scholarly journals Does craving for cocaine mediate cocaine use? Analysis of a randomized controlled pilot trial of memory-focused cognitive therapy

2019 ◽  
Vol 10 (3) ◽  
pp. 204380871986071 ◽  
Author(s):  
Camille Goetz ◽  
Tim Meynen ◽  
Luke Mitcheson ◽  
Nick Grey ◽  
Brian Eastwood ◽  
...  
Keyword(s):  
Emotion Regulation ◽  
Cognitive Therapy ◽  
Psychological Intervention ◽  
Behavioral Control ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Cocaine Use ◽  
Medication Therapy ◽  
Randomized Controlled ◽  
Cocaine Craving

Cocaine use disorder (CUD) is a debilitating psychopathology, with no recommended medication therapy or specific psychological intervention. Memory-focused cognitive therapy (MFCT) is a novel psychotherapy for CUD, theorized to modify and reconsolidate cocaine craving-related memories for cognitive and behavioral control. A pilot randomized controlled trial indicated that this therapy is associated with reduced craving and cocaine use. With an 80% confidence interval (CI) set for null hypothesis testing, we conducted an exploratory causal mediation analysis with confounder adjustment to determine whether increased cocaine abstinence following MFCT is mediated by reduced craving experience and increased emotion regulation. Participant data on the Difficulties in Emotion Regulation Scale did not meet screening evaluation as a potential mediator. Cocaine craving (assessed by the frequency version of the Craving Experiences Questionnaire) was associated with a total treatment effect of MFCT on cocaine abstinence at follow-up (1.499; 80% CI 1.114 to 1.970; p = .012). A significant natural indirect effect indicated that reductions in cocaine use were strongly mediated by reduced frequency of craving experience (1.753; 80% CI: 1.334 to 2.936; p < .0001). This study provides exploratory evidence in support of the theoretical action for MFCT and underscores the importance of craving as a therapeutic target.

Neurocognitive mechanisms of change following Preventive Cognitive Therapy for preventing relapse in depression: a randomized controlled trial.

2021 ◽  
Author(s):  
Marie-José van Tol ◽  
Rozemarijn Surya van Kleef ◽  
Ronja Eike ◽  
Evelien van Valen ◽  
Jan-Bernard Marsman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Emotion Regulation ◽  
Positive Affect ◽  
Cognitive Therapy ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Waiting List ◽  
List Condition ◽  
Randomized Controlled ◽  
Biased Processing

Major Depressive Disorder (MDD) is a prevalent psychiatric disorder, characterized by high relapse risk. With every new episode, risk for relapse increases. This makes preventing relapse an important clinical target in limiting the personal and societal burden of MDD. Preventive Cognitive Therapy (PCT) is a protocolized psychological therapy which has shown to lower relapse risk. How PCT attains its effects needs further elucidation. Understanding the treatment mechanisms provides a window to identify critical target points to prevent depressive relapse. In this randomized controlled trial, 50 patients remitted from at least two depressive episodes in the past five years were randomized to eight sessions of PCT (n=25) or to a waiting list condition (n=25) in the context of the NEWPRIDE trial. Primary outcome measures were changes in brain activation during effortful emotion regulation and in biased processing, covering both negative and positive valence dimensions. All patients were assessed twice (baseline and three-month follow-up) for these outcome measures, as well as their diagnosis, symptomatology, cognitive and affective reactivity, and emotion regulation styles. Linear Mixed Models and Repeated Measures ANOVAs were conducted to objectify the immediate changes induced by the therapy in brain reactivity, and clinical and cognitive measures. Following PCT, patients showed decreased recruitment of dorsomedial prefrontal regions during upregulation of positive affect and stable recruitment of the pregenual anterior cingulate cortex during regulation of emotions over valences, compared to the waiting list. No effects on biased processing of emotional information were observed. Furthermore, PCT resulted in a lower increase of depressive symptomatology over three months as compared to the waiting list condition. Finally, PCT resulted in increased activation of positive thoughts following reading positive self-related scenarios, lower responsivity of negative affect to negative stimuli and increased successful application of cognitive reappraisal to modify affective states. These results suggest that PCT obtains its relapse preventing effects by targeting mechanisms that underpin regulation of mood. More specifically, changes in regulation of positive affect and content of positive cognitions may decrease negative mood and affect. This supports cross-valence compensatory models of cognitive therapy and suggests that strengthening and shifting cognition and affect to more positive content may guard against the activation of negative cognitions and affect in the face of daily hassles and life events.

Preventive cognitive therapy versus care as usual in cognitive behavioral therapy responders: A randomized controlled trial.

