RuminationRFCBT-INCT05980130
Can Rumination-Focused Cognitive Behavioral Therapy Reduce the Risk of Cardio-vascular Disease?
A study testing Rumination-Focused Cognitive Behavior Therapy in people with Rumination and Depressive Symptoms, run by University of Louisville at 1 site in United States.
Trial summary
Many people know that a poor diet, exercise, smoking, and alcohol use cause heart disease. However, a less known factor that increases the risk of heart disease is depression. In addition, heart disease can also make depression worse. Almost half of American adults have some form of heart disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rumination, Depressive Symptoms, Blood Pressure
- What is being tested?
- Rumination-Focused Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 12 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- RSQ-Brooding score: >= 11
- PHQ-9 score: 10-20
- SBP: >= 120 and/or DBP: >= 80)
- fluent in English
Who cannot join
- None besides the described inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RFCBT I - Proof of Concept Study/Single Subject Design
Many people know that a poor diet, exercise, smoking, and alcohol use cause heart disease. However, a less known factor that increases the risk of heart disease is depression. In addition, heart disease can also make depression worse. Almost half of American adults have some form of heart disease. Patients with low income are at an even greater risk. The circular relation between depression and heart disease raises the question of whether or not there are factors that lead to both. Attacking a factor that affects both depression and heart disease could help prevent them both. One such factor is rumination which is when someone tends to have repeated negative thoughts that loop without end. This loop in turn tears and wears down the body over time, making the person be at risk for heart disease and depression. Rumination-Focused Cognitive Behavioral Therapy (RFCBT) is a tool that targets rumination and, by doing so, reduces the risk for depression. While research has shown RFCBT helps to reduce or stop the loop that leads to depression, this project will further look at the effect of RFCBT on measures of heart health persons with low income.
Read the detailed description
Objectives Objective #1: Determine whether RFCBT will impact blood pressure as a biomarker of cardiovascular health. The investigators hypothesize that RFCBT will lead to an improvement in blood pressure.
Objective #2: Determine whether RFCBT will impact stress biomarkers of cardiovascular health. The investigators hypothesize that RF-CBT will lead to an improvement of salivary cortisol.
Objective #3: Determine whether RFCBT will impact inflammatory biomarkers of cardiovascular health. The investigators hypothesize that RF-CBT will lead to an improvement of salivary C-Reactive Protein (h-CRP), interleukin (IL-6), and tumor necrosis factor-alpha (TNF-α).
Objective #4: Determine the acceptability of RFCBT for individuals with low income. While the investigators cannot predict the themes that will be generated, the information will have implications for the use of RFCBT with individuals with low income.
Study Design/Methodology The investigators will use a multiple baseline design - a type of Single Case Experimental Design (SCED) and collect survey, interview, and biological (blood pressure \& saliva) data. Because of the study design, all participants will receive Rumination-Focused Cognitive Behavioral Training (RFCBT); the study is not blinded, and no non-intervention control group is necessary. As participants will be selected non-randomly, they will be randomly assigned to a group or in other words after how many weeks of baseline phase they will perceive RFCBT using the random number generator in the statistics package R. That is, 1/3rd of the participants will participate in 5 baseline waves of data collection, each one week apart, before starting RFCBT, another 1/3rd of participants will participate in 6 baseline waves before starting RFCBT, and the final 1/3rd of participants will participate in 6 baseline waves before starting RFCBT. Thus, all participants will participate in 5 to 7 weekly baseline waves. Next, each participant will participate with their trainer in up to 18 50-minute meetings of RFCBT. In this time, each participant will participate in 6 to 9 waves of training data collection (one wave of data collection every 2 RFCBT meetings). After completion of the training, each participant will be followed for another 10 weeks during which they participate in 5 waves of follow-up data collection (one wave of data collection every 2 weeks). Thus, each participant participates in 28 to 36 weeks in the study and takes part in 16 to 21 waves of data collection.
The investigators plan to recruit 27 adults with low income who have an elevated Response Style Questionnaire (RSQ)-Brooding score (>= 11), Patient Health Questionnaire (PHQ)-9 score (10-20), and blood pressure (systolic blood pressure [SBP]/ diastolic blood pressure [DBP]: >= 120 and/or 80) - that Have A Heart Clinic personnel administers regularly - and speak fluent English. There are no other exclusion criteria including any medical or psychological treatment. Patients who fulfill the above listed inclusion criteria are referred by Have A Heart Clinic personnel to the research team.
At each wave of data collection, the investigators will administer all the surveys listed in this report. All questions will be administered at each wave except for the questions about demographic information which will be asked during Baseline-1 only.
