Complex Health ConcernsNCT06711172
Assessing the Feasibility of VA Whole Health Coaching for Veterans With Complex Health Concerns
A study testing VA Whole Health coaching in people with Complex Health Concerns, run by War Related Illness and Injury Study Center at 1 site in United States.
Trial summary
This study examines the impact of a VA Whole Health coaching program aimed at improving Veteran's health and well-being by increasing healthy lifestyle behaviors in treatment-seeking Veterans receiving care at the DC and CA War Related Illness and Injury Study Centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Health Concerns
- What is being tested?
- VA Whole Health coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Veterans receiving a clinical evaluation at the War Related Illness and Injury Study Centers in Washington, DC or Palo Alto, California.
Who cannot join
- Current active suicidal or homicidal ideation
- Current or lifetime history of a psychiatric disorder with primary psychotic features
- Current or lifetime bipolar disorder
- Acute or unstable psychiatric condition(s) and/or chronic illnesses that would benefit from immediate referral for treatment
- Neurological disorders such as Alzheimer's disease, advanced Parkinson's disease, and unstable epilepsy
- Pregnancy
Show all 9Show fewer
- Current exposure to trauma, or exposure to trauma in the past 3 months
- Current or within the past 30 days substance abuse or dependence (except nicotine)
- Excessive alcohol intake defined as an AUDIT score ≥ 4 for men and an AUDIT score ≥ 3 for women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington, DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, 20422
About this study
Official title: Assessing the Feasibility and Acceptability of VA Whole Health Coaching for Veterans With Complex Health Concerns
This study examines the impact of a VA Whole Health coaching program aimed at improving Veteran's health and well-being by increasing healthy lifestyle behaviors in treatment-seeking Veterans receiving care at the DC and CA War Related Illness and Injury Study Centers.
- Conditions
- Complex Health Concerns
- Being tested
- VA Whole Health coaching
- Keywords
- Health coaching, chronic multisymptom illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA Whole Health coachingOther
The VA Whole Health coaching intervention will consist of seventeen, 30 to 60-minute telehealth sessions that were dispersed over seven to nine months. Participants will work closely with a health coach to create a plan for making appropriate lifestyle changes.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | Not described Receives: Other: VA Whole Health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (recruitment rate)
Calculated as the number of participants who consented into the study divided by the number of participants who were approached for study participation.
Measured: Through study completion, an average of 7 months
Feasibility (retention rate)
Calculated as a percentage for each time point (3 months and 6 months).
Measured: Through study completion, an average of 7 months
Feasibility (adherence rate)
Calculated as the number of health coaching sessions completed out of 17 total sessions.
Measured: Through study completion, an average of 7 months
Safety of Whole Health coaching intervention
Reported as the number of adverse events self-reported by participants during the intervention
Measured: Through study completion, an average of 7 months
Acceptability
Acceptability was evaluated qualitatively using feedback captured during health coaching sessions.
Measured: Through study completion, an average of 7 months
Secondary outcomes (5)
RAND 36-Item Short Form Health Survey (SF-36)
To measure physical and mental health-related quality of life.
Measured: Baseline to mid-intervention and baseline to post-intervention
Pittsburgh Sleep Quality Index (PSQI)
To assess sleep quality and sleep disturbances
Measured: Baseline to post-intervention
Generalized Anxiety Disorder scale (GAD-7)
To assess the level of anxiety symptoms
Measured: Baseline to post-intervention
Five Facet Mindfulness Questionnaire (FFMQ)
To evaluate mindfulness
Measured: Baseline to post-intervention
Patient Health Questionnaire-8 (PHQ8)
To assess the level of depression symptoms
Measured: Baseline to post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start3 Jun 2021
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complex Health ConcernsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- War Related Illness and Injury Study Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rebecca McCullers, RN, NBC-HWC, Principal investigator, War Related Illness and Injury Study Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711172
- Sponsor's protocol ID
- 1592308
- Status last verified
- Feb 2026
- First submitted
- 26 Nov 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breneman CB, Summers AC, McCullers R, Jachimowicz W, Allen N, Chester J, Tschida S, Proctor L, Bayley PJ, Barrett J, Reinhard MJ, Costanzo M. Assessing the Feasibility and Acceptability of VA Whole Health Coaching Among Veterans With Complex Health Care Needs-A Pilot Study. Am J Lifestyle Med. 2026 Jul 2:15598276261460841. doi: 10.1177/15598276261460841. Online ahead of print.
