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A Pilot Nurse-Administered CBT Intervention for Insomnia in Patients with Schizophrenic Disorder: A Randomized Clinical Effectiveness Trial.

ABSTRACT: Insomnia is a highly prevalent disorder among the population with schizophrenia and has a significant impact on their quality of life. Cognitive behavioural therapies (CBT) have shown effectiveness in the treatment of insomnia in the general population. The aim of this this pilot study was to evaluate the effectiveness of a group intervention led by nurses in an outpatient mental health centre. The group work combined cognitive behavioural and psychoeducational therapeutic interventions to improve insomnia in patients with schizophrenic disorder and their health-related quality of life. This randomized clinical trial included intervention and control groups with follow-up assessments at 6 and 9 months, using the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and EuroQol-5D (EQ-5D) scales. The inclusion criteria were as follows: over 18 years of age, diagnosis of schizophrenia, and a score of >7 on the ISI scale. The total sample was 40 participants. The ISI scale showed a mean difference of 3.63 (CI 95%: 2.02-5.23) (p = 0.000) and 4.10 (CI 95%: 2.45-5.75) (p = 0.000) and a large effect size (F: 28.36; p = 0.000; ηp2: 0.427). Regarding the PSQI scale, the mean difference was 3.00 (CI 95%: 1.53-4.49) (p = 0.000) and 2.30 (CI 95%: 0.85-3.75) (p = 0.000), with a medium effect size (F: 18.31; p = 0.000 ηp2: 0.325). The EQ-VAS scale showed a difference in mean scores between the groups of 10.48 (CI 95%: -19.66--1.29) (p = 0.027). CBT adapted for populations with mental disorders, carried out by nurses, is effective in improving insomnia and health-related quality of life.

SUBMITTER: Batalla-Martin D

PROVIDER: S-EPMC10573965 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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A Pilot Nurse-Administered CBT Intervention for Insomnia in Patients with Schizophrenic Disorder: A Randomized Clinical Effectiveness Trial.

Batalla-Martin David D Martorell-Poveda Maria-Antonia MA Belzunegui-Eraso Angel A Marieges Gordo Alejandro A Batlle Lleal Helena H Pasqual Melendez Raquel R Querol Girona Raquel R López-Ruiz Marina M

Journal of clinical medicine 20230923 19

Insomnia is a highly prevalent disorder among the population with schizophrenia and has a significant impact on their quality of life. Cognitive behavioural therapies (CBT) have shown effectiveness in the treatment of insomnia in the general population. The aim of this this pilot study was to evaluate the effectiveness of a group intervention led by nurses in an outpatient mental health centre. The group work combined cognitive behavioural and psychoeducational therapeutic interventions to impro ...[more]

PMID: 37834794

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Project description:BackgroundAdjustment problems and disorders are highly prevalent among university students worldwide. These problems can cause significant interference in academic and social functioning and increase vulnerability to other mental health disorders. Unfortunately, only half of students in need receive psychological help. Furthermore, few studies have evaluated psychological interventions for adjustment disorders in students. New, more scalable forms of treatment for students with an adjustment disorder need to be developed, evaluated, and implemented. The study aims to determine the effectiveness of an online transdiagnostic cognitive behavioural intervention for students experiencing adjustment disorder and to assess mediators of change.Method/designIn this three-arm randomized controlled trial, we plan to recruit 214 Polish students diagnosed with an adjustment disorder. Participants who meet initial eligibility criteria will be randomly assigned to one of three 6-week conditions: (1) online cognitive behavioural therapy intervention based on an existing, empirically supported transdiagnostic protocol, the unified protocol; (2) online progressive muscle relaxation training as an active control group; or (3) waiting-list control group. Both interventions are asynchronous, interactive, and include minimal amount of therapist support. Assessments will consist of self-report questionnaires, daily diary measures, and neurocognitive tasks for evaluating cognitive functioning. These will be conducted at baseline, post-treatment, and 1-month follow-up. Daily diary measures will be taken during the first and last week of treatment (or waitlist period). Primary outcome measures will include adjustment disorder severity; secondary outcome measures will consist of other negative (psychopathology: depression, anxiety, and stress) and positive (life satisfaction) indexes of mental health as well as process measures (e.g. mindfulness, experiential avoidance, cognitive fusion).DiscussionTo our knowledge, the current study is the first to evaluate the effectiveness of a psychological intervention for students with adjustment disorder. Therefore, it may have important practical implications for students with this disorder. It can potentially guide the development of a scalable, validated treatment option.Trial registrationClinical Trials, NCT05768308, registered 14 March 2023, https://www.Clinicaltrialsgov/ct2/show/NCT05768308.

Project description:AbstractAlcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. Individuals with AUD often experience insomnia and other sleep disturbances at various phases of recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia. Internet-based CBT-I could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound Internet intervention for insomnia. Despite the promise of Internet-based CBT-I interventions, to date, no randomized controlled trials (RCTs) exist examining the feasibility/efficacy of an Internet-based CBT-I program among treatment-seeking individuals recovering from AUD. This is a two-phase RCT assessing feasibility/acceptability and efficacy of the SHUTi program among individuals with AUD in recovery with insomnia. Phase I will focus on assessing the feasibility and acceptability of program delivery and data collection (n = 10). Phase II will be an RCT powered to examine preliminary intervention efficacy (n = 30 per group). Participants for this study must meet criteria for "moderate to severe" insomnia. Individuals randomized to the intervention group will receive the SHUTi intervention (initiated while inpatient and completed while outpatient), and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: (1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (phase I), (2) compare the preliminary efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (phase II), and (3) explore specific domains associated with improved outcomes, e.g., demographic, psychiatric, and drinking-related factors (phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time.Trial registrationNCT#03493958; registered 1 June 2018.

