Skip to main content
OpenTrials
Completed

NCT Number: NCT06336551

Acceptance and Commitment Therapy for Insomnia

Insomnia is a common sleep problem that impacts both physical and mental health. Acceptance and Commitment Therapy for Insomnia (ACT-I) is proposed as a promising new treatment for insomnia. However, its effectiveness without overlapping behavioral components of the current standard treatment, cognitive behavioral therapy, remains largely unknown.

The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults with insomnia, compared to a waitlist control group. The second goal is to explore the potential working mechanisms of ACT-I, using network intervention analysis.

Adults with insomnia will be randomized to an ACT-I or waitlist group. Both the ACT-I treatment and waiting period span 7 weeks. Assessments take place at baseline (pre), after 4 weeks (mid), and after 8 weeks (post), followed by a 3- and 6-month follow-up for the ACT-I group.

The main questions this RCT aims to answer are:

* Is ACT-I superior to a waitlist control group in improving insomnia severity (primary outcome) in addition to sleep diary measures, anxiety, depression, general mental health, and sleep-related quality of life (secondary outcomes)? * How do networks of insomnia symptoms or potential treatment processes (i.e., psychological (in)flexibility, sleep-related arousal, dysfunctional cognitions, and sleep-related safety behaviors) develop during and following ACT-I?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Amsterdam

Amsterdam, North Holland, 1018 WS, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • insomnia severity index score ≥ 15
  • clinical insomnia disorder diagnosis, as confirmed by the SCID-S-5 insomnia interview
  • age of 18 years or above
  • proficiency in Dutch
  • ability to come on-site for the treatment sessions

Exclusion criteria

  • previously received ACT
  • started psychotherapy within the last 6 months or currently awaiting psychotherapy
  • changed psychoactive medication in the last 3 months
  • diagnosis of psychosis or schizophrenia
  • severe depressive complaints (BDI-II score ≥ 29) or active suicidal ideation

Treatment and study plan

Acceptance and Commitment Therapy for insomnia (ACT-I)

Behavioral

During ACT-I patients are encouraged to let go of the struggle to control sleep and to focus on meaningful daytime activities. Treatment goals are addressed through ACT processes of creative hopelessness and self-as-context (session 1), acceptance (session 2), defusion (session 3), followed by values, committed action, and present moment awareness (sessions 4 and 5).

Other names: ACT

Primary outcomes

  1. Insomnia severity

    Time frame: Change from baseline to 8-weeks post-randomization

    Insomnia severity is assessed with the Insomnia Severity Index (ISI). The ISI consists of seven items evaluating insomnia symptoms on a 5-point scale (range: 0-28). Higher scores indicate greater severity of insomnia symptoms.

Secondary outcomes

  1. Insomnia severity

    Time frame: Change from baseline to 4-weeks post-randomization

    Insomnia severity is assessed with the Insomnia Severity Index (ISI). The ISI consists of seven items evaluating insomnia symptoms on a 5-point scale (range: 0-28). Higher scores indicate greater severity of insomnia symptoms.

  2. Insomnia severity

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Insomnia severity is assessed with the Insomnia Severity Index (ISI). The ISI consists of seven items evaluating insomnia symptoms on a 5-point scale (range: 0-28). Higher scores indicate greater severity of insomnia symptoms.

  3. Insomnia severity

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Insomnia severity is assessed with the Insomnia Severity Index (ISI). The ISI consists of seven items evaluating insomnia symptoms on a 5-point scale (range: 0-28). Higher scores indicate greater severity of insomnia symptoms.

  4. General well-being

    Time frame: Change from baseline to 4-weeks post-randomization

    General well-being is assessed with the Mental Health Continuum Short Form (MHC-SF), which includes 14 items rated on a 6-point scale (range: 0-70). Higher scores indicate greater well-being.

  5. General well-being

    Time frame: Change from baseline to 8-weeks post-randomization

    General well-being is assessed with the Mental Health Continuum Short Form (MHC-SF), which includes 14 items rated on a 6-point scale (range: 0-70). Higher scores indicate greater well-being.

  6. General well-being

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    General well-being is assessed with the Mental Health Continuum Short Form (MHC-SF), which includes 14 items rated on a 6-point scale (range: 0-70). Higher scores indicate greater well-being.

  7. General well-being

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    General well-being is assessed with the Mental Health Continuum Short Form (MHC-SF), which includes 14 items rated on a 6-point scale (range: 0-70). Higher scores indicate greater well-being.

  8. Sleep-related quality of life

    Time frame: Change from baseline to 4-weeks post-randomization

    Sleep-related quality of life is evaluated using the Glasgow Sleep Impact Index (GSII). Respondents define and rate their three main domains of sleep-related impairment on a Visual Analog Scale (range: 0-100). Higher scores indicate more sleep-related impairment.

  9. Sleep-related quality of life

    Time frame: Change from baseline to 8-weeks post-randomization

    Sleep-related quality of life is evaluated using the Glasgow Sleep Impact Index (GSII). Respondents define and rate their three main domains of sleep-related impairment on a Visual Analog Scale (range: 0-100). Higher scores indicate more sleep-related impairment.

  10. Sleep-related quality of life

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Sleep-related quality of life is evaluated using the Glasgow Sleep Impact Index (GSII). Respondents define and rate their three main domains of sleep-related impairment on a Visual Analog Scale (range: 0-100). Higher scores indicate more sleep-related impairment.

  11. Sleep-related quality of life

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Sleep-related quality of life is evaluated using the Glasgow Sleep Impact Index (GSII). Respondents define and rate their three main domains of sleep-related impairment on a Visual Analog Scale (range: 0-100). Higher scores indicate more sleep-related impairment.

  12. Anxiety symptoms

    Time frame: Change from baseline to 4-weeks post-randomization

    Anxiety symptoms are assessed with the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A), featuring seven items rated on a 4-point scale (range: 0-21). Higher scores indicate more anxiety symptoms.

  13. Anxiety symptoms

    Time frame: Change from baseline to 8-weeks post-randomization

    Anxiety symptoms are assessed with the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A), featuring seven items rated on a 4-point scale (range: 0-21). Higher scores indicate more anxiety symptoms.

  14. Anxiety symptoms

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Anxiety symptoms are assessed with the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A), featuring seven items rated on a 4-point scale (range: 0-21). Higher scores indicate more anxiety symptoms.

  15. Anxiety symptoms

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Anxiety symptoms are assessed with the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A), featuring seven items rated on a 4-point scale (range: 0-21). Higher scores indicate more anxiety symptoms.

  16. Depression symptoms

    Time frame: Change from baseline to 4-weeks post-randomization

    Depression symptoms are assessed with the Patient Health Questionnaire depression scale (PHQ-9), a nine-item questionnaire scored on a 4-point scale (range: 0-36). Higher scores indicate more depression symptoms.

  17. Depression symptoms

    Time frame: Change from baseline to 8-weeks post-randomization

    Depression symptoms are assessed with the Patient Health Questionnaire depression scale (PHQ-9), a nine-item questionnaire scored on a 4-point scale (range: 0-36). Higher scores indicate more depression symptoms.

  18. Depression symptoms

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Depression symptoms are assessed with the Patient Health Questionnaire depression scale (PHQ-9), a nine-item questionnaire scored on a 4-point scale (range: 0-36). Higher scores indicate more depression symptoms.

  19. Depression symptoms

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Depression symptoms are assessed with the Patient Health Questionnaire depression scale (PHQ-9), a nine-item questionnaire scored on a 4-point scale (range: 0-36). Higher scores indicate more depression symptoms.

  20. Sleep diary: total sleep time

    Time frame: Change from baseline to 4-weeks post-randomization

    Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time.

  21. Sleep diary: total sleep time

    Time frame: Change from baseline to 8-weeks post-randomization

    Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time.

  22. Sleep diary: total sleep time

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time.

  23. Sleep diary: total sleep time

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time.

  24. Sleep diary: sleep onset latency

    Time frame: Change from baseline to 4-weeks post-randomization

    Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency.

  25. Sleep diary: sleep onset latency

    Time frame: Change from baseline to 8-weeks post-randomization

    Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency.

  26. Sleep diary: sleep onset latency

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency.

  27. Sleep diary: sleep onset latency

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency.

  28. Sleep diary: wake after sleep onset

    Time frame: Change from baseline to 4-weeks post-randomization

    Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset.

  29. Sleep diary: wake after sleep onset

    Time frame: Change from baseline to 8-weeks post-randomization

    Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset.

  30. Sleep diary: wake after sleep onset

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset.

  31. Sleep diary: wake after sleep onset

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset.

  32. Sleep diary: sleep efficiency

    Time frame: Change from baseline to 4-weeks post-randomization

    Sleep efficiency (in percentage) is assessed with the consensus sleep diary (CSD), calculated as the total sleep time*100 divided by the time in bed. Higher scores indicate higher sleep efficiency.

  33. Sleep diary: sleep efficiency

    Time frame: Change from baseline to 8-weeks post-randomization

    Sleep efficiency (in percentage) is assessed with the consensus sleep diary (CSD), calculated as the total sleep time*100 divided by the time in bed. Higher scores indicate higher sleep efficiency.

  34. Sleep diary: sleep efficiency

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Sleep efficiency (in percentage) is assessed with the consensus sleep diary (CSD), calculated as the total sleep time*100 divided by the time in bed. Higher scores indicate higher sleep efficiency.

  35. Sleep diary: sleep efficiency

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Sleep efficiency (in percentage) is assessed with the consensus sleep diary (CSD), calculated as the total sleep time*100 divided by the time in bed. Higher scores indicate higher sleep efficiency.