To measure blood pressure, the investigators will use an oscillometric measurement device. To do so, a blood pressure cuff will be placed about an inch above the elbow crease. For reliability purposes, blood pressure will be measured three-times with about 1 minute time between the measures.
To measure cortisol, h-CRP, IL-6, and TNF-α levels in saliva, participants will also be asked to provide saliva samples. Participants will be asked to avoid eating food or drinking caffeine for 3 hours prior to the saliva data collection in order to prepare for the saliva testing.
Once after the participants finish the RFCBT, they will be invited to take part in a semi-structured interview to explore their experiences in and acceptability of the training. The investigators intend to do these interviews with all participants who begin RFCBT (i.e., defined as completing at least one 50-minute meeting with their trainer), including those who drop out of the training, in-person, by phone, or a secure video platform.
The RFCBT exclusively addresses one possible mechanism underlying depression, rumination. In general, a participant and their trainer will identify when the participant ruminates in an unhelpful manner, what triggers the rumination, what function the rumination fulfills for the participant, and how the participant already does to stop ruminating. Building on this knowledge both together will change the environment to reduce the likelihood of the participant to ruminate, use consciously strategies to stop rumination when it occurs, and replace rumination by more helpful strategies. In the proposed single subject study, the participant and the trainer will meet in person or using a UofL approved video platform up to 18 times for 50-minutes.
Plan for Analysis of Results Following the best practice guidelines of the What Works Clearinghouse Standards for SCEDs, the investigators will examine consistency, intervention effect, immediacy, and auto-correlations for rumination, depressive symptoms, blood pressure, cortisol, h-CRP, IL-6, and TNF-α. The investigators will use Bayesian unknown changepoint models to estimate the parameters and model the treatment effect. A mixed effects model will be used to model the hierarchical structure of the data. The dependent variables are rumination, depressive symptoms, blood pressure, cortisol, h-CRP, IL-6, and TNF-α. The independent variable is phase. Bayesian estimation will be used to address the small sample nature of the data. For these statistical analyses the investigators will use R and "Just Another Gibbs Sampler" (JAGS). The investigators will conduct semi-structured interviews and analyze data using thematic analysis to generate themes associated with the data. The statistical program Dedoose will be utilized to facilitate this process.
- Conditions
- Rumination, Depressive Symptoms, Blood Pressure
- Being tested
- Rumination-Focused Cognitive Behavior Therapy
- Keywords
- rumination, depressive symptoms, blood pressure, rumination-focused cognitive behavioral therapy, Proof of Concept Study, Single subject design
- Medical subject headings
- Rumination Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rumination-Focused Cognitive Behavior TherapyBehavioural
The RFCBT exclusively addresses one possible mechanism underlying depression, rumination. In general, a participant and their therapist will identify when the participant ruminates in an unhelpful manner, what triggers the rumination, what function the rumination fulfills for the participant, and how the participant already does to stop ruminating. Building on this knowledge both together will change the environment to reduce the likelihood of the participant to ruminate, use consciously strategies to stop rumination when it occurs, and replace rumination by more helpful strategies. In the proposed single subject study, the participant and the therapist will meet in person or using a UofL approved video platform up to 18 times for 50-minutes.
| Study group | Role | What they receive |
|---|---|---|
| RFCBT | Experimental | This is a single subject design study. Thus, all participants receive Rumination-Focused Cognitive Behavior Therapy Receives: Behavioral: Rumination-Focused Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: Baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 1 week after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 2 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 3 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 4 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 5 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 6 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 7 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 9 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 11 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 13 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 15 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 17 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 19 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 21 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 23 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 25 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 27 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 29 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 31 weeks after baseline 1
Response Style Questionnaire
sadness rumination, Score range: 5-20, higher score = more rumination
Measured: 33 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: Baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 1 week after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 2 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 3 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 4 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 5 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 6 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 7 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 9 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 11 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 13 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 15 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 17 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 19 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 21 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 23 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 25 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 27 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 29 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 31 weeks after baseline 1
Patient Health Questionnaire-9
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Measured: 33 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: Baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 1 week after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 2 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 3 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 4 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 5 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 6 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 7 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 9 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 11 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 13 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 15 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 17 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 19 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 21 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 23 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 25 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 27 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 29 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 31 weeks after baseline 1
systolic blood pressure measures
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 33 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: Baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 1 week after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 2 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 3 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 4 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 5 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 6 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 7 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 9 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 11 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 13 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 15 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 17 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 19 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 21 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 23 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 25 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 27 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 29 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 31 weeks after baseline 1
diastolic blood pressure measures
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Measured: 33 weeks after baseline 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start15 Aug 2023
- Primary completion12 Sep 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RuminationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single subject design
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Possel, University of Louisville
- Investigators
- Patrick Possel, Dr.rer.soc., Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980130
- Sponsor's protocol ID
- 23.0150
- Acronym
- RFCBT-I
- Status last verified
- Dec 2025
- First submitted
- 7 Jun 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RFCBT I - Proof of Concept Study/Single Subject Design
- ClinicalTrials.gov ID
- NCT05980130
- Acronym / sponsor ID
- RFCBT-I / 23.0150
- Conditions
- Rumination, Depressive Symptoms, Blood Pressure
- Keywords
- rumination, depressive symptoms, blood pressure, rumination-focused cognitive behavioral therapy, Proof of Concept Study, Single subject design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 7 Aug 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.
