scholarly journals Efficacy of the FIBROWALK Multicomponent Program Moved to a Virtual Setting for Patients with Fibromyalgia during the COVID-19 Pandemic: A Proof-of-Concept RCT Performed Alongside the State of Alarm in Spain

2021 ◽  
Vol 18 (19) ◽  
pp. 10300
Author(s):  
Mayte Serrat ◽  
Mireia Coll-Omaña ◽  
Klara Albajes ◽  
Sílvia Solé ◽  
Miriam Almirall ◽  
...  
Keyword(s):  
Functional Impairment ◽  
Depressive Symptomatology ◽  
Behavioral Therapy ◽  
Proof Of Concept ◽  
Therapeutic Exercise ◽  
Treatment As Usual ◽  
Intention To Treat ◽  
Secondary Outcomes ◽  
Multicomponent Program ◽  
Virtual Setting

FIBROWALK is a multicomponent program including pain neuroscience education, therapeutic exercise, cognitive behavioral therapy and mindfulness training that has recently been found to be effective in patients with fibromyalgia (FM). This RCT started before the COVID-19 pandemic and was moved to a virtual format (i.e., online videos) when the lockdown was declared in Spain. This study is aimed to evaluate the efficacy of a virtual FIBROWALK compared to Treatment-As-Usual (TAU) in patients with FM during the first state of alarm in Spain. A total of 151 patients with FM were randomized into two study arms: FIBROWALK plus TAU vs. TAU alone. The primary outcome was functional impairment. Secondary outcomes were kinesiophobia, anxiety and depressive symptomatology, and physical functioning. Differences between groups at post-treatment assessment were analyzed using Intention-To-Treat (ITT) and completer approaches. Baseline differences between clinical responders and non-responders were also explored. Statistically significant improvements with small-to-moderate effect sizes were observed in FIBROWALK+TAU vs. TAU regarding functional impairment and most secondary outcomes. In our study, the NNT was 5, which was, albeit modestly, indicative of an efficacious intervention. The results of this proof-of-concept RCT preliminarily support the efficacy of virtual FIBROWALK in patients with FM during the Spanish COVID-19 lockdown.

scholarly journals Metacognitive reflection and insight therapy (MERIT) for patients with schizophrenia

2018 ◽  
Vol 49 (2) ◽  
pp. 303-313 ◽  
Author(s):  
S. de Jong ◽  
R. J. M. van Donkersgoed ◽  
M. E. Timmerman ◽  
M. aan het Rot ◽  
L. Wunderink ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Drop Out ◽  
Future Research ◽  
Control Group ◽  
Treatment As Usual ◽  
Self Reflection ◽  
Intention To Treat ◽  
Metacognitive Reflection ◽  
Secondary Outcomes

AbstractBackgroundImpaired metacognition is associated with difficulties in the daily functioning of people with psychosis. Metacognition can be divided into four domains: Self-Reflection, Understanding the Other's Mind, Decentration, and Mastery. This study investigated whether Metacognitive Reflection and Insight Therapy (MERIT) can be used to improve metacognition.MethodsThis study is a randomized controlled trial. Patients in the active condition (n = 35) received forty MERIT sessions, the control group (n = 35) received treatment as usual. Multilevel intention-to-treat and completers analyses were performed for metacognition and secondary outcomes (psychotic symptomatology, cognitive insight, Theory of Mind, empathy, depression, self-stigma, quality of life, social functioning, and work readiness).ResultsEighteen out of 35 participants finished treatment, half the drop-out stemmed from therapist attrition (N = 5) or before the first session (N = 4). Intention-to-treat analysis demonstrated that in both groups metacognition improved between pre- and post-measurements, with no significant differences between the groups. Patients who received MERIT continued to improve, while the control group returned to baseline, leading to significant differences at follow-up. Completers analysis (18/35) showed improvements on the Metacognition Assessment Scale (MAS-A) scales Self Reflectivity and metacognitive Mastery at follow-up. No effects were found on secondary outcomes.ConclusionsOn average, participants in the MERIT group were, based on MAS-A scores, at follow-up more likely to recognize their thoughts as changeable rather than as facts. MERIT might be useful for patients whose self-reflection is too limited to benefit from other therapies. Given how no changes were found in secondary measures, further research is needed. Limitations and suggestions for future research are discussed.

