Clinical trial NCT06259682: A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia.
Official title: A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia. Assessing Acceptability, Feasibility and Preliminary Effectiveness.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Comorbidities and Coexisting Conditions
Keywords: Insomnia disorder
mechanisms
mixed-methods
paradoxical intention
sleep performance anxiety
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2024-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled pilot study using mixed methods investigation.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 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:
measure: Sleep diary
timeFrame: 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: Work and Social Adjustment Scale (WSAS)
timeFrame: 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: Depression Anxiety Stress Scales (DASS)
timeFrame: 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: Brunnsviken Brief Quality of Life Scale (BBQ
timeFrame: 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:
measure: Sleep Anxiety Scale (SAS)
timeFrame: 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: Glasgow Sleep Effort Scale (GSES)
timeFrame: 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: Metacognitions Questionnaire - Insomnia (MCQ-I)
timeFrame: 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: Sleep Problem Acceptance Questionnaire (SPAQ)
timeFrame: 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: Client Satisfaction Questionnaire (CSQ)
timeFrame: One assessment at week 4 of treatment program following the fourth and final module.
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Once at week 1 of treatment (immediately following module 1)
measure: Negative effects Questionnaire (NEQ)
timeFrame: Once at week 4 of treatment (immediately following fourth and final module)
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
city: Stockholm
country: Sweden
facility: Karolinska Institute
city: Örebro
country: Sweden
facility: Örebro University
state: Örebro Län
Study officials:
References: