ACT Guide for Insomnia

Overseen By Gabe San Miguel, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Utah State University

Must not be taking: Sleep medications

Disqualifiers: Other sleep disorders, Therapy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates an online therapy program, known as ACT (Acceptance and Commitment Therapy), to help college students with insomnia. The study aims to determine if this online approach effectively and practically treats sleep troubles in students. Participants will either use the ACT Guide for Insomnia program or join a waitlist for eight weeks. College students in the U.S. diagnosed with insomnia who seek treatment, but are not currently in therapy or taking sleep medications, might be a good fit. As an unphased trial, this study offers students a unique opportunity to explore a new, accessible treatment option for insomnia.

Will I have to stop taking my current medications?

The trial requires that participants are not currently taking medications to treat insomnia or other sleep-inducing medications.

What prior data suggests that this online ACT intervention is safe for treating insomnia in college students?

Studies have shown that Acceptance and Commitment Therapy (ACT) can help people with insomnia sleep better. Research suggests that ACT improves sleep by encouraging acceptance of thoughts and feelings. The studies do not report any serious side effects or safety concerns related to ACT for insomnia. Since ACT involves talking and exercises, it is generally easy for people to handle. By helping individuals manage their thoughts and feelings instead of trying to change them, ACT offers a safe option for treating insomnia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACT Guide for Insomnia because it offers a novel approach to treating insomnia by using Acceptance and Commitment Therapy (ACT), which focuses on psychological flexibility and mindfulness. Unlike traditional treatments like medication or cognitive-behavioral therapy (CBT), this method is delivered entirely online, making it highly accessible to users, especially college students. This digital format allows participants to engage with the therapy at their own pace, potentially increasing adherence and effectiveness.

What evidence suggests that the ACT Guide for Insomnia might be an effective treatment for insomnia?

Research has shown that Acceptance and Commitment Therapy (ACT) can improve sleep in people with insomnia. Studies have found that ACT reduces the urge to avoid unpleasant thoughts and helps people manage their emotions more effectively. Clinical trials and research support using ACT specifically for treating insomnia, showing positive results in enhancing sleep-related quality of life. In this trial, participants will either receive the ACT Guide for Insomnia or be placed on a waitlist. This therapy encourages individuals to accept their thoughts and feelings and commit to actions that enhance their sleep. Overall, ACT appears to be an effective treatment for insomnia, especially when other options are difficult to access. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for college students over 18 in the US, enrolled in a 2- or 4-year program, who have insomnia but no other sleep disorders. They must speak English, have internet access, and be seeking treatment for insomnia. Students already receiving therapy for emotional disorders or taking sleep medications are excluded.

Inclusion Criteria

I have been diagnosed with acute insomnia.

I am actively seeking treatment.

Currently residing in the US

Exclusion Criteria

I have a sleep disorder that is not insomnia.

I am currently in therapy for anxiety, depression, or insomnia.

I am taking medication for insomnia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the online ACT intervention for insomnia, with access to Module 1 from week 1 and Module 2 from week 3

4 weeks

Online access to modules

Follow-up

Participants are monitored for effectiveness of the intervention with questionnaires at 1-month follow-up

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ACT Guide for Insomnia

Trial Overview The study tests an online Acceptance and Commitment Therapy (ACT) intervention to see if it's effective and practical for treating insomnia in college students. Participants will either wait or use the ACT Guide for Insomnia and complete questionnaires at different stages.

How Is the Trial Designed?

Group I: ACT Guide for Insomnia Experimental Treatment 1 Intervention

Participants will complete 2 modules of an online Acceptance and Commitment Therapy (ACT) Guide designed to focus on insomnia among college students. Module 1 will be available to participants at the start of week 1 and throughout the course of the study. Module 2 will become available at the start of week 3 and participants will have access throughout the study

Group II: Waitlist Active Control 1 Intervention

Participants randomized into the waitlist condition will not have access to the ACT Guide for Insomnia until the conclusion of their time in the study (8 weeks after randomization).

Who Is Running the Clinical Trial?

Utah State University

Lead Sponsor

Trials

48

Recruited

5,200+

Published Research Related to This Trial

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]

Acceptance and Commitment Therapy (ACT) was found to significantly improve sleep quality and reduce anxiety in patients with chronic primary insomnia, showing particular effectiveness in those with high anxiety about sleep problems.

