Cystic FibrosisNCT04114227
Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients
A study testing Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF) in people with Cystic Fibrosis, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The objective of the study is to assess the utility of "Acceptance and Commitment Therapy" (ACT) in which subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors, over "Supportive Psychotherapy" in which subjects talk about their experiences to date in a cohort of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Oct 2023
- 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
- Men and women aged 18 and above.
- Able to read/understand English.
- Diagnosis of cystic fibrosis.
- PHQ-9 score > 4 or GAD-7 score > 4.
Who cannot join
- History of suicidal attempts or acute suicidal ideation on clinical assessment.
- Presence of psychotic disorder or symptoms.
- Pregnant women.
- Presence of psychiatric disorders that interfere with the participation of the study, judged by the study or treating clinician. Presence of other medical conditions that interfere with participation in the study, judged by the study or treating clinician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Center City Clinic for Behavioral Medicine
Philadelphia, Pennsylvania, 19107
About this study
The objective of the study is to assess the utility of "Acceptance and Commitment Therapy" (ACT) in which subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors, over "Supportive Psychotherapy" in which subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients. The hypothesis is that six telehealth/webcam sessions of ACT will lead to an improvement in medication and visit compliance, as well as an overall improved sense of well-being and coping skills, particularly as compared with 6 telehealth/webcam sessions of supportive psychotherapy.
Read the detailed description
Patients will be consented in the adult cystic fibrosis clinic at Drexel University, Children's Hospital of Philadelphia, University of Pennsylvania Medical Center, St. Christopher's Hospital for Children, Duke University Medical Center, Augusta University and the University of Pittsburgh. For Philadelphia sites (CHOP, Drexel, UPenn, St. Chris), Chelsi Nurse will consent patients to treatment. If at remote sites (Duke Univ Med Center, Augusta Univ, U Pittsburgh) by our local site appointed representatives will consent patients to the study. All CF patients will be approached to assess interest.
If patients are willing to be in the study, they will be given a packet of screening questionnaires (addendum #1). These questionnaires will ask patients: 1) how often participants experience different thoughts and feelings, including some related to having cystic fibrosis; 2) how often participants take their cystic fibrosis medications; 3) their coping style, including how long participants persist in thinking about something that has happened to them; The subject will complete each questionnaire again after 6 appointments (i.e., about 6 weeks later), and again about 3-months after their sixth appointment.
Finally, the investigators hope to learn whether these therapies affect how often subjects take their cystic fibrosis medications, and how this affects their health and wellbeing.
To study this, the investigators will review the number of appointments that are missed six months before enrolling in the program, and six months after completing therapy.The investigators will also review their pulmonary function tests, whether subjects go to the hospital or see their doctor for any extra visits, and the presence of any ongoing symptoms of depression or anxiety. All data will be taken from Allscripts, the Drexel outpatient medical chart. Data will be taken only from the departments of the pi and co-pi's. At UPenn, the social worker at the site will input data into Drexel Redcap through a link sent to them.
Participants will complete 6 sessions of our ACT with CF manualized intervention. Participants will be asked to complete a series of brief questionnaires at the time of consent. If desired, they can take these homes to complete and mail back.
These questionnaires will ask participants about: 1) how often they experience different thoughts and feelings, including some related to having cystic fibrosis; 2) how often they take their cystic fibrosis medications; 3) their coping style, including how long they persist in thinking about something that has happened to them.
Participants will complete each questionnaire again after 6 appointments (i.e., about 6 weeks later), and again about 3-months after their sixth appointment.
