Caregiver DistressNCT03557515
Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study
A study testing Stress Management and CBT and Stress Management and Metta-Meditation in people with Caregiver Distress, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Distress
- What is being tested?
- Stress Management and CBT and Stress Management and Metta-Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2018to 5 May 2021
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informal caregiver of a patient screening for a phase 1 clinical trial
- Self-identifies as a caregiver as consistent with the National Study Of Caregiving (NSOC) definition13- individuals who help a patient with self-care, mobility, or household activities (the latter, for health or functioning related reasons) and are either related to the patient (paid or and non-paid) or are unrelated non-paid helpers.
- Provision to sign and date the consent form.
- Completes the Patient Health Questionnaire (PHQ-4) screener with a total score of >3.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Age >18
- Has consistent access to a telephone
- Able to read and understand English
Who cannot join
- Has a cognitive or psychiatric condition prohibiting participation.
- Current enrollment in another psychosocial intervention trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Universtiy of Colorado Denver
Denver, Colorado, 80045
About this study
This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial.
Read the detailed description
This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial. The P1-CaLL study uses a psychosocial intervention aimed at decreasing distress through the utilization of adaptive coping strategies (e.g., meditation, emotion-focused coping) and cognitive behavioral techniques. Caregivers will receive 4 weeks of stress-management sessions (over the phone). Then, they will be randomized to receive 4 more weekly sessions of either Cognitive Behavioral Therapy or Metta-Meditation (over the phone). Participants will receive tasks to complete each week.
- Conditions
- Caregiver Distress
- Being tested
- Stress Management and CBT, Stress Management and Metta-Meditation
- Keywords
- Depression, Cognitive Behavioral Therapy, Coping, Meditation, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management and CBTBehavioural
Stress Management will focus on:
- Mind-Body Connection
- Coping Skills
- Communication
- Social Support
Cognitive Behavioral Therapy will focus on:
- Intro to CBT-Tracking Automatic Thoughts
- Identifying Distorted Thoughts
- Challenging Distorted Thoughts
- Core Beliefs/Relapse Prevention
Stress Management and Metta-MeditationBehavioural
Stress Management will focus on:
- Mind-Body Connection
- Coping Skills
- Communication
- Social Support
Metta-Meditation will focus on:
- Intro to Meditation vis Mindfulness of the Breath and Body-Noticing Critical Self Talk
- Intro to Brief Loving-Kindness Meditation and Self-Care
- Continuing with Additional Metta-Based Exercises to Cultivate Compassion for Oneself and Others and Mitigating Self-Criticism
- Review/Plan for Future
| Study group | Role | What they receive |
|---|---|---|
| CBT Telephonic Sessions | Experimental | All participants will receive four stress management sessions. Then, the participant is randomly assigned to receive 4 weekly additional CBT telephonic sessions. Participants will be given weekly assignments to practice the skills learned in the sessions. Sessions will last 45 minutes to 1 hour. Optional grief and loss telephonic session will be offered. Receives: Behavioral: Stress Management and CBT |
| Metta-Meditation Telephonic Sessions | Experimental | All participants will receive four stress management sessions. Then, the participant is randomly assigned to receive 4 weekly additional Metta-meditation sessions. Participants will be given weekly assignments to practice the skills learned in the sessions. Sessions will last 45 minutes to 1 hour. Optional grief and loss telephonic session will be offered. Receives: Behavioral: Stress Management and Metta-Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention
Fifty percent of those approached decide to enroll (recruitment), and fifty percent of those enrolled complete all sessions (retention).
Measured: Baseline to end of study period (up to one year)
Determine the acceptability of the P1-CaLL intervention using a Likert scale
Quantitatively measure the acceptability of the P1-CaLL intervention (at least fifty percent of those that complete the intervention rate it) as average or above average on a Likert Scale of Acceptability.
Measured: Baseline to end of study period (up to one year)
Secondary outcomes (8)
Depression Anxiety and Stress Scale (DASS)
The between-subject change in symptoms of distress as measured by response on the Depression Anxiety and Stress Scale (DASS) from baseline (week one) to post-assessment (week nine).
Measured: Baseline to post-assessment (up to 9 weeks)
PROMIS-Depression
Measure between-subject changes in psychosocial variablesin caregivers of phase 1 clinical trial participants.
Measured: Baseline to post-assessment (up to 9 weeks)
PROMIS-Anxiety
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Measured: Baseline to post-assessment (up to 9 weeks)
Caregiver Burden (CRA)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Measured: Baseline to post-assessment (up to 9 weeks)
Positive Benefit Finding (Positive Aspects of Caregiving)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Measured: Baseline to post-assessment (up to 9 weeks)
Self-Efficacy (CGI)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Measured: Baseline to post-assessment (up to 9 weeks)
Compassion (Compassion Scale)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Measured: Baseline to post-assessment (up to 9 weeks)
Dysfunctional Thoughts (ATD)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Measured: Baseline to post-assessment (up to 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start12 Jun 2018
- Primary completion2 Jan 2020
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver DistressStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Kilbourn, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557515
- Sponsor's protocol ID
- 17-0514.cc
- Status last verified
- May 2021
- First submitted
- 22 May 2018
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study
- ClinicalTrials.gov ID
- NCT03557515
- Acronym / sponsor ID
- 17-0514.cc
- Conditions
- Caregiver Distress
- Keywords
- Depression, Cognitive Behavioral Therapy, Coping, Meditation, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 15 Jun 2018 (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 seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial.
