A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorÖrebro University, Sweden
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Paradoxical Intention
BehavioralParadoxical 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
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Intervention armOther 1 intervention
Trial outcomes
Primary outcomes
1
Insomnia Severity Index (ISI)
Measure of severity of insomnia
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 completionSecondary outcomes
1
Sleep diary
Idiographic 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 completion2
Work and Social Adjustment Scale (WSAS)
Measure of functional impairment
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 completion3
Depression Anxiety Stress Scales (DASS)
Measure of depressive anxiety symptoms
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 completion4
Brunnsviken Brief Quality of Life Scale (BBQ
Measure of quality of life.
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 completionOther outcomes
1
Sleep Anxiety Scale (SAS)
Measure of anticipatory anxiety before bedtime
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 completion2
Glasgow Sleep Effort Scale (GSES)
Measure of sleep effort exerted.
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 completion3
Metacognitions Questionnaire - Insomnia (MCQ-I)
Measure of metacognitions around sleep.
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 completion4
Sleep Problem Acceptance Questionnaire (SPAQ)
Measure of acceptance of sleep issues
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 completionSponsors and contacts
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Örebro University, Sweden
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: