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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Comorbidities and Coexisting Conditions
• Intervention / Treatment: Behavioral: Paradoxical Intention

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annika Norell; Phone Number: +4619302259; Email: Annika.Norell@oru.se
• Study Contact Backup: Name: Osame Salim; Phone Number: +4619302259; Email: osame.salim@oru.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet
    • Contact: Christina Sandlund; Email: Christina.Sandlund@ki.se
  • Stockholm, Sweden
    • Karolinska Institute
    • Contact: Markus Jansson-Fröjmark; Email: markus.jansson-frojmark@ki.se
  • Örebro Län
    • Örebro, Örebro Län, Sweden
      • Örebro University
      • Contact: Osame Salim; Phone Number: +4619302259; Email: osame.salim@oru.se
      • Contact: Annika Norell; Email: Annika.Norell@oru.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention arm; Only one arm, all participants are given the treatment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Client Satisfaction Questionnaire (CSQ)	Measure of satisfaction of treatment.	One assessment at week 4 of treatment program following the fourth and final module.
Credibility/Expectancy Questionnaire (CEQ)	Credibility and expectancy measure for participant to answer	Once at week 1 of treatment (immediately following module 1)
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)

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: mechanisms; Insomnia disorder; mixed-methods; paradoxical intention; sleep performance anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2023-06594-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No