Cognitive Behavioral Therapy for Sleep Disorders Due to Loss

(RESTore Plus Trial)

Overseen By Jessica L. Thomas, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Prescribed sleep medications, Steroids

Disqualifiers: Sleep disorders, Autoimmune diseases, Illegal substances, others

Compensation: Varies

Number of Visits: 4

Duration: 6-8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to help people who have recently lost a spouse or partner improve their sleep through a special type of therapy called Cognitive Behavior Therapy for Insomnia (CBT-I). Participants will have several online sessions with a trained therapist to learn better sleep habits. The study will compare this therapy to another group that only receives one informational session.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have been taking prescribed sleep medications for 6 months or more, you would not be eligible to participate.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-i) leads to significant improvements in sleep quality, daytime functioning, and overall quality of life. Studies have found that CBT-i is effective for people with insomnia, regardless of age or other health conditions, and it helps reduce the severity of insomnia and improve sleep efficiency. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally considered safe and does not have the risks associated with sleeping medications. However, there is limited information on adverse events, and more research is needed to fully understand any potential negative effects. ^{5 6 7 8 9}

How is Targeted Cognitive Behavior Therapy for Insomnia different from other treatments for sleep disorders?

Targeted Cognitive Behavior Therapy for Insomnia is unique because it combines cognitive therapy, sleep hygiene, stimulus control, sleep restriction, and relaxation training to address insomnia without medication. This approach helps patients change their thoughts and behaviors related to sleep, making it a safe and effective alternative to drugs, and it can be delivered in various formats, including online and self-help options. ^{10 11 12 13 14}

Eligibility Criteria

This trial is for adults who've lost a spouse or long-term partner within the last 3 months and are having sleep problems. They need internet access for online sessions and must score above a threshold on a sleep quality survey. Excluded are non-English speakers, pregnant/nursing women, those with certain medical conditions, long-term users of prescribed sleep meds, diagnosed with specific sleep disorders (except controlled OSA), drug users, and people on immunological medications.

Inclusion Criteria

Scores 5 or above on the Pittsburgh Sleep Quality Inventory (PSQI; administered by research staff during phone screening call)

Has experienced the loss of a spouse/long-term cohabitating partner within the past 3 months

I am 18 years old or older.

Exclusion Criteria

I am under 18 years old.

Non-English speakers

Those who have been vaccinated in the past two weeks

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the targeted CBT-I intervention or the information-only control. The targeted CBT-I intervention includes 6 online sessions over 6 weeks, while the control includes 1 online session.

6-8 weeks

2 visits (in-person), 6 visits (virtual for CBT-I group), 1 visit (virtual for control group)

Follow-up

Participants are monitored for changes in sleep disturbance, inflammation, and quality of life at post-treatment and 6-month follow-up.

6 months

2 visits (in-person)

Treatment Details

Interventions

• Information-Only Control
• Targeted Cognitive Behavior Therapy for Insomnia

Trial Overview The study tests whether targeted Cognitive Behavior Therapy for Insomnia (CBT-I) can improve sleep among recently bereaved spouses compared to just getting information. Participants will either join six weekly online CBT-I sessions or attend one informational session and have their sleep monitored through watches and diaries at different stages.

Participant Groups

Group I: Targeted Intervention for Sleep and Bereavement (Targeted CBT-I) Experimental Treatment 1 Intervention

This intervention consists of 6, 50-60-minute online individual sessions delivered via video conference. Content will include a CBT-I based program adapted to the specific needs of spousally bereaved individuals.

Group II: Information-Only Control Placebo Group 1 Intervention

The information-only control consists of 1, 50-60-minute online individual session delivered via video conference. Content will provide basic psychoeducation about sleep and aging.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a study of 188 adults with persistent insomnia, full cognitive behavior therapy (CBT) showed the greatest overall improvements in sleep, with 67.3% of participants responding positively after treatment, compared to 67.4% for behavior therapy (BT) and 42.4% for cognitive therapy (CT).

While BT provided quicker results, its benefits were not as long-lasting, with a significant drop in response rates at the 6-month follow-up, whereas CT showed slower but sustained improvements over time, highlighting the different effectiveness trajectories of these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial. Harvey, AG., Bélanger, L., Talbot, L., et al.[2022]

Internet-based cognitive-behavioral therapy for insomnia (ICBT-i) significantly improves sleep outcomes in adults, with participants experiencing a decrease in sleep onset latency by 18.41 minutes and an increase in total sleep time by 22.30 minutes based on a meta-analysis of 15 studies involving 1013 participants.