  36. Psychological flexibility

    Time frame: Change from baseline to 4-weeks post-randomization

    Psychological flexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological flexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological flexibility.

  37. Psychological flexibility

    Time frame: Change from baseline to 8-weeks post-randomization

    Psychological flexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological flexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological flexibility.

  38. Psychological flexibility

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Psychological flexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological flexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological flexibility.

  39. Psychological flexibility

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Psychological flexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological flexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological flexibility.

  40. Psychological inflexibility

    Time frame: Change from baseline to 4-weeks post-randomization

    Psychological inflexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological inflexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological inflexibility.

  41. Psychological inflexibility

    Time frame: Change from baseline to 8-weeks post-randomization

    Psychological inflexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological inflexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological inflexibility.

  42. Psychological inflexibility

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Psychological inflexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological inflexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological inflexibility.

  43. Psychological inflexibility

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Psychological inflexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological inflexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological inflexibility.

  44. Sleep-related arousal

    Time frame: Change from baseline to 4-weeks post-randomization

    Sleep-related arousal will be assessed with the Pre-Sleep Arousal Scale (PSAS), which comprises 16 items scored on a 5-point scale (range: 16-80). Higher scores indicate higher sleep-related arousal.

  45. Sleep-related arousal

    Time frame: Change from baseline to 8-weeks post-randomization

    Sleep-related arousal will be assessed with the Pre-Sleep Arousal Scale (PSAS), which comprises 16 items scored on a 5-point scale (range: 16-80). Higher scores indicate higher sleep-related arousal.

  46. Sleep-related arousal

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Sleep-related arousal will be assessed with the Pre-Sleep Arousal Scale (PSAS), which comprises 16 items scored on a 5-point scale (range: 16-80). Higher scores indicate higher sleep-related arousal.

  47. Sleep-related arousal

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Sleep-related arousal will be assessed with the Pre-Sleep Arousal Scale (PSAS), which comprises 16 items scored on a 5-point scale (range: 16-80). Higher scores indicate higher sleep-related arousal.

  48. Dysfunctional sleep-related cognitions

    Time frame: Change from baseline to 4-weeks post-randomization

    Dysfunctional sleep-related cognitions will be evaluated by the short form of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), which includes 16 items scored on an 11-point agreement scale (range: 0-160). Higher scores indicate more dysfunctional sleep-related cognitions.

  49. Dysfunctional sleep-related cognitions

    Time frame: Change from baseline to 8-weeks post-randomization

    Dysfunctional sleep-related cognitions will be evaluated by the short form of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), which includes 16 items scored on an 11-point agreement scale (range: 0-160). Higher scores indicate more dysfunctional sleep-related cognitions.

  50. Dysfunctional sleep-related cognitions

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Dysfunctional sleep-related cognitions will be evaluated by the short form of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), which includes 16 items scored on an 11-point agreement scale (range: 0-160). Higher scores indicate more dysfunctional sleep-related cognitions.

  51. Dysfunctional sleep-related cognitions

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Dysfunctional sleep-related cognitions will be evaluated by the short form of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), which includes 16 items scored on an 11-point agreement scale (range: 0-160). Higher scores indicate more dysfunctional sleep-related cognitions.

  52. Sleep-related safety behaviors

    Time frame: Change from baseline to 4-weeks post-randomization

    Sleep-related safety behaviors will be measured with the sleep-related behaviors questionnaire short form (SRBQ-20), which consists of 20 items on coping with fatigue or improving sleep, scored on a 5-point scale (range: 0-80), with higher scores indicating more sleep-related safety behavior.

  53. Sleep-related safety behaviors

    Time frame: Change from baseline to 8-weeks post-randomization

    Sleep-related safety behaviors will be measured with the sleep-related behaviors questionnaire short form (SRBQ-20), which consists of 20 items on coping with fatigue or improving sleep, scored on a 5-point scale (range: 0-80), with higher scores indicating more sleep-related safety behavior.

  54. Sleep-related safety behaviors

    Time frame: Change from baseline to 3-month follow-up (ACT-I group only)

    Sleep-related safety behaviors will be measured with the sleep-related behaviors questionnaire short form (SRBQ-20), which consists of 20 items on coping with fatigue or improving sleep, scored on a 5-point scale (range: 0-80), with higher scores indicating more sleep-related safety behavior.

  55. Sleep-related safety behaviors

    Time frame: Change from baseline to 6-month follow-up (ACT-I group only)

    Sleep-related safety behaviors will be measured with the sleep-related behaviors questionnaire short form (SRBQ-20), which consists of 20 items on coping with fatigue or improving sleep, scored on a 5-point scale (range: 0-80), with higher scores indicating more sleep-related safety behavior.

Sponsors and collaborators

Lead sponsor

University of Amsterdam

Other

Registry information

Official study title

Efficacy of Acceptance and Commitment Therapy as a Stand-Alone Treatment for Insomnia: Protocol of a Randomized Waitlist Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.