AnxietyNCT02647216
Mindfulness for Breast Cancer
A study testing Mindfulness Based Cognitive Therapy and Treatment as Usual in people with Anxiety and Depression, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) vs. Treatment as Usual (TAU) for depression and anxiety symptoms in breast cancer patients in recovery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Depression, Breast Cancer
- What is being tested?
- Mindfulness Based Cognitive Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 1 Mar 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and over
- Able to speak and read English
- Diagnosis of breast cancer (any stage) for which active treatment (e.g., surgery, chemotherapy, and/or radiotherapy) has been completed within 2 months to 2 years
Who cannot join
- Cognitive impairment or mental illness that would impair ability to provide consent or participate in the program;
- Major psychiatric disorder (e.g., psychosis, personality disorder)
- Current suicidal ideation or suicide attempt within past 3 months
- Past participation in an MBCT group
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Mindfulness Training to Improve Well-being in Post-Treatment Breast Cancer Patients
The primary purpose of this study is to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) vs. Treatment as Usual (TAU) for depression and anxiety symptoms in breast cancer patients in recovery. Investigators will examine whether MBCT-related improvements in sleep quality, illness-related distress, and rumination (escalating cycles of negative thinking) predict MBCT-related decreases in depression and anxiety symptoms (Aim 2). Exploratory analyses will examine whether demographics (e.g., age, sex, race/ethnicity), individual differences (e.g., perceived stress, social support), clinical characteristics (e.g., stage/severity of diagnosis), and treatment adherence (e.g., sessions attended, hours of weekly practice) help determine for whom MBCT is most effective (Aim 3).
- Conditions
- Anxiety, Depression, Breast Cancer
- Being tested
- Mindfulness Based Cognitive Therapy, Treatment as Usual
- Keywords
- Mindfulness Based Cognitive Therapy (MBCT), anxiety, depression
- Medical subject headings
- Anxiety Disorders, Depression, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
Weekly MBCT sessions consist of: a) mindfulness practice including breath-focused sitting meditation, body scanning, and mindful stretching; b) review of previous weeks' homework and an overview of the current week's homework; c) barriers to completing the homework. Homework includes: a) practicing the mindfulness exercise reviewed in class using the CDs provided to each participant (guided practice of the relevant exercise); b) maintaining a calendar of pleasant events; c) mindfully engaging in activities of daily living; and d) logging practice efforts in a daily log.
Treatment as UsualBehavioural
Subjects randomized to the Treatment as Usual group will be advised to seek help from their family doctor or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) | Active comparator | MBCT is a structured 8-week group intervention which integrates aspects of cognitive behavioral therapy (CBT) with components of the Mindfulness Based Stress Reduction (MBSR) program. Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| Treatment as Usual (TAU) | Active comparator | Subjects randomized to TAU will be advised to seek help from their family doctor or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study. All treatments received over the course of the study (for the TAU group) and outside of the study (for the MBCT group) will be assessed at the 3-month follow up (Visit 3). Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Level using the State-Trait Anxiety Inventory (STAI)-Form Y
This measure consists of 20-items that assess trait anxiety and 20 for state anxiety.
Measured: 3 Months
Change in level of Depression using the Beck Depression Inventory-II (BDI-II)
The 21-item version of this widely used measure will be used to assess depressive symptoms.
Measured: 3 Months
Secondary outcomes (6)
Change in Quality of Life using the Patient Reported Outcomes Measurement Information System (PROMISE)
PROMISE: 10 Item measure of quality of life
Measured: 3 Months
Change in fatigues score using a Functional Assessment of Cancer Therapy Breast and Fatigue subscales (FACIT-B and F):
Measured: 3 Months
Change in Physical Health Symptoms
Measured: 3 Months
Change in Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI):
This 19-item measure assesses habitual sleep quality over the last month. It consists of 7 subscales (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction), and also provides a global sleep quality score.
Measured: 3 Months
Change in Illness Perceptions using the Brief Illness Perception Questionnaire (B-IPQ)
Measured: 3 Months
Change in Rumination using the Ruminative Responses Scale (RSS):
Change in the level of escalating cycles of negative thinking
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionFeb 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanya Spruill, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647216
- Sponsor's protocol ID
- 14-01138
- Status last verified
- May 2020
- First submitted
- 30 Dec 2015
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training to Improve Well-being in Post-Treatment Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02647216
- Acronym / sponsor ID
- 14-01138
- Conditions
- Anxiety, Depression, Breast Cancer
- Keywords
- Mindfulness Based Cognitive Therapy (MBCT), anxiety, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 6 Jan 2016 (estimated)
- 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.
The primary purpose of this study is to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) vs. Treatment as Usual (TAU) for depression and anxiety symptoms in breast cancer patients in recovery. Investigators will examine whether MBCT-related improvements in sleep quality, illness-related distress, and rumination (escalating cycles of negative thinking) predict MBCT-related decreases in depression and anxiety symptoms (Aim 2). Exploratory analyses will examine whether demographics (e.g., age, sex, race/ethnicity), individual differences (e.g., perceived stress, social support), clinical characteristics (e.g., stage/severity of diagnosis), and treatment adherence (e.g., sessions attended, hours of weekly practice) help determine for whom MBCT is most effective (Aim 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) | Active comparator | Behavioral: Mindfulness Based Cognitive TherapyMBCT is a structured 8-week group intervention which integrates aspects of cognitive behavioral therapy (CBT) with components of the Mindfulness Based Stress Reduction (MBSR) program. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as UsualSubjects randomized to TAU will be advised to seek help from their family doctor or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study. All treatments received over the course of the study (for the TAU group) and outside of the study (for the MBCT group) will be assessed at the 3-month follow up (Visit 3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and over
- Able to speak and read English
- Diagnosis of breast cancer (any stage) for which active treatment (e.g., surgery, chemotherapy, and/or radiotherapy) has been completed within 2 months to 2 years
Key exclusion criteria (4 listed)
- Cognitive impairment or mental illness that would impair ability to provide consent or participate in the program;
- Major psychiatric disorder (e.g., psychosis, personality disorder)
- Current suicidal ideation or suicide attempt within past 3 months
- Past participation in an MBCT group
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 |
|---|---|---|
| Mindfulness Based Cognitive TherapyWeekly MBCT sessions consist of: a) mindfulness practice including breath-focused sitting meditation, body scanning, and mindful stretching; b) review of previous weeks' homework and an overview of the current week's homework; c) barriers to completing the homework. Homework includes: a) practicing the mindfulness exercise reviewed in class using the CDs provided to each participant (guided practice of the relevant exercise); b) maintaining a calendar of pleasant events; c) mindfully engaging in activities of daily living; and d) logging practice efforts in a daily log. | Behavioural | Mindfulness Based Cognitive Therapy (MBCT) |
| Treatment as UsualSubjects randomized to the Treatment as Usual group will be advised to seek help from their family doctor or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Change in Anxiety Level using the State-Trait Anxiety Inventory (STAI)-Form Y
Time frame: 3 Months
This measure consists of 20-items that assess trait anxiety and 20 for state anxiety.
Change in level of Depression using the Beck Depression Inventory-II (BDI-II)
Time frame: 3 Months
The 21-item version of this widely used measure will be used to assess depressive symptoms.
6 secondary outcomes
Change in Quality of Life using the Patient Reported Outcomes Measurement Information System (PROMISE)
Time frame: 3 Months
Change in fatigues score using a Functional Assessment of Cancer Therapy Breast and Fatigue subscales (FACIT-B and F):
Time frame: 3 Months
Change in Physical Health Symptoms
Time frame: 3 Months
Change in Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI):
Time frame: 3 Months
Change in Illness Perceptions using the Brief Illness Perception Questionnaire (B-IPQ)
Time frame: 3 Months
Change in Rumination using the Ruminative Responses Scale (RSS):
Time frame: 3 Months
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 18 May 2020.
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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.
Tanya Spruill principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy and Treatment as Usual in people with Anxiety and Depression, run by NYU Langone Health 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 3 inclusion and 4 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 18 May 2020. 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?
Change in Anxiety Level using the State-Trait Anxiety Inventory (STAI)-Form Y (time frame: 3 Months). 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 18 May 2020.