Many people know that a poor diet, exercise, smoking, and alcohol use cause heart disease. However, a less known factor that increases the risk of heart disease is depression. In addition, heart disease can also make depression worse. Almost half of American adults have some form of heart disease. Patients with low income are at an even greater risk. The circular relation between depression and heart disease raises the question of whether or not there are factors that lead to both. Attacking a factor that affects both depression and heart disease could help prevent them both. One such factor is rumination which is when someone tends to have repeated negative thoughts that loop without end. This loop in turn tears and wears down the body over time, making the person be at risk for heart disease and depression. Rumination-Focused Cognitive Behavioral Therapy (RFCBT) is a tool that targets rumination and, by doing so, reduces the risk for depression. While research has shown RFCBT helps to reduce or stop the loop that leads to depression, this project will further look at the effect of RFCBT on measures of heart health persons with low income.
Detailed description
Objectives Objective #1: Determine whether RFCBT will impact blood pressure as a biomarker of cardiovascular health. The investigators hypothesize that RFCBT will lead to an improvement in blood pressure.
Objective #2: Determine whether RFCBT will impact stress biomarkers of cardiovascular health. The investigators hypothesize that RF-CBT will lead to an improvement of salivary cortisol.
Objective #3: Determine whether RFCBT will impact inflammatory biomarkers of cardiovascular health. The investigators hypothesize that RF-CBT will lead to an improvement of salivary C-Reactive Protein (h-CRP), interleukin (IL-6), and tumor necrosis factor-alpha (TNF-α).
Objective #4: Determine the acceptability of RFCBT for individuals with low income. While the investigators cannot predict the themes that will be generated, the information will have implications for the use of RFCBT with individuals with low income.
Study Design/Methodology The investigators will use a multiple baseline design - a type of Single Case Experimental Design (SCED) and collect survey, interview, and biological (blood pressure \& saliva) data. Because of the study design, all participants will receive Rumination-Focused Cognitive Behavioral Training (RFCBT); the study is not blinded, and no non-intervention control group is necessary. As participants will be selected non-randomly, they will be randomly assigned to a group or in other words after how many weeks of baseline phase they will perceive RFCBT using the random number generator in the statistics package R. That is, 1/3rd of the participants will participate in 5 baseline waves of data collection, each one week apart, before starting RFCBT, another 1/3rd of participants will participate in 6 baseline waves before starting RFCBT, and the final 1/3rd of participants will participate in 6 baseline waves before starting RFCBT. Thus, all participants will participate in 5 to 7 weekly baseline waves. Next, each participant will participate with their trainer in up to 18 50-minute meetings of RFCBT. In this time, each participant will participate in 6 to 9 waves of training data collection (one wave of data collection every 2 RFCBT meetings). After completion of the training, each participant will be followed for another 10 weeks during which they participate in 5 waves of follow-up data collection (one wave of data collection every 2 weeks). Thus, each participant participates in 28 to 36 weeks in the study and takes part in 16 to 21 waves of data collection.
The investigators plan to recruit 27 adults with low income who have an elevated Response Style Questionnaire (RSQ)-Brooding score (>= 11), Patient Health Questionnaire (PHQ)-9 score (10-20), and blood pressure (systolic blood pressure [SBP]/ diastolic blood pressure [DBP]: >= 120 and/or 80) - that Have A Heart Clinic personnel administers regularly - and speak fluent English. There are no other exclusion criteria including any medical or psychological treatment. Patients who fulfill the above listed inclusion criteria are referred by Have A Heart Clinic personnel to the research team.
At each wave of data collection, the investigators will administer all the surveys listed in this report. All questions will be administered at each wave except for the questions about demographic information which will be asked during Baseline-1 only.
To measure blood pressure, the investigators will use an oscillometric measurement device. To do so, a blood pressure cuff will be placed about an inch above the elbow crease. For reliability purposes, blood pressure will be measured three-times with about 1 minute time between the measures.
