Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06259682

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Insomnia Comorbidities and Coexisting Conditions Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University, Örebro, Örebro County, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 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 outcomes

  1. Sleep diary

    Time frame: 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

  2. Work and Social Adjustment Scale (WSAS)

    Time frame: 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

  3. Depression Anxiety Stress Scales (DASS)

    Time frame: 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

  4. Brunnsviken Brief Quality of Life Scale (BBQ

    Time frame: 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 outcomes

  1. Sleep Anxiety Scale (SAS)

    Time frame: 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

  2. Glasgow Sleep Effort Scale (GSES)

    Time frame: 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.

  3. Metacognitions Questionnaire - Insomnia (MCQ-I)

    Time frame: 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.

  4. Sleep Problem Acceptance Questionnaire (SPAQ)

    Time frame: 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

  5. Client Satisfaction Questionnaire (CSQ)

    Time frame: One assessment at week 4 of treatment program following the fourth and final module.

    Measure of satisfaction of treatment.

  6. Credibility/Expectancy Questionnaire (CEQ)

    Time frame: Once at week 1 of treatment (immediately following module 1)

    Credibility and expectancy measure for participant to answer

  7. Negative effects Questionnaire (NEQ)

    Time frame: Once at week 4 of treatment (immediately following fourth and final module)

    Measure of clients experience of negative effects during therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Annika Norell

CONTACT

[email protected]

+4619302259

Osame Salim

CONTACT

[email protected]

+4619302259

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.