NCT04252638

Acceptance and Commitment Therapy as a New Treatment for Adults With Insomnia Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Bern · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Acceptance and Commitment Therapy plus sleep restriction (ACT) will be compared to Cognitive Behavioral Therapy for insomnia (CBT-I). CBT-I is the first line treatment for insomnia according to current guidelines. 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.

Detailed description

Insomnia is a major health problem worldwide and a risk factor for the onset of other diseases, including cardiovascular and mental disorders. The prevalence of insomnia is 10% in the adult population. Cognitive Behavioral Therapy for insomnia (CBT-I) is the most effective treatment according to current guidelines. However, with response rates of around 70% and remission rates of around 40%, many patients need additional treatment. Common difficulties are that i) behavioral treatment elements, especially sleep restriction, are not implemented by patients, and that ii) quality of life does not improve despite improvements in sleep. Long-term pharmacological treatment is not recommended because it is often associated with a loss of efficacy and the risk of severe side effects. The aim of this research project is to improve behavioral treatment options for patients with insomnia. Acceptance and Commitment Therapy (ACT) is a new form of behavioral therapy. Efficacy, primarily an improvement of quality of life, has already been proven for other conditions including chronic pain and depression - however, no controlled study in patients with insomnia has yet been conducted. In a feasibility study, our workgroup provided first evidence that this treatment is feasible and potentially efficacious mainly for the improvement of sleep related quality of life. The current proposal is designed to extend this preliminary work in form of a prospective randomized controlled pilot trial. ACT will be compared with the gold standard treatment (CBT-I) in 60 patients with a primary diagnosis of insomnia disorder. The primary aim of this research is to test for differential efficacy, i.e. whether ACT is more effective for the improvement of i) insomnia severity and ii) sleep-related quality of life. The planned study is prospective, randomized, controlled, confirmatory, two-armed, single-blinded.

Conditions

• Insomnia Chronic

Interventions

Type	Name	Description
BEHAVIORAL	Acceptance and Commitment Therapy plus Sleep Restriction	Acceptance and Commitment Therapy (ACT) is a newer form of behavioral therapy working with acceptance, and the clarification of personal values. Acceptance, in this case, means the willingness to (temporarily) experience unpleasant sensations such as sleeplessness or tiredness without attempting to control or change them. Aims are, first, to reduce suffering due to unsuccessful control attempts (such as frustration, anger, anxiety) and second, to improve processes that are typically worsened by increased control efforts (such as sleep). Clarification of values means identifying aspects of life that are perceived as rewarding and encouraging approach-behavior in valued aspects of life (instead of avoidance-behavior that is often associated with insomnia and mental disorders).
BEHAVIORAL	Cognitive Behavioral Therapy including Sleep Restriction	CBT-I, the gold standard treatment for insomnia, consists of sleep education, relaxation, sleep restriction, and cognitive therapy.

Timeline

• Start date: 2020-01-13
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2020-02-05
• Last updated: 2023-03-09

Locations

1 site across 1 country: Switzerland