Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT

NCT05555108 | Completed

• 1 other identifier: SFRH/BD/147556/2019
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Insomnia; CBT

Keywords

Chronic Insomnia; CBT-I; ACT; Compassion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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 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 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 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 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

Study Arms (2)

ACTCOM-I Intervention

EXPERIMENTAL

Behavioral: ACTCOM-I Intervention

Standard CBT-I Intervention

ACTIVE COMPARATOR

Behavioral: Standard CBT-I Intervention

Interventions

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.

ACTCOM-I Intervention

Standard CBT-I Intervention BEHAVIORAL

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

Standard CBT-I Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Insomnia Diagnosis (ICSD-3; DSM-5)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

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

Coimbra, Portugal

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellowship at Center for Research in Neuropsychology and Cognitive Bebavioral Intervention (CINEICC)

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: September 26, 2022
• Study Start: January 29, 2021
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

PT (1)