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

NCT ID: NCT04773197

Last Updated: 2022-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-08-03

Brief Summary

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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

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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.

Conditions

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Depression, Anxiety Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Coach-assisted C-CBT with BtB

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.

Group Type EXPERIMENTAL

Beating the Blues (BtB)

Intervention Type BEHAVIORAL

Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.

Coaching

Intervention Type BEHAVIORAL

A coach will spend approximately 5-10 minutes after each session with the patient to link the C-CBT content with patient's disease specific experiences and to motivate them to continue the program. They will also spend approximately 5 minutes between sessions to motivate a patient to complete assignments and to remind them about starting the next session on time.

Coach-assisted animated C-CBT with EMW

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.

Group Type ACTIVE_COMPARATOR

Entertain Me Well (EMW)

Intervention Type BEHAVIORAL

Entertain Me Well (EMW) is is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.

Coaching

Intervention Type BEHAVIORAL

A coach will spend approximately 5-10 minutes after each session with the patient to link the C-CBT content with patient's disease specific experiences and to motivate them to continue the program. They will also spend approximately 5 minutes between sessions to motivate a patient to complete assignments and to remind them about starting the next session on time.

Standard stand-alone C-CBT with BtB

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

Group Type ACTIVE_COMPARATOR

Beating the Blues (BtB)

Intervention Type BEHAVIORAL

Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.

Interventions

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Beating the Blues (BtB)

Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.

Intervention Type BEHAVIORAL

Entertain Me Well (EMW)

Entertain Me Well (EMW) is is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.

Intervention Type BEHAVIORAL

Coaching

A coach will spend approximately 5-10 minutes after each session with the patient to link the C-CBT content with patient's disease specific experiences and to motivate them to continue the program. They will also spend approximately 5 minutes between sessions to motivate a patient to complete assignments and to remind them about starting the next session on time.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Baldrick's Foundation

OTHER

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anao Zhang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00165949

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2019.159

Identifier Type: -

Identifier Source: org_study_id

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