These questionnaires take about 45 minutes to complete. Participants will also be asked to complete 6 'Zoom' therapy sessions (using a webcam in their own home or on their own tablet/smartphone and HIPAA-compliant Zoom webcam service) of either "Acceptance and Commitment Therapy", in which participants will learn new ways to manage uncomfortable experiences and feelings (e.g., depression, anxiety) and to engage in positive behaviors, or to "Supportive Psychotherapy", in which participants will talk about their experiences to date. The type of therapy that participants get will be chosen by chance, like flipping a coin. Neither subject nor the study doctor will choose what treatment the participant will get. Participants will have an equal chance of being given each therapy. Audio and video recordings will be taken during each 'Zoom' therapy session. Recordings will be kept on password encrypted USB drives and stored in a locked office only accessible to the principal investigator and adherence coder. Finally, the investigators hope to learn whether these therapies affect how often participants take their cystic fibrosis medications, and how this affects their health and wellbeing. To study this, the investigators will review information from medical charts such as the number of appointments that kept, the number of appointments missed, pulmonary function tests, number of hospital or doctor visits, and the presence of any symptoms of depression or anxiety.
Measures administered are as follows:
Page 1-2: Demographics Page 3-6: CFMHWQ: CF Mental Health and Wellness Self-Report Measure. Page 7-8: BDI-II: Beck Depression Inventory-II. Page 9: BAI: The Beck Anxiety Index. Pearson. Page 10-13: CFQ-R: Cystic Fibrosis Questionnaire-Revised. Page 14: Medical Coping Modes Questionnaire. Page 15: CFS: Coping Flexibility Scale. Page 16: My CF Treatments: Treatment Adherence Questionnaire-CF. Page 17-18: ACT Demographics Page 19: CFQ13: Cognitive Fusion Questionnaire. Page 20: Short Grit Scale Page 21: AAQ-II: Acceptance and Action Questionnaire. Page 22-23: Styles of Coping Word-Pairs.
- Conditions
- Cystic Fibrosis
- Being tested
- Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF), Supportive Psychotherapy (Treatment as Usual Control)
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF)Behavioural
Subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors
Supportive Psychotherapy (Treatment as Usual Control)Behavioural
Subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Active comparator | Participants will learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors. Receives: Behavioral: Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF) |
| Supportive Psychotherapy | Active comparator | Participants will talk about their experiences to date. Receives: Behavioral: Supportive Psychotherapy (Treatment as Usual Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory (BAI)
This scale is a self-report measure of anxiety.
Measured: Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.
Beck Depression Inventory-II (BDI-II)
Widely used indicator of the severity of depression.
Measured: Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.
Cognitive Fusion Questionnaire (CFQ13)
Change in cognitive fusion (rigid attachment to one's thoughts as Truth) measures.
Measured: Beginning of study, after 6 weeks, after 3 months.
Acceptance and Action Questionnaire (AAQ-II)
Change in acceptance measures.
Measured: Beginning of study, after 6 weeks, after 3 months.
Secondary outcomes (3)
FEV1/ FVC ratio
Change in FEV1/FVC ratio.
Measured: 3 months before study, 3 months after study.
The Treatment Adherence Questionnaire-CF
Participant change in medication adherence.
Measured: Beginning of study, after 6 weeks, after 3 months.
The Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Change in CF-related quality of life
Measured: Beginning of study, after 6 weeks, after 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Jul 2019
- Primary completion31 Jul 2023
- Study completion31 Oct 2023
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 Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C. Virginia O'Hayer, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114227
- Sponsor's protocol ID
- 1905007203
- Status last verified
- Apr 2024
- First submitted
- 23 Sep 2019
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Smith PJ, Drescher CF, Bruschwein H, Ingle K, Nurse C, O'Hayer CV. Psychological Flexibility, Coping Styles, and Mood Among Individuals With Cystic Fibrosis. Biopsychosoc Sci Med. 2025 May 1;87(4):271-279. doi: 10.1097/PSY.0000000000001387. Epub 2025 Mar 24.
PubMed 40167140O'Hayer CV, Smith PJ, Drescher CF, Bruschwein H, Nurse CN, Kushner HM, Ingle K, Stephen MJ, Hoag JB. ACT with CF: A randomized trial of acceptance and commitment therapy vs supportive psychotherapy for adults with cystic fibrosis. Gen Hosp Psychiatry. 2024 Nov-Dec;91:212-222. doi: 10.1016/j.genhosppsych.2024.11.011. Epub 2024 Nov 26.
