Personalized attention control therapy for PTSD: effectiveness and moderators of outcome in a randomized controlled trial

2020 ◽  
pp. 1-11
Author(s):  
Adva Segal ◽  
Daniel S. Pine ◽  
Yair Bar-Haim
Keyword(s):  
Treatment Outcome ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Post Treatment ◽  
Attention Control ◽  
Randomized Controlled ◽  
Control Therapy ◽  
Pre Treatment ◽  
Attentional Interference

Abstract Background Previous randomized controlled trials (RCTs) suggest that attention control therapy (ACT), targeting aberrant fluctuations of attention toward and away from threats in patients with PTSD, may be effective in reducing symptoms. The current RCT examined whether the use of personalized-trauma stimuli enhances ACT efficacy in patients with PTSD. Additional moderators of treatment outcome were tested on an exploratory basis. Methods Sixty patients with PTSD were randomly assigned to either personalized ACT, non-personalized ACT, or a control condition. Changes in symptoms were examined across pre-treatment, post-treatment, and a 3-month follow-up. Attentional interference was examined pre- and post-treatment. Baseline clinical and cognitive indices as well as the time elapsed since the trauma were tested as potential moderators of treatment outcome. Results A significant reduction in clinical symptoms was noted for all three conditions with no between-group differences. Attention bias variability decreased following ACT treatment. Personalized ACT was more effective relative to the control condition when less time had elapsed since the trauma. Baseline clinical and cognitive indices did not moderate treatment outcome. Conclusions In this RCT of patients with PTSD, ACT was no more effective in reducing PTSD symptoms than a control condition. The data also suggest a potential benefit of personalized ACT for patients who experienced their trauma more recently.

Attention control therapy for acute stress disorder: A randomized controlled trial

2020 ◽  
Vol 37 (10) ◽  
pp. 1017-1025
Author(s):  
Adva Segal ◽  
Ilan Wald ◽  
Daniel S. Pine ◽  
Pinchas Halpern ◽  
Yair Bar‐Haim
Keyword(s):  
Randomized Controlled Trial ◽  
Stress Disorder ◽  
Acute Stress ◽  
Controlled Trial ◽  
Acute Stress Disorder ◽  
Attention Control ◽  
Randomized Controlled ◽  
Control Therapy

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

scholarly journals Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Dawn M. Ehde ◽  
Kevin N. Alschuler ◽  
Melissa A. Day ◽  
Marcia A. Ciol ◽  
Makena L. Kaylor ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Usual Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Average Pain Intensity ◽  
Average Pain ◽  
Pre Treatment ◽  
Management Approaches

Abstract Background Chronic pain is one of the most prevalent and disabling symptoms associated with multiple sclerosis (MS). Individuals with MS are interested in nonpharmacologic pain management approaches. Cognitive-behavioral therapy (CBT) is efficacious in improving MS-related pain outcomes. Mindfulness-based cognitive therapy (MBCT) is a promising, alternative approach. Little is known about moderators of these treatments’ outcomes, however. This article describes the study protocol for the first randomized controlled trial comparing MBCT, CBT, and usual care and examining treatment effect moderators in individuals with chronic pain and MS. Methods We will conduct a single-center, randomized, single blind, parallel-group trial comparing MBCT, CBT, and usual care in adults with MS and chronic pain. Both interventions will be delivered via eight group sessions using videoconferencing technology. Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep) will be assessed pre-treatment, mid-treatment, post-treatment, and at 6-month follow up. Potential treatment moderators will be assessed pre-treatment. We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up. We also hypothesize that mindfulness, pain catastrophizing, and behavioral activation pre-treatment will moderate response to both active treatments, but not response to usual care. Discussion Findings will provide important new information about the efficacy and moderators of two nonpharmacologic pain management approaches delivered using technology to overcome common barriers to treatment access. The knowledge gained may lead to better patient-treatment matching and, ultimately, better pain treatment outcomes in MS. Trial registration ClinicalTrials.gov, NCT03782246. Registered on 20 December 2018.

Discrepancy between post-treatment infarct volume and 90-day outcome in the ESCAPE randomized controlled trial

2020 ◽  
pp. 174749302092994 ◽  
Author(s):  
Aravind Ganesh ◽  
Bijoy K Menon ◽  
Zarina A Assis ◽  
Andrew M Demchuk ◽  
Fahad S Al-Ajlan ◽  
...  
Keyword(s):  
Risk Factors ◽  
Infarct Volume ◽  
Controlled Trial ◽  
Post Treatment ◽  
Sensitivity Analyses ◽  
Vascular Risk ◽  
Factors Associated ◽  
Post Stroke ◽  
Randomized Controlled ◽  
Pre Treatment

