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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06259682
Other study ID # 2023-06594-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date June 2025

Study information

Verified date March 2024
Source Örebro University, Sweden
Contact Annika Norell
Phone +4619302259
Email Annika.Norell@oru.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date June 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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: - Excludes candidates with bipolar or psychotic disorders. - Suicidal intentions or actions is an exclusion criteria and the applicant will be referred to appropriate services.. - Reports of current substance abuse - Recent changes in psychopharmacotherapy within the last three months.

Study Design


Related Conditions & MeSH terms

  • Comorbidities and Coexisting Conditions
  • Insomnia
  • Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
Paradoxical 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

Locations

Country Name City State
Sweden Örebro University Örebro Örebro Län
Sweden Karolinska Institute Stockholm
Sweden Karolinska Institutet Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Örebro University, Sweden Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other Glasgow Sleep Effort Scale (GSES) 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
Other 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
Other 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
Other Client Satisfaction Questionnaire (CSQ) Measure of satisfaction of treatment. One assessment at week 4 of treatment program following the fourth and final module.
Other Credibility/Expectancy Questionnaire (CEQ) Credibility and expectancy measure for participant to answer Once at week 1 of treatment (immediately following module 1)
Other 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)
Primary 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
Secondary 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
Secondary Work and Social Adjustment Scale (WSAS) 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
Secondary 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
Secondary 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
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