A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia.

Insomnia Clinical Trial

Official title:

A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia. Assessing Acceptability, Feasibility and Preliminary Effectiveness.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06259682
• Other study ID #: 2023-06594-01
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

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