Background Some patients with ischemic stroke have poor outcomes despite small infarcts after endovascular thrombectomy, while others with large infarcts sometimes fare better. Aims We explored factors associated with such discrepancies between post-treatment infarct volume (PIV) and functional outcome. Methods We identified patients with small PIV (volume ≤ 25th percentile) and large PIV (volume ≥ 75th percentile) on 24–48-h CT/MRI in the ESCAPE randomized-controlled trial. Demographics, comorbidities, baseline, and 24–48-h stroke severity (NIHSS), stroke location, treatment type, post-stroke complications, and other outcome scales like Barthel Index, and EQ-5D were compared between “discrepant cases” – those with 90-day modified Rankin Scale(mRS) ≤ 2 despite large PIV or mRS ≥ 3 despite small PIV – and “non-discrepant cases”. Multi-variable logistic regression was used to identify pre-treatment and post-treatment factors associated with small-PIV/mRS ≥ 3 and large-PIV/mRS ≤ 2. Sensitivity analyses used different definitions of small/large PIV and good/poor outcome. Results Among 315 patients, median PIV was 21 mL; 27/79 (34.2%) patients with PIV ≤ 7 mL (25th percentile) had mRS ≥ 3; 12/80 (15.0%) with PIV ≥ 72 mL (75th percentile) had mRS ≤ 2. Discrepant cases did not differ by CT versus MRI-based PIV ascertainment, or right versus left-hemisphere involvement ( p = 0.39, p = 0.81, respectively, for PIV ≤ 7 mL/mRS ≥ 3). Pre-treatment factors independently associated with small-PIV/mRS ≥ 3 included older age ( p = 0.010), cancer, and vascular risk-factors; post-treatment factors included 48-h NIHSS ( p = 0.007) and post-stroke complications ( p = 0.026). Absence of vascular risk-factors ( p = 0.004), CT-based lentiform nucleus sparing ( p = 0.002), lower 24-hour NIHSS ( p = 0.001), and absence of complications ( p = 0.013) were associated with large-PIV/mRS ≤ 2. Sensitivity analyses yielded similar results. Conclusions Discrepancies between functional ability and PIV are likely explained by differences in age, comorbidities, and post-stroke complications, emphasizing the need for high-quality post-thrombectomy stroke care. Clinical trial registration https://clinicaltrials.gov/ct2/show/NCT01778335 .

scholarly journals An Integrative Neuro-Psychotherapy Treatment to Foster the Adjustment in Acquired Brain Injury Patients—A Randomized Controlled Study

2020 ◽  
Vol 9 (6) ◽  
pp. 1684
Author(s):  
Antoine Urech ◽  
Tobias Krieger ◽  
Eveline Frischknecht ◽  
Franziska Stalder-Lüthy ◽  
Martin grosse Holtforth ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Brain Injury ◽  
Brain Injuries ◽  
Controlled Trial ◽  
Acquired Brain Injury ◽  
Post Treatment ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Treatment Standard

Adjustment disorders (AjD) with depressive symptoms following an acquired brain injury (ABI) is a common phenomenon. Although brain injuries are increasing more and more, research on psychological therapies is comparably scarce. The present study compared, by means of a randomized controlled trial (RCT), a newly developed integrative treatment (Standard PLUS) to a standard neuropsychological treatment (Standard). Primary outcomes were depressive symptoms assessed with the Beck Depression Inventory (BDI-II) at post-treatment and 6-month follow-up assessment. In total, 25 patients (80% after a stroke) were randomized to one of the two conditions. Intention-to-treat analyses showed that the two groups did not significantly differ either at post-treatment nor at follow-up assessment regarding depressive symptoms. Both treatments showed large within-group effect sizes on depressive symptoms. Regarding secondary outcomes, patients in the Standard PLUS condition reported more emotion regulation skills at post-assessment than in the control condition. However, this difference was not present anymore at follow-up assessment. Both treatments showed medium to large within-group effects sizes on most measures for patients suffering from an AjD after ABI. More research with larger samples is needed to investigate who profits from which intervention.

A Comparison of Acupuncture with Advice and Exercises on the Symptomatic Treatment of Osteoarthritis of the Hip – a Randomised Controlled Trial

2001 ◽  
Vol 19 (1) ◽  
pp. 19-26 ◽  
Author(s):  
Roisin Haslam
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Symptomatic Treatment ◽  
Post Treatment ◽  
Control Group ◽  
Group A ◽  
Pre Treatment ◽  
Group B ◽  
Randomised Controlled