OS10.4.A The effects of SmartCare on neuro-oncology family caregivers’ distress: a randomized controlled trial

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii13-ii13
Author(s):  
F W Boele ◽  
J M Weimer ◽  
J Proudfoot ◽  
A L Marsland ◽  
T S Armstrong ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Family Caregivers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Significant Group ◽  
Intention To Treat ◽  
Secondary Outcomes ◽  
Physical Consequences

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. MATERIAL AND METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

QOLP-29. THE EFFECTS OF AN ONLINE, NURSE-LED NEEDS-BASED SUPPORT PROGRAM ON NEURO-ONCOLOGY FAMILY CAREGIVERS' DISTRESS: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi189-vi189
Author(s):  
Florien Boele ◽  
Paula Sherwood ◽  
Jason Weimer ◽  
Judith Proudfoot ◽  
Anna Marsland ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Family Caregivers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Support Program ◽  
Significant Group ◽  
Intention To Treat ◽  
Secondary Outcomes

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

scholarly journals 1087 Early Session Effects of CBT-I on Insomnia and Depression

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A413-A414
Author(s):  
T M Bishop ◽  
H F Crean ◽  
J S Funderburk ◽  
K J Speed ◽  
W R Pigeon
Keyword(s):  
Depressive Symptomatology ◽  
Behavioral Therapy ◽  
Severity Index ◽  
Sleep Diary ◽  
Treatment As Usual ◽  
Optimal Balance ◽  
Patient Health ◽  
Clinically Significant ◽  
Multiple Domains ◽  
Insomnia Severity

Abstract Introduction Cognitive behavioral therapy for insomnia (CBT-I) has been shown to reduce depressive symptomatology among patients with co-occurring insomnia and depression. Brief forms of CBT-I have been tested in various settings including primary care. As delivery formats of CBT-I broaden, it is important to enhance our understanding of what doses and what components of CBT-I, provide the optimal balance of treatment efficacy and brevity. In the present study, we examine session-by-session effects of CBT-I on insomnia and depression. Methods Fifty-four Veterans with insomnia and co-occurring depression or posttraumatic stress disorder were randomized to either four sessions of CBT-I or treatment as usual in a published parent study. We report here on the effects among those who received CBT-I (n =22). At each session participants provided a completed sleep diary and completed the Insomnia Severity Index (ISI) and Patient Health Questionnaire-9 for depression (PHQ-9). Results At baseline, participants endorsed a moderate level of both insomnia (ISI score = 18.5 [SD=4.2]) and depression (PHQ-9 score = 15.6 [SD=5.2]). A mean decrease of 4.0 points in ISI total score was observed between sessions 1 and 2 [t(21)=-3.88, p<.001] and a 3.3 points between sessions 2 and 3 [t(19)=-2.63, p<.05]. Mean PHQ-9 scores decreased by 2.9 points between sessions 1 and 2 [t(21)=-2.84, p<.01] and a 2.8 points between sessions 2 and 3 [t(19)=-2.77, p<.05]. In contrast, changes in ISI and PHQ-9 scores between baseline and session 1, and sessions 3 and 4 did not reach significance. Conclusion The majority of improvements in both insomnia and depression were observed following sessions 1 and 2 of CBT-I. Findings suggest that even a limited exposure to CBT-I may have a clinically significant impact on functioning across multiple domains. Whether such early improvements represent an optimal balance compared with the more modest additional improvements achieved by adding more sessions is discussed. Support This work was supported by the VISN 2 Center of Excellence for Suicide Prevention at the Canandaigua VAMC.

scholarly journals A randomized clinical trial of cognitive behavioral therapy and interpersonal psychotherapy for panic disorder with agoraphobia

2012 ◽  
Vol 42 (12) ◽  
pp. 2661-2672 ◽  
Author(s):  
S. P. F. Vos ◽  
M. J. H. Huibers ◽  
L. Diels ◽  
A. Arntz
Keyword(s):  
Panic Disorder ◽  
Cognitive Behavioral Therapy ◽  
Life Stress ◽  
Behavioral Therapy ◽  
Interpersonal Psychotherapy ◽  
Primary Diagnosis ◽  
Panic Attacks ◽  
Cognitive Behavioral ◽  
Intention To Treat ◽  
Secondary Outcomes

