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Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114227
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Catherine O'Hayer, Drexel University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Behavioral: Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF) Behavioral: Supportive Psychotherapy (Treatment as Usual Control) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Active Comparator: Acceptance and Commitment Therapy
Participants will learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors.
Behavioral: 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

Active Comparator: Supportive Psychotherapy
Participants will talk about their experiences to date.
Behavioral: Supportive Psychotherapy (Treatment as Usual Control)
Subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients.




Primary Outcome Measures :
  1. Generalized Anxiety Disorder Questionnaire 7 (GAD-7) [ 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. ]
    Rapid screening for the presence of a clinically significant anxiety disorder.

  2. Patient Health Questionnaire 9 (PHQ-9) [ 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. ]
    Use as a screening tool to assist the clinician in making the diagnosis of depression and to quantify depression symptoms and monitor severity.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. FEV1/ FVC ratio [ Time Frame: 3 months before study, 3 months after study. ]
    Change in FEV1/FVC ratio.

  2. 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.

  3. Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: Beginning of study, after 6 weeks, after 3 months. ]
    Change in acceptance measures.

  4. Self-Reported Medication Adherence Questionnaire [ Time Frame: Beginning of study, after 6 weeks, after 3 months. ]
    Participant change in medication adherence.

  5. Participant re-hospitalization and unscheduled office visits secondary to CF exacerbation's. [ Time Frame: 3 months before study, 3 months after study. ]
    Participant change in re-hospitalization and unscheduled office visits secondary to CF exacerbation's.

  6. Scheduled CF clinic visits. [ Time Frame: 3 months before study, 3 months after study. ]
    Scheduled CF clinic visits kept.

  7. Body Mass Index (BMI) [ Time Frame: 3 months before study, 3 months after study. ]
    Change in Body Mass Index (BMI).

  8. Patient rated outcomes measures (PRO) Questionnaire. [ Time Frame: Beginning of study, after 6 weeks, after 3 months. ]
    Change in patient rated outcomes measures (PRO) including quality of care questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114227


Contacts
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Contact: Dr. C. Virginia F O'Hayer, Ph.D. 267-507-6569 cvo32@drexel.edu

Locations
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United States, Pennsylvania
Adult Cystic Fibrosis Center at Drexel Pulmonary Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Chelsi N Nurse, MS    267-507-6581    cnn38@drexel.edu   
Sponsors and Collaborators
Drexel University
  Study Documents (Full-Text)

Documents provided by Catherine O'Hayer, Drexel University:
Study Protocol  [PDF] July 1, 2019
Informed Consent Form  [PDF] June 24, 2019


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Responsible Party: Catherine O'Hayer, Principal Investigator, Drexel University
ClinicalTrials.gov Identifier: NCT04114227    
Other Study ID Numbers: 1905007203
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases