State the primary objective(s) of the study:
The objective of the study is to assess the effectiveness of "ACT with CF Self Help Toolkit" in improving cognitive fusion, depression, anxiety, psychological flexibility and value-based living among adults with cystic fibrosis.
State the secondary objectives(s) of the study:
The investigators are aiming to examine whether the ACT with CF Self Help Toolkit improves medication adherence, and spirometry results among adults with cystic fibrosis. Data collected from electronic health records will be used for analysis.
What benefit or knowledge will be gained? Findings can inform psychosocial interventions for adults with cystic fibrosis and other chronic health conditions.
State hypothesis tested:
ACT with CF Self Help Toolkit will prove more effective than Waitlist Control in reducing cognitive fusion, depression and anxiety, and improving psychological flexibility and value-based living among adults with cystic fibrosis. Similarly, those in the Waitlist Control will, once they receive access to the Toolkit 6 weeks later, also demonstrate significant improvements in cognitive fusion, depression and anxiety, psychological flexibility and value-based living.
Patients will be recruited from the following: Thomas Jefferson University Hospital Cystic Fibrosis Clinic, the Boomer Esiason Foundation social media pages (facebook, instagram), Cystic Fibrosis Foundation listserv (used by CF Clinic Mental Health Providers), CF Social Worker listserv, other mental health provider listservs, physicians who recruited patients for our previous clinical trials, and the Cystic Fibrosis Research Institute. Patients who are interested in participating must show that they have a diagnosis of cystic fibrosis (sharing a MyChart or similar record, referral from a CF physician specialist).
If patients are willing to be in the study, they will be given a consent form to sign and return as well as a packet of screening questionnaires containing the GAD-7, PHQ-9, and some questions regarding their CF diagnosis to determine eligibility. If found eligible, they will then be sent a baseline measures packet containing demographic questions, questions regarding their feelings about ACT, the CF Mental Health and Wellness Self-Report Measure, the AAQ-II, the CFQ-13, the BDI-II, the BAI, the VLQ, the Styles of Coping Word Pairs Measure, the B-PQSI, and the CFQ-R. All packets will be sent to participants digitally using RedCap.
These questionnaires will ask patients: 1) how often the participant experiences different thoughts and feelings, including some related to having cystic fibrosis; 2) how often the participant takes their cystic fibrosis medications; 3) the participant's coping style, including how long they persist in thinking about something that has happened to them.
The participant will complete each questionnaire again after 6 weeks, and again about 3-months later. Some variation exists in the packets based on timepoint.
Participants in the waitlist condition will receive a secondary baseline packet before starting the ACT with CF intervention. This packet includes all the same measures as the original waitlist packet, but also contains the GAD-7 and PHQ-9 to observe any change in measures collected during screening.
6 weeks after beginning treatment, all participants will complete another measures packet. This packet contains all previously used measures. Additionally, this packet includes the TEX-Q2 and a series of novel qualitative and quantitative measures to establish participant feelings about ACT with CF.
All participants will complete their final packet 3 months after treatment. This packet will contain all previous measures, as well as some of the novel measures about ACT that were included in the 6 week packet.
These questionnaires take about 45 minutes to complete. Participants in the Waitlist Control condition will also complete this packet prior to gaining access to the ACT with CF Self-Help Toolkit (so will complete measures at baseline, 6 weeks/start of Toolkit, 6 weeks later, and 3 months later).
The ACT with CF Self-Help Toolkit will include 6 main modules, each with 3 or 4 kernels, which will be short videos, in which participants will learn new ways to manage uncomfortable experiences and feelings (e.g., anxiety, depression) and to engage in positive behaviors. These videos are based on the main interventions in our ACT with CF individual therapy protocol. For example, the first main module focuses on how the participant wants to live their life (Values Clarification Intervention), and the kernels in this module are 1-3 minute video clips demonstrating different ways to figure this out (Card Sort, 70th Birthday exercise, accessing barriers).
De-identified data will be sent to UNC-Chapel Hill for analysis.
In addition, the investigators estimate that power will be more favorable to characterize the associations between intervention process measures and treatment-related changes in psychological functioning throughout the active treatment period. Using similar assumptions to our primary model above, the investigators anticipate that a sample size of 42 individuals would be sufficient to examine associations from a linear, repeated measures, mixed modeling approach incorporating data from weeks one through six.
The investigators will analyze the data with each subject serving as their own control, with the first packet of questionnaires prior to accessing the Toolkit being compared with the questionnaires immediately after having the Toolkit for 6 weeks and then three months later. The investigators will use a standard data analysis using a two-tailed t-test to see if there are significant differences between their responses in the first set of questionnaires before receiving the Toolkit to the second set after having access to the Toolkit for 6 weeks.
Repeated measures mixed modeling will be used to examine changes in depressive and anxious symptoms over time, with psychological functioning measured as a mean rank score across all four measures. Within this model the investigators will control for baseline psychological functioning, age, gender, and FEV1 values, with treatment group as the predictor of interest. The investigators will also examine the interaction between frequency of ACT with CF Toolkit access (how often participants engage with the Toolkit) and outcome scores. In addition, explanatory analyses of process-related psychological mechanisms will be examined using general linear models
