Trial Outcomes & Findings for Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors (NCT NCT04430335)
NCT ID: NCT04430335
Last Updated: 2023-08-16
Results Overview
To determine participation rate, investigators will track the total number of individuals approached, the number of individuals who met all eligibility criteria and percent who agree to participate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
12 weeks after start of intervention
Results posted on
2023-08-16
Participant Flow
Participant milestones
| Measure |
Telephone-Based Cognitive Behavioral Therapy
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
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|---|---|
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Telephone-Based Cognitive Behavioral Therapy
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors
Baseline characteristics by cohort
| Measure |
Telephone-Based Cognitive Behavioral Therapy
n=8 Participants
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
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|---|---|
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Age, Continuous
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45.1 years
STANDARD_DEVIATION 13.5 • n=5 Participants
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Sex: Female, Male
Female
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7 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Origin of Ethnicity - Mexico
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5 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Origin of Ethnicity - Honduras
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1 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Origin of Ethnicity - Nicaragua
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1 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Origin of Ethnicity - Spain
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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8 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 12 weeks after start of interventionTo determine participation rate, investigators will track the total number of individuals approached, the number of individuals who met all eligibility criteria and percent who agree to participate.
Outcome measures
| Measure |
Telephone-Based Cognitive Behavioral Therapy
n=7 Participants
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
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Participation Rate - Percentage Who Agreed to Participate
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88.9 percentage of participants
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PRIMARY outcome
Timeframe: 12 weeks after start of interventionAccrual rates will be calculated by calculating the mean number of participants recruited per month.
Outcome measures
| Measure |
Telephone-Based Cognitive Behavioral Therapy
n=7 Participants
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
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|---|---|
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Accrual Rate
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1.1 participants accrued per month
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PRIMARY outcome
Timeframe: 13 weeks after the start of interventionStudy retention will be estimated by the proportion of participants who complete the Week 13 visit. Drop-out is defined as 100% minus the dropout %
Outcome measures
| Measure |
Telephone-Based Cognitive Behavioral Therapy
n=7 Participants
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
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Retention Rate - Percentage of Completed Visits
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87.5 percentage of completion of Wk. 13 visit
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PRIMARY outcome
Timeframe: 12 weeks after start of interventionIntervention adherence will be estimated as the mean percentage of therapy or check-in sessions each participant completes. Participants must complete at least 9 of the 12 sessions (75%) to be considered adherent.
Outcome measures
| Measure |
Telephone-Based Cognitive Behavioral Therapy
n=7 Participants
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
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|---|---|
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Adherence - Percentage of Completed Therapy Sessions
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87.5 percentage to complete 9 or more session
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SECONDARY outcome
Timeframe: At baseline, 7 weeks and 13 weeks after start of interventionThe General Anxiety Disorder (GAD)-7 is a self-report measure of DSM-IV symptoms of general anxiety disorder. Participants rate 7 questions on a scale of 0 (not at all), 1 (several days), 2 (more than half the days) and 3 (nearly every day); one additional question assesses the interference of these symptoms with functioning. The first 7 questions are summed to create a total score. Scoring range is 0-21 with the higher score indicating a higher level of anxiety (scores 0 to less than or equal to 9 = no/mild anxiety; scores greater than or equal to 10 to less than or equal to 14 = moderate anxiety; scores greater than or equal to 15 to 21 = severe anxiety).
Outcome measures
| Measure |
Telephone-Based Cognitive Behavioral Therapy
n=7 Participants
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
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Anxiety Questionnaire - General Anxiety Disorder (GAD)-7
Baseline
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12.9 score on a scale
Standard Error 2.0
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Anxiety Questionnaire - General Anxiety Disorder (GAD)-7
Week 7
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4.3 score on a scale
Standard Error 2.3
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Anxiety Questionnaire - General Anxiety Disorder (GAD)-7
Week 13
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4.1 score on a scale
Standard Error 2.1
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SECONDARY outcome
Timeframe: At baseline, 7 weeks and 13 weeks after start of interventionThe Patient Health Questionnaire (PHQ)-9 is a self-report measure of DSM-IV symptoms of Major Depressive Disorder. Participants rate how often they have experienced nine symptoms over the past 2 weeks on a scale of 0 (not at all); 1 (several days), 2 (more than half the days) and 3 (nearly every day). Responses are summed, with higher scores indicating greater depressive symptomatology. Scoring scale = 0-27 (scores 0 to less than or equal to 7 = no/mild depressive symptoms; scores greater than or equal to 8 to less than or equal to 14 = moderate depressive symptoms; scores greater than or equal to 15 to 27 = severe depressive symptoms)
Outcome measures
| Measure |
Telephone-Based Cognitive Behavioral Therapy
n=7 Participants
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
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Depressive Symptoms Questionnaire - Patient Health Questionnaire (PHQ)-9
Baseline
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11.9 score on a scale
Standard Error 2.0
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Depressive Symptoms Questionnaire - Patient Health Questionnaire (PHQ)-9
Week 7
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4.3 score on a scale
Standard Error 2.3
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Depressive Symptoms Questionnaire - Patient Health Questionnaire (PHQ)-9
Week 13
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4.1 score on a scale
Standard Error 2.1
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SECONDARY outcome
Timeframe: At baseline and 13 weeks after start of interventionThe Fear of Cancer Recurrence Inventory (FCRI; severity subscale) will be used to measure self-reported fear of recurrence. This 9-item subscale measures the presence and severity of the intrusive thoughts or images associated with the fear of recurrence. Scoring scale ranges from 0 (not at all or never) to 4 (a great deal or all of the time). Score ranges from 0-36. The higher the score, the greater the participants' fear of recurrence.
Outcome measures
| Measure |
Telephone-Based Cognitive Behavioral Therapy
n=7 Participants
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
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|---|---|
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Fear of Cancer Recurrence Inventory Questionnaire
Baseline
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15.5 score on a scale
Standard Error 3.1
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Fear of Cancer Recurrence Inventory Questionnaire
Week 13
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11.6 score on a scale
Standard Error 3.3
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Adverse Events
Telephone-Based Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Study Coordinator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-9055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place