Depression Intervention for Head and Neck Cancer

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist people with head and neck cancer who experience depression. The main goal is to determine if this innovative depression intervention can effectively reduce depression and improve adherence to swallowing and dental care routines. Participants will complete questionnaires and undergo a depression intervention to assess its impact on their mental health and treatment adherence. The trial seeks individuals with head and neck cancer who feel down or depressed, as indicated by their responses to a standard depression questionnaire. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital mental health tools, like the one in this trial, are generally safe. In some studies, about 14.8% of participants felt more depressed after using a digital program, but only 4.8% attributed this to the program. This suggests that most people handle these tools well.

Another study found that mobile health (mHealth) tools can effectively reduce depression symptoms. Although detailed safety information isn't always available, the general view is that these treatments are well-tolerated.

In summary, while some individuals might feel worse, most do not blame the program. Most users find these programs safe and helpful.12345

Why are researchers excited about this trial?

Researchers are excited about the Depression Intervention for head and neck cancer patients because it aims to tackle depression, which is often overlooked in cancer care. Unlike standard treatments like medication or traditional therapy that may take longer to show results, this intervention may offer a more immediate improvement in mental health, potentially improving adherence to cancer treatments. By focusing on mental well-being, this approach could enhance overall treatment outcomes and quality of life for patients, making it a promising addition to current care strategies.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that treatments for depression can be very effective. One study found that people who received appropriate care for depression had much lower rates of depression after six months compared to those who did not receive such care (24% versus 70%). In this trial, participants will receive a combination of a Depression Intervention and a Questionnaire, which includes tools like a Pictorial Educational Tool or Verbal Counseling Tool. Digital mental health treatments, similar to the one being tested, have also effectively reduced depression symptoms. Additionally, exercise programs have helped alleviate symptoms of depression and anxiety, indicating that various methods can be beneficial. Overall, these findings suggest that structured treatments can potentially reduce depression levels in patients.56789

Who Is on the Research Team?

EH

Eileen H. Shinn, PhD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Stage I-IV
Speak and read English at a 7th grade level
Are oriented to time, person, and place
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Radiation Treatment

Participants undergo weekly depression screenings during radiation treatment

6 weeks
6 visits (virtual)

Depression Intervention

Participants identified as depressed receive cognitive-behavioral therapy sessions

7 weeks
2 visits (in-person or virtual), 5 visits (telephone)

Follow-up

Participants complete follow-up questionnaires to assess depression and adherence

12 months
5 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Depression Intervention
  • Questionnaire

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Questionnaire + Depression InterventionExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

The Effects of Primary Care Depression Treatment on ...

At six months, patients with appropriate care, compared to those without it, had lower rates of depressive disorder (24 percent versus 70 percent), better ...

Digital mental health interventions for the treatment of ...

Our study provides robust evidence for the effectiveness of digital interventions for depression while highlighting important factors associated with treatment ...

Prognosis and improved outcomes in major depression

This literature review sought to investigate factors closely linked to outcome and summarize existing and novel strategies for improvement.

Digital Mental Health Interventions for Depression, Anxiety ...

The majority of programs were either effective (42, 47%) or partially effective (30, 34%) in producing beneficial changes in the main ...

Effectiveness of physical activity interventions for improving ...

Findings suggest that PA interventions are effective in improving symptoms of depression and anxiety.

The Safety of Digital Mental Health Interventions

At follow-up, 14.8% of the participants showed worse depression. Subjective deterioration attributed to the program was at 4.8%. A total of 4 AEs ( ...

Efficacy, Safety, and Evaluation Criteria of mHealth ...

This review suggests that mHealth interventions can be effective in reducing depressive symptoms, with hybrid interventions achieving the best results.

Safety and efficacy of Deep TMS for adolescent depression ...

There was a significant decrease in depression severity after treatment (p<0.0001, Chi-square test; PHQ-9 categorical distribution).

The Treatment for Adolescents With Depression Study ...

Almost 30% of the TADS participants exhibited clinically significant suicidal ideation at baseline, with 2% reporting high-intensity suicidal ideation. Suicidal ...