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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 4-weeks post-randomization |
| Insomnia severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Looman I Mathilde, MSc | University of Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Amsterdam | Amsterdam | North Holland | 1018 WS | Netherlands |
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| Label | URL |
|---|---|
| Analysis plan for network intervention analysis (NIA), registered on OSF on the 13th of April. | View source |
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Data will be made available upon requests.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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 3-month follow-up (ACT-I group only) |
| 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 6-month follow-up (ACT-I group only) |
| General well-being | 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. | Change from baseline to 4-weeks post-randomization |
| General well-being | 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. | Change from baseline to 8-weeks post-randomization |
| General well-being | 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. | Change from baseline to 3-month follow-up (ACT-I group only) |
| General well-being | 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. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Sleep-related quality of life | 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. | Change from baseline to 4-weeks post-randomization |
| Sleep-related quality of life | 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. | Change from baseline to 8-weeks post-randomization |
| Sleep-related quality of life | 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. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Sleep-related quality of life | 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. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Anxiety symptoms | 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. | Change from baseline to 4-weeks post-randomization |
| Anxiety symptoms | 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. | Change from baseline to 8-weeks post-randomization |
| Anxiety symptoms | 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. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Anxiety symptoms | 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. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Depression symptoms | 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. | Change from baseline to 4-weeks post-randomization |
| Depression symptoms | 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. | Change from baseline to 8-weeks post-randomization |
| Depression symptoms | 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. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Depression symptoms | 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. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Sleep diary: total sleep time | Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time. | Change from baseline to 4-weeks post-randomization |
| Sleep diary: total sleep time | Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time. | Change from baseline to 8-weeks post-randomization |
| Sleep diary: total sleep time | Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Sleep diary: total sleep time | Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Sleep diary: sleep onset latency | Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency. | Change from baseline to 4-weeks post-randomization |
| Sleep diary: sleep onset latency | Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency. | Change from baseline to 8-weeks post-randomization |
| Sleep diary: sleep onset latency | Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Sleep diary: sleep onset latency | Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Sleep diary: wake after sleep onset | Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset. | Change from baseline to 4-weeks post-randomization |
| Sleep diary: wake after sleep onset | Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset. | Change from baseline to 8-weeks post-randomization |
| Sleep diary: wake after sleep onset | Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Sleep diary: wake after sleep onset | Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Sleep diary: sleep efficiency | 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. | Change from baseline to 4-weeks post-randomization |
| Sleep diary: sleep efficiency | 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. | Change from baseline to 8-weeks post-randomization |
| Sleep diary: sleep efficiency | 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. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Sleep diary: sleep efficiency | 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. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Psychological flexibility | 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. | Change from baseline to 4-weeks post-randomization |
| Psychological flexibility | 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. | Change from baseline to 8-weeks post-randomization |
| Psychological flexibility | 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. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Psychological flexibility | 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. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Psychological inflexibility | 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. | Change from baseline to 4-weeks post-randomization |
| Psychological inflexibility | 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. | Change from baseline to 8-weeks post-randomization |
| Psychological inflexibility | 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. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Psychological inflexibility | 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. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Sleep-related arousal | 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. | Change from baseline to 4-weeks post-randomization |
| Sleep-related arousal | 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. | Change from baseline to 8-weeks post-randomization |
| Sleep-related arousal | 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. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Sleep-related arousal | 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. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Dysfunctional sleep-related cognitions | 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. | Change from baseline to 4-weeks post-randomization |
| Dysfunctional sleep-related cognitions | 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. | Change from baseline to 8-weeks post-randomization |
| Dysfunctional sleep-related cognitions | 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. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Dysfunctional sleep-related cognitions | 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. | Change from baseline to 6-month follow-up (ACT-I group only) |
| Sleep-related safety behaviors | 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. | Change from baseline to 4-weeks post-randomization |
| Sleep-related safety behaviors | 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. | Change from baseline to 8-weeks post-randomization |
| Sleep-related safety behaviors | 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. | Change from baseline to 3-month follow-up (ACT-I group only) |
| Sleep-related safety behaviors | 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. | Change from baseline to 6-month follow-up (ACT-I group only) |
| D001523 |
| Mental Disorders |