Acceptance and Commitment Therapy for Insomnia (ACT-I)

Acceptance and Commitment Therapy for Chronic Insomnia in Adults

Insomnia is a frequent complaint and is associated with impairments in physical and psychological health. Although Cognitive-Behavioral Therapy (CBT) demonstrates effective results for insomnia, there are those who do not respond to this type of intervention or present difficulties in adherence. Acceptance and Commitment Therapy (ACT) presents itself as a potentially useful intervention for the treatment of insomnia, for which, instead of focusing on controlling the symptoms, the respective approach focuses on accepting the feelings and thoughts associated, through value-based actions. The aim of this study is to evaluate the effectiveness of ACT for chronic insomnia in adults. Participants will be 150 adults aged between 18 and 59 years, diagnosed with chronic insomnia who will be randomly assigned to the ACT, CBT and wait list (WL) groups. For both groups (ACT and CBT), the intervention will be performed in six group and weekly sessions. Assessments of sleep patterns, insomnia, depression, anxiety, psychological flexibility, acceptance of sleep, beliefs about sleep, personality traits will be performed in the pre-treatment, post-treatment and six-month follow-up. After the intervention is completed, participants will respond to an inventory of compliance and satisfaction. Treatment effects will assessed using the fixed effects of group variables (ACT vs. CBT-I and ACT vs. waitlist) and their interaction with time (pre-test vs. post-test and pretest vs. six-month follow-up). Estimated pairwise contrasts to examine changes across time within groups will be used. Variables will analyzed using generalized mixed models (GMM).

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy for Insomnia; Behavioral: Cognitive Behavioral Therapy for Insomnia

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403903
    • University of Sao Paulo General Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of chronic insomnia

Exclusion Criteria:

• Neurological degenerative disease
• Psychotic disorder
• sleep apnea, restless legs or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)
• cognitive impairments
• unavailability in attending the sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait List
Experimental: ACT for Insomnia	Behavioral: Acceptance and Commitment Therapy for Insomnia; ACT-I treatment group: Participants diagnosed with chronic insomnia will receive group treatment. The six sessions will be aimed at psychoeducation about sleep added to the therapeutic processes of acceptance, mindfulness, availability, values, defusion and commitment, used in ACT.; Other Names: ACT-I
Active Comparator: CBT for Insomnia	Behavioral: Cognitive Behavioral Therapy for Insomnia; Active control group CBT-I: Participants diagnosed with chronic insomnia will receive treatment in a group. The six sessions will be aimed at cognitive-behavioral components, such as education and sleep hygiene, stimulus control, sleep restriction and demystification / restructuring of belief beliefs.; Other Names: CBT-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the score of Insomnia Severity Index (ISI)	Change in the total score of Insomnia Severity Index (ISI)	baseline, 7 weeks and 24 weeks after treatment commencement.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Sleep Onset Latency (SOL)	Reduction in Sleep Onset Latency (SOL) measured by sleep diary	baseline, 7 weeks and 24 weeks after treatment commencement.
Reduction in Wake After Sleep Onset (WASO)	Reduction in Wake After Sleep Onset (WASO) measured by sleep diary	baseline, 7 weeks and 24 weeks after treatment commencement.
Increase in Total Sleep Time (TST)	Increase in Total Sleep Time (TST) measured by sleep diary	baseline, 7 weeks and 24 weeks after treatment commencement.
Increase in Sleep Efficiency (SE)	Increase in Sleep Efficiency (SE) measured by sleep diary	baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the Hospital Anxiety and Depression Scale (HADS)	Change in the total score for the anxiety variable (HADAS-A) and total score for the depression variable (HADAS-D)	baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the Acceptance and Action Questionnaire-II (AAQ-II)	Change in the the total score of Acceptance and Action Questionnaire-II (AAQ-II)	baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the Sleep Problem Acceptance Questionnaire (SPAQ)	Change in the the total score of Sleep Problem Acceptance Questionnaire (SPAQ)	baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)	Change in the the total score of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)	baseline, 7 weeks and 24 weeks after treatment commencement.
Remission - categorical variable	a final ISI score under 8 points	baseline, 7 weeks and 24 weeks after treatment commencement.
Treatment response - categorical variable	change or reduction in the ISI total score of 8 points or more	baseline, 7 weeks and 24 weeks after treatment commencement.

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: RENATHA RAFIHI-FERREIRA, PHD, University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; acceptance and commitment therapy; INSOMNIA; SLEEP
• 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: 65743917.2.0000.0068

Drug and device information, study documents

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