Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients

University of Michigan Rogel Cancer Center

Status: Terminated

Conditions: Depression, Anxiety; Cancer

Treatments: Behavioral: Beating the Blues (BtB); Behavioral: Entertain Me Well (EMW); Behavioral: Coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT04773197

UMCC 2019.159

HUM00165949 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 15 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Coach-assisted C-CBT with BtB

Experimental group

Description:

Participants will receive coach- assisted Beating the Blues (BtB), a C- CBT program, which contains 8 weekly sessions. A coach will provide between session support throughout the 8 sessions.

Treatment:

Behavioral: Beating the Blues (BtB)

Behavioral: Coaching

Coach-assisted animated C-CBT with EMW

Active Comparator group

Description:

Participants will receive coach- assisted Entertain Me Well (EMW), an animated C-CBT program, which contains 8 weekly sessions. A coach will provide between session support throughout the 8 sessions.

Treatment:

Behavioral: Coaching

Behavioral: Entertain Me Well (EMW)

Standard stand-alone C-CBT with BtB

Active Comparator group

Description:

Participants will use the stand-alone BtB for 8 weekly sessions, without coach assistance.

Treatment:

Behavioral: Beating the Blues (BtB)