.
6 secondary outcomes
Homeostatic Model Assessment of Insulin Resistance (HOMA)
Time frame: Change from baseline to 1 week after completion of sleep intervention
Hemoglobin A1c (HbA1c)
Time frame: Change from baseline to 6 months after completion of sleep intervention
Body Mass Index (BMI)
Time frame: Change from baseline to 1 week after completion of sleep intervention
Central adiposity
Time frame: Change from baseline to 1 week after completion of sleep intervention
Actigraphy
Time frame: Change from baseline to 1 week after completion of sleep intervention
Dyslipidemia
Time frame: Change from baseline to 1 week after completion of sleep 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 15 Apr 2026.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data (IPD) available to other researchers as this is a pilot study.
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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.
Monica Kelly, PhD principal investigator
UCLA / VA Greater Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Sleep Education Intervention in people with Posttraumatic Stress Disorder and Insomnia, run by University of California, Los Angeles at 1 site 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 7 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Monica Kelly, PhD (818-891-7711 ext. 36066, monica.kelly2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus sleep diary questionnaire (time frame: Change from baseline to 1 week after completion of sleep intervention). The study lists 6 primary outcomes in all. 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 15 Apr 2026.