PubMed 42404660
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Acceptability of VA Whole Health Coaching for Veterans With Complex Health Concerns
- ClinicalTrials.gov ID
- NCT06711172
- Acronym / sponsor ID
- 1592308
- Conditions
- Complex Health Concerns
- Keywords
- Health coaching, chronic multisymptom illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- War Related Illness and Injury Study CenterUS federal agency
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 2 Dec 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 study examines the impact of a VA Whole Health coaching program aimed at improving Veteran's health and well-being by increasing healthy lifestyle behaviors in treatment-seeking Veterans receiving care at the DC and CA War Related Illness and Injury Study Centers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Other: VA Whole Health coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Veterans receiving a clinical evaluation at the War Related Illness and Injury Study Centers in Washington, DC or Palo Alto, California.
Key exclusion criteria (9 listed)
- Current active suicidal or homicidal ideation
- Current or lifetime history of a psychiatric disorder with primary psychotic features
- Current or lifetime bipolar disorder
- Acute or unstable psychiatric condition(s) and/or chronic illnesses that would benefit from immediate referral for treatment
- Neurological disorders such as Alzheimer's disease, advanced Parkinson's disease, and unstable epilepsy
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 |
|---|---|---|
| VA Whole Health coachingThe VA Whole Health coaching intervention will consist of seventeen, 30 to 60-minute telehealth sessions that were dispersed over seven to nine months. Participants will work closely with a health coach to create a plan for making appropriate lifestyle changes. | Other | Health Coaching |
Primary outcome
Feasibility (recruitment rate)
Time frame: Through study completion, an average of 7 months
Calculated as the number of participants who consented into the study divided by the number of participants who were approached for study participation.
Feasibility (retention rate)
Time frame: Through study completion, an average of 7 months
Calculated as a percentage for each time point (3 months and 6 months).
Feasibility (adherence rate)
Time frame: Through study completion, an average of 7 months
Calculated as the number of health coaching sessions completed out of 17 total sessions.
Safety of Whole Health coaching intervention
Time frame: Through study completion, an average of 7 months
Reported as the number of adverse events self-reported by participants during the intervention
Acceptability
Time frame: Through study completion, an average of 7 months
Acceptability was evaluated qualitatively using feedback captured during health coaching sessions.
5 secondary outcomes
RAND 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline to mid-intervention and baseline to post-intervention
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline to post-intervention
Generalized Anxiety Disorder scale (GAD-7)
Time frame: Baseline to post-intervention
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Baseline to post-intervention
Patient Health Questionnaire-8 (PHQ8)
Time frame: Baseline to post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Derived from this study: PubMed 42404660Breneman CB, Summers AC, McCullers R, Jachimowicz W, Allen N, Chester J, Tschida S, Proctor L, Bayley PJ, Barrett J, Reinhard MJ, Costanzo M. Assessing the Feasibility and Acceptability of VA Whole Health Coaching Among Veterans With Complex Health Care Needs-A Pilot Study. Am J Lifestyle Med. 2026 Jul 2:15598276261460841. doi: 10.1177/15598276261460841. Online ahead of print.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Rebecca McCullers, RN, NBC-HWC principal investigator
War Related Illness and Injury Study Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA Whole Health coaching in people with Complex Health Concerns, run by War Related Illness and Injury Study Center 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 13 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (recruitment rate) (time frame: Through study completion, an average of 7 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06711172, which also lists 1 linked publication.
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 13 Feb 2026.