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

Trial Summary

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 data supports the effectiveness of the treatment Sleep Treatment Education Program Together (STEP-Together) for insomnia?

Research shows that cognitive behavioral therapy for insomnia (CBT-I), which is a key component of STEP-Together, is effective in improving sleep quality and reducing insomnia severity. Studies have found that both group and individual CBT-I can significantly improve sleep onset, sleep efficiency, and overall sleep quality, with effects lasting over time. ^{1 2 3 4 5}

How is the STEP-Together treatment for insomnia different from other treatments?

The STEP-Together treatment is unique because it likely incorporates a stepped-care model, which provides different levels of cognitive behavioral therapy (CBT) interventions based on the patient's needs, making it more accessible and tailored compared to traditional one-size-fits-all approaches. ^{1 3 6 7 8}

What is the purpose of this trial?

This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a synchronous group session by videoconference.

Research Team

Christopher Recklitis, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Regular access to the internet

Able to read and write in English

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 have been diagnosed with Bipolar or Seizure Disorder, am on medication to prevent seizures, or had a seizure in the last year.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of sleep skills education on sleep quality in patients attending a psychiatry partial hospitalization program. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Stepped care for insomnia: an evaluation of implementation in routine practice. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A meta-analysis of group cognitive behavioral therapy for insomnia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for insomnia disorder: Extending the stepped care model. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Behavioral treatment of insomnia: a proposal for a stepped-care approach to promote public health. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy of a behavioral self-help treatment with or without therapist guidance for co-morbid and primary insomnia--a randomized controlled trial. [2022]