NCT05980130

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

June 7, 2023

Last Update Submit

December 30, 2025

Conditions

RuminationDepressive SymptomsBlood Pressure

Keywords

ruminationdepressive symptomsblood pressurerumination-focused cognitive behavioral therapyProof of Concept StudySingle subject design

Outcome Measures

Primary Outcomes (84)

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    Baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    1 week after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    2 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    3 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    4 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    5 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    6 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    7 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    9 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    11 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    13 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    15 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    17 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    19 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    21 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    23 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    25 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    27 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    29 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    31 weeks after baseline 1

  • Response Style Questionnaire

    sadness rumination, Score range: 5-20, higher score = more rumination

    33 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    Baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    1 week after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    2 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    3 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    4 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    5 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    6 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    7 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    9 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    11 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    13 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    15 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    17 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    19 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    21 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    23 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    25 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    27 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    29 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    31 weeks after baseline 1

  • Patient Health Questionnaire-9

    depressive symptoms, Score range: 0-27, higher score = more depressive symptoms

    33 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    Baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    1 week after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    2 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    3 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    4 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    5 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    6 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    7 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    9 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    11 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    13 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    15 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    17 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    19 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    21 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    23 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    25 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    27 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    29 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    31 weeks after baseline 1

  • systolic blood pressure measures

    systolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    33 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    Baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    1 week after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    2 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    3 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    4 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    5 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    6 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    7 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    9 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    11 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    13 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    15 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    17 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    19 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    21 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    23 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    25 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    27 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    29 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    31 weeks after baseline 1

  • diastolic blood pressure measures

    diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure

    33 weeks after baseline 1

Study Arms (1)

RFCBT

EXPERIMENTAL

This is a single subject design study. Thus, all participants receive Rumination-Focused Cognitive Behavior Therapy

Behavioral: Rumination-Focused Cognitive Behavior Therapy

Interventions

Rumination-Focused Cognitive Behavior TherapyBEHAVIORAL

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.

RFCBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • RSQ-Brooding score: \>= 11
  • PHQ-9 score: 10-20
  • SBP: \>= 120 and/or DBP: \>= 80)
  • fluent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Have a Heart clinic

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Rumination SyndromeDepression

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Patrick Possel, Dr.rer.soc.

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This is a Single subject design study. Thus, as all participants receive the intervention, there is no masking possible.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single subject design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 7, 2023

First Posted

August 7, 2023

Study Start

August 15, 2023

Primary Completion

September 12, 2025

Study Completion

September 12, 2025

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)