Depression, AnxietyNCT04773197
Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients
A study testing Beating the Blues (BtB), Entertain Me Well (EMW) and Coaching in people with Depression, Anxiety and Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Depression, Anxiety, Cancer
- What is being tested?
- Beating the Blues (BtB), Entertain Me Well (EMW) and Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 3 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cancer survivor, either receiving active treatment or completed cancer treatment
- Experiencing depression and anxiety as measured by PHQ-9 or GAD-7
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety, Cancer
- Being tested
- Beating the Blues (BtB), Entertain Me Well (EMW), Coaching
- Medical subject headings
- Depression, Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beating the Blues (BtB)Behavioural
Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.
Entertain Me Well (EMW)Behavioural
Entertain Me Well (EMW) is is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.
CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coach-assisted C-CBT with BtB | Experimental | 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. Receives: Behavioral: Beating the Blues (BtB); Behavioral: Coaching |
| Coach-assisted animated C-CBT with EMW | Active comparator | 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. Receives: Behavioral: Entertain Me Well (EMW); Behavioral: Coaching |
| Standard stand-alone C-CBT with BtB | Active comparator | Participants will use the stand-alone BtB for 8 weekly sessions, without coach assistance. Receives: Behavioral: Beating the Blues (BtB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of C-CBT completion
Percentage of participants in each arm who complete at least 6 out of 8 sessions, as measured by online service usage data.
Measured: 10 weeks
Percentage of participants who confirm acceptability of the intervention during interviews
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.
Measured: 10 weeks
Secondary outcomes (5)
Change in level of depression from baseline to end of intervention
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.
Measured: 10 weeks
Change in level of anxiety from baseline to end of intervention
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.
Measured: 10 weeks
Change in level of distress from baseline to end of intervention
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.
Measured: 10 weeks
Change in level of self-efficacy from baseline to end of intervention
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.
Measured: 10 weeks
Change in level of involvement and participation in health care from baseline to end of intervention
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start30 Nov 2020
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- St. Baldrick's Foundation
- Responsible party
- Sponsor
- Investigators
- Anao Zhang, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773197
- Sponsor's protocol ID
- UMCC 2019.159
- Other IDs
- HUM00165949
- Status last verified
- Dec 2021
- First submitted
- 23 Feb 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients
- ClinicalTrials.gov ID
- NCT04773197
- Acronym / sponsor ID
- UMCC 2019.159
- Conditions
- Depression, Anxiety, Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- St. Baldrick's Foundation
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Coach-assisted C-CBT with BtB | Experimental | Behavioral: Beating the Blues (BtB), Behavioral: CoachingParticipants 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 | Active comparator | Behavioral: Entertain Me Well (EMW), Behavioral: CoachingParticipants 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 | Active comparator | Behavioral: Beating the Blues (BtB)Participants will use the stand-alone BtB for 8 weekly sessions, without coach assistance. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Cancer survivor, either receiving active treatment or completed cancer treatment
- Experiencing depression and anxiety as measured by PHQ-9 or GAD-7
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beating the Blues (BtB)Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks. | Behavioural | Coach-assisted C-CBT with BtB, Standard stand-alone C-CBT with BtB |
| Entertain Me Well (EMW)Entertain Me Well (EMW) is is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks. | Behavioural | Coach-assisted animated C-CBT with EMW |
| CoachingA 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. | Behavioural | Coach-assisted C-CBT with BtB, Coach-assisted animated C-CBT with EMW |
Primary outcome
Rate of C-CBT completion
Time frame: 10 weeks
Percentage of participants in each arm who complete at least 6 out of 8 sessions, as measured by online service usage data.
Percentage of participants who confirm acceptability of the intervention during interviews
Time frame: 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.
5 secondary outcomes
Change in level of depression from baseline to end of intervention
Time frame: 10 weeks
Change in level of anxiety from baseline to end of intervention
Time frame: 10 weeks
Change in level of distress from baseline to end of intervention
Time frame: 10 weeks
Change in level of self-efficacy from baseline to end of intervention
Time frame: 10 weeks
Change in level of involvement and participation in health care from baseline to end of intervention
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anao Zhang, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beating the Blues (BtB), Entertain Me Well (EMW) and Coaching in people with Depression, Anxiety and Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of C-CBT completion (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.