In a study of 30 patients over four weeks, both ACT and Cognitive Behavior Therapy for Insomnia (CBT-I) improved insomnia symptoms, but only ACT led to a significant reduction in anxiety, suggesting it may be a valuable alternative for patients who do not respond to CBT-I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Acceptance and Commitment Therapy (ACT) and Cognitive Behavior Therapy (CBT) for Chronic Insomnia: A Pilot Randomized Controlled Trial. Shin, JW., Kim, S., Shin, YJ., et al.[2023]

A study involving 45 adults with chronic insomnia found that both Acceptance and Commitment Therapy-based Behavioral Intervention for Insomnia (ACT-BBI-I) and Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep patterns and reduced insomnia symptoms, with benefits maintained for six months after treatment.

ACT-BBI-I focuses on acceptance and commitment processes, while CBT-I emphasizes cognitive restructuring; both approaches showed effectiveness, suggesting that integrating ACT principles with behavioral techniques could be beneficial for insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy-based behavioral intervention for insomnia: a pilot randomized controlled trial. El Rafihi-Ferreira, R., Morin, CM., Toscanini, AC., et al.[2021]

In a study of 37 adults with chronic insomnia, both Acceptance and Commitment Therapy for Insomnia (ACT-I) and Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly reduced insomnia severity, but CBT-I had a higher proportion of treatment responders immediately after treatment (64.7% vs. 50.0%).

Six months later, ACT-I showed continued improvement in insomnia severity, while the effectiveness of CBT-I slightly decreased, suggesting that ACT-I may offer longer-term benefits in managing insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial (RCT) of Acceptance and Commitment Therapy Versus Cognitive Behavioral Therapy for Chronic Insomnia. El Rafihi-Ferreira, R., Morin, CM., Hasan, R., et al.[2023]

A study involving 149 women veterans with insomnia found that the novel treatment, acceptance and commitment therapy for insomnia (ABC-I), was as effective as cognitive behavioral therapy for insomnia (CBT-I) in improving sleep outcomes after treatment and at a 3-month follow-up.

ABC-I showed better adherence to some treatment elements compared to CBT-I, suggesting it may be a more acceptable option for women veterans seeking insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel treatment based on acceptance and commitment therapy versus cognitive behavioral therapy for insomnia: A randomized comparative effectiveness trial in women veterans. Martin, JL., Carlson, GC., Kelly, MR., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective, but many patients struggle with sticking to the treatment, leading to early discontinuation.

Acceptance and Commitment Therapy (ACT) offers a promising alternative for treating insomnia, with unique components and mechanisms that may enhance adherence and effectiveness compared to traditional CBT-I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy as an Adjunct or Alternative Treatment to Cognitive Behavioral Therapy for Insomnia. Saldaña, KS., McGowan, SK., Martin, JL.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7916154/

Acceptance and Commitment Therapy (ACT) Improves ... Acceptance and commitment therapy (ACT) improves sleep quality, experiential avoidance, and emotion regulation in individuals with insomnia.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589979124000179

Efficacy of acceptance and commitment therapy as a stand ... In this protocol paper, we describe a randomized controlled trial that aims to test the efficacy of ACT-I as a stand-alone intervention for insomnia.

3. link.springer.com link.springer.com/book/10.1007/978-3-031-50710-6

Acceptance and Commitment Therapy for Insomnia This book presents a complete guide for psychotherapists to apply a protocol based on Acceptance and Commitment Therapy (ACT) to the treatment of insomnia.

4. thesleepsphere.com thesleepsphere.com/articles/actforinsomniacambridge?srsltid=AfmBOoqyHhvVtNhB49bVDOFUUGo6GyeP2bVk2p-WLVae3-dypy3hZ4Mb

ACT for Insomnia: How Acceptance and Commitment ... The data for Acceptance and Commitment Therapy (ACT) for insomnia has been growing steadily, supported by clinical trials and research studies.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04252638

Acceptance and Commitment Therapy as a New Treatment ... The aim of the study is to investigate the efficacy of ACT, compared to CBT-I, for the improvement of sleep-related quality of life and insomnia severity.

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/9781119891192.ch18

Acceptance and Commitment Therapy (ACT) for Insomnia ACT centres on two therapeutic modules: first, acceptance of thoughts, emotions and sensations and, second, commitment to individual life goals.

7. contextualscience.org contextualscience.org/acceptance_commitment_therapy_insomnia_acti_dr_guy_meadows

Acceptance and Commitment Therapy for Insomnia (ACT-I) ... The application and merits for using ACT approaches such as acceptance and willingness, mindfulness and defusion and values and committed action for the ...