ICBT-i also enhances sleep efficiency by 9.58% and reduces wake after sleep onset by 22.31 minutes, demonstrating its effectiveness as a treatment for insomnia that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive-behavioural therapy for insomnia (ICBT-i): a meta-analysis of randomised controlled trials. Ye, YY., Chen, NK., Chen, J., et al.[2019]

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]

In a review of 99 randomized controlled trials on cognitive behavioral therapy for insomnia (CBTI), only 32.3% addressed adverse events, highlighting a significant gap in monitoring during psychological treatment compared to pharmacotherapy.

Only 7.1% of the studies met all criteria for adequate reporting of adverse events, indicating a need for improved standards in documenting potential negative effects of CBTI to ensure patient safety and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. Condon, HE., Maurer, LF., Kyle, SD.[2021]

Cognitive behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

Cognitive behavioral therapy for insomnia (CBTi) is a highly effective non-drug treatment for insomnia, showing comparable efficacy to sleep medications in randomized control trials, with better long-term maintenance of benefits after treatment ends.

Due to its strong empirical support, both the National Institutes of Health and the American Academy of Sleep Medicine recommend CBTi as the standard treatment for insomnia, highlighting its importance in addressing the public health burden of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. Siebern, AT., Manber, R.[2018]

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

Cognitive-behavioral therapy (CBT) is a safe and effective treatment for insomnia, showing positive results in 70% to 80% of patients, and can be used alone or alongside medication.

CBT addresses insomnia through behavioral, cognitive, and educational strategies, significantly reducing sleep-onset latency and wake-after-sleep onset, while also helping patients regain control over their sleep and reduce emotional distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral approaches to the treatment of insomnia. Morin, CM.[2022]

Cognitive behavior therapy (CBT) for insomnia is an effective nonpharmacologic intervention that can lead to reliable and sustained improvements in sleep patterns for patients suffering from chronic insomnia, which affects 10 to 30 percent of the population.

CBT includes various components such as cognitive psychotherapy, sleep hygiene, and relaxation techniques, typically delivered over four to eight weekly sessions, making it a recommended first-line treatment for chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic management of chronic insomnia. Harsora, P., Kessmann, J.[2022]

Cognitive Behavioral Therapy for insomnia (CBTi) is an effective alternative to medication for treating insomnia, which affects up to 30% of adults, and has been shown to improve various sleep-related outcomes such as sleep onset latency and sleep quality.

CBTi includes techniques like sleep hygiene and cognitive therapy, making it a safe and beneficial option for both adults and adolescents, although access to this therapy can be limited by certain barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy in the Treatment of Insomnia. Haynes, J., Talbert, M., Fox, S., et al.[2018]

The HUS Helsinki University Hospital-iCBT for Insomnia program demonstrated significant effectiveness in treating insomnia, with 75.4% of the 2,464 patients completing the treatment and an average decline of 7.04 points on the Insomnia Severity Index (ISI).

A large proportion of participants (34.0%) achieved remission by the end of the treatment, and the effect size was substantial (Cohen's d = -1.449), indicating that this publicly funded, therapist-supported program is effective in routine care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile-delivered, therapist-assisted cognitive behavioral therapy for insomnia in nationwide routine clinical care in Finland. Stenberg, JH., Ritola, V., Joffe, G., et al.[2023]

A randomized controlled trial is evaluating the effectiveness of provider-supported self-help Cognitive Behavioral Therapy for Insomnia (Tele-Self CBTi) in veterans with insomnia, aiming to improve access to treatment for this population with significant sleep difficulties.

If proven effective, Tele-Self CBTi could serve as a crucial entry-level intervention for veterans, potentially addressing the high demand for insomnia treatment and improving overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. Ulmer, CS., Bosworth, HB., Zervakis, J., et al.[2023]

References

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

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Internet-based cognitive-behavioural therapy for insomnia (ICBT-i): a meta-analysis of randomised controlled trials. [2019]

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

Treating primary insomnia: clinical effectiveness and predictors of outcomes on sleep, daytime function and health-related quality of life. [2022]

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

Impact of comorbid anxiety and depressive disorders on treatment response to cognitive behavior 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

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. [2021]

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

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]

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

Insomnia and its effective non-pharmacologic treatment. [2018]

9. England pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). [2021]

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

Cognitive-behavioral approaches to the treatment of insomnia. [2022]

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

Nonpharmacologic management of chronic insomnia. [2022]

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

Cognitive Behavioral Therapy in the Treatment of Insomnia. [2018]

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

Effectiveness of mobile-delivered, therapist-assisted cognitive behavioral therapy for insomnia in nationwide routine clinical care in Finland. [2023]

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

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. [2023]