Insomnia ChronicNCT04252638
Acceptance and Commitment Therapy as a New Treatment for Adults With Insomnia Disorder
A study testing Acceptance and Commitment Therapy plus Sleep Restriction and Cognitive Behavioral Therapy including Sleep Restriction in people with Insomnia Chronic, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- Acceptance and Commitment Therapy plus Sleep Restriction and Cognitive Behavioral Therapy including Sleep Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jan 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Acceptance and Commitment Therapy plus Sleep Restriction, Cognitive Behavioral Therapy including Sleep Restriction
- Keywords
- Insomnia, Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, Randomized Controlled Trial, Sleep, Quality of life
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy plus Sleep RestrictionBehavioural
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 RestrictionBehavioural
CBT-I, the gold standard treatment for insomnia, consists of sleep education, relaxation, sleep restriction, and cognitive therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive Behavioral Therapy including Sleep Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: change over six weeks (directly before and directly after therapy)
Secondary outcomes (2)
Change from Baseline Insomnia Severity at six months
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.
Measured: change over six months (directly before therapy and six months later)
Change from Baseline Glasgow Sleep Impact Index at six months
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.
Measured: change over six months (directly before therapy and six months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start13 Jan 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Hertenstein, PhD, Principal investigator, UPD Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252638
- Sponsor's protocol ID
- 2020-AI
- Status last verified
- Mar 2023
- First submitted
- 28 Jan 2020
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy as a New Treatment for Adults With Insomnia Disorder
- ClinicalTrials.gov ID
- NCT04252638
- Acronym / sponsor ID
- 2020-AI
- Conditions
- Insomnia Chronic
- Keywords
- Insomnia, Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, Randomized Controlled Trial, Sleep, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy plus Sleep Restriction | Experimental | Behavioral: Acceptance and Commitment Therapy plus Sleep RestrictionAcceptance 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. |
| Cognitive Behavioral Therapy including Sleep Restriction | Active comparator | Behavioral: Cognitive Behavioral Therapy including Sleep RestrictionThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy plus Sleep RestrictionAcceptance 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). | Behavioural | Acceptance and Commitment Therapy plus Sleep Restriction |
| Cognitive Behavioral Therapy including Sleep RestrictionCBT-I, the gold standard treatment for insomnia, consists of sleep education, relaxation, sleep restriction, and cognitive therapy. | Behavioural | Cognitive Behavioral Therapy including Sleep Restriction |
Primary outcome
Change from Baseline Insomnia Severity at six weeks
Time frame: change over six weeks (directly before and directly after therapy)
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 from Baseline Glasgow Sleep Impact Index at six weeks
Time frame: change over six weeks (directly before and directly after therapy)
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.
2 secondary outcomes
Change from Baseline Insomnia Severity at six months
Time frame: change over six months (directly before therapy and six months later)
Change from Baseline Glasgow Sleep Impact Index at six months
Time frame: change over six months (directly before therapy and six months later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Hertenstein, PhD principal investigator
UPD Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy plus Sleep Restriction and Cognitive Behavioral Therapy including Sleep Restriction in people with Insomnia Chronic, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Insomnia Severity at six weeks (time frame: change over six weeks (directly before and directly after therapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.