Acceptance and Commitment Therapy for Insomnia

NCT04866914 | Completed

• 1 other identifier: 65743917.2.0000.0068
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Insomnia

Keywords

INSOMNIA; acceptance and commitment therapy; Cognitive behavioral therapy; SLEEP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Remission - categorical variable

  baseline, 7 weeks and 24 weeks after treatment commencement.

• Treatment response - categorical variable

  baseline, 7 weeks and 24 weeks after treatment commencement.

• Reduction in Sleep Onset Latency (SOL)

  baseline, 7 weeks and 24 weeks after treatment commencement.

• Reduction in Wake After Sleep Onset (WASO)

  baseline, 7 weeks and 24 weeks after treatment commencement.

• Increase in Total Sleep Time (TST)

  baseline, 7 weeks and 24 weeks after treatment commencement.

Study Arms (3)

ACT for Insomnia

EXPERIMENTAL

Behavioral: Acceptance and Commitment Therapy for Insomnia

CBT for Insomnia

ACTIVE COMPARATOR

Behavioral: Cognitive Behavioral Therapy for Insomnia

Wait List

NO INTERVENTION

Interventions

Acceptance and Commitment Therapy for Insomnia BEHAVIORAL

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.

Also known as: ACT-I

ACT for Insomnia

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

Also known as: CBT-I

CBT for Insomnia

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of chronic insomnia

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Sao Paulo General Hospital.

São Paulo, 05403903, Brazil

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• RENATHA RAFIHI-FERREIRA, PHD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 30, 2021
• Study Start: March 15, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: November 9, 2023

Record last verified: 2021-05

Locations

BR (1)