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

NCT04252638 | Completed

• 1 other identifier: 2020-AI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic

Keywords

Insomnia; Acceptance and Commitment Therapy; Cognitive Behavioral Therapy; Randomized Controlled Trial; Sleep; Quality of life

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Insomnia Severity at six weeks

  The ISI is a valid, reliable and change-sensitive self-rating questionnaire that is widely used as an outcome measure in clinical trials in insomnia research. A self-rating questionnaire in contrast to objective sleep measures such as polysomnography or actigraphy is reasonable and widely accepted for measuring insomnia severity because insomnia is defined on the basis of subjective sleep perception and objective measures often deviate from this perception. Advantages of the ISI, compared to a sleep diary, are that it combines different aspects of insomnia such as sleep onset difficulties, sleep maintenance difficulties, and daytime impairment in one summary score, and that it is easier to use for patients. Following Morin et al., response is defined as an improvement of \> seven points on the ISI. Remission is defined as a post-treatment ISI score of \< 8. The minimum score is 0 points, the maximum score is 28 points. Higher score indicate more severe insomnia.

  change over six weeks (directly before and directly after therapy)

• Change from Baseline Glasgow Sleep Impact Index at six weeks

  In the GSII, patients are asked to specify the most important aspect of daytime functioning which they perceive to be negatively affected by their insomnia. The degree of impairment is rated on visual analogue scale. The minimum value of the scale is 0 points, the maximum value is 100 points. Higher values indicate better sleep-related quality of life.

  change over six weeks (directly before and directly after therapy)

Secondary Outcomes (2)

• Change from Baseline Insomnia Severity at six months

  change over six months (directly before therapy and six months later)

• Change from Baseline Glasgow Sleep Impact Index at six months

  change over six months (directly before therapy and six months later)

Study Arms (2)

Acceptance and Commitment Therapy plus Sleep Restriction

EXPERIMENTAL

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.

Behavioral: Acceptance and Commitment Therapy plus Sleep Restriction

Cognitive Behavioral Therapy including Sleep Restriction

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Behavioral Therapy including Sleep Restriction

Interventions

Acceptance and Commitment Therapy plus Sleep Restriction 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).

Acceptance and Commitment Therapy plus Sleep Restriction

Cognitive Behavioral Therapy including Sleep Restriction BEHAVIORAL

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

Cognitive Behavioral Therapy including Sleep Restriction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Current other psychotherapy

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Universitäre Psychiatrische Dienste Bern

Bern, 3000, Switzerland

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Elisabeth Hertenstein, PhD

  UPD Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: January 13, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)