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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neurobehavioral Effects of Partial Sleep Deprivation

NCT02128737

Control 1 Night Recovery Sleep 3 Nights Recovery Sleep +1 more

COMPLETED NA

Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production

NCT03883724

Sleep Fragmentation Poor Quality Sleep Nocturia +1 more

COMPLETED NA

Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans

NCT02027558

Insomnia Apnea

COMPLETED NA

Improving Sleep Using Mentored Behavioral and Environmental Restructuring

NCT03327324

Insomnia

COMPLETED NA

Pain Sensitization and Habituation in a Model of Experimentally-induced Insomnia Symptoms

NCT02484742

Sleep Control Condition Insomnia Symptoms Induction Condition

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insomnia Comorbidities and Coexisting Conditions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Uncontrolled pilot study using mixed methods investigation.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm

Only one arm, all participants are given the treatment

Group Type OTHER

Paradoxical Intention

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No