Implantable Defibrillator UserNCT06037785
Self-Management Interventions After an ICD Shock
A study testing Self-Paced Self-Management (SPSM) in people with Implantable Defibrillator User and Stress Reaction, run by University of Washington at 1 site in United States.
Trial summary
This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Defibrillator User, Stress Reaction, Ptsd
- What is being tested?
- Self-Paced Self-Management (SPSM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 31 Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA),
- receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment;
- able to read, speak and write English;
- access to online resources and telephone for study duration.
Who cannot join
- current diagnosis of PTSD, schizophrenia or bipolar disorder;
- Short BLESSED score >6 indicating cognitive dysfunction [73];
- age <18 years;
- AUDIT-C score ≥4 for alcohol use;
- regular non-medical use of illicit drugs
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
University of Washington
Seattle, Washington, 98195
Cynthia Dougherty, ARNP, PhD, 206-221-7927, cindyd@u.washington.edu
Cynthia Dougherty, ARNP, PhD
About this study
Official title: Biobehavioral Intervention to Reduce PTSD After ICD Shock
This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30/group). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of patients with an ICD, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. Study findings will be used to design future larger RCTs to test intervention effectiveness for more diverse samples and settings.
- Conditions
- Implantable Defibrillator User, Stress Reaction, Ptsd, Stress Management, Social Cognitive Theory
- Being tested
- Self-Paced Self-Management (SPSM)
- Keywords
- implantable cardioverter defibrillator, ptsd, stress management
- Medical subject headings
- Fractures, Stress, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Paced Self-Management (SPSM)Behavioural
(SPSM) consists of two components: 1) HR Self-monitoring, and 2) online Shock Management modules (N=4) with weekly telephone coaching, completed over 1 month.
| Study group | Role | What they receive |
|---|---|---|
| SPSM intervention | Experimental | Heart rate self monitoring Online shock management modules Receives: Behavioral: Self-Paced Self-Management (SPSM) |
| usual care | No intervention | standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICD Shock anxiety
Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.
Measured: Baseline, 1, 6 months
Secondary outcomes (8)
Total daily physical activity(steps/day)
Step Watch Activity Monitor, 0-unlimited number of steps. Higher is more steps.
Measured: Baseline, 1, 6 months
Depression
PHQ-9, 0-27. Higher is higher depression.
Measured: Baseline, 1, 6 months
PTSD Symptoms
Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms
Measured: Baseline, 1, 6 months
Quality of Life-Physical and Mental
PROMIS Global v 2.0, 0-50. Higher is higher qol.
Measured: Baseline, 1, 6 months
Self-Efficacy Expectations
Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy
Measured: Baseline, 1, 6 months
Outcome expectation, 0-90. Higher is higher OE.
OE Scale
Measured: Baseline, 1, 6 months
Salivary cortisol
Cortisol in saliva, the range in humans varies. measured in pg/ml.
Measured: Baseline, 1, 6 months
Acceptability
Acceptability of interventions and materials measured in terms of patient burden (time to complete questionnaires \& data collection, ease in understanding, implementing the intervention). These are qualitative open ended answers to questions and do not produce a number.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Oct 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantable Defibrillator UserStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- East Carolina University, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Cynthia M. Dougherty, University of Washington
- Investigators
- Cynthia M Dougherty, ARNP, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037785
- Sponsor's protocol ID
- STUDY00007840
- Other IDs
- 1R21NR020967-01
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To support efforts by other researchers in replicating this study, and clinicians and healthcare systems to implement the interventions, we will 1) share the detailed study protocol, patient provider intervention materials, measures, and tools; 2) share a de-identified dataset.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Intervention to Reduce PTSD After ICD Shock
- ClinicalTrials.gov ID
- NCT06037785
- Acronym / sponsor ID
- STUDY00007840
- Conditions
- Implantable Defibrillator User, Stress Reaction, Ptsd, Stress Management, Social Cognitive Theory
- Keywords
- implantable cardioverter defibrillator, ptsd, stress management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- East Carolina University, National Institute of Nursing Research (NINR)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 14 Sep 2023 (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, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30/group). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of patients with an ICD, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. Study findings will be used to design future larger RCTs to test intervention effectiveness for more diverse samples and settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPSM intervention | Experimental | Behavioral: Self-Paced Self-Management (SPSM)Heart rate self monitoring Online shock management modules |
| usual care | No intervention | –standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA),
- receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment;
- able to read, speak and write English;
- access to online resources and telephone for study duration.
Key exclusion criteria (5 listed)
- current diagnosis of PTSD, schizophrenia or bipolar disorder;
- Short BLESSED score >6 indicating cognitive dysfunction [73];
- age <18 years;
- AUDIT-C score ≥4 for alcohol use;
- regular non-medical use of illicit drugs
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 |
|---|---|---|
| Self-Paced Self-Management (SPSM)(SPSM) consists of two components: 1) HR Self-monitoring, and 2) online Shock Management modules (N=4) with weekly telephone coaching, completed over 1 month. | Behavioural | SPSM intervention |
Primary outcome
ICD Shock anxiety
Time frame: Baseline, 1, 6 months
Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.
8 secondary outcomes
Total daily physical activity(steps/day)
Time frame: Baseline, 1, 6 months
Depression
Time frame: Baseline, 1, 6 months
PTSD Symptoms
Time frame: Baseline, 1, 6 months
Quality of Life-Physical and Mental
Time frame: Baseline, 1, 6 months
Self-Efficacy Expectations
Time frame: Baseline, 1, 6 months
Outcome expectation, 0-90. Higher is higher OE.
Time frame: Baseline, 1, 6 months
Salivary cortisol
Time frame: Baseline, 1, 6 months
Acceptability
Time frame: 6 months
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 24 Sep 2025.
- Individual participant dataSharing planned: Yes. To support efforts by other researchers in replicating this study, and clinicians and healthcare systems to implement the interventions, we will 1) share the detailed study protocol, patient provider intervention materials, measures, and tools; 2) share a de-identified dataset.
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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.
Cynthia M Dougherty, ARNP, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Paced Self-Management (SPSM) in people with Implantable Defibrillator User and Stress Reaction, run by University of Washington 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 4 inclusion and 5 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 24 Sep 2025. 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 Cynthia M Dougherty, ARNP, PhD (206 221-7927, cindyd@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICD Shock anxiety (time frame: Baseline, 1, 6 months). 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 24 Sep 2025.