Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) |
The PHQ-9 consists of nine questions measuring frequency of depressive symptoms, rated on a Likert scale from 0 "not at all" to 3 "nearly every day," with total score ranging 0-27. Clinical severity scores have been established with scores of 5, 10, 15, and 20 representing cut-off scores for mild, moderate, moderately severe, and severe depression, respectively. |
3 months (Baseline to Pre-intervention) for the waitlist control group; immediately post-intervention (2 to 3 months from pre-CBT assessment) for both arms; 3 months and 6 months post-intervention for both arms |
|
| Primary |
Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7) |
The GAD-7 is a 7-item measure of symptoms of anxiety. Likert scale ratings allow total scores of 0-21. Scores of 5, 10, and 15 correspond to severity ratings of mild, moderate and severe anxiety. |
3 months (Baseline to Pre-intervention) for the waitlist control group; immediately post-intervention (2 to 3 months from pre-CBT assessment) for both arms; 3 months and 6 months post-intervention for both arms |
|
| Secondary |
Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items |
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report measure that assesses patient service satisfaction,rated on a 4-point scale from 1=lowest to 4=highest satisfaction. Post-intervention treatment satisfaction will also be assessed with a series of structured and open-ended questions specific to the study intervention. Assessed one time immediately post-intervention. |
Immediately post-intervention |
|
| Secondary |
Change from baseline in Perceived Stress measured by the Perceived Stress Scale (PSS) |
The PSS is a 10-item measure assessing the degree to which individuals perceive that current demands exceed their abilities to cope |
3 months (Baseline to Pre-intervention) for the waitlist control group; immediately post-intervention (2 to 3 months from pre-CBT assessment) for both arms; 3 months and 6 months post-intervention for both arms |
|
| Secondary |
Change from baseline in Cystic Fibrosis Health-Related Quality of Life measured by the adult/teen version of the Cystic Fibrosis Questionnaire-Revised (CFQ-R). |
The CFQ-R is a well-established measure of health-related quality of life (HrQoL). The CFQ-R contains 12 subscales, with five scales measuring physical HrQoL (Physical Functioning - 8 items; Eating Disturbances -3 items; Vitality -4 items; Respiratory - 6 items; Digestion -3 items) and seven measuring psychosocial HrQoL (e.g, Health Perceptions -3 items, Treatment Burden -3 items; Emotional Functioning - 5 items; Social Functioning -6 items; Body Image -3 items; Role Functioning - 4-items). Items are rated on 4-point Likert scale with higher scores reflecting better quality of life. Scaled scores are obtained for each subscale. |
3 months (Baseline to Pre-intervention) for the waitlist control group; immediately post-intervention (2 to 3 months from pre-CBT assessment) for both arms; 3 months and 6 months post-intervention for both arms |
|
| Secondary |
Change from baseline in Coping Self-Efficacy measured by the CF Coping Self-Efficacy Measure developed for this study |
The CF Coping Self-Efficacy measure includes 25 items and was developed for this study to assess patient-reported confidence in their ability to use CBT coping skills that are introduced in the CF-CBT intervention to manage general stressors and those related to having CF. Each item is rated on a 10-point Likert scale from 10 to 100 from "very uncertain" to "very certain" about the ability to use each skill , with higher scores indicating greater confidence in being able to use coping skills. Mean scores are obtained for each of 5 proposed subscales (Relaxation; Behavioral Activation; Adaptive Thinking/Cognitive Restructuring; Active Coping/Problem-Solving; and CF-Specific Coping). |
3 months (Baseline to Pre-intervention) for the waitlist control group; immediately post-intervention (2 to 3 months from pre-CBT assessment) for both arms; 3 months and 6 months post-intervention for both arms |
|
| Secondary |
Feasibility of the intervention will be indicated by Rate of Attrition, or rate of drop-out or non-completion of the CF-CBT program once enrolled |
Rate of attrition will be summarized by calculating the percentage of CF-CBT sessions completed by participants over the course of the study period. The CF-CBT program consists of 8 sessions, and the proposed sample size of the study will be 60 participants, such that an Attrition Rate of 0% would be calculated if all 480 CF-CBT sessions were completed. |
From baseline to post-intervention (2 to 3 months for the immediate intervention arm; 5 to 6 months for the waitlist arm) |
|
| Secondary |
Feasibility of the intervention will also be indicated by Treatment Fidelity, measured as percent adherence to general and CF-CBT session-specific objectives. |
Treatment Fidelity will be rated independently for a random 20% of CF-CBT sessions. Each session that is rated will have a general objectives and session-specific objectives rating. The general objectives rating includes 6 items rated on a 6-point Likert scale from "poor/not at all" to "Excellent," with total score ranging from 0-36. Session-specific objectives will include between 5 and 7 items that are dichotomous indicating whether or not (yes/no) a specific objective was met. A percentage of the possible total will be calculated for both general and session-specific objectives for each rated session. All CF-CBT sessions will be recorded so that a random 20% may be independently rated. The initial 8 sessions for each newly trained interventionist will be excluded from analysis. |
2 years and 3 months (Over the course of the study period) |
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