Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351839
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-02-29
Brief Title:
Sleep Well Despite Persistent Pain Symptoms
Sponsor:
University of Tromso
Organization:
University of Tromso
Study Overview
Official Title:
Metacognitive Behavioral Therapy Integrated in Sleep Treatment for Comorbid Insomnia in Patients With Persistent Pain A Randomized Controlled Semi-Crossover Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sleep-Well
Brief Summary:
Background The prevalence of comorbid insomnia is 8-10 times higher in patients with chronic pain than in the general population Insomnia adds a considerable burden as it worsens the quality of life restoration and repair mental health and pain symptoms Since pain and sleep problems are mutually reinforcing improvements in sleep may have beneficial effects on pain Unfortunately the customary use of sleep medication TAU treatment-as-usual often yields short-lived plus side effects The Sleep-Well intervention examines if a group-based intervention program focusing on sleep literacy sleep restriction stimulus control and metacognitive therapy modules may perform better than TAU in improving patients insomnia and sleep quality
Eligible patients Investigators target adult patients referred to the University Hospital of North Norway Tromsø for a diagnostic evaluation of their pain condition Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder Patients are not eligible if they use drugs or large doses of morphine 100 equivalents are engaged in an insurance case due to their diagnosis or participate in other ongoing group programs at the hospital
Aims This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients TAU The primary outcome measures are reductions in diagnostic criteria for insomnia self-reported insomnia symptoms quality of life and actigraphy-measured insomnia indicators long sleep onset latency frequent nightly awakenings and early morning awakening The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve In addition it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints dysfunctional sleep and pain cognitions anxiety and depression
The intervention The Sleep-Well program schedules group sessions that cover four topics sleep literacy behavioural and mental strategies maintenance and relapse prevention All sessions are led by two therapists Those randomized to the active control group TAU cross over to the Sleep-Well intervention three months later
Eligible patients Investigators target adult patients referred to the University Hospital of North Norway Tromsø for a diagnostic evaluation of their pain condition Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder Patients are not eligible if they use drugs or large doses of morphine 100 equivalents are engaged in an insurance case due to their diagnosis or participate in other ongoing group programs at the hospital
Aims This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients TAU The primary outcome measures are reductions in diagnostic criteria for insomnia self-reported insomnia symptoms quality of life and actigraphy-measured insomnia indicators long sleep onset latency frequent nightly awakenings and early morning awakening The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve In addition it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints dysfunctional sleep and pain cognitions anxiety and depression
The intervention The Sleep-Well program schedules group sessions that cover four topics sleep literacy behavioural and mental strategies maintenance and relapse prevention All sessions are led by two therapists Those randomized to the active control group TAU cross over to the Sleep-Well intervention three months later
Detailed Description:
Background Insomnia is 8-10 times more prevalent among patients with chronic pain than in the general population The disrupted sleep restoration caused by insomnia can be exhausting for the patient as insomnia also impairs pain inhibition Sleep medications often yield short-lived clinical responses and further introduce risks of hangover tolerance and even addiction Psychological sleep treatment is thus clearly preferable given sufficient effect
Cognitive Behavioral Therapy is the recommended first-line treatment of insomnia CBT-i Psychological interventions are also recognized in the treatment and follow-up of chronic pain However the evidence of psychological treatment of comorbid insomnia in patients with chronic pain is very limited although some few results are promising
Insomnia is the most common sleep disorder and involves nocturnal symptoms eg long sleep onset latency nightly awakenings and early morning awakening and daytime problems eg fatigue mood swings concentration difficulties impaired function at work school or in social life Acute insomnia symptoms triggered by adverse life events or acute illnesses are normal whereas the transition to chronic insomnia is not Chronic pain is a chronic stressor and may act both as a precipitating and perpetuating factor for insomnia generating high levels of stress-activating hormones
Rumination on the causes of pain is frequently observed in chronic pain often combined with a cognitive inclination towards catastrophizing ie repetitive intrusive and difficult-to-ignore thoughts Meta-cognitions such as rumination and catastrophizing may perpetuate insomnia by maintaining a high level of sleep-disruptive psychophysiological arousal and loss of deep sleep Affective and anxiety disorders are other frequent comorbidities of chronic pain that may further aggravate the effects of rumination and catastrophizing on both sleep and pain
Meta-Cognitive Therapy MCT has well-documented effects on depression and anxiety disorders Studies of MCT in insomnia are limited which is unfortunate as it seems to modulate symptoms substantially across multiple health conditions The advantage of MCT is the focus on how one relates to evaluates monitors or reacts emotionally to internal thoughts rather than their specific content or experienced truth as in CBT Change in dysfunctional cognitions about sleep is a central element of CBT-i The strong association between insomnia and sleep-related metacognitions thought patterns rather than negative sleep-related cognitions thought content suggests that psychological treatment of insomnia should include MCT
