N/A
Completed N=145
Mobile App of CBT for Anxiety and Cancer
Source: ClinicalTrials.gov NCT02286466 ↗Enrolled (actual)
145
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Change in Anxiety Symptoms From Baseline to Post-assessment — -2.99; -1.85 Units on a scale — p=0.412
Summary
The proposed study seeks to implement a randomized controlled trial to evaluate the effectiveness and generalizability of an efficacious cognitive-behavioral therapy (CBT) intervention for use as a self-administered mobile application (mobile app) to treat anxiety in patients with metastatic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Anxiety Symptoms From Baseline to Post-assessment |
-2.99; -1.85 | 0.412 |
| SECONDARY Change in Quality of Life From Baseline to Post-assessment |
7.88; 7.87 | 0.997 |
| SECONDARY Change in Mood Symptoms From Baseline to Post-assessment |
-4.33; -3.55; -1.89; -1.41 | 0.215 |
| SECONDARY Change in Depression Symptoms From Baseline to Post-assessment |
-2.29; -2.14 | 0.852 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of a metastatic solid tumor
- Report clinically significant anxiety symptoms (i.e., Hospital Anxiety and Depression Scale (HADS) -Anxiety Subscale > or equal to 8)
- Anxiety is principal psychiatric problem
- At least four weeks after cancer diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Age greater than 18 years
- Ability to read and respond to questions in English
Exclusion Criteria
- Co-morbid delirium, dementia, or active and untreated major psychiatric condition such as schizophrenia will be excluded from the study
Data sourced from ClinicalTrials.gov (NCT02286466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.