Acceptance and Commitment Therapy for Insomnia
Key facts
- Who runs it
- University of Amsterdam
- Where
- Netherlands1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 93 people enrolled
- Started
- 2 Apr 2024
- Ended
- 13 Jan 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Acceptance and Commitment Therapy for insomnia (ACT-I)
- Record updated
- 17 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- previously received ACT
- changed psychoactive medication in the last 3 months
- started psychotherapy within the last 6 months or currently awaiting psychotherapy
- diagnosis of psychosis or schizophrenia
- severe depressive complaints (BDI-II score ≥ 29) or active suicidal ideation
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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?
The 2 groups in the trial
- Acceptance and Commitment Therapy for insomnia (ACT-I)Treatment being tested
In this condition, participants receive five individual face-to-face 60-minute sessions of ACT-I psychotherapy within a 7-week treatment period.
- Waitlist controlNo study treatment, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of Acceptance and Commitment Therapy as a Stand-Alone Treatment for Insomnia: Protocol of a Randomized Waitlist Controlled Trial
- Record updated
- 17 April 2026