Telehealth delivery of adapted CBT-I for insomnia in chronic pain patients: a single arm feasibility study
Ontology highlight
ABSTRACT:
SUBMITTER: Zambelli Z
PROVIDER: S-EPMC10808483 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:ObjectivePeople commonly cope with chronic low back pain (cLBP) by ignoring and distraction. Can mindful interoceptive exposure to the pain sensation itself and its phenomenological components be an alternative approach?MethodsSingle-arm feasibility study in patients with cLBP using a 2-minute attention exercise guided by a smartphone app several times per day over 8 weeks. We assessed feasibility, pre/post pain, function, and psychological parameters using mixed methods: standard questionnaires, ecological momentary assessment, and exit interviews that included micro-phenomenology technique and subsequent reflexive thematic qualitative analysis.ResultsWe enrolled 31 participants, mostly female, mean age 48, the majority had pain for >5 years; 29 completed. Mean pain intensity [0-10] improved from 4.8 ±1.7 to 3.1 ±1.9 (p < .0001); mean PEG scores (intensity and interference with daily life; range 0-30) improved from 13.7 ±6.2 to 8.4 ±6.6 (p < .0001); pain impact (9 items incl physical function) 22.3 ±8.7 to 19.7 ±8.1 (p = .0010). Twenty-one of 29 improved PEG score ≥30%. There were significant improvements in PCS Rumination and MAIA Not-Worrying. Participants became aware of their usual habit of avoidance and the challenge of and resistance to focusing on pain. They were surprised how pain sensations varied over time, and that pain intensity and the threat value of pain could diminish by focusing on it. They described a variety of 3D pain shapes (e.g., football, pool ball, rod, nail, brick, stars) with a range of colors, transparency, temperature, and density that for some changed with mindful attention. Most struggled to find appropriate words for sensory awareness and attention regulation and found that the threat value of their pain diminished.ConclusionsMindful interoceptive exposure to the sensations of their cLBP using a 2-minute attention exercise with a phone app-rather than ignoring and distracting from it-may be a beneficial intervention for cLBP.Trial registrationClinicalTrials.gov #NCT06186193.
| S-EPMC11500934 | biostudies-literature
Project description:BackgroundA subgroup of adolescent and young adult (AYA) survivors of cancer during adolescence report high levels of psychological distress. To date, evidence-based psychological interventions tailored to the cancer-related concerns experienced by this population are lacking. The present study aimed to (1) examine the feasibility and preliminary efficacy of an individualized cognitive behavioral therapy (CBT) intervention for AYA survivors of cancer during adolescence; and (2) identify and conceptualize cancer-related concerns as well as maintaining factors using cognitive-behavioral theory.MethodsA single-arm trial, whereby AYA survivors of cancer during adolescence (aged 17-25 years) were provided individualized face-to-face CBT at a maximum of 15 sessions. Clinical outcomes were assessed at baseline, post-intervention, and three-month follow-up. Intervention uptake, retention, intervention delivery, and reliable change index scores were examined. An embedded qualitative study consisted of two unstructured interviews with each participant pre-intervention. Along with individual behavioral case formulations developed to guide the intervention, interview data was analyzed to identify and conceptualize cancer-related concerns and potential maintaining factors.ResultsTen out of 213 potential participants invited into the study were included, resulting in an overall participation rate of 4.7%. Nine participants completed the intervention, with respectively seven and eight participants completing the post-intervention and three month follow-up assessment. The majority of reported cancer-related concerns and maintaining factors were conceptualized into four themes: social avoidance, fear of emotions and bodily symptoms, imbalance in activity, and worry and rumination.ConclusionsGiven significant recruitment difficulties, further research is required to examine barriers to help-seeking in the AYA cancer survivor population. However, the conceptualization of cancer-related concerns and maintaining factors experienced by the population may represent an important first step in the development of psychological support tailored toward AYA cancer survivors' unique needs.
