Anxiety DisorderFOCUSNCT01929720
Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors
A study testing Cognitive-behavioral therapy for worry, uncertainty & insomnia in people with Anxiety Disorder and Worry, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies a cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorder, Worry, Uncertainty
- What is being tested?
- Cognitive-behavioral therapy for worry, uncertainty & insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung cancer
- stage III or IV colorectal cancer
- pancreatic cancer
- esophageal cancer
- multiple myeloma
- leukemia
Show all 13Show fewer
- stage IIIC and IV melanoma
- ovarian cancer
- stage III \& IV cervical cancer
- stage III \& IV uterine cancer
- stage IIIB, IIIC, and IV breast cancer
- glioblastoma multiforme
- early relapse (< 1 year) lymphoma
Who cannot join
- co-morbid immunologic disease (i.e. rheumatoid arthritis, systemic lupus)
- neurologic disease (i.e. multiple sclerosis, Parkinson's, Alzheimer's) that would affect neuro-immune assessment or completion of study questionnaires
- mania (if patient has bipolar disorder)
- active substance abuse disorders such as alcohol dependence and cocaine abuse will also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Wexner Medical Center at The Ohio State University Department of Psychiatry
Columbus, Ohio, 43210
About this study
Official title: Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
This randomized clinical trial studies a cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. This study also explores the neuro-immunologic correlates of anxiety and insomnia.
Read the detailed description
PRIMARY OBJECTIVES:
- To complete a randomized pilot trial of a cognitive-behavioral anxiety-insomnia intervention to determine the impact of this intervention on patient worry, intolerance of uncertainty, and sleep efficiency.
II. Explore the underlying endocrine and immune mechanisms responsible for a specific symptom cluster (anxiety-insomnia-depression-pain-fatigue) observed among advanced cancer patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary and worry record daily in weeks 1 and 5. Patients also receive education on the components of anxiety (physical cognitive, and behavioral) and practice relaxation techniques and behavioral sleep strategies in weeks 2-5. Blood draw is optional.
ARM II: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary and worry record daily in weeks 1 and 5. Blood draw is also optional. This is a wait-list control arm, so patients in this arm, after a six-week period of treatment as usual with their oncologist, then receive the intervention.
- Conditions
- Anxiety Disorder, Worry, Uncertainty, Sleep Disorders, Insomnia, Fatigue
- Being tested
- Cognitive-behavioral therapy for worry, uncertainty & insomnia
- Keywords
- cancer, cancer survivors, worry, insomnia, symptoms, fatigue, depression, anxiety
- Medical subject headings
- Anxiety Disorders, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Fatigue, Pain, Depression, Esophageal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy for worry, uncertainty & insomniaBehavioural
Also called Cognitive-behavioral Therapy, Acceptance and Commitment Therapy, Psychological Intervention, Behavior Therapy
This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (CBT for worry, uncertainty & insomnia) | Experimental | Patients wear a wrist actigraph and complete a sleep diary and worry record daily in weeks 1 and 5. Patients participate in a Behavioral Intervention (cognitive-behavioral therapy) in which they receive education on the components of anxiety (physical cognitive, and behavioral) and practice relaxation techniques and behavioral sleep strategies in weeks 2-5. Receives: Behavioral: Cognitive-behavioral therapy for worry, uncertainty & insomnia |
| Arm II (wait-list control) | Active comparator | Patients wear a wrist actigraph and complete a sleep diary and worry record daily in weeks 1 and 5. This is a wait-list comparison, so after six weeks, patients in the control group complete the behavioral (cognitive-behavioral therapy)intervention for worry, uncertainty, and insomnia. Receives: Behavioral: Cognitive-behavioral therapy for worry, uncertainty & insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in worry on the Penn State Worry Questionnaire
A linear mixed model will be used to evaluate the change from pre to post on the Penn State Worry Questionnaire. The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then the outcomes will be log transformed in order to meet these assumptions for the mixed models.
