Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT

University of Coimbra1 site in 1 country31 target enrollmentJanuary 29, 2021

ConditionsChronic Insomnia CBT

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Insomnia
Sponsor: University of Coimbra
Enrollment: 31
Locations: 1
Primary Endpoint: Change in insomnia severity scores
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

January 29, 2021

End Date

May 13, 2024

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Coimbra

Responsible Party

Principal Investigator

Mariana Miller-Mendes

PhD fellowship at Center for Research in Neuropsychology and Cognitive Bebavioral Intervention (CINEICC)

University of Coimbra

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

Change in pre-sleep arousal 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 psychological flexibility 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 personal values enactment 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 dysfunctional beliefs and attitudes about sleep 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 positive and negative affect 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 anxiety and depression symptoms 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 sleep effort 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 trait mindfulness 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 cognitive fusion 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(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(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)