Acupuncture is becoming a common technique within the physiotherapy profession as a treatment modality for pain relief; however, few randomised controlled trials have been undertaken to assess the effectiveness of acupuncture, particularly in the treatment of osteoarthritis (OA) of the hip. Therefore, a randomised trial to compare the effectiveness of acupuncture with advice and exercises on the symptomatic treatment of OA of the hip was carried out. Thirty-two patients awaiting a total hip arthroplasty were randomly allocated to either the experimental group, (A), to have six sessions of acupuncture each lasting up to 25 minutes, or the control group, (B), to be given advice and exercises for their hip over a six week period. Group A consisted of three men and 13 women, and group B consisted of four men and eight women. The average age in group A was 66 years and in group B it was 68 years. Patients were assessed for pain and functional ability, using a modified version of the WOMAC questionnaire, pre-treatment, immediately post-treatment and at eight weeks post-treatment. The pre-treatment WOMAC scores in the two groups were similar (p=0.85). There was a significant improvement in group A (decrease in WOMAC score) immediately post-treatment (p=0.002) and this was maintained at the eight-week follow-up (p=0.03). There were no significant changes in group B. When the changes in WOMAC scores were compared between groups, a significantly greater improvement was found between pre-treatment and immediately post-treatment in group A, compared with group B (p=0.02). The changes between pre-treatment and the eight-week follow-up also showed a significant improvement in group A compared with group B (p=0.03). In conclusion, this trial supports the hypothesis that acupuncture is more effective than advice and exercises in the symptomatic treatment of OA of the hip.

scholarly journals 0532 Cognitive Behavioral Therapy Delivered Via Telemedicine vs. Face-to-Face: Results from a Randomized Controlled Non-Inferiority Trial

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A203-A204
Author(s):  
J Arnedt ◽  
D Conroy ◽  
A Mooney ◽  
K DuBuc ◽  
S Balstad ◽  
...  
Keyword(s):  
Behavioral Therapy ◽  
Severity Index ◽  
Healthcare Services ◽  
Post Treatment ◽  
Self Report ◽  
Daytime Functioning ◽  
Face To Face ◽  
Randomized Controlled ◽  
Pre Treatment

Abstract Introduction Telemedicine is increasingly an option for delivery of healthcare services, but its efficacy and acceptability for delivering CBT for insomnia has not been adequately tested. In a randomized controlled non-inferiority trial, we compared face-to-face and telemedicine delivery (via the AASM SleepTM platform) of CBT for insomnia for improving sleep and daytime functioning at post-treatment and 12-week follow-up. Methods Sixty-five adults with chronic insomnia (46 women, mean age 47.2 ± 16.3 years) were recruited primarily from insomnia clinics and screened for disqualifying sleep, medical, and mental health disorders. Eligible participants were randomized to 6 sessions of CBT for insomnia delivered face-to-face (n=32) or via AASM SleepTM (n=33). Participants completed self-report measures of insomnia (Insomnia Severity Index, ISI) and daytime functioning (fatigue, depression, anxiety, and overall functioning) at pre-treatment, post-treatment, and 12-week follow-up. The ISI was the primary non-inferiority outcome. Results Telemedicine was non-inferior to face-to-face delivery of CBT for insomnia, based on a non-inferiority margin of 4 points on the ISI (β = -0.07, 95% CI -2.28 to 2.14). Compared to pre-treatment, ISI scores improved significantly at post-treatment (β = -9.02, 95% CI -10.56 to -7.47) and at 12-week follow-up (β = -9.34, 95% CI -10.89 to -7.79). Similarly, daytime functioning measures improved from pre- to post-treatment, with sustained improvements at 12-week follow-up. Scores on the fatigue scale were lower in the telemedicine group at both post-treatment (F=4.64, df=1,119, p<.03) and follow-up (F=5.79, df=1,119, p<.02). Conclusion Insomnia and daytime functioning improve similarly whether CBT for insomnia is delivered via telemedicine or face-to-face. Telemedicine delivery of CBT for insomnia should be implemented more systematically to improve access to this evidence-based treatment. Support American Sleep Medicine Foundation Grant # 168-SR-17 (JT Arnedt, PhD)

Randomized controlled trial and uncontrolled 9-month follow-up of an adjunctive emotion regulation group therapy for deliberate self-harm among women with borderline personality disorder

2013 ◽  
Vol 44 (10) ◽  
pp. 2099-2112 ◽  
Author(s):  
K. L. Gratz ◽  
M. T. Tull ◽  
R. Levy
Keyword(s):  
Emotion Dysregulation ◽  
Controlled Trial ◽  
Borderline Personality ◽  
Post Treatment ◽  
Randomized Controlled ◽  
Self Harm ◽  
Treatment Gains ◽  
Destructive Behaviors