PubMed 39626332
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT04114227
- Acronym / sponsor ID
- 1905007203
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 3 Oct 2019 (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.
The objective of the study is to assess the utility of "Acceptance and Commitment Therapy" (ACT) in which subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors, over "Supportive Psychotherapy" in which subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients. The hypothesis is that six telehealth/webcam sessions of ACT will lead to an improvement in medication and visit compliance, as well as an overall improved sense of well-being and coping skills, particularly as compared with 6 telehealth/webcam sessions of supportive psychotherapy.
Detailed description
Patients will be consented in the adult cystic fibrosis clinic at Drexel University, Children's Hospital of Philadelphia, University of Pennsylvania Medical Center, St. Christopher's Hospital for Children, Duke University Medical Center, Augusta University and the University of Pittsburgh. For Philadelphia sites (CHOP, Drexel, UPenn, St. Chris), Chelsi Nurse will consent patients to treatment. If at remote sites (Duke Univ Med Center, Augusta Univ, U Pittsburgh) by our local site appointed representatives will consent patients to the study. All CF patients will be approached to assess interest.
If patients are willing to be in the study, they will be given a packet of screening questionnaires (addendum #1). These questionnaires will ask patients: 1) how often participants experience different thoughts and feelings, including some related to having cystic fibrosis; 2) how often participants take their cystic fibrosis medications; 3) their coping style, including how long participants persist in thinking about something that has happened to them; The subject will complete each questionnaire again after 6 appointments (i.e., about 6 weeks later), and again about 3-months after their sixth appointment.
Finally, the investigators hope to learn whether these therapies affect how often subjects take their cystic fibrosis medications, and how this affects their health and wellbeing.
To study this, the investigators will review the number of appointments that are missed six months before enrolling in the program, and six months after completing therapy.The investigators will also review their pulmonary function tests, whether subjects go to the hospital or see their doctor for any extra visits, and the presence of any ongoing symptoms of depression or anxiety. All data will be taken from Allscripts, the Drexel outpatient medical chart. Data will be taken only from the departments of the pi and co-pi's. At UPenn, the social worker at the site will input data into Drexel Redcap through a link sent to them.
Participants will complete 6 sessions of our ACT with CF manualized intervention. Participants will be asked to complete a series of brief questionnaires at the time of consent. If desired, they can take these homes to complete and mail back.
These questionnaires will ask participants about: 1) how often they experience different thoughts and feelings, including some related to having cystic fibrosis; 2) how often they take their cystic fibrosis medications; 3) their coping style, including how long they persist in thinking about something that has happened to them.
Participants will complete each questionnaire again after 6 appointments (i.e., about 6 weeks later), and again about 3-months after their sixth appointment.
These questionnaires take about 45 minutes to complete. Participants will also be asked to complete 6 'Zoom' therapy sessions (using a webcam in their own home or on their own tablet/smartphone and HIPAA-compliant Zoom webcam service) of either "Acceptance and Commitment Therapy", in which participants will learn new ways to manage uncomfortable experiences and feelings (e.g., depression, anxiety) and to engage in positive behaviors, or to "Supportive Psychotherapy", in which participants will talk about their experiences to date. The type of therapy that participants get will be chosen by chance, like flipping a coin. Neither subject nor the study doctor will choose what treatment the participant will get. Participants will have an equal chance of being given each therapy. Audio and video recordings will be taken during each 'Zoom' therapy session. Recordings will be kept on password encrypted USB drives and stored in a locked office only accessible to the principal investigator and adherence coder. Finally, the investigators hope to learn whether these therapies affect how often participants take their cystic fibrosis medications, and how this affects their health and wellbeing. To study this, the investigators will review information from medical charts such as the number of appointments that kept, the number of appointments missed, pulmonary function tests, number of hospital or doctor visits, and the presence of any symptoms of depression or anxiety.