| S-EPMC7085902 | biostudies-literature
Project description: Not available
| S-EPMC9284679 | biostudies-literature
Project description:ObjectivesThis study evaluated the feasibility of exercising into pain in rotator cuff related shoulder pain (RCRSP), data collection procedures, feedback from physiotherapists and patients, and clinically important changes in patient-reported outcome measures (PROMs).DesignUnblinded non-randomised single-group study.SettingPhysiotherapy clinic in Belgium.ParticipantsTwelve patients with unilateral RCRSP for minimum 3 months, aged 18-65 years.InterventionsTwelve weeks of four individualised exercises, with nine physiotherapist-led sessions with pain ratings 4-7 out of 10 on a verbal Numeric Pain Rating Scale for 9 weeks and then pain ratings 0-2 for 3 weeks. Every physiotherapy session included 15 min of manual therapy. Non-supervised exercises were: 2×/week in weeks with physiotherapy session, 3×/week in weeks without physiotherapy session.Outcome measuresPrimary: adherence, where patients were considered adherent with 78% (7/9 sessions) attendance for supervised sessions and 81% (22/27 sessions) completion for non-supervised exercises, and Shoulder Pain and Disability Index (SPADI); secondary: fear-avoidance behaviour, fear of pain, physical outcomes (strength, range of motion, scapular dyskinesis); others: ultrasound (US) imaging outcomes (acromionhumeral distance, supraspinatus tendon thickness, occupation ratio), global perceived effect (GPE). PROMs were collected via online survey, except for the GPE (via closed envelope). US measures were taken after physical measures.ResultsAdherence and adverse effects were analysed in patients who had the possibility to attend minimum seven supervised sessions (n=8): 88% of them adhered to supervised sessions, 50% to non-supervised exercises; none of them withdrew from the study, three of them obtained individual clinically important improvements in SPADI score above 20 points. The measurement protocol of physical and ultrasonographic outcomes took around 60 min.ConclusionsAdherence to supervised sessions was satisfactory, the adherence to non-supervised exercises must be improved. Data collection procedures were feasible to perform, but some changes are recommended.Trial registration numberNCT04154345.
| S-EPMC10565173 | biostudies-literature
Project description:Objectives Trauma- and emotion-focused chronic pain interventions, particularly Emotional Awareness and Expression Therapy (EAET), show much promise for reducing pain and improving functioning. We developed a novel, single-session, telehealth-delivered EAET class (“Pain, Stress, and Emotions”; PSE) and tested it on adults with chronic pain of mixed etiology. Methods After an initial developmental phase, we conducted an uncontrolled trial, providing PSE to 74 individuals with chronic pain (63.5% female; 64.9% White; 60.8% with pain duration >5 years) in four class administrations. Participants completed self-report measures (primary outcomes: pain intensity and pain interference) at baseline and multiple follow-ups to 12 weeks. Linear mixed-models examined changes over time, and effect sizes were calculated on change from baseline to 4-week (primary endpoint) and 12-week follow-ups. The trial was registered with clinicaltrials.gov (NCT05014126) Results Participants reported high satisfaction with the PSE class. Pain intensity showed a significant, medium reduction across time (p < .001; d = 0.60 at 4 weeks); one-quarter of participants had clinically meaningful pain reduction (≥30%). Pain interference had a large reduction (p < .001; d = 0.74). There were significant but smaller improvements in most secondary outcomes (ds = 0.15 to 0.55; ps < .01). Effects were generally maintained or increased at 12-week follow-up. Higher education and baseline ambivalence over emotional expression predicted greater pain reductions. Conclusions People taking this EAET class had reduced pain severity and interference and improvements in other pain-related outcomes. The single-session, telehealth class holds promise as an easily delivered, efficient, and potentially impactful intervention for some patients with chronic pain, although controlled trials are needed.
