Clinical trial NCT04773197: Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients
Official title: Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression, Anxiety
Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: St. Baldrick's Foundation
First posted: 2021-02-26
Enrollment: 9
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a three-arm, prospective randomized controlled trial with participants being randomly assigned into one of the three groups: (1) coach-assisted BtB intervention (treatment condition 1), (2) coach-assisted animated EMW (treatment condition 2), and (3) standard BtB (control group).
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project's overall goal is to test the feasibility, acceptability and efficacy of two coach-assisted, computer-based, cognitive- behavioral therapy (C-CBT) interventions in treating depression and anxiety in adolescent and young adult cancer survivors. The two coach-assisted interventions will be compared to the standard C-CBT intervention.

Detailed description: This will be a three-arm randomized controlled trial with two treatment arms and one control arm. Participants in the first treatment arm will receive a coach-assisted C-CBT intervention called "Beating the Blues" (BtB). A second treatment arm will receive a coach-assisted, animated C-CBT intervention called "Entertain Me Well" (EMW). Both treatment arms will have 8 weekly sessions that contain core components of CBT. A coach will provide between-session support throughout the 8 sessions. The control arm will use the standard care of BtB without coach assistance.

Eligibility criteria: Inclusion Criteria:

* Cancer survivor, either receiving active treatment or completed cancer treatment
* Experiencing depression and anxiety as measured by PHQ-9 or GAD-7

Exclusion Criteria:

* Severe medical or mental condition (e.g. suicidal ideation)
* Medical condition that prevents patients from operating a computer or tablet
* Receiving end-of-life care

Primary outcomes:
measure: Rate of C-CBT completion
timeFrame: 10 weeks
measure: Percentage of participants who confirm acceptability of the intervention during interviews
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in level of depression from baseline to end of intervention
timeFrame: 10 weeks
measure: Change in level of anxiety from baseline to end of intervention
timeFrame: 10 weeks
measure: Change in level of distress from baseline to end of intervention
timeFrame: 10 weeks
measure: Change in level of self-efficacy from baseline to end of intervention
timeFrame: 10 weeks
measure: Change in level of involvement and participation in health care from baseline to end of intervention
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Anao Zhang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: