Sleep Education Program for Insomnia

Overseen By STEP-Together Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Seizure medications

Disqualifiers: Bipolar, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist cancer survivors struggling with insomnia. Participants engage in a group video session to learn strategies for better sleep. The program, STEP-Together (Sleep Treatment Education Program Together), includes an educational session and may offer a follow-up coaching session. Suitable candidates are cancer survivors not currently in active treatment who frequently experience sleep difficulties. Participants need internet access and the ability to participate in English.

As an unphased trial, this study provides a unique opportunity for participants to gain valuable, tailored sleep improvement strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking medications to prevent seizures, you may not be eligible to participate.

What prior data suggests that the STEP-Together program is safe for participants?

Research has shown that the Sleep Treatment Education Program Together (STEP-Together) is manageable for participants. Studies have found that the program helps with insomnia, anxiety, depression, and overall quality of life without causing safety issues. Participants reported improvements, and no major negative effects occurred. This indicates that STEP-Together is safe for individuals with insomnia, particularly cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for insomnia that often rely on medication or cognitive behavioral therapy, the STEP-Together program is an innovative educational approach delivered through online group videoconferences. This method not only makes the treatment more accessible and convenient for participants but also emphasizes peer support and interaction, which can enhance motivation and engagement. Researchers are excited about this trial because it explores the potential benefits of combining education with community support, potentially offering a new, non-pharmacological option for people struggling with insomnia.

What evidence suggests that the STEP-Together program is effective for insomnia?

Research has shown that the Sleep Treatment Education Program Together (STEP-Together), which participants in this trial will receive, can help reduce insomnia symptoms. In a past study, this program greatly improved sleep problems in cancer survivors. Participants reported better sleep and reduced anxiety and depression. Another study found that similar sleep education programs improved people's quality of life. These results suggest that STEP-Together may help people with insomnia, especially cancer survivors, sleep better and feel better overall. ^{1 2 4 5 6}

Who Is on the Research Team?

Christopher Recklitis, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for off-treatment cancer survivors who are experiencing symptoms of insomnia. Participants should be able to attend group sessions via videoconference.

Inclusion Criteria

Regular access to the internet

Able to read and write in English

I was diagnosed with a cancer other than non-melanoma skin cancer more than 6 months ago.

Exclusion Criteria

Usual bedtime does not fall between 5:00 pm and 5:00 am

Employment in a position where falling asleep at work could impact public safety (such as air traffic-controller, operating heavy machinery)

I do not have any impairments that prevent me from completing study tasks on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete the STEP-Together educational intervention session delivered by an interventionist during an online group videoconference session

1 week

1 virtual group session

Coaching

Up to 12 participants take part in a coaching session 1 week after the virtual intervention session

1 week

1 virtual coaching session

Follow-up

Participants are monitored for changes in insomnia severity, mood disturbance, cognitive impairment, and quality of life

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Treatment Education Program Together (STEP-Together)

Trial Overview The study is testing the STEP-Together program, which involves educational coaching sessions aimed at improving sleep, delivered through synchronous group videoconferences.

How Is the Trial Designed?

Group I: STEP-Together Intervention Experimental Treatment 2 Interventions

Enrolled participants will complete the educational intervention session (STEP-Together) delivered by an interventionist during an online group videoconference session. -Up to 12 participants will also take part in a coaching session 1 week after the virtual intervention session.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

Cognitive Behavioral Treatment for Insomnia (CBTI) is highly effective, showing significant improvements in various sleep measures across 87 randomized controlled trials involving 3724 patients, with an overall effect size of 0.98 for insomnia severity.

Face-to-face CBTI treatments with at least four sessions are more effective than shorter or self-help interventions, and the effectiveness of CBTI remains consistent across different patient demographics and comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. van Straten, A., van der Zweerde, T., Kleiboer, A., et al.[2022]

A study involving 210 adults with insomnia compared three interventions: a cognitive behavioral therapy for insomnia (CBTI) workshop, self-help CBTI, and sleep hygiene education (SHE). All interventions significantly improved insomnia severity, anxiety, depressive symptoms, and quality of life, but there were no significant differences in effectiveness between the groups.

Self-help CBTI emerged as a preferred option in the stepped-care model for insomnia due to its comparable efficacy and adherence rates to workshop-based interventions, while being more accessible and requiring fewer resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Intensity Cognitive Behavioral Therapy for Insomnia as the Entry of the Stepped-Care Model in the Community: A Randomized Controlled Trial. Wong, KY., Chung, KF., Au, CH.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06736548

Sleep Treatment Education Program for Cancer Survivors: ... This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39608001

Sleep Treatment Education Program for Cancer Survivors The STEP-1 intervention presents educational information on the development of insomnia after cancer and offers suggestions for improving insomnia symptoms.

3. withpower.com withpower.com/trial/sleep-education-program-for-insomnia-2f860

Sleep Education Program for Insomnia All interventions significantly improved insomnia severity, anxiety, depressive symptoms, and quality of life, but there were no significant differences in ...

4. researchprotocols.org researchprotocols.org/2024/1/e60762

Sleep Treatment Education Program for Cancer Survivors In a single-arm pilot study, STEP-1 was found to significantly reduce insomnia symptoms in cancer survivors [ Evaluating the Sleep Treatment ...

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.5496

Results from a 1-Year Follow-Up Study Adolescents' sleep log data showed a significant reduction in SOL during the 12-month study period (χ2(4) = 24.05, p < 0.001, see Figure 2A). Post hoc ...

6. trialx.com trialx.com/clinical-trials/listings/296956/sleep-treatment-education-program-for-cancer-survivors-step-together/?&radius=10&place=All%20Participating%20Sites&user_country=Germany

Sleep Treatment Education Program for Cancer Survivors This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education ...