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NCT Number: NCT05555108

Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT

The main aim of this study is to test the efficacy of a Compassive Acceptance Intervention protocol (developed by the research team) for Chronic Insomnia in comparison with the standard treatment (CBT-I).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Medicina do Sono do Centro Hospitalar e Universitário de Coimbra

Coimbra, Portugal

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Insomnia Diagnosis (ICSD-3; DSM-5)

Exclusion criteria

  • Comorbidity with severe psychiatric/psychological disorder (e.g. severe depression; psychotic disorder)
  • Comorbidity with other untreated sleep disorder
  • Altered Sleep patterns due to factors different from insomnia (e.g. shift-work; pregnancy)

Treatment and study plan

ACTCOM-I Intervention

Behavioral

ACTCOM-I s an individual treatment protocol based on Acceptance and Commitment Therapy (ACT) with targeted behavioral components for insomnia treatment and a specific focus on selfcompassion as a protector for sleep disturbance.

Standard CBT-I Intervention

Behavioral

Standard CBT-I treatment for chronic insomnia. Treatment protocol adapted from Morin's protocol (1993)

Primary outcomes

  1. Change in insomnia severity scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Insomnia severity assessed by the Insomnia Severity Index (ISI). The ISI is a 7-item self-report questionnaire that evaluates the nature, severity, and impact of insomnia. Scores range from 0 to 28 points with higher scores indicating more severe insomnia symptoms.

Secondary outcomes

  1. Change in pre-sleep arousal scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Pre-sleep arousal assessed by the Pre-Sleep Arousal Scale (PSAS). The PSAS is a 16-item self-report questionnaire that evaluates symptoms of arousal at bedtime. Eight items evaluate symptoms of cognitive arousal and eight evaluate symptoms of somatic arousal experienced when attempting to fall asleep. Scores range from 8 to 40 in each subscale, where higher scores indicate greater activation.

  2. Change in sleep effort scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Sleep effort assessed by the Glasgow Sleep Effort Scale (GSES). The GSES is a 7-item self-report questionnaire that evaluates the presence of a state of sleep effort. Scores range from 0 to 14 where higher scores indicate greater effort to sleep

  3. Change in dysfunctional beliefs and attitudes about sleep scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Dysfunctional beliefs and attitudes about sleep assessed by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS). The DBAS is a 30-item self-report questionnaire that addresses several beliefs and attitudes about sleep and insomnia. A global score is found by averaging scores on all items, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.

  4. Change in anxiety and depression symptoms scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Anxiety and depression symptoms assessed by the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item self-report questionnaire of which 7 items assess depression and 7 items assess anxiety. Scores range from 0 to 21 for each subscale where higher scores denote higher distress (anxiety and depression).

  5. Change in positive and negative affect scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Assessment of affect using the PANAS Portuguese Short Version (PANAS-VRP). The PANAS-VRP is a 10-item self-report questionnaire of which 5 items evaluate positive affect and 5 items evaluate negative affect. Scores range from 5 to 25 for each subscale where higher scores indicate high positive and negative affect, for each subscale respectively.

  6. Change in trait mindfulness scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Assessment of trait mindfulness using the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a 39-item self-report questionnaire evaluating the trait-like tendency to be mindful in daily life. The scale provides a global mindfulness score (sum of each facet score) and comprises five related facets (observing; describing; acting with awareness; nonjudging; nonreactivity). Facet scores range from 8-40, except for the nonreactivity facet, which ranges from 7-35. Higher scores indicate higher mindfulness trait.

  7. Change in psychological flexibility scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Assessment of psychological inflexibility or experiential avoidance using the Acceptance and Action Questionnaire-II (AAQ-II). The AAQ-II is a 7-item self-report questionnaire with total scores ranging from 7 to 49 where higher scores indicate higher levels of psychological inflexibility.

  8. Change in cognitive fusion scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Assessment of the process of cognitive fusion using the Cognitive Fusion Questionnaire (CFQ). The CFQ is a 7-item self-report questionnaire that evaluates the degree to which people tend to fuse with their thoughts. Scores range from 7 to 49 points, where higher scores indicate higher levels of cognitive fusion.

  9. Change in personal values enactment scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Assessment of one's engagement in valued action (personal values enactment) using the Valuing Questionnaire (VQ). The VQ is a 10-item self-report questionnaire that evaluates how consistently an individual is living according with their chosen values. The scale measures two constructs - progress and obstruction - and each subscale is scored from 0 to 30 points. On the progress subscale, higher scores indicate higher valued based action and, on the obstruction subscale, higher scores denote higher interference with acting according to one's values.

  10. Change in self-compassion scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Assessment of self-compassion using the Self-Compassion Scale (SCS). The SCS is a 26-item self-report questionnaire that evaluates the capacity for self-compassion through six subscales (Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; Over-identification). Total scores range from 26 to 130 points. Higher scores indicate higher self-compassion for total scores and subscale scores.

  11. Change in Quality of life scores

    Time frame: Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion

    Assessment of individual facets relating to quality of life using the World Health Organization Quality Of Life Scale (WHOQOL-BREF). The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items). Total scores range from 26 to 130 points. Higher scores indicate better satisfaction with quality of life on total score and subscale scores.

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Registry information

Acronym: ACTCOM-I

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2022
Registry last updated
Sep 5, 2025

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.

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