Ignite Creation Date:
2024-05-06 @ 1:45 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04114227
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2019-09-23
Brief Title:
Acceptance and Commitment Therapy vs Supportive Psychotherapy With Cystic Fibrosis Patients
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Acceptance and Commitment Therapy vs Supportive Psychotherapy With Cystic Fibrosis Patients
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 telehealthwebcam 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 telehealthwebcam sessions of supportive psychotherapy
Detailed Description:
Patients will be consented in the adult cystic fibrosis clinic at Drexel University Childrens Hospital of Philadelphia University of Pennsylvania Medical Center St Christophers 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 ie 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 therapyThe 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-pis 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 ie 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 tabletsmartphone 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 eg 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
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 ie 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 therapyThe 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-pis 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 ie 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 tabletsmartphone 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None