2019 ◽  
Vol 87 (6) ◽  
pp. 521-529 ◽  
Author(s):  
Margo de Jonge ◽  
Claudi L. H. Bockting ◽  
Martijn J. Kikkert ◽  
Maarten K. van Dijk ◽  
Digna J. F. van Schaik ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Cognitive Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled

scholarly journals Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
J. Dubreucq ◽  
M. Faraldo ◽  
M. Abbes ◽  
B. Ycart ◽  
H. Richard-Lepouriel ◽  
...  
Keyword(s):  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Cognitive Therapy ◽  
Social Functioning ◽  
Serious Mental Illness ◽  
Controlled Trial ◽  
Control Group ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Self-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention combining psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma and its impact on recovery-related outcomes. Despite evidence of its effectiveness on self-stigma in schizophrenia-related disorders, it is unclear whether NECT can impact social functioning. Methods This is a 12-centre stepped-wedge cluster randomized controlled trial of NECT effectiveness on social functioning in SMI, compared to treatment as usual. One hundred and twenty participants diagnosed with schizophrenia, bipolar disorder or borderline personality disorder will be recruited across the 12 sites. The 12 centres participating to the study will be randomized into two groups: one group (group 1) receiving the intervention at the beginning of the study (T0) and one group (group 2) being a control group for the first 6 months and receiving the intervention after (T1). Outcomes will be compared in both groups at T0 and T1, and 6-month and 12-month outcomes for groups 1 and 2 will be measured without a control group at T2 (to evaluate the stability of the effects over time). Evaluations will be conducted by assessors blind to treatment allocation. The primary outcome is personal and social performance compared across randomization groups. Secondary outcomes include self-stigma, self-esteem, wellbeing, quality of life, illness severity, depressive symptoms and personal recovery. Discussion NECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial, it is likely that NECT will be implemented in psychiatric rehabilitation services with subsequent implications for routine clinical practice. Trial registration ClinicalTrials.gov NCT03972735. Trial registration date 31 May 2019.

Exploring cannabidiol effects on inflammatory markers in individuals with cocaine use disorder: a randomized controlled trial

2021 ◽  
Author(s):  
Florence Morissette ◽  
Violaine Mongeau-Pérusse ◽  
Elie Rizkallah ◽  
Paméla Thébault ◽  
Stéphanie Lepage ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Cocaine Use ◽  
Randomized Controlled

scholarly journals ‘Tracking Together’—Simultaneous Use of Human and Dog Activity Trackers: Protocol for a Factorial, Randomized Controlled Pilot Trial

2021 ◽  
Vol 18 (4) ◽  
pp. 1561
Author(s):  
Wasantha Jayawardene ◽  
Lesa Huber ◽  
Jimmy McDonnell ◽  
Laurel Curran ◽  
Sarah Larson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Activity Level ◽  
Analysis Of Covariance ◽  
Moderate Intensity ◽  
Randomized Controlled ◽  
Activity Trackers ◽  
Dog Owners ◽  
Simultaneous Use

Dog-walkers are more likely to achieve moderate-intensity physical activity. Linking the use of activity trackers with dog-walking may be beneficial both in terms of improving the targeted behavior and increasing the likelihood of sustained use. This manuscript aims to describe the protocol of a pilot study which intends to examine the effects of simultaneous use of activity trackers by humans and their dogs on the physical activity level of humans and dogs. This study uses nonprobability sampling of dog owners of age 25–65 (N = 80) and involves four parallel groups in an observational randomized controlled trial with a 2 × 2 factorial design, based on use of dog or human activity trackers for eight weeks. Each group consists of dog-human duos, in which both, either or none are wearing an activity tracker for eight weeks. At baseline and end, all human subjects wear ActiGraph accelerometers that quantify physical activity for one week. Commercial activity trackers are used for tracking human and dog activity remotely. Additional measures for humans are body composition and self-reported physical activity. Dog owners also report dog’s weight and physical activity using a questionnaire. A factorial analysis of covariance (ANCOVA) is used to compare physical activity across the four groups from baseline to week-10.

scholarly journals Oral dexamethasone for the prevention of acute migraine recurrence in pediatric patients presenting to the emergency department with migraine

2018 ◽  
Vol 1 ◽  
pp. 251581631880415
Author(s):  
Serena L Orr ◽  
Lawrence Richer ◽  
Nick Barrowman ◽  
Roger Zemek
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Recruitment Rate ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Oral Dexamethasone ◽  
Safety Outcomes

Objective: To assess the feasibility of a randomized controlled trial protocol that aims to determine the efficacy and safety of oral dexamethasone compared to placebo for the prevention of migraine recurrence in children and adolescents visiting the pediatric emergency department (ED) with migraine. Methods: This study was a two-arm, parallel-group, randomized, placebo-controlled, double-blind pilot trial of patients presenting to the pediatric ED with migraine. Eligible participants were randomized at 1:1 ratio to receive either oral dexamethasone 0.6 mg/kg (maximum 15 mg) or matched placebo as a single dose. Efficacy and safety outcomes were assessed at discharge, 48 h and 7 days after discharge. The primary outcome of the trial was feasibility and was assessed through participant recruitment rate, follow-up completion rates, participant satisfaction ratings and comparison of enrolled versus non-enrolled participants. Efficacy and safety outcomes were not analyzed given that this was a pilot study. Results: Twelve participants were enrolled over the 6-month recruitment period. This represents 60% of the planned sample size and a 10.5% recruitment rate. No other feasibility issues were identified and patients expressed high satisfaction rates with their treatment: 90.9% were satisfied with their treatment at discharge and at 48-h follow-up and 81.8% were satisfied with their treatment at 7-day follow-up (81.8%). There were no significant differences observed when comparing enrolled participants to those not enrolled. Conclusion: This pilot randomized controlled trial is the first to assess dexamethasone in the pediatric ED for the prevention of migraine recurrence. The protocol is feasible but recruitment in a single center was lower than expected. Future pediatric ED migraine studies may use innovative or pragmatic trial designs to maximize feasibility from a recruitment standpoint.

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