BackgroundInterpersonal psychotherapy (IPT) seems to be as effective as cognitive behavioral therapy (CBT) in the treatment of major depression. Because the onset of panic attacks is often related to increased interpersonal life stress, IPT has the potential to also treat panic disorder. To date, a preliminary open trial yielded promising results but there have been no randomized controlled trials directly comparing CBT and IPT for panic disorder.MethodThis study aimed to directly compare the effects of CBT versus IPT for the treatment of panic disorder with agoraphobia. Ninety-one adult patients with a primary diagnosis of DSM-III or DSM-IV panic disorder with agoraphobia were randomized. Primary outcomes were panic attack frequency and an idiosyncratic behavioral test. Secondary outcomes were panic and agoraphobia severity, panic-related cognitions, interpersonal functioning and general psychopathology. Measures were taken at 0, 3 and 4 months (baseline, end of treatment and follow-up).ResultsIntention-to-treat (ITT) analyses on the primary outcomes indicated superior effects for CBT in treating panic disorder with agoraphobia. Per-protocol analyses emphasized the differences between treatments and yielded larger effect sizes. Reductions in the secondary outcomes were equal for both treatments, except for agoraphobic complaints and behavior and the credibility ratings of negative interpretations of bodily sensations, all of which decreased more in CBT.ConclusionsCBT is the preferred treatment for panic disorder with agoraphobia compared to IPT. Mechanisms of change should be investigated further, along with long-term outcomes.

Concordance between clinician, supervisor and observer ratings of therapeutic competence in CBT and treatment as usual: does clinician competence or supervisor session observation improve agreement?

2019 ◽  
Vol 48 (3) ◽  
pp. 350-363 ◽  
Author(s):  
EB Caron ◽  
Michela A. Muggeo ◽  
Heather R. Souer ◽  
Jeffrey E. Pella ◽  
Golda S. Ginsburg
Keyword(s):  
Behavioral Therapy ◽  
Training Methods ◽  
Rater Training ◽  
Treatment As Usual ◽  
School Based ◽  
Audio Recordings ◽  
Evidence Based Treatments ◽  
Therapeutic Competence ◽  
Observer Ratings ◽  
The Cost

AbstractBackground:Lowering the cost of assessing clinicians’ competence could promote the scalability of evidence-based treatments such as cognitive behavioral therapy (CBT).Aims:This study examined the concordance between clinicians’, supervisors’ and independent observers’ session-specific ratings of clinician competence in school-based CBT and treatment as usual (TAU). It also investigated the association between clinician competence and supervisory session observation and rater agreement.Method:Fifty-nine school-based clinicians (90% female, 73% Caucasian) were randomly assigned to implement TAU or modular CBT for youth anxiety. Clinicians rated their confidence after each therapy session (n = 1898), and supervisors rated clinicians’ competence after each supervision session (n = 613). Independent observers rated clinicians’ competence from audio recordings (n = 395).Results:Patterns of rater discrepancies differed between the TAU and CBT groups. Correlations with independent raters were low across groups. Clinician competence and session observation were associated with higher agreement among TAU, but not CBT, supervisors and clinicians.Conclusions:These results support the gold standard practice of obtaining independent ratings of adherence and competence in implementation contexts. Further development of measures and/or rater training methods for clinicians and supervisors is needed.

435 Single Session CBT to Improve PAP Initiation and Adherence among Veterans with OSA

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A172-A172
Author(s):  
Todd Bishop ◽  
Patrick Walsh ◽  
Tracy Stecker ◽  
Katrina Speed ◽  
Lisham Ashrafioun ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Comparison Group ◽  
Behavioral Therapy ◽  
Subsequent Treatment ◽  
Single Session ◽  
Post Intervention ◽  
Chi Square ◽  
Treatment As Usual ◽  
Obstructive Sleep

