New therapy for insomnia using Acceptance and Commitment Therapy
Efficacy of Acceptance and Commitment Therapy as a Stand-Alone Treatment for Insomnia: Protocol of a Randomized Waitlist Controlled Trial
This study is testing a new therapy called Acceptance and Commitment Therapy for Insomnia to see if it can help adults with insomnia sleep better compared to those who are just waiting for treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Amsterdam Academic / other |
| Locations | 1 site (Amsterdam, Noord-Holland) |
| Trial ID | NCT06336551 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Acceptance and Commitment Therapy for Insomnia (ACT-I) as a stand-alone treatment for adults suffering from insomnia. Participants will be randomly assigned to either the ACT-I group or a waitlist control group, with treatment and assessment periods spanning 7 weeks. The study aims to determine if ACT-I can significantly improve insomnia symptoms compared to the waitlist group and to explore the mechanisms behind its efficacy through network intervention analysis. Assessments will occur at baseline, mid-treatment, and post-treatment, with follow-ups at 3 and 6 months for those receiving ACT-I.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of insomnia and a severity index score of 15 or higher.
Not a fit: Patients with severe depressive symptoms, psychosis, or those who have recently received psychotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new, effective treatment option for individuals struggling with insomnia.
How similar studies have performed: While ACT has been explored in various contexts, this specific application for insomnia is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam, Noord-Holland
- University of Amsterdam — Amsterdam, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Looman I Mathilde, MSc — University of Amsterdam
- Study coordinator: Mathilde I Looman, MSc
- Email: m.i.looman@uva.nl
- Phone: (0)20 525 6810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.