Measures administered are as follows:
Page 1-2: Demographics Page 3-6: CFMHWQ: CF Mental Health and Wellness Self-Report Measure. Page 7-8: BDI-II: Beck Depression Inventory-II. Page 9: BAI: The Beck Anxiety Index. Pearson. Page 10-13: CFQ-R: Cystic Fibrosis Questionnaire-Revised. Page 14: Medical Coping Modes Questionnaire. Page 15: CFS: Coping Flexibility Scale. Page 16: My CF Treatments: Treatment Adherence Questionnaire-CF. Page 17-18: ACT Demographics Page 19: CFQ13: Cognitive Fusion Questionnaire. Page 20: Short Grit Scale Page 21: AAQ-II: Acceptance and Action Questionnaire. Page 22-23: Styles of Coping Word-Pairs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Active comparator | Behavioral: Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF)Participants will learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors. |
| Supportive Psychotherapy | Active comparator | Behavioral: Supportive Psychotherapy (Treatment as Usual Control)Participants will talk about their experiences to date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 18 and above.
- Able to read/understand English.
- Diagnosis of cystic fibrosis.
- PHQ-9 score > 4 or GAD-7 score > 4.
Key exclusion criteria (4 listed)
- History of suicidal attempts or acute suicidal ideation on clinical assessment.
- Presence of psychotic disorder or symptoms.
- Pregnant women.
- Presence of psychiatric disorders that interfere with the participation of the study, judged by the study or treating clinician. Presence of other medical conditions that interfere with participation in the study, judged by the study or treating clinician.
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 |
|---|---|---|
| Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF)Subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors | Behavioural | Acceptance and Commitment Therapy |
| Supportive Psychotherapy (Treatment as Usual Control)Subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients. | Behavioural | Supportive Psychotherapy |
Primary outcome
Beck Anxiety Inventory (BAI)
Time frame: Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.
This scale is a self-report measure of anxiety.
Beck Depression Inventory-II (BDI-II)
Time frame: Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.
Widely used indicator of the severity of depression.
Cognitive Fusion Questionnaire (CFQ13)
Time frame: Beginning of study, after 6 weeks, after 3 months.
Change in cognitive fusion (rigid attachment to one's thoughts as Truth) measures.
Acceptance and Action Questionnaire (AAQ-II)
Time frame: Beginning of study, after 6 weeks, after 3 months.
Change in acceptance measures.
3 secondary outcomes
FEV1/ FVC ratio
Time frame: 3 months before study, 3 months after study.
The Treatment Adherence Questionnaire-CF
Time frame: Beginning of study, after 6 weeks, after 3 months.
The Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: Beginning of study, after 6 weeks, after 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 15 Apr 2024.
- Derived from this study: PubMed 40167140Smith PJ, Drescher CF, Bruschwein H, Ingle K, Nurse C, O'Hayer CV. Psychological Flexibility, Coping Styles, and Mood Among Individuals With Cystic Fibrosis. Biopsychosoc Sci Med. 2025 May 1;87(4):271-279. doi: 10.1097/PSY.0000000000001387. Epub 2025 Mar 24.
- Derived from this study: PubMed 39626332O'Hayer CV, Smith PJ, Drescher CF, Bruschwein H, Nurse CN, Kushner HM, Ingle K, Stephen MJ, Hoag JB. ACT with CF: A randomized trial of acceptance and commitment therapy vs supportive psychotherapy for adults with cystic fibrosis. Gen Hosp Psychiatry. 2024 Nov-Dec;91:212-222. doi: 10.1016/j.genhosppsych.2024.11.011. Epub 2024 Nov 26.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF) in people with Cystic Fibrosis, run by Thomas Jefferson University 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 4 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 15 Apr 2024. 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?
Beck Anxiety Inventory (BAI) (time frame: Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.). The study lists 4 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 NCT04114227, 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 15 Apr 2024.