| S-EPMC9715975 | biostudies-literature
Project description:Lay abstractDepression in youth is a significant public health problem worldwide, particularly for autistic youth who are over twice as likely to experience depression than their non-autistic peers. Although pathways to depression are complex, emotional reactivity and negative self-esteem are two risk factors for depression in autistic and non-autistic youth. Although autistic youth are more likely to experience depression than their non-autistic peers, psychotherapy options for autistic youth are very limited; community guidance in the development and testing of psychotherapy programs is a promising approach in autism. Therefore, in this study, we designed an autism-adapted CBT-DAY, in collaboration with autistic community members. Specifically, CBT-DAY combined neurodiversity-affirming and cognitive behavioral approaches to target emotional reactivity and self-esteem in youth to improve depressive symptom severity in a group setting across 12 weeks. We examined the preliminary feasibility, acceptability, and efficacy of CBT-DAY in a pilot non-randomized trial. In addition, we implemented a rigorous protocol for assessing, monitoring, and addressing potential harms in this intervention. Results from 24 autistic youth (11-17 years old) suggest that CBT-DAY may be feasible to use in an outpatient clinical setting and generally acceptable to youth and their caregivers. Participation in CBT-DAY may be associated with significant improvements in youth emotional reactivity and self-esteem, as well as depressive symptom severity per self-report only. Exploratory analyses showed that participation in CBT-DAY may also be associated with significant improvements in internalizing symptoms. Findings demonstrate the potential promise of neurodiversity-affirming and cognitive behavioral approaches to treating depressive symptoms in some autistic youth.
| S-EPMC11128473 | biostudies-literature
Project description:IntroductionCirculating prostaglandin E2 levels are elevated in acutely decompensated cirrhosis and have been shown to contribute to immune suppression. Albumin binds and inactivates this hormone. Human albumin solution could thus be repurposed as an immune restorative drug in these patients.This feasibility study aims to determine whether it is possible and safe to restore serum albumin to >30 g/L and maintain it at this level in patients admitted with acute decompensated cirrhosis using repeated 20% human albumin infusions according to daily serum albumin levels.Methods and analysisAlbumin To prevenT Infection in chronic liveR failurE (ATTIRE) stage 1 is a multicentre, open label dose feasibility trial. Patients with acutely decompensated cirrhosis admitted to hospital with a serum albumin of <30 g/L are eligible, subject to exclusion criteria. Daily intravenous human albumin solution will be infused, according to serum albumin levels, for up to 14 days or discharge in all patients. The primary end point is daily serum albumin levels for the duration of the treatment period and the secondary end point is plasma-induced macrophage dysfunction. The trial will recruit 80 patients. Outcomes will be used to assist with study design for an 866 patient randomised controlled trial at more than 30 sites across the UK.Ethics and disseminationResearch ethics approval was given by the London-Brent research ethics committee (ref: 15/LO/0104). The clinical trials authorisation was issued by the medicines and healthcare products regulatory agency (ref: 20363/0350/001-0001).ResultsWill be disseminated through peer reviewed journals and international conferences. Recruitment of the first participant occurred on 26/05/2015.Trial registration numberThe trial is registered with the European Medicines Agency (EudraCT 2014-002300-24) and has been adopted by the NIHR (ISRCTN 14174793). This manuscript refers to V.4.0 of the protocol; Pre-results.
| S-EPMC4735307 | biostudies-literature
Project description:IntroductionApproximately 50% of individuals with fibromyalgia (a chronic widespread pain condition) have comorbid insomnia. Treatment for these comorbid cases typically target pain, but growing research supports direct interventions for insomnia (eg, cognitive behavioural treatment for insomnia (CBT-I)) in these patients. Previous research suggests sustained hyperarousal mediated by a neural central sensitisation mechanism may underlie insomnia and chronic pain symptoms in fibromyalgia. We hypothesise CBT-I will improve insomnia symptoms, improve clinical pain and reduce central sensitisation. The trial will be the first to evaluate the short-term and long-term neural mechanisms underlying insomnia and pain improvements in fibromyalgia. Knowledge obtained from this trial might allow us to develop new or modify current treatments to better target pain mechanisms, perhaps reversing chronic pain or preventing it.Methods and analysisFemale participants (n=130) 18 years of age and older with comorbid fibromyalgia (with pain severity of at least 50/100) and insomnia will be recruited from the University of Missouri in Columbia, Missouri, and surrounding areas. Participants will be randomised to 8 weeks (plus 4 bimonthly booster sessions) of CBT-I or a sleep hygiene control group (SH). Participants will be assessed at baseline, post-treatment, 6 and 12 months follow-ups. The following assessments will be completed: 2 weeks of daily diaries measuring sleep and pain, daily actigraphy, insomnia severity index, pain-related disability, single night of polysomnography recording, arousal (heart rate variability, cognitive affective arousal), structural and functional MRI to examine pain-related neural activity and plasticity and mood (depression, anxiety).Ethics and disseminationEthics approval was obtained in July 2018 from the University of Missouri. All data are expected to be collected by 2022. Full trial results are planned to be published by 2024. Secondary analyses of baseline data will be subsequently published.Trial registration numberNCT03744156.