Detailed description
This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial. The P1-CaLL study uses a psychosocial intervention aimed at decreasing distress through the utilization of adaptive coping strategies (e.g., meditation, emotion-focused coping) and cognitive behavioral techniques. Caregivers will receive 4 weeks of stress-management sessions (over the phone). Then, they will be randomized to receive 4 more weekly sessions of either Cognitive Behavioral Therapy or Metta-Meditation (over the phone). Participants will receive tasks to complete each week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT Telephonic Sessions | Experimental | Behavioral: Stress Management and CBTAll participants will receive four stress management sessions. Then, the participant is randomly assigned to receive 4 weekly additional CBT telephonic sessions. Participants will be given weekly assignments to practice the skills learned in the sessions. Sessions will last 45 minutes to 1 hour. Optional grief and loss telephonic session will be offered. |
| Metta-Meditation Telephonic Sessions | Experimental | Behavioral: Stress Management and Metta-MeditationAll participants will receive four stress management sessions. Then, the participant is randomly assigned to receive 4 weekly additional Metta-meditation sessions. Participants will be given weekly assignments to practice the skills learned in the sessions. Sessions will last 45 minutes to 1 hour. Optional grief and loss telephonic session will be offered. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informal caregiver of a patient screening for a phase 1 clinical trial
- Self-identifies as a caregiver as consistent with the National Study Of Caregiving (NSOC) definition13- individuals who help a patient with self-care, mobility, or household activities (the latter, for health or functioning related reasons) and are either related to the patient (paid or and non-paid) or are unrelated non-paid helpers.
- Provision to sign and date the consent form.
- Completes the Patient Health Questionnaire (PHQ-4) screener with a total score of >3.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
Key exclusion criteria (2 listed)
- Has a cognitive or psychiatric condition prohibiting participation.
- Current enrollment in another psychosocial intervention trial.
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 |
|---|---|---|
| Stress Management and CBTStress Management will focus on: 1. Mind-Body Connection 2. Coping Skills 3. Communication 4. Social Support Cognitive Behavioral Therapy will focus on: 1. Intro to CBT-Tracking Automatic Thoughts 2. Identifying Distorted Thoughts 3. Challenging Distorted Thoughts 4. Core Beliefs/Relapse Prevention | Behavioural | CBT Telephonic Sessions |
| Stress Management and Metta-MeditationStress Management will focus on: 1. Mind-Body Connection 2. Coping Skills 3. Communication 4. Social Support Metta-Meditation will focus on: 1. Intro to Meditation vis Mindfulness of the Breath and Body-Noticing Critical Self Talk 2. Intro to Brief Loving-Kindness Meditation and Self-Care 3. Continuing with Additional Metta-Based Exercises to Cultivate Compassion for Oneself and Others and Mitigating Self-Criticism 4. Review/Plan for Future | Behavioural | Metta-Meditation Telephonic Sessions |
Primary outcome
Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention
Time frame: Baseline to end of study period (up to one year)
Fifty percent of those approached decide to enroll (recruitment), and fifty percent of those enrolled complete all sessions (retention).
Determine the acceptability of the P1-CaLL intervention using a Likert scale
Time frame: Baseline to end of study period (up to one year)
Quantitatively measure the acceptability of the P1-CaLL intervention (at least fifty percent of those that complete the intervention rate it) as average or above average on a Likert Scale of Acceptability.
8 secondary outcomes
Depression Anxiety and Stress Scale (DASS)
Time frame: Baseline to post-assessment (up to 9 weeks)
PROMIS-Depression
Time frame: Baseline to post-assessment (up to 9 weeks)
PROMIS-Anxiety
Time frame: Baseline to post-assessment (up to 9 weeks)
Caregiver Burden (CRA)
Time frame: Baseline to post-assessment (up to 9 weeks)
Positive Benefit Finding (Positive Aspects of Caregiving)
Time frame: Baseline to post-assessment (up to 9 weeks)
Self-Efficacy (CGI)
Time frame: Baseline to post-assessment (up to 9 weeks)
Compassion (Compassion Scale)
Time frame: Baseline to post-assessment (up to 9 weeks)
Dysfunctional Thoughts (ATD)
Time frame: Baseline to post-assessment (up to 9 weeks)
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 26 May 2021.
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Recruiting
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A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Alzheimer's Disease (RESOLVE)
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Project EMPOWER-OCD
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The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project
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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.
Kristin Kilbourn, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management and CBT and Stress Management and Metta-Meditation in people with Caregiver Distress, run by University of Colorado, Denver 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 8 inclusion and 2 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 26 May 2021. 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?
Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention (time frame: Baseline to end of study period (up to one year)). The study lists 2 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 26 May 2021.