Abstract Introduction Obstructive sleep apnea (OSA) is a condition that is prevalent, pernicious, and linked to the development and exacerbation of several disease processes. Positive airway pressure (PAP) is a highly efficacious intervention; however, initiation and adherence rates are poor. This represents a critical gap in care and a missed opportunity to reduce morbidity and mortality associated with OSA. The present study piloted a single session of cognitive behavioral therapy for treatment seeking (CBT-TS) among veterans diagnosed with obstructive sleep apnea and newly prescribed PAP. Methods Participants were asked to complete assessments at baseline and at two- and four-weeks post-intervention. A sample of 40 Veterans were enrolled in the study and completed a baseline interview, 27 completed CBT-TS. A matched comparison group of 64 veterans who did not receive the intervention was constructed using electronic medical record and PAP adherence data. Mann Whitney U and Chi Square tests were used to examine group differences in initiation and adherence. Results Participants who completed the CBT-TS session were more likely to initiate PAP (at least 3 consecutive nights of use) as compared to those receiving treatment as usual (TAU) [(CBT-TS; 96.3%; 26/27) versus (TAU; 64.1%; 41/64); X2(1, N = 91) = 10.16, p = .001]. Participants in the CBT-TS group also used their PAP devices for a greater number of nights over the first month than the comparison group [(CBT-TS; M = 21.7 (SD = 8.9), Mdn = 26.0) versus (TAU; M = 14.4 (SD = 12.6), Mdn = 15.5); U = 555.0, p = .007] and were more likely to use the device in an adherent manner (i.e., ≥4 hours use in an evening); [(CBT-TS; M = 15.1 (SD = 11.2); Mdn = 15.0) versus (TAU; M = 10.3 (SD = 11.2), Mdn = 6.5); U =630.0, p = .038]. Conclusion These preliminary data suggest that CBT-TS may have utility in increasing initiation of PAP and subsequent treatment adherence among Veterans diagnosed with OSA and newly prescribed PAP. Support (if any) This work was supported by the VA Center of Excellence for Suicide Prevention in the Finger Lakes Healthcare System.

scholarly journals Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

2017 ◽  
Vol 42 ◽  
pp. 103-110 ◽  
Author(s):  
C.I. Mahlke ◽  
S. Priebe ◽  
K. Heumann ◽  
A. Daubmann ◽  
K. Wegscheider ◽  
...  
Keyword(s):  
Mental Illness ◽  
Peer Support ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Treatment As Usual ◽  
Secondary Outcomes ◽  
One To One ◽  
Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

scholarly journals An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial

10.2196/14648 ◽  
2019 ◽  
Vol 6 (10) ◽  
pp. e14648 ◽  
Author(s):  
Peter Johansson ◽  
Mats Westas ◽  
Gerhard Andersson ◽  
Urban Alehagen ◽  
Anders Broström ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Primary Outcome ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Eq Vas

Background Depression is a common cause of reduced well-being and prognosis in patients with cardiovascular disease (CVD). However, there is a lack of effective intervention strategies targeting depression. Objective The study aimed to evaluate the effects of a nurse-delivered and adapted internet-based cognitive behavioral therapy (iCBT) program aimed at reducing depression in patients with CVD. Methods A randomized controlled trial was conducted. A total of 144 patients with CVD with at least mild depression (Patient Health Questionnaire–9 [PHQ-9] score ≥5) were randomized 1:1 to a 9-week program of iCBT (n=72) or an active control participating in a Web-based discussion forum (online discussion forum [ODF], n=72). The iCBT program, which included 7 modules, was adapted to fit patients with CVD. Nurses with an experience of CVD care provided feedback and a short introduction to cognitive behavioral therapy. The primary outcome, depression, was measured using PHQ-9. Secondary outcomes were depression measured using the Montgomery-Åsberg Depression Rating Scale–self-rating version (MADRS-S), health-related quality of life (HRQoL) measured using Short Form 12 (SF-12) survey and EuroQol Visual Analogue Scale (EQ-VAS), and the level of adherence. An intention-to-treat analysis with multiple imputations was used. Between-group differences in the primary and secondary outcomes were determined by the analysis of covariance, and a sensitivity analysis was performed using mixed models. Results Compared with ODF, iCBT had a significant and moderate treatment effect on the primary outcome depression (ie, PHQ-9; mean group difference=−2.34 [95% CI −3.58 to −1.10], P<.001, Cohen d=0.62). In the secondary outcomes, compared with ODF, iCBT had a significant and large effect on depression (ie, MADRS-S; P<.001, Cohen d=0.86) and a significant and moderate effect on the mental component scale of the SF-12 (P<.001, Cohen d=0.66) and the EQ-VAS (P<.001, Cohen d=0.62). Overall, 60% (n=43) of the iCBT group completed all 7 modules, whereas 82% (n=59) completed at least half of the modules. No patients were discontinued from the study owing to a high risk of suicide or deterioration in depression. Conclusions Nurse-delivered iCBT can reduce depression and improve HRQoL in patients with CVD, enabling treatment for depression in their own homes and at their preferred time. Trial Registration ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074

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