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

NCT06259682 | Not Yet Recruiting

• 1 other identifier: 2023-06594-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Insomnia; Comorbidities and Coexisting Conditions

Keywords

Insomnia disorder; mechanisms; mixed-methods; paradoxical intention; sleep performance anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

  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)

  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

  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 Outcomes (7)

• Sleep Anxiety Scale (SAS)

  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)

  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)

  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

Study Arms (1)

Intervention arm

OTHER

Only one arm, all participants are given the treatment

Behavioral: Paradoxical Intention

Interventions

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

Intervention arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Karolinska Institutet: collaborator

Study Sites (3)

Karolinska Institutet

Stockholm, Sweden

Location

Karolinska Institute

Stockholm, Sweden

Location

Örebro University

Örebro, Örebro County, Sweden

Location

Related Publications (1)

• Salim O, Jansson-Frojmark M, Sandlund C, Norell A. Paradoxical intention as a treatment for insomnia disorder: study protocol for a mixed-methods pilot trial. BMJ Open. 2024 Oct 10;14(10):e086676. doi: 10.1136/bmjopen-2024-086676.

  PMID: 39389596 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Annika Norell

CONTACT

+4619302259; Annika.Norell@oru.se

Osame Salim

CONTACT

+4619302259; osame.salim@oru.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Uncontrolled pilot study using mixed methods investigation.

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 14, 2024
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)