18 and older, any sex, with Post-Lung Transplantation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Global Psychological DistressPrimary· Baseline to 12 weeks
A composite distress score will assess change from baseline to 12 weeks (post-intervention) and combine the following instruments: General Health Questionnaire, Perceived Stress Scale, Beck Depression Inventory-II, State Trait Anxiety Inventory, and PROMIS Anger. The composite distress score is the average of the participant's rank for change (from baseline to 12 weeks) on each of the 5 scales. A lower rank represents more improvement (decrease in global distress) and higher ranks represent less improvement (or worsening of distress). Scoring is based on the number of participants analyzed; in
Group
Value
95% CI
Coping Skills Training Combined With Exercise (CSTEX)
91
± 40
Standard of Care Plus Education (SOC-ED)
87
± 33
Change in Functional CapacitySecondary· Baseline to 12 weeks
Functional capacity will be measured by distance walked on a standard Six Minute Walk Test (6MWT) at baseline and again post-intervention at 12 weeks. Distance measured in feet. Greater distance represents better functional capacity. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Group
Value
95% CI
Coping Skills Training Combined With Exercise (CSTEX)
1451
± 332
Standard of Care Plus Education (SOC-ED)
1472
± 262
Change in Physical ActivitySecondary· Baseline to 12 weeks
Daily physical activity (average steps per day) will be assessed via a wrist-worn activity monitor (Actigraph GT9X Link) for 7 consecutive days at baseline and again post-intervention at 12 weeks. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Group
Value
95% CI
Coping Skills Training Combined With Exercise (CSTEX)
8037
± 3103
Standard of Care Plus Education (SOC-ED)
8612
± 3161
Change in Sleep QualitySecondary· Baseline to 12 weeks
Sleep quality (average total minutes of sleep per night) will be assessed via the Pittsburgh Sleep Quality Index at baseline and again post-intervention at 12 weeks. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Group
Value
95% CI
Coping Skills Training Combined With Exercise (CSTEX)
421
± 92
Standard of Care Plus Education (SOC-ED)
401
± 66
Change in Quality of LifeSecondary· Baseline to 12 weeks
Quality of Life will be assessed via the Lung Transplant Quality of Life Survey, which is comprised of 10 scales that measure symptoms, health perceptions, functioning, and well being at baseline and again post-intervention at 12 weeks. The QOL overall score ranges from 1 to 5, with a higher score indicating worse health. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Group
Value
95% CI
Coping Skills Training Combined With Exercise (CSTEX)
1.78
± 0.49
Standard of Care Plus Education (SOC-ED)
1.78
± 0.56
Change in FrailtySecondary· Baseline to 12 weeks
Frailty will be measured by performance on the Fried Frailty Index. This assessment includes measures on patient's weight, exhaustion level, physical activity, walking speed, and hand grip strength at baseline and again post-intervention at 12 weeks. Scores range from 0 to 5, with lower scores indicating less frailty. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Group
Value
95% CI
Coping Skills Training Combined With Exercise (CSTEX)
0.62
± 0.74
Standard of Care Plus Education (SOC-ED)
0.52
± 0.73
Change in Problem-Focused CopingSecondary· Baseline to 12 weeks
Coping was assessed via the Brief COPE Inventory, which is composed of scales that measure problem-focused coping, emotion-focused coping, and avoidant coping responses at baseline and again post-intervention at 12 weeks. Items are scored on a 4-point Likert scale, with 1 indicating a coping mechanism that the participant has not been doing at all, to 4 indicating a coping mechanism in which the participant has been doing a lot. A higher average score within the problem-focused subscale indicates better coping strategies. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Group
Value
95% CI
Coping Skills Training Combined With Exercise (CSTEX)
2.64
± 0.79
Standard of Care Plus Education (SOC-ED)
2.73
± 0.79
Change in Emotion-Focused CopingSecondary· Baseline to 12 weeks
Coping was assessed via the Brief COPE Inventory, which is composed of scales that measure problem-focused coping, emotion-focused coping, and avoidant coping responses at baseline and again post-intervention at 12 weeks. Items are scored on a 4-point Likert scale, with 1 indicating a coping mechanism that the participant has not been doing at all, to 4 indicating a coping mechanism in which the participant has been doing a lot. A higher score within the emotion-focused coping subscale indicates better coping strategies. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Group
Value
95% CI
Coping Skills Training Combined With Exercise (CSTEX)
2.26
± 0.51
Standard of Care Plus Education (SOC-ED)
2.25
± 0.49
Change in Avoidant CopingSecondary· Baseline to 12 weeks
Coping was assessed via the Brief COPE Inventory, which is composed of scales that measure problem-focused coping, emotion-focused coping, and avoidant coping responses at baseline and again post-intervention at 12 weeks. Items are scored on a 4-point Likert scale, with 1 indicating a coping mechanism that the participant has not been doing at all, to 4 indicating a coping mechanism in which the participant has been doing a lot. A lower score within the avoidant coping subscale indicates a more useful coping strategy. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Group
Value
95% CI
Coping Skills Training Combined With Exercise (CSTEX)
1.45
± 0.36
Standard of Care Plus Education (SOC-ED)
1.46
± 0.34
Change in Self-EfficacySecondary· Baseline to 12 weeks
Self-efficacy will be assessed via the General Self-Efficacy Scale, which is a 10-item scale that measures emotional distress at baseline and again post-intervention at 12 weeks. Scores range from 10-40 with a higher score indicating better self-efficacy. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Group
Value
95% CI
Coping Skills Training Combined With Exercise (CSTEX)
33.3
± 5.1
Standard of Care Plus Education (SOC-ED)
33.1
± 4.7
Sponsor's own description
This study evaluates the effectiveness of a coping skills and exercise (CSTEX) intervention among post lung transplant patients aimed to reduce distress and improve functional capacity. Half of the patients will receive CSTEX and half will receive the standard of care plus transplant education (SOC-ED).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04093869.