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

NCT ID: NCT04252638

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2022-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acceptance and Commitment Therapy plus Sleep Restriction

Acceptance and Commitment therapy is a well-established treatment for other disorders including depression, anxiety and chronic pain, but has not been thoroughly investigated for insomnia. The therapy consists of mindfulness, acceptance, identification of personal life values and committed action. In addition, patients in this group will receive sleep restriction, a behavioral therapy component of cognitive behavioral therapy for insomnia. The treatment will consist of six weekly sessions of group psychotherapy and will be conducted in an outpatient setting.

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy plus Sleep Restriction

Intervention Type: BEHAVIORAL

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).

Cognitive Behavioral Therapy including Sleep Restriction

The control intervention is Cognitive Behavioral Therapy for insomnia (CBT-I). This is the first line treatment for adults with chronic insomnia. The therapy consists of education, relaxation, and behavioral therapy, including sleep restriction. The treatment will consist of six weekly sessions of group psychotherapy and will be conducted in an outpatient setting.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy including Sleep Restriction

Intervention Type: BEHAVIORAL

CBT-I, the gold standard treatment for insomnia, consists of sleep education, relaxation, sleep restriction, and cognitive therapy.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18-75 years
• Ability to give written informed consent
• Sufficient fluency in German to participate in group therapy and fill in questionnaires
• Meeting research diagnostic criteria for insomnia disorder according to DSM 5

Exclusion Criteria

• Serious medical condition (e.g. tumor disease, epilepsy, encephalitis, history of traumatic brain injury, other organic brain syndromes), severe heart disease and other debilitating or instable medical conditions or upcoming surgery
• Acute pain or poorly managed chronic pain
• Suicidality
• Severe psychiatric disorder (e.g. psychosis, bipolar disorder, borderline personality disorder, intellectual disability, autism) or other psychiatric disorder requiring treatment outside of study
• Alcohol or drug abuse or dependency including benzodiazepine dependency
• Evidence of untreated sleep apnea
• Evidence of restless legs syndrome
• Evidence of parasomnia
• Circadian rhythm disorder including night shift work
• Alteration of medication within 4 weeks prior to study treatment, stable medication does not lead to exclusion
• Current other psychotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Hertenstein, PhD

Role: PRINCIPAL_INVESTIGATOR

UPD Bern

Locations

Universitäre Psychiatrische Dienste Bern

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2020-AI

Identifier Type: -

Identifier Source: org_study_id