To measure cortisol, h-CRP, IL-6, and TNF-α levels in saliva, participants will also be asked to provide saliva samples. Participants will be asked to avoid eating food or drinking caffeine for 3 hours prior to the saliva data collection in order to prepare for the saliva testing.
Once after the participants finish the RFCBT, they will be invited to take part in a semi-structured interview to explore their experiences in and acceptability of the training. The investigators intend to do these interviews with all participants who begin RFCBT (i.e., defined as completing at least one 50-minute meeting with their trainer), including those who drop out of the training, in-person, by phone, or a secure video platform.
The RFCBT exclusively addresses one possible mechanism underlying depression, rumination. In general, a participant and their trainer will identify when the participant ruminates in an unhelpful manner, what triggers the rumination, what function the rumination fulfills for the participant, and how the participant already does to stop ruminating. Building on this knowledge both together will change the environment to reduce the likelihood of the participant to ruminate, use consciously strategies to stop rumination when it occurs, and replace rumination by more helpful strategies. In the proposed single subject study, the participant and the trainer will meet in person or using a UofL approved video platform up to 18 times for 50-minutes.
Plan for Analysis of Results Following the best practice guidelines of the What Works Clearinghouse Standards for SCEDs, the investigators will examine consistency, intervention effect, immediacy, and auto-correlations for rumination, depressive symptoms, blood pressure, cortisol, h-CRP, IL-6, and TNF-α. The investigators will use Bayesian unknown changepoint models to estimate the parameters and model the treatment effect. A mixed effects model will be used to model the hierarchical structure of the data. The dependent variables are rumination, depressive symptoms, blood pressure, cortisol, h-CRP, IL-6, and TNF-α. The independent variable is phase. Bayesian estimation will be used to address the small sample nature of the data. For these statistical analyses the investigators will use R and "Just Another Gibbs Sampler" (JAGS). The investigators will conduct semi-structured interviews and analyze data using thematic analysis to generate themes associated with the data. The statistical program Dedoose will be utilized to facilitate this process.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single subject design
| Arm | Type | Receives |
|---|---|---|
| RFCBT | Experimental | Behavioral: Rumination-Focused Cognitive Behavior TherapyThis is a single subject design study. Thus, all participants receive Rumination-Focused Cognitive Behavior Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- RSQ-Brooding score: >= 11
- PHQ-9 score: 10-20
- SBP: >= 120 and/or DBP: >= 80)
- fluent in English
Key exclusion criteria (1 listed)
- None besides the described inclusion criteria
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 |
|---|---|---|
| Rumination-Focused Cognitive Behavior TherapyThe RFCBT exclusively addresses one possible mechanism underlying depression, rumination. In general, a participant and their therapist will identify when the participant ruminates in an unhelpful manner, what triggers the rumination, what function the rumination fulfills for the participant, and how the participant already does to stop ruminating. Building on this knowledge both together will change the environment to reduce the likelihood of the participant to ruminate, use consciously strategies to stop rumination when it occurs, and replace rumination by more helpful strategies. In the proposed single subject study, the participant and the therapist will meet in person or using a UofL approved video platform up to 18 times for 50-minutes. | Behavioural | RFCBT |
Primary outcome
Response Style Questionnaire
Time frame: Baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 1 week after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 2 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 3 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 4 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 5 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 6 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 7 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 9 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 11 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 13 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 15 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 17 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 19 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 21 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 23 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 25 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 27 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 29 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 31 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Response Style Questionnaire
Time frame: 33 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
Patient Health Questionnaire-9
Time frame: Baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 1 week after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 2 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 3 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 4 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 5 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 6 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 7 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 9 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 11 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 13 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 15 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 17 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 19 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 21 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 23 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 25 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 27 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 29 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 31 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
Patient Health Questionnaire-9
Time frame: 33 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
systolic blood pressure measures
Time frame: Baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 1 week after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 2 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 3 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 4 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 5 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 6 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 7 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 9 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 11 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 13 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 15 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 17 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 19 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 21 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 23 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 25 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 27 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 29 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 31 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
systolic blood pressure measures
Time frame: 33 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: Baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 1 week after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 2 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 3 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 4 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 5 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 6 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 7 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 9 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 11 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 13 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 15 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 17 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 19 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 21 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 23 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 25 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 27 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 29 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 31 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
Time frame: 33 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
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 31 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Patrick Possel, Dr.rer.soc. principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rumination-Focused Cognitive Behavior Therapy in people with Rumination and Depressive Symptoms, run by University of Louisville 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 1 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 31 Dec 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?
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?
Response Style Questionnaire (time frame: Baseline 1). The study lists 84 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 31 Dec 2025.