Comorbidities and Coexisting Conditions, Insomnia
Conditions
Keywords
Insomnia disorder, mechanisms, mixed-methods, paradoxical intention, sleep performance anxiety
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALParadoxical Intention
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
Sponsors
Karolinska Institutet
Örebro University, Sweden
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Uncontrolled pilot study using mixed methods investigation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing three screening phases: a web-based questionnaire, a telephone interview with a structured assessment, and a 7-day sleep diary completion. * Screening resulting in diagnosis of insomnia, including co-morbid insomnia. * Participant should fulfill the following DSM-5 criteria. (1)Difficulty in sleep Initiation, maintenance, or early morning awakening. (2)Frequency and duration of at least three nights per week and has been present for at least three months.(3) Problems persist despite candidates having had adequate opportunity and circumstances for sleep. (4) The sleep disturbance causes significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. * Age above 18 and Swedish resident and language proficient.
Exclusion criteria
* Severe depressive episode with suicidal intentions or actions * Current or past diagnosis of psychotic or bipolar disorders * Current substance use disorder * Recent changes in psychopharmacotherapy (within the last three months) or use of as-needed hypnotic medications during the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 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 of severity of insomnia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Idiographic sleep diary |
| Work and Social Adjustment Scale (WSAS) | 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 | Measure of functional impairment |
| Depression Anxiety Stress Scales (DASS) | 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 | Measure of depressive anxiety symptoms |
| Brunnsviken Brief Quality of Life Scale (BBQ | 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 quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Credibility/Expectancy Questionnaire (CEQ) | Once at week 1 of treatment (immediately following module 1) | Credibility and expectancy measure for participant to answer |
| Sleep Anxiety Scale (SAS) | 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 | Measure of anticipatory anxiety before bedtime |
| Negative effects Questionnaire (NEQ) | Once at week 4 of treatment (immediately following fourth and final module) | Measure of clients experience of negative effects during therapy |
| Glasgow Sleep Effort Scale (GSES) | 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 | Measure of sleep effort exerted. |
| Metacognitions Questionnaire - Insomnia (MCQ-I) | 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 | Measure of metacognitions around sleep. |
| Sleep Problem Acceptance Questionnaire (SPAQ) | 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 | Measure of acceptance of sleep issues |
| Client Satisfaction Questionnaire (CSQ) | One assessment at week 4 of treatment program following the fourth and final module. | Measure of satisfaction of treatment. |
Countries
Sweden
Contacts
Primary ContactAnnika Norell
Backup ContactOsame Salim
Outcome results
None listed