NCT03432832

Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial

Extracted Fields (from Registry)
Protocol IDNCT03432832
Registration Date2018-02-14
Statuscompleted
SponsorUniversity of Pittsburgh
CountryUnited States
Industrynot industry
Blindingblinded
Center Typemulticenter RCT
Scopenational RCT
First Patient In2018-01-30
Last Patient Out2024-07-30
Publicationn
Gender %ALL
Mean Age12 Years - 21 Years
LLM Classifications (Side-by-Side)
Field GLM
glm-5.1
11657ms / 9477 tok
CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
7056ms / 10665 tok
OPENAI
gpt-4o
Thinking: o3
4720ms / 9257 tok
Review
rct_type parallel RCT parallel RCT parallel RCT OK
cancer_status non-cancer non-cancer non-cancer OK
non_cancer_spec N/A N/A N/A OK
setting_patient outpatient outpatient outpatient OK
setting_place other other other OK
feasibility fully powered RCT fully powered RCT fully powered RCT OK
intervention_pharmacologic no no no OK
intervention_chemo_immuno_radio no no no OK
intervention_complementary no no no OK
intervention_device no no no OK
intervention_psychological yes yes yes OK
intervention_complex no yes → yes
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — The EASE intervention is a multicomponent program that fundamentally combines individual therapy sessions with active parent involvement, community practice, and a secure website (e-Coach) designed to interact and augment overall treatment intensity.
no yes → yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — The EASE intervention combines multiple interacting components from different categories: behavioral therapy sessions with therapists, parent involvement/training, community practice sessions, and an online support platform (e-Coach), creating a multimodal approach that explicitly integrates individual therapy, family involvement, and technology-based supports. Thinking: no — EASE is a single behavioral intervention for emotion regulation delivered through multiple modalities (therapy sessions, parent involvement, online support), not distinct interacting components from different categories.
no no → no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The EASE program is a behavioral intervention focused on emotion regulation, mindfulness, and skill enhancement and does not combine distinct components from different categories. Thinking: no — EASE is a single-modality behavioral/psychological therapy (mindfulness-based skills training) even though it includes parent and web supports, so it lacks multiple distinct intervention types from different categories.
OK
intervention_acp no no no OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative no no no OK
intervention_education no no no OK
intervention_digital yes yes yes OK
intervention_other no no no OK
outcome_symptom yes yes → yes
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — The trial includes the Brief Psychiatric Rating Scale (BPRS) to measure psychiatric symptoms and the Emotion Dysregulation Inventory (EDI) to assess emotional reactivity.
yes no → yes
shaky reasoning
✓ Unanimous Initial: no Requery: yes — The Brief Psychiatric Rating Scale (BPRS) is listed as a secondary outcome, which is a validated instrument that measures psychiatric symptoms including depression and anxiety.
yes yes → yes
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — The primary outcome measures include the Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF), which evaluates emotional reactivity and regulation, directly addressing symptoms in the study population.
OK
outcome_qol no no no OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — All outcomes measure symptom severity (emotion dysregulation, psychiatric symptoms, and overall clinical improvement), which falls under the symptom category.
no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — All primary and secondary outcomes measure symptom severity and emotional regulation functioning, which fall under symptom-related categories.
no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — All outcomes focus on symptom improvement and quality of life through emotion regulation adjustment.
OK
pharmacologic_sub N/A N/A N/A OK
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