Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT (ACTCOM-I)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: CBT; Chronic Insomnia
• Intervention / Treatment: Behavioral: ACTCOM-I Intervention; Behavioral: Standard CBT-I Intervention

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana M Mendes; Phone Number: 925268951; Email: mariana.miller.mendes@gmail.com

Study Locations

• Portugal
  • Coimbra, Portugal
    • Centro de Medicina do Sono do Centro Hospitalar e Universitário de Coimbra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACTCOM-I Intervention	Behavioral: ACTCOM-I Intervention; 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.
Active Comparator: Standard CBT-I Intervention	Behavioral: Standard CBT-I Intervention; Standard CBT-I treatment for chronic insomnia. Treatment protocol adapted from Morin's protocol (1993)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in insomnia severity scores	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pre-sleep arousal scores	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.	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
Change in sleep effort scores	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	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
Change in dysfunctional beliefs and attitudes about sleep scores	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.	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
Change in anxiety and depression symptoms scores	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).	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
Change in positive and negative affect scores	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.	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
Change in trait mindfulness scores	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.	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
Change in psychological flexibility scores	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.	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
Change in cognitive fusion scores	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.	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
Change in personal values enactment scores	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.	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
Change in self-compassion scores	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.	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
Change in Quality of life scores	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.	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

Collaborators and Investigators

• Sponsor: University of Coimbra

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: ACT; Compassion; Chronic Insomnia; CBT-I
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: SFRH/BD/147556/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No