Acceptance and Commitment Therapy for Insomnia
- Conditions
- Insomnia
- Interventions
- Behavioral: Acceptance and Commitment Therapy for insomnia (ACT-I)
- Registration Number
- NCT06336551
- Lead Sponsor
- University of Amsterdam
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acceptance and Commitment Therapy for insomnia (ACT-I) 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.
- Primary Outcome Measures
Name Time Method Insomnia severity Change from baseline to 8-weeks post-randomization 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.
- Secondary Outcome Measures
Name Time Method Depression symptoms Change from baseline to 6-month follow-up (ACT-I group only) Depression symptoms are assessed with the Patient Health Questionnaire depression scale (PHQ-9), a nine-item questionnaire scored on a 4-point scale (range: 0-36). Higher scores indicate more depression symptoms.
Insomnia severity Change from baseline to 6-month follow-up (ACT-I group only) 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.
Sleep diary: total sleep time Change from baseline to 6-month follow-up (ACT-I group only) Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time.
Sleep diary: sleep onset latency Change from baseline to 6-month follow-up (ACT-I group only) Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency.
General well-being Change from baseline to 6-month follow-up (ACT-I group only) General well-being is assessed with the Mental Health Continuum Short Form (MHC-SF), which includes 14 items rated on a 6-point scale (range: 0-70). Higher scores indicate greater well-being.
Sleep-related quality of life Change from baseline to 6-month follow-up (ACT-I group only) Sleep-related quality of life is evaluated using the Glasgow Sleep Impact Index (GSII). Respondents define and rate their three main domains of sleep-related impairment on a Visual Analog Scale (range: 0-100). Higher scores indicate more sleep-related impairment.
Anxiety symptoms Change from baseline to 6-month follow-up (ACT-I group only) Anxiety symptoms are assessed with the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A), featuring seven items rated on a 4-point scale (range: 0-21). Higher scores indicate more anxiety symptoms.
Sleep diary: wake after sleep onset Change from baseline to 6-month follow-up (ACT-I group only) Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset.
Psychological flexibility Change from baseline to 6-month follow-up (ACT-I group only) Psychological flexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological flexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological flexibility.
Psychological inflexibility Change from baseline to 6-month follow-up (ACT-I group only) Psychological inflexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological inflexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological inflexibility.
Sleep-related arousal Change from baseline to 6-month follow-up (ACT-I group only) Sleep-related arousal will be assessed with the Pre-Sleep Arousal Scale (PSAS), which comprises 16 items scored on a 5-point scale (range: 16-80). Higher scores indicate higher sleep-related arousal.
Dysfunctional sleep-related cognitions Change from baseline to 6-month follow-up (ACT-I group only) Dysfunctional sleep-related cognitions will be evaluated by the short form of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), which includes 16 items scored on an 11-point agreement scale (range: 0-160). Higher scores indicate more dysfunctional sleep-related cognitions.
Sleep-related safety behaviors Change from baseline to 6-month follow-up (ACT-I group only) Sleep-related safety behaviors will be measured with the sleep-related behaviors questionnaire short form (SRBQ-20), which consists of 20 items on coping with fatigue or improving sleep, scored on a 5-point scale (range: 0-80), with higher scores indicating more sleep-related safety behavior.
Sleep diary: sleep efficiency Change from baseline to 6-month follow-up (ACT-I group only) Sleep efficiency (in percentage) is assessed with the consensus sleep diary (CSD), calculated as the total sleep time\*100 divided by the time in bed. Higher scores indicate higher sleep efficiency.
Trial Locations
- Locations (1)
University of Amsterdam
🇳🇱Amsterdam, Noord-Holland, Netherlands