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

Not Applicable

Terminated

• Conditions: Depression, Anxiety; Cancer
• Interventions: Behavioral: Beating the Blues (BtB); Behavioral: Entertain Me Well (EMW); Behavioral: Coaching

• Registration Number: NCT04773197
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Study Timeline

• Study Start: 2020-11-30
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-26
• Primary Completion: 2021-08-03
• Study Completion: 2021-08-03
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coach-assisted C-CBT with BtB	Coaching	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.
Coach-assisted C-CBT with BtB	Beating the Blues (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.
Coach-assisted animated C-CBT with EMW	Entertain Me Well (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.
Coach-assisted animated C-CBT with EMW	Coaching	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.
Standard stand-alone C-CBT with BtB	Beating the Blues (BtB)	Participants will use the stand-alone BtB for 8 weekly sessions, without coach assistance.

Primary Outcome Measures

Name	Time	Method
Percentage of participants who confirm acceptability of the intervention during interviews	10 weeks	Participants will be interviewed about their perceptions regarding the delivery format, treatment content, and other treatment related factors. Qualitative interviews will be transcribed by research staff and coded using thematic content analysis and axial coding. Qualitative data will be reviewed iteratively until saturation is reached, that is when no new information seems to emerge during coding. Emergence or non-emergence of acceptability theme will be assessed. Findings will be descriptive and will include the percentage of participants who confirm acceptability.
Rate of C-CBT completion	10 weeks	Percentage of participants in each arm who complete at least 6 out of 8 sessions, as measured by online service usage data.

Secondary Outcome Measures

Name	Time	Method
Change in level of distress from baseline to end of intervention	10 weeks	The Brief Symptom Inventory, 18-item (BSI-18) is a validated distress screening tool especially for cancer patients. Participants will answer the questionnaire at their baseline assessment and at their post-intervention assessment.
Change in level of involvement and participation in health care from baseline to end of intervention	10 weeks	The Patient Activation Measure (PAM) is a 13-item validated tool to evaluate patients' involvement and participation in their health care. Participants will answer the questionnaire at their baseline assessment and at their post-intervention assessment.
Change in level of depression from baseline to end of intervention	10 weeks	The Patient Health Questionnaire, 9 -item (PHQ-9) is a validated brief measure of depression. Participants will answer the questionnaire at their baseline assessment, at the beginning of each session, and at their post-intervention assessment.
Change in level of anxiety from baseline to end of intervention	10 weeks	The Generalized Anxiety Disorder, 7-item (GAD-7) is a validated brief measure of anxiety. Participants will answer the questionnaire at their baseline assessment and at their post-intervention assessment.
Change in level of self-efficacy from baseline to end of intervention	10 weeks	The PROMIS Self-Efficacy for Managing Chronic Conditions (PROMIS SM Scale) is a 28-item validated tool to assess patients' self-efficacy in managing their chronic condition symptoms.

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States