Measured: From baseline to 6 weeks
Changes in sleep efficiency on the Insomnia Severity Index
A linear mixed model will be used to evaluate the change from pre to post on the Insomnia Severity Index. The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then this outcome will be log transformed in order to meet these assumptions for the mixed models.
Measured: From baseline to 6 weeks
Changes in intolerance of uncertainty on the Intolerance of Uncertainty Scale
A linear mixed model will be used to evaluate the change from pre to post on the Intolerance of Uncertainty Scale . The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then the outcome will be log transformed in order to meet these assumptions for the mixed models.
Measured: From baseline to 6 weeks
Secondary outcomes (3)
Levels of cortisol
This is an exploratory hypothesis. We are using only baseline data to estimate the correlation between the continuous anxiety scale (STAI scores range from 20 - 80) and plasma and serum cortisol.
Measured: Baseline
Levels of pro and anti-inflammatory cytokines
This is an exploratory hypothesis. We are using only baseline data to estimate the correlation between the continuous anxiety scale (STAI scores range from 20 - 80) and pro and anti inflammatory cytokines.
Measured: Baseline
Levels of myeloid-derived suppressor cells (MDSC)
This is an exploratory hypothesis. We are using only baseline data to estimate the correlation between the continuous anxiety scale (STAI scores range from 20 - 80) and myeloid-derived suppressor values.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startAug 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Lance Armstrong Foundation
- Responsible party
- Principal investigator, Sharla Wells-Di Gregorio, Ohio State University Comprehensive Cancer Center
- Investigators
- Sharla Wells-Di Gregorio, Ph.D., Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929720
- Sponsor's protocol ID
- OSU-09096
- Other IDs
- NCI-2012-02879
- Acronym
- FOCUS
- Status last verified
- Apr 2017
- First submitted
- 13 Mar 2013
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PubMed 41170811Wells-Di Gregorio S, Flowers S, Peng J, Marks DR, Probst D, Zaleta A, Benson D, Cohn DE, Lustberg M, Carson W, Magalang U, Baltimore S, Ancoli-Israel S. Combined Treatment With Cognitive Behavioral Therapy for Insomnia and Acceptance and Commitment Therapy Enhances Objective and Subjective Reports of Sleep in Patients With Advanced Cancer. Psychooncology. 2025 Apr;34(4):e70141. doi: 10.1002/pon.70141.
PubMed 40204663
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
- ClinicalTrials.gov ID
- NCT01929720
- Acronym / sponsor ID
- FOCUS / OSU-09096
- Conditions
- Anxiety Disorder, Worry, Uncertainty, Sleep Disorders, Insomnia, Fatigue
- Keywords
- cancer, cancer survivors, worry, insomnia, symptoms, fatigue, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Lance Armstrong Foundation
- Study start
- Aug 2011 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Aug 2013 (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.
This randomized clinical trial studies a cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. This study also explores the neuro-immunologic correlates of anxiety and insomnia.
Detailed description
PRIMARY OBJECTIVES:
- To complete a randomized pilot trial of a cognitive-behavioral anxiety-insomnia intervention to determine the impact of this intervention on patient worry, intolerance of uncertainty, and sleep efficiency.
II. Explore the underlying endocrine and immune mechanisms responsible for a specific symptom cluster (anxiety-insomnia-depression-pain-fatigue) observed among advanced cancer patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary and worry record daily in weeks 1 and 5. Patients also receive education on the components of anxiety (physical cognitive, and behavioral) and practice relaxation techniques and behavioral sleep strategies in weeks 2-5. Blood draw is optional.