The sleep intervention for the present intervention study hereafter Sleep-Well applies a modified version of a Norwegian CBT-i manual by the Diakonhjemmet hospital in Oslo integrating elements of MCT Sleep-Well is group-based and covers four modules ie 1 introduction information about sleep physiology causes of sleep problems sleep hygiene and the use of sleep diaries 2 behavioral strategies concerns stimulus control and sleep restriction 3 cognitive strategies represent a CBTMCT part focusing on sleep-disturbing cognitions and metacognition common to pain and sleep and 4 maintenance and prevention of relapse
Hypotheses This trial examines if the Sleep-Well intervention performs better than the treatment as usual TAU group ie rudimentary sleep evaluation and education plus sleep medication on indication in terms of statistically significant improvements in
1 primary hypotheses self-reported insomnia symptoms diagnostic criteria for insomnia health-related quality of life and actigraphy recorded indicators of insomnia ie SOL-sleep onset latency WASO-wakeup after sleep onset EMA-early morning awakening and SE-sleep efficiency
2 secondary hypotheses self-reported symptoms of fatigue symptoms of anxiety and depression pain-symptoms related to acceptance intensity and interference and need for sleep medication In addition improvements in objective sleep recordings the Home Sleep Test related to the proportion and duration of slow-wave sleep periods and sleep disturbance as indicated by the EEG-based arousal-index
In addition this trial explores
whether mediator variables as described in the Measurement Outcomes section under other variables may identify treatment mechanisms related to the Sleep-Well program
through qualitative interviews participants perceived feasibility and acceptability of Sleep-Well and if qualitative contrasts are present between those benefitting well versus poorly with regard to primary insomnia symptoms
Study design and procedures This study uses a randomized semi-crossover design Participants are randomized to the Sleep-Well or the active treatment-as-usual TAU comparator condition receiving standard sleep treatment at the hospital or their general practitioner Participants are block randomized block size 4 to maintain equal treatment and TAU group sizes After three months of waiting time the TAU participants cross over to the Sleep-Well group
The outcome measurements are registered at baseline before the randomization and after finishing the Sleep-Well intervention posttest 3 months In addition we conduct two follow-ups at three and 12 months to examine relapse The TAU group carries out two pre-tests before randomization and before initiation of Sleep-Well to control for sleep function changes during the waiting period
Statistical power and analyses Power calculation A meta-analysis of comparable somatic diagnoses 5 studies indicated a standardized mean difference Cohens d between intervention and control ranging between 060-080 Tang et al 2015 With randomization done on an individual level a correlation 05 between pre- and post-test R-sq25 alpha 005 power 080 and minimum Cohens d 060 at least N 68 patients are required to reject the null hypothesis With an estimate of ICC intra-class correlation 05 adjustment for similarities that occur between patients due to sharing of a treatment group cluster size6 which yields a design effect of 125 16-1ICC at least N 85 participants are needed By adding a safety margin of 20 dropout the final sample estimate is N 106 patients
Statistical analyses Generalized linear mixed models GenLinMixed are used as a general rule due to great flexibility in handling both continuous binary and count-based outcome variables and estimation of random effects for adjustment purposes due to dependency in the outcome measures at different levels eg repeated data treatment group clusters The analyses are carried out conservatively as intention-to-treat Alpha 05 and 01 are assumed for the hypotheses about primary sleep treatment outcomes insomnia sleep quality and secondaryexploratory treatment effects affective health fatigue quality of life and moderatorsmediators respectively
Qualitative analyses The transcribed semi-structured interview data will be analyzed using the reflexive thematic analysis methodology which across five steps seeks to identify the number of overall conceptual dimensions that meaningfully account for all the interview texts The Consolidated Criteria for Reporting Qualitative Research will be applied
Interaction with user representatives The project has included two user representatives with first-hand experiences with chronic pain They actively participate in multiple parts of the research process and are particularly consulted in questions related to relevance eg regarding questionnaires and the content of Sleep-Well the process of implementing the Sleep-Well intervention and on issues related to avoiding over-burdening the participants
Ethics The Sleep-Well study has been approved by the Regional Committee for Medical and Health Research Ethics CaseID 500457 The project is assessed by the Center for Information Security and Privacy in Research SIKT and the Privacy Commissioner at UiT The Arctic University of Norway regarding Data Protection Impact Assessment DPIA Initiation of the study will be pending upon approval by all parties
Cognitive Behavioral Therapy is the recommended first-line treatment of insomnia CBT-i Psychological interventions are also recognized in the treatment and follow-up of chronic pain However the evidence of psychological treatment of comorbid insomnia in patients with chronic pain is very limited although some few results are promising
Insomnia is the most common sleep disorder and involves nocturnal symptoms eg long sleep onset latency nightly awakenings and early morning awakening and daytime problems eg fatigue mood swings concentration difficulties impaired function at work school or in social life Acute insomnia symptoms triggered by adverse life events or acute illnesses are normal whereas the transition to chronic insomnia is not Chronic pain is a chronic stressor and may act both as a precipitating and perpetuating factor for insomnia generating high levels of stress-activating hormones