| S-EPMC7493102 | biostudies-literature
Project description:BackgroundChronic pain is a poorly managed symptom of inflammatory bowel disease (IBD). Cognitive behavioural therapy (CBT) has an evidence base in functional gastrointestinal conditions and chronic pain. This study aimed to test the feasibility and acceptability of a 9-week online facilitator-supported CBT intervention, tailored for people with chronic IBD-related pain.DesignA single-arm pre-post design with nested qualitative interviews was used. Twenty individuals with IBD and chronic pain were recruited through an online IBD charity and had consented to research in a previous survey or responded to an online charity advert. Individuals who indicated a pain-interference score of ≥ 4/10 (Brief Pain Inventory) and met inclusion criteria were invited to take part. Outcomes included recruitment and retention rates, pain interference and severity, quality of life (QoL) and psychosocial measures.ResultsOf 145 individuals contacted, 55 (37.9%) responded. Two individuals were recruited from the study advertisement. Twenty out of 57 (35.1%) met screening and eligibility criteria. Eighty-five percent of the sample engaged with intervention sessions and 55% completed at least 5/9 sessions. Eighty percent of recruited participants completed the post-intervention questionnaire at week 9. The mean score for overall acceptability was 43.4 (0-70). Qualitative feedback demonstrated the value of thought monitoring and facilitator support. Scores improved for QoL and pain self-efficacy and reduced for depression, anxiety, pain catastrophising and avoidance resting behaviour.ConclusionsOnline CBT for chronic IBD-related pain appears feasible and acceptable. The study suggests positive effects for improving QoL and reducing psychological distress; however, online and face-to-face recruitment methods are recommended and establishing efficacy through larger randomised controlled trials is required.
| S-EPMC8050888 | biostudies-literature
Project description:IntroductionLong waiting time is an important barrier to accessing recommended care for low back pain (LBP) in Australia's public health system. This study describes the protocol for a randomised controlled trial (RCT) that aims to establish the feasibility of delivering and evaluating stratified care integrated with telehealth ('Rapid Stratified Telehealth'), which aims to reduce waiting times for LBP.Methods and analysisWe will conduct a single-centre feasibility and pilot RCT with nested qualitative interviews. Sixty participants with LBP newly referred to a hospital outpatient clinic will be randomised to receive Rapid Stratified Telehealth or usual care. Rapid Stratified Telehealth involves matching the mode and type of care to participants' risk of persistent disabling pain (using the Keele STarT MSK Tool) and presence of potential radiculopathy. 'Low risk' patients are matched to one session of advice over the telephone, 'medium risk' to telehealth physiotherapy plus App-based exercises, 'high risk' to telehealth physiotherapy, App-based exercises, and an online pain education programme, and 'potential radiculopathy' fast tracked to usual in-person care. Primary outcomes include the feasibility of delivering Rapid Stratified Telehealth (ie, acceptability assessed through interviews with clinicians and patients, intervention fidelity, appointment duration, App useability and online pain education programme usage) and evaluating Rapid Stratified Telehealth in a future trial (ie, recruitment rates, consent rates, lost to follow-up and missing data). Secondary outcomes include waiting times, number of appointments, intervention and healthcare costs, clinical outcomes (pain, function, quality of life, satisfaction), healthcare use and adverse events (AEs). Quantitative analyses will be descriptive and inform a future adequately-powered RCT. Interview data will be analysed using thematic analysis.Ethics and disseminationThis study has received approval from the Ethics Review Committee (RPAH Zone: X21-0221). Results will be published in peer-reviewed journals and presented at conferences.Trial registration numberACTRN12621001104842.
| S-EPMC8753403 | biostudies-literature