Acceptance and Commitment Therapy for Insomnia

NCT ID: NCT06336551

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2026-01-26

Brief Summary

Insomnia is a common sleep problem that impacts both physical and mental health. Acceptance and Commitment Therapy for Insomnia (ACT-I) is proposed as a promising new treatment for insomnia. However, its effectiveness without overlapping behavioral components of the current standard treatment, cognitive behavioral therapy, remains largely unknown.

The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults with insomnia, compared to a waitlist control group. The second goal is to explore the potential working mechanisms of ACT-I, using network intervention analysis.

Adults with insomnia will be randomized to an ACT-I or waitlist group. Both the ACT-I treatment and waiting period span 7 weeks. Assessments take place at baseline (pre), after 4 weeks (mid), and after 8 weeks (post), followed by a 3- and 6-month follow-up for the ACT-I group.

The main questions this RCT aims to answer are:

• Is ACT-I superior to a waitlist control group in improving insomnia severity (primary outcome) in addition to sleep diary measures, anxiety, depression, general mental health, and sleep-related quality of life (secondary outcomes)?
• How do networks of insomnia symptoms or potential treatment processes (i.e., psychological (in)flexibility, sleep-related arousal, dysfunctional cognitions, and sleep-related safety behaviors) develop during and following ACT-I?

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acceptance and Commitment Therapy for insomnia (ACT-I)

In this condition, participants receive five individual face-to-face 60-minute sessions of ACT-I psychotherapy within a 7-week treatment period.

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy for insomnia (ACT-I)

Intervention Type: BEHAVIORAL

During ACT-I patients are encouraged to let go of the struggle to control sleep and to focus on meaningful daytime activities. Treatment goals are addressed through ACT processes of creative hopelessness and self-as-context (session 1), acceptance (session 2), defusion (session 3), followed by values, committed action, and present moment awareness (sessions 4 and 5).

Waitlist control

In this condition, participants fill out assessments only during a 7-week waiting period. After completing the post-assessment, participants in the control condition receive ACT-I treatment as well.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acceptance and Commitment Therapy for insomnia (ACT-I)

During ACT-I patients are encouraged to let go of the struggle to control sleep and to focus on meaningful daytime activities. Treatment goals are addressed through ACT processes of creative hopelessness and self-as-context (session 1), acceptance (session 2), defusion (session 3), followed by values, committed action, and present moment awareness (sessions 4 and 5).

Intervention Type: BEHAVIORAL

Other Intervention Names

ACT

Eligibility Criteria

Inclusion Criteria

• insomnia severity index score ≥ 15
• clinical insomnia disorder diagnosis, as confirmed by the SCID-S-5 insomnia interview
• age of 18 years or above
• proficiency in Dutch
• ability to come on-site for the treatment sessions

Exclusion Criteria

• previously received ACT
• started psychotherapy within the last 6 months or currently awaiting psychotherapy
• changed psychoactive medication in the last 3 months
• diagnosis of psychosis or schizophrenia
• severe depressive complaints (BDI-II score ≥ 29) or active suicidal ideation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Amsterdam

OTHER

Sponsor Role: lead

Responsible Party

Mathilde Looman

Clinical Psychology PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Looman I Mathilde, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Amsterdam

Locations

University of Amsterdam

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Mathilde I Looman, MSc

Role: CONTACT

m.i.looman@uva.nl

(0)20 525 6810 ext. +31

Jaap Lancee, PhD

Role: CONTACT

j.lancee@uva.nl

(0)20 525 6810 ext. +31

Facility Contacts

Mathilde I Looman, MSc

Role: primary

m.i.looman@uva.nl

(0)20 525 6810 ext. +31

Other Identifiers

UniversityAmsterdam

Identifier Type: -

Identifier Source: org_study_id