Acceptance and Commitment Therapy for Insomnia

NCT06336551 | Completed

• 1 other identifier: UniversityAmsterdam
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Keywords

Acceptance and Commitment Therapy; ACT-I; stand-alone; efficacy; mechanisms; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Insomnia severity

  Insomnia severity is assessed with the Insomnia Severity Index (ISI). The ISI consists of seven items evaluating insomnia symptoms on a 5-point scale (range: 0-28). Higher scores indicate greater severity of insomnia symptoms.

  Change from baseline to 8-weeks post-randomization

Secondary Outcomes (55)

• Insomnia severity

  Change from baseline to 4-weeks post-randomization

• Insomnia severity

  Change from baseline to 3-month follow-up (ACT-I group only)

• Insomnia severity

  Change from baseline to 6-month follow-up (ACT-I group only)

• General well-being

  Change from baseline to 4-weeks post-randomization

• General well-being

  Change from baseline to 8-weeks post-randomization

Study Arms (2)

Acceptance and Commitment Therapy for insomnia (ACT-I)

EXPERIMENTAL

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

Behavioral: Acceptance and Commitment Therapy for insomnia (ACT-I)

Waitlist control

NO INTERVENTION

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.

Interventions

Acceptance and Commitment Therapy for insomnia (ACT-I) 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).

Also known as: ACT

Acceptance and Commitment Therapy for insomnia (ACT-I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Amsterdam: lead

Study Sites (1)

University of Amsterdam

Amsterdam, North Holland, 1018 WS, Netherlands

Location

Related Links

• Analysis plan for network intervention analysis (NIA), registered on OSF on the 13th of April.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Looman I Mathilde, MSc

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychology PhD student

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: April 2, 2024
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)