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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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The investigators aim to test the preliminary efficacy as well as the acceptability and feasibility of paradoxical intention, which is a psychotherapeutic technique, for improving insomnia symptoms in adults. Previous research has tested this technique for insomnia and found overall positive results. However, during the last decades very few studies have examined paradoxical intention. Therefore the investigators wish to conduct a pilot study examining the effects in a modern context.
In the 1970s, Ascher and Efran developed paradoxical intention (PI), instructing sleep onset insomnia patients to stay awake instead of trying to sleep. The American Academy of Sleep Medicine confirmed PI's effectiveness. However, between 2006-2018, PI use in clinical practice declined.
The study will investigate PI's acceptability, mechanisms, and predictors for effectiveness. It involves a pilot trial with 40 insomnia patients in Sweden, recruited through advertisements and screened through web questionnaires, phone interviews, and sleep diaries. Criteria are based on insomnia research standards and Diagnostic and Statistical Manual Fifth Edition (DSM-5), including insomnia with common comorbidities.
Participants will undergo baseline assessments, then receive four weekly online PI modules, including educational texts, behavioral experiments, and homework. Weekly therapist meetings via phone or video will support and troubleshoot issues.
Post-treatment, 10-15 participants will be randomly selected for qualitative interviews to evaluate their experiences with PI, focusing on sleep patterns, text volume, therapist support, and homework's impact on sleep quality and treatment adherence. Interviews will be audio-recorded and analyzed thematically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Other | Only one arm, all participants are given the treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paradoxical Intention | Behavioral | Paradoxical intention (PI). PI is described as instructing patients with sleep onset insomnia to try to remain awake for as long as possible rather than to focus on trying to fall asleep |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | Measure of severity of insomnia | Baseline (Week 0). Weekly assessments every week for four weeks, with a final assessment following the fourth and final module (total duration of 4 weeks). Follow-up assessment at 12 weeks post-treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep diary | Idiographic sleep diary | Baseline (Week 0). One assessment at week 2 of treatment program following second module and one at week 4 following the fourth and final module. Follow-up assessment at 12 weeks post-treatment completion |
| Work and Social Adjustment Scale (WSAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Anxiety Scale (SAS) | Measure of anticipatory anxiety before bedtime | Baseline (Week 0). One assessment at week 2 of treatment program following second module and one at week 4 following the fourth and final module. Follow-up assessment at 12 weeks post-treatment completion |
| Glasgow Sleep Effort Scale (GSES) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annika Norell | Contact | +4619302259 | Annika.Norell@oru.se | |
| Osame Salim | Contact | +4619302259 | osame.salim@oru.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39389596 | Derived | Salim O, Jansson-Frojmark M, Sandlund C, Norell A. Paradoxical intention as a treatment for insomnia disorder: study protocol for a mixed-methods pilot trial. BMJ Open. 2024 Oct 10;14(10):e086676. doi: 10.1136/bmjopen-2024-086676. |
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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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Uncontrolled pilot study using mixed methods investigation.
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Measure of functional impairment |
| Baseline (Week 0). One assessment at week 4 of treatment program following the completion of the fourth and final module. Follow-up assessment at 12 weeks post-treatment completion |
| Depression Anxiety Stress Scales (DASS) | Measure of depressive anxiety symptoms | Baseline (Week 0). One assessment at week 2 of treatment program following second module and one at week 4 following the fourth and final module. Follow-up assessment at 12 weeks post-treatment completion |
| Brunnsviken Brief Quality of Life Scale (BBQ | Measure of quality of life. | Baseline (Week 0). One assessment at week 4 of treatment program following the fourth and final module. Follow-up assessment at 12 weeks post-treatment completion |
Measure of sleep effort exerted. |
| Baseline (Week 0). One assessment at week 2 of treatment program following second module and one at week 4 following the fourth and final module. Follow-up assessment at 12 weeks post-treatment completion |
| Metacognitions Questionnaire - Insomnia (MCQ-I) | Measure of metacognitions around sleep. | Baseline (Week 0). One assessment at week 2 of treatment program following second module and one at week 4 following the fourth and final module. Follow-up assessment at 12 weeks post-treatment completion |
| Sleep Problem Acceptance Questionnaire (SPAQ) | Measure of acceptance of sleep issues | Baseline (Week 0). One assessment at week 2 of treatment program following second module and one at week 4 following the fourth and final module. Follow-up assessment at 12 weeks post-treatment completion |
| Client Satisfaction Questionnaire (CSQ) | Measure of satisfaction of treatment. | One assessment at week 4 of treatment program following the fourth and final module. |
| Credibility/Expectancy Questionnaire (CEQ) | Credibility and expectancy measure for participant to answer | Once at week 1 of treatment (immediately following module 1) |
| Negative effects Questionnaire (NEQ) | Measure of clients experience of negative effects during therapy | Once at week 4 of treatment (immediately following fourth and final module) |
| Karolinska Institute | Stockholm | Sweden |
|
| Örebro University | Örebro | Örebro County | Sweden |
|
| D001523 |
| Mental Disorders |