Project description:BACKGROUND:Patients with chronic pain often have limited access to comprehensive care that includes behavioral pain management strategies. Virtual reality (VR) is an immersive technology and emerging digital behavioral pain therapy with analgesic efficacy for acute pain. We found no scientific literature on skills-based VR behavioral programs for chronic pain populations. OBJECTIVE:The primary aim of this study is to evaluate the feasibility of a self-administered VR program that included content and skills informed by evidence-based behavioral treatment for chronic pain. The secondary aim is to determine the preliminary efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, stress, mood, and sleep, and its impact on pain-related cognition and self-efficacy. The tertiary aim was to conduct a randomized controlled trial (RCT) and compare the VR treatment with an audio-only treatment. This comparison isolated the immersive effects of the VR program, thereby informing potential mechanisms of effect. METHODS:We conducted an RCT involving a web-based convenience sample of adults (N=97) aged 18-75 years with self-reported chronic nonmalignant low back pain or fibromyalgia, with an average pain intensity >4 over the past month and chronic pain duration >6 months. Enrolled participants were randomly assigned to 1 of 2 unblinded treatments: (1) VR: a 21-day, skills-based VR program for chronic pain; and (2) audio: an audio-only version of the 21-day VR program. The analytic data set included participants who completed at least 1 of 8 surveys administered during the intervention period: VR (n=39) and audio (n=35). RESULTS:The VR and audio groups launched a total of 1067 and 1048 sessions, respectively. The majority of VR participants (n=19/25, 76%) reported no nausea or motion sickness. High satisfaction ratings were reported for VR (n=24/29, 83%) and audio (n=26/33, 72%). For VR efficacy, symptom improvement over time was found for each pain variable (all P<.001), with results strengthening after 2 weeks. Importantly, significant time×group effects were found in favor of the VR group for average pain intensity (P=.04), pain-related inference with activity (P=.005), sleep (P<.001), mood (P<.001), and stress (P=.003). For pain catastrophizing and pain self-efficacy, we found a significant declining trend for both treatment groups. CONCLUSIONS:High engagement and satisfaction combined with low levels of adverse effects support the feasibility and acceptability of at-home skills-based VR for chronic pain. A significant reduction in pain outcomes over the course of the 21-day treatment both within the VR group and compared with an audio-only version suggests that VR has the potential to provide enhanced treatment and greater improvement across a range of pain outcomes. These findings provide a foundation for future research on VR behavioral interventions for chronic pain.

Project description:ImportanceDespite evidence of efficacious psychological and pharmacologic therapies for insomnia, there is little information about what first-line treatment should be and how best to proceed when initial treatment fails.ObjectiveTo evaluate the comparative efficacy of 4 treatment sequences involving psychological and medication therapies for insomnia and examine the moderating effect of psychiatric disorders on insomnia outcomes.Design, setting, and participantsIn a sequential multiple-assignment randomized trial, patients were assigned to first-stage therapy involving either behavioral therapy (BT; n = 104) or zolpidem (zolpidem; n = 107), and patients who did not remit received a second treatment involving either medication (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy [CT]). The study took place at Institut Universitaire en Santé Mentale de Québec, Université Laval, Québec City, Québec, Canada, and at National Jewish Health, Denver, Colorado, and enrollment of patients took place from August 2012 through July 2017.Main outcomes and measuresThe primary end points were the treatment response and remission rates, defined by the Insomnia Severity Index total score.ResultsPatients included 211 adults (132 women; mean [SD] age, 45.6 [14.9] years) with a chronic insomnia disorder, including 74 patients with a comorbid anxiety or mood disorder. First-stage therapy with BT or zolpidem produced equivalent weighted percentages of responders (BT, 45.5%; zolpidem, 49.7%; OR, 1.18; 95% CI, 0.60-2.33) and remitters (BT, 38.03%; zolpidem, 30.3%; OR, 1.41; 95% CI, 0.75-2.65). Second-stage therapy produced significant increases in responders for the 2 conditions, starting with BT (BT to zolpidem, 40.6% to 62.7%; OR, 2.46; 95% CI, 1.14-5.30; BT to CT, 50.1% to 68.2%; OR, 2.09; 95% CI, 1.01-4.35) but no significant change following zolpidem treatment. Significant increase in percentage of remitters was observed in 2 of 4 therapy sequences (BT to zolpidem, 38.1% to 55.9%; OR, 2.06; 95% CI, 1.04-4.11; zolpidem to trazodone, 31.4% to 49.4%; OR, 2.13; 95% CI, 0.91-5.00). Although response/remission rates were lower among patients with psychiatric comorbidity, treatment sequences that involved BT followed by CT or zolpidem followed by trazodone yielded better outcomes for patients with comorbid insomnia. Response and remission rates were well sustained through the 12-month follow-up.Conclusions and relevanceBehavioral therapy and zolpidem medication produced equivalent response and remission rates. Adding a second treatment produced an added value for those whose insomnia failed to remit with initial therapies.Trial registrationClinicalTrials.gov Identifier: NCT01651442.

Dataset Information

A Pilot Nurse-Administered CBT Intervention for Insomnia in Patients with Schizophrenic Disorder: A Randomized Clinical Effectiveness Trial.

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A Pilot Nurse-Administered CBT Intervention for Insomnia in Patients with Schizophrenic Disorder: A Randomized Clinical Effectiveness Trial.

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