Rumination on the causes of pain is frequently observed in chronic pain often combined with a cognitive inclination towards catastrophizing ie repetitive intrusive and difficult-to-ignore thoughts Meta-cognitions such as rumination and catastrophizing may perpetuate insomnia by maintaining a high level of sleep-disruptive psychophysiological arousal and loss of deep sleep Affective and anxiety disorders are other frequent comorbidities of chronic pain that may further aggravate the effects of rumination and catastrophizing on both sleep and pain
Meta-Cognitive Therapy MCT has well-documented effects on depression and anxiety disorders Studies of MCT in insomnia are limited which is unfortunate as it seems to modulate symptoms substantially across multiple health conditions The advantage of MCT is the focus on how one relates to evaluates monitors or reacts emotionally to internal thoughts rather than their specific content or experienced truth as in CBT Change in dysfunctional cognitions about sleep is a central element of CBT-i The strong association between insomnia and sleep-related metacognitions thought patterns rather than negative sleep-related cognitions thought content suggests that psychological treatment of insomnia should include MCT
The sleep intervention for the present intervention study hereafter Sleep-Well applies a modified version of a Norwegian CBT-i manual by the Diakonhjemmet hospital in Oslo integrating elements of MCT Sleep-Well is group-based and covers four modules ie 1 introduction information about sleep physiology causes of sleep problems sleep hygiene and the use of sleep diaries 2 behavioral strategies concerns stimulus control and sleep restriction 3 cognitive strategies represent a CBTMCT part focusing on sleep-disturbing cognitions and metacognition common to pain and sleep and 4 maintenance and prevention of relapse
Hypotheses This trial examines if the Sleep-Well intervention performs better than the treatment as usual TAU group ie rudimentary sleep evaluation and education plus sleep medication on indication in terms of statistically significant improvements in
1 primary hypotheses self-reported insomnia symptoms diagnostic criteria for insomnia health-related quality of life and actigraphy recorded indicators of insomnia ie SOL-sleep onset latency WASO-wakeup after sleep onset EMA-early morning awakening and SE-sleep efficiency
2 secondary hypotheses self-reported symptoms of fatigue symptoms of anxiety and depression pain-symptoms related to acceptance intensity and interference and need for sleep medication In addition improvements in objective sleep recordings the Home Sleep Test related to the proportion and duration of slow-wave sleep periods and sleep disturbance as indicated by the EEG-based arousal-index
In addition this trial explores
whether mediator variables as described in the Measurement Outcomes section under other variables may identify treatment mechanisms related to the Sleep-Well program
through qualitative interviews participants perceived feasibility and acceptability of Sleep-Well and if qualitative contrasts are present between those benefitting well versus poorly with regard to primary insomnia symptoms
Study design and procedures This study uses a randomized semi-crossover design Participants are randomized to the Sleep-Well or the active treatment-as-usual TAU comparator condition receiving standard sleep treatment at the hospital or their general practitioner Participants are block randomized block size 4 to maintain equal treatment and TAU group sizes After three months of waiting time the TAU participants cross over to the Sleep-Well group
The outcome measurements are registered at baseline before the randomization and after finishing the Sleep-Well intervention posttest 3 months In addition we conduct two follow-ups at three and 12 months to examine relapse The TAU group carries out two pre-tests before randomization and before initiation of Sleep-Well to control for sleep function changes during the waiting period
Statistical power and analyses Power calculation A meta-analysis of comparable somatic diagnoses 5 studies indicated a standardized mean difference Cohens d between intervention and control ranging between 060-080 Tang et al 2015 With randomization done on an individual level a correlation 05 between pre- and post-test R-sq25 alpha 005 power 080 and minimum Cohens d 060 at least N 68 patients are required to reject the null hypothesis With an estimate of ICC intra-class correlation 05 adjustment for similarities that occur between patients due to sharing of a treatment group cluster size6 which yields a design effect of 125 16-1ICC at least N 85 participants are needed By adding a safety margin of 20 dropout the final sample estimate is N 106 patients
Statistical analyses Generalized linear mixed models GenLinMixed are used as a general rule due to great flexibility in handling both continuous binary and count-based outcome variables and estimation of random effects for adjustment purposes due to dependency in the outcome measures at different levels eg repeated data treatment group clusters The analyses are carried out conservatively as intention-to-treat Alpha 05 and 01 are assumed for the hypotheses about primary sleep treatment outcomes insomnia sleep quality and secondaryexploratory treatment effects affective health fatigue quality of life and moderatorsmediators respectively
Qualitative analyses The transcribed semi-structured interview data will be analyzed using the reflexive thematic analysis methodology which across five steps seeks to identify the number of overall conceptual dimensions that meaningfully account for all the interview texts The Consolidated Criteria for Reporting Qualitative Research will be applied
Interaction with user representatives The project has included two user representatives with first-hand experiences with chronic pain They actively participate in multiple parts of the research process and are particularly consulted in questions related to relevance eg regarding questionnaires and the content of Sleep-Well the process of implementing the Sleep-Well intervention and on issues related to avoiding over-burdening the participants
Ethics The Sleep-Well study has been approved by the Regional Committee for Medical and Health Research Ethics CaseID 500457 The project is assessed by the Center for Information Security and Privacy in Research SIKT and the Privacy Commissioner at UiT The Arctic University of Norway regarding Data Protection Impact Assessment DPIA Initiation of the study will be pending upon approval by all parties
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None