ARM II: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary and worry record daily in weeks 1 and 5. Blood draw is also optional. This is a wait-list control arm, so patients in this arm, after a six-week period of treatment as usual with their oncologist, then receive the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (CBT for worry, uncertainty & insomnia) | Experimental | Behavioral: Cognitive-behavioral therapy for worry, uncertainty & insomniaPatients wear a wrist actigraph and complete a sleep diary and worry record daily in weeks 1 and 5. Patients participate in a Behavioral Intervention (cognitive-behavioral therapy) in which they receive education on the components of anxiety (physical cognitive, and behavioral) and practice relaxation techniques and behavioral sleep strategies in weeks 2-5. |
| Arm II (wait-list control) | Active comparator | Behavioral: Cognitive-behavioral therapy for worry, uncertainty & insomniaPatients wear a wrist actigraph and complete a sleep diary and worry record daily in weeks 1 and 5. This is a wait-list comparison, so after six weeks, patients in the control group complete the behavioral (cognitive-behavioral therapy)intervention for worry, uncertainty, and insomnia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- lung cancer
- stage III or IV colorectal cancer
- pancreatic cancer
- esophageal cancer
- multiple myeloma
Key exclusion criteria (4 listed)
- co-morbid immunologic disease (i.e. rheumatoid arthritis, systemic lupus)
- neurologic disease (i.e. multiple sclerosis, Parkinson's, Alzheimer's) that would affect neuro-immune assessment or completion of study questionnaires
- mania (if patient has bipolar disorder)
- active substance abuse disorders such as alcohol dependence and cocaine abuse will also be excluded
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 |
|---|---|---|
| Cognitive-behavioral therapy for worry, uncertainty & insomniaAlso: Cognitive-behavioral Therapy, Acceptance and Commitment Therapy, Psychological Intervention, Behavior TherapyThis intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice. | Behavioural | Arm I (CBT for worry, uncertainty & insomnia), Arm II (wait-list control) |
Primary outcome
Changes in worry on the Penn State Worry Questionnaire
Time frame: From baseline to 6 weeks
A linear mixed model will be used to evaluate the change from pre to post on the Penn State Worry Questionnaire. The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then the outcomes will be log transformed in order to meet these assumptions for the mixed models.
Changes in sleep efficiency on the Insomnia Severity Index
Time frame: From baseline to 6 weeks
A linear mixed model will be used to evaluate the change from pre to post on the Insomnia Severity Index. The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then this outcome will be log transformed in order to meet these assumptions for the mixed models.
Changes in intolerance of uncertainty on the Intolerance of Uncertainty Scale
Time frame: From baseline to 6 weeks
A linear mixed model will be used to evaluate the change from pre to post on the Intolerance of Uncertainty Scale . The model will include group (treatment vs. control), time (pre vs. post), and group-time interaction effects. If the outcome measure is not normally distributed with equal variance across groups, then the outcome will be log transformed in order to meet these assumptions for the mixed models.
3 secondary outcomes
Levels of cortisol
Time frame: Baseline
Levels of pro and anti-inflammatory cytokines
Time frame: Baseline
Levels of myeloid-derived suppressor cells (MDSC)
Time frame: Baseline
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 5 Apr 2017.
- Derived from this study: PubMed 41170811Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
- Derived from this study: PubMed 40204663Wells-Di Gregorio S, Flowers S, Peng J, Marks DR, Probst D, Zaleta A, Benson D, Cohn DE, Lustberg M, Carson W, Magalang U, Baltimore S, Ancoli-Israel S. Combined Treatment With Cognitive Behavioral Therapy for Insomnia and Acceptance and Commitment Therapy Enhances Objective and Subjective Reports of Sleep in Patients With Advanced Cancer. Psychooncology. 2025 Apr;34(4):e70141. doi: 10.1002/pon.70141.
- Center for Palliative CareLink provided by the sponsor.
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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.
Sharla Wells-Di Gregorio, Ph.D. principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy for worry, uncertainty & insomnia in people with Anxiety Disorder and Worry, run by Ohio State University Comprehensive Cancer Center 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 13 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 5 Apr 2017. 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?
Changes in worry on the Penn State Worry Questionnaire (time frame: From baseline to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01929720, which also lists 2 linked publications.
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 5 Apr 2017.