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Acceptance and Commitment Therapy for Insomnia (ACT-I)

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring INSOMNIA, acceptance and commitment therapy, Cognitive behavioral therapy, SLEEP

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sao Paulo General Hospital.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

ACT for Insomnia

CBT for Insomnia

Wait List

Arm Description

Outcomes

Primary Outcome Measures

Change in the score of Insomnia Severity Index (ISI)
Change in the total score of Insomnia Severity Index (ISI)

Secondary Outcome Measures

Reduction in Sleep Onset Latency (SOL)
Reduction in Sleep Onset Latency (SOL) measured by sleep diary
Reduction in Wake After Sleep Onset (WASO)
Reduction in Wake After Sleep Onset (WASO) measured by sleep diary
Increase in Total Sleep Time (TST)
Increase in Total Sleep Time (TST) measured by sleep diary
Increase in Sleep Efficiency (SE)
Increase in Sleep Efficiency (SE) measured by sleep diary
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)
Change in the Acceptance and Action Questionnaire-II (AAQ-II)
Change in the the total score of Acceptance and Action Questionnaire-II (AAQ-II)
Change in the Sleep Problem Acceptance Questionnaire (SPAQ)
Change in the the total score of Sleep Problem Acceptance Questionnaire (SPAQ)
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)

Full Information

First Posted
April 13, 2021
Last Updated
October 17, 2023
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04866914
Brief Title
Acceptance and Commitment Therapy for Insomnia
Acronym
ACT-I
Official Title
Acceptance and Commitment Therapy for Chronic Insomnia in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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). We will estimated pairwise contrasts to examine changes across time within groups. Variables will analyzed using generalized mixed models (GMM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
INSOMNIA, acceptance and commitment therapy, Cognitive behavioral therapy, SLEEP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
227 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT for Insomnia
Arm Type
Experimental
Arm Title
CBT for Insomnia
Arm Type
Active Comparator
Arm Title
Wait List
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy for Insomnia
Other Intervention Name(s)
ACT-I
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
CBT-I
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the score of Insomnia Severity Index (ISI)
Description
Change in the total score of Insomnia Severity Index (ISI)
Time Frame
baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary Outcome Measure Information:
Title
Reduction in Sleep Onset Latency (SOL)
Description
Reduction in Sleep Onset Latency (SOL) measured by sleep diary
Time Frame
baseline, 7 weeks and 24 weeks after treatment commencement.
Title
Reduction in Wake After Sleep Onset (WASO)
Description
Reduction in Wake After Sleep Onset (WASO) measured by sleep diary
Time Frame
baseline, 7 weeks and 24 weeks after treatment commencement.
Title
Increase in Total Sleep Time (TST)
Description
Increase in Total Sleep Time (TST) measured by sleep diary
Time Frame
baseline, 7 weeks and 24 weeks after treatment commencement.
Title
Increase in Sleep Efficiency (SE)
Description
Increase in Sleep Efficiency (SE) measured by sleep diary
Time Frame
baseline, 7 weeks and 24 weeks after treatment commencement.
Title
Change in the Hospital Anxiety and Depression Scale (HADS)
Description
Change in the total score for the anxiety variable (HADAS-A) and total score for the depression variable (HADAS-D)
Time Frame
baseline, 7 weeks and 24 weeks after treatment commencement.
Title
Change in the Acceptance and Action Questionnaire-II (AAQ-II)
Description
Change in the the total score of Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame
baseline, 7 weeks and 24 weeks after treatment commencement.
Title
Change in the Sleep Problem Acceptance Questionnaire (SPAQ)
Description
Change in the the total score of Sleep Problem Acceptance Questionnaire (SPAQ)
Time Frame
baseline, 7 weeks and 24 weeks after treatment commencement.
Title
Change in the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
Description
Change in the the total score of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
Time Frame
baseline, 7 weeks and 24 weeks after treatment commencement.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RENATHA RAFIHI-FERREIRA, PHD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital.
City
São Paulo
ZIP/Postal Code
05403903
Country
Brazil

12. IPD Sharing Statement

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Acceptance and Commitment Therapy for Insomnia

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