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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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

Other trials in United States

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 groups in NCT04114227
Study groupRoleWhat they receive
Acceptance and Commitment TherapyActive comparatorParticipants 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 PsychotherapyActive comparatorParticipants 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.

  1. 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.

  2. 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.

  3. 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.

  4. Acceptance and Action Questionnaire (AAQ-II)

    Change in acceptance measures.

    Measured: Beginning of study, after 6 weeks, after 3 months.

Secondary outcomes (3)
  1. FEV1/ FVC ratio

    Change in FEV1/FVC ratio.

    Measured: 3 months before study, 3 months after study.

  2. The Treatment Adherence Questionnaire-CF

    Participant change in medication adherence.

    Measured: Beginning of study, after 6 weeks, after 3 months.

  3. 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.

  1. First posted3 Oct 2019
  2. Study start1 Jul 2019
  3. Primary completion31 Jul 2023
  4. Study completion31 Oct 2023

Resources

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)
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 40167140
  • O'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

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.

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