Insomnia
Conditions
Keywords
Acceptance and Commitment Therapy, ACT-I, stand-alone, efficacy, mechanisms, randomized controlled trial
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?
Interventions
BEHAVIORALAcceptance 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).
Sponsors
University of Amsterdam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Insomnia severity | Change from baseline to 4-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. |
| General well-being | Change from baseline to 4-weeks post-randomization | 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 4-weeks post-randomization | 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 4-weeks post-randomization | 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. |
| Depression symptoms | Change from baseline to 4-weeks post-randomization | 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. |
| Sleep diary: total sleep time | Change from baseline to 4-weeks post-randomization | 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 4-weeks post-randomization | Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency. |
| Sleep diary: wake after sleep onset | Change from baseline to 4-weeks post-randomization | Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset. |
| Sleep diary: sleep efficiency | Change from baseline to 4-weeks post-randomization | 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. |
| Psychological flexibility | Change from baseline to 4-weeks post-randomization | 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 4-weeks post-randomization | 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 4-weeks post-randomization | 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 4-weeks post-randomization | 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 4-weeks post-randomization | 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. |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORLooman I Mathilde, MSc
University of Amsterdam
Outcome results
None listed