Clinical trial NCT04252638: Acceptance and Commitment Therapy as a New Treatment for Adults With Insomnia Disorder
Official title: Acceptance and Commitment Therapy as a New Treatment for Adults With Insomnia Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Keywords: Insomnia
Acceptance and Commitment Therapy
Cognitive Behavioral Therapy
Randomized Controlled Trial
Sleep
Quality of life
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Insomnia Severity at six weeks
timeFrame: change over six weeks (directly before and directly after therapy)
measure: Change from Baseline Glasgow Sleep Impact Index at six weeks
timeFrame: change over six weeks (directly before and directly after therapy)
Secondary outcomes:
measure: Change from Baseline Insomnia Severity at six months
timeFrame: change over six months (directly before therapy and six months later)
measure: Change from Baseline Glasgow Sleep Impact Index at six months
timeFrame: change over six months (directly before therapy and six months later)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitäre Psychiatrische Dienste Bern
Study officials:
affiliation: UPD Bern
name: Elisabeth Hertenstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: