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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

College students experience higher rates of insomnia compared the general population, and accessibility and availability for the appropriate intervention is difficult due limited resources available to them in a college environment. Theorefore, it is vital to offer an intervention that can be just as effective yet more accessible than other available treatments targeting insomnia. That is why this study will investigate the efficacy and feasibility of an online ACT intervention for insomnia among college students. Specifically, Is an online ACT for college students effective in treating insomnia? And, is an online ACT for college students feasible and acceptable in treating insomnia? Participants will be randomized into one of two conditions: waitlist or online ACT guide. Participants will receive questionnaires at baseline, post-treatment (4 weeks), and 1-month follow up.

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 data supports the effectiveness of the treatment ACT Guide for Insomnia?

Research shows that Acceptance and Commitment Therapy (ACT) for insomnia can be as effective as Cognitive Behavioral Therapy (CBT), which is a well-known treatment for sleep problems. Studies suggest that ACT may help people stick with their treatment better, which can lead to improved sleep. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy for Insomnia safe for humans?

The research articles reviewed do not specifically mention any safety concerns related to Acceptance and Commitment Therapy for Insomnia, suggesting it is generally considered safe for humans. ^{1 2 3 4 6}

How is the ACT Guide for Insomnia treatment different from other insomnia treatments?

The ACT Guide for Insomnia is unique because it focuses on acceptance and commitment therapy (ACT), which emphasizes accepting thoughts and feelings rather than trying to change them, and committing to actions aligned with personal values. This approach is different from cognitive behavioral therapy for insomnia (CBT-I), which typically focuses on changing negative thoughts and behaviors related to sleep. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial (RCT) of Acceptance and Commitment Therapy Versus Cognitive Behavioral Therapy for Chronic Insomnia. [2023]

2. New Zealand 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. [2023]

3. Brazil pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy-based behavioral intervention for insomnia: a pilot randomized controlled trial. [2021]

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

Acceptance and Commitment Therapy as an Adjunct or Alternative Treatment to Cognitive Behavioral Therapy for Insomnia. [2023]

5. United States 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. [2023]

6. 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]