BackgroundDespite the clinical importance of deliberate self-harm (DSH; also referred to as non-suicidal self-injury) within borderline personality disorder (BPD), empirically supported treatments for this behavior among individuals with BPD are difficult to implement in many clinical settings. To address this limitation, a 14-week, adjunctive emotion regulation group therapy (ERGT) for DSH among women with BPD was developed. The current study examined the efficacy of this ERGT in a randomized controlled trial (RCT) and the durability of treatment gains over a 9-month uncontrolled follow-up period.MethodFemale out-patients with BPD and recent recurrent DSH were randomly assigned to receive this ERGT in addition to their ongoing out-patient therapy immediately (n = 31) or after 14 weeks (n = 30). Measures of DSH and other self-destructive behaviors, psychiatric symptoms, adaptive functioning and the proposed mechanisms of change (emotion dysregulation/avoidance) were administered pre- and post-treatment or -waitlist (to assess treatment efficacy), and 3 and 9 months post-treatment (to assess durability of treatment gains).ResultsIntent-to-treat (ITT) analyses (n = 61) revealed significant effects of this ERGT on DSH and other self-destructive behaviors, emotion dysregulation, BPD symptoms, depression and stress symptoms, and quality of life. Analyses of all participants who began ERGT (across treatment and waitlist conditions; n = 51) revealed significant improvements from pre- to post-treatment on all outcomes, additional significant improvements from post-treatment to 9-month follow-up for DSH, emotion dysregulation/avoidance, BPD symptoms and quality of life, and no significant changes from post-treatment to 9-month follow-up on the other measures.ConclusionsThe results support the efficacy of this ERGT and the durability of treatment gains.

Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial

2021 ◽  
pp. 108705472110569
Author(s):  
Stephen P. Becker ◽  
Kara M. Duraccio ◽  
Craig A. Sidol ◽  
Chaya E. M. Fershtman ◽  
Kelly C. Byars ◽  
...  
Keyword(s):  
Sleep Problems ◽  
Controlled Trial ◽  
Preliminary Evidence ◽  
Post Treatment ◽  
Open Trial ◽  
Post Intervention ◽  
Sleep Diaries ◽  
Adolescent Parent ◽  
Pre Treatment

Objective: An open trial tested the feasibility, acceptability, and preliminary effectiveness of a behavioral sleep intervention in adolescents with ADHD. Method: Fourteen adolescents (ages 13–17 years; 50% male) with ADHD and co-occurring sleep problems received the cognitive-behavioral-based Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-C). Adolescent, parent, and teacher ratings, actigraphy, and daily sleep diaries were collected at pre-intervention, post-intervention, and 3-month follow-up. Results: Adolescents experienced moderate to large improvements in sleep, mental health symptoms, and daily life executive functioning from pre-treatment to post-treatment, and improvements were generally maintained at 3 months. Pre-intervention, 71.4% of adolescents were classified as poor sleepers and this was reduced to 21.4% and 28.6% at post-treatment and follow-up, respectively. Conclusion: This study provides strong preliminary evidence that TranS-C improves sleep and associated outcomes in adolescents with ADHD and co-occurring sleep problems. A randomized controlled trial is needed to rigorously test the efficacy of TranS-C in this population.

Effect of Acupressure and Trigger Points in Treating Headache: A Randomized Controlled Trial

2010 ◽  
Vol 38 (01) ◽  
pp. 1-14 ◽  
Author(s):  
Lisa Li-Chen Hsieh ◽  
Horng-Huei Liou ◽  
Liang-Huei Lee ◽  
Tony Hsiu-Hsi Chen ◽  
Amy Ming-Fang Yen
Keyword(s):  
Muscle Relaxant ◽  
Chronic Headache ◽  
Controlled Trial ◽  
Trigger Points ◽  
Post Treatment ◽  
Controlled Clinical Trial ◽  
Treatment Technique ◽  
Medication Group ◽  
Randomized Controlled

The efficacy of acupressure in relieving pain has been documented; however, its effectiveness for chronic headache compared to the muscle relaxant medication has not yet been elucidated. To address this, a randomized, controlled clinical trial was conducted in a medical center in Southern Taiwan in 2003. Twenty-eight patients suffering chronic headache were randomly assigned to the acupressure group ( n = 14) or the muscle relaxant medication group ( n = 14). Outcome measures regarding self-appraised pain scores (measured on a visual analogue scale; VAS) and ratings of how headaches affected life quality were recorded at baseline, 1 month after treatment, and at a 6-month follow-up. Pain areas were recorded in order to establish trigger points. Results showed that mean scores on the VAS at post-treatment assessment were significantly lower in the acupressure group (32.9±26.0) than in the muscle relaxant medication group (55.7±28.7) ( p = 0.047). The superiority of acupressure over muscle relaxant medication remained at 6-month follow-up assessments ( p = 0.002). The quality of life ratings related to headache showed similar differences between the two groups in the post treatment and at six-month assessments. Trigger points BL2, GV20, GB20, TH21, and GB5 were used most commonly for etiological assessment. In conclusion, our study suggests that 1 month of acupressure treatment is more effective in reducing chronic headache than 1 month of muscle relaxant treatment, and that the effect remains 6 months after treatment. Trigger points help demonstrate the treatment technique recommended if a larger-scale study is conducted in the future.

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