Within-treatment Changes Research Articles

Cannabis use and trauma-focused treatment for co-occurring posttraumatic stress disorder and substance use disorders: A meta-analysis of individual patient data

High rates of cannabis use among people with posttraumatic stress disorder (PTSD) have raised questions about the efficacy of evidence-based PTSD treatments for individuals reporting cannabis use, particularly those with co-occurring alcohol or other substance use disorders (SUDs). Using a subset of four randomized clinical trials (RCTs) included in Project Harmony, an individual patient meta-analysis of 36 RCTs (total N = 4046) of treatments for co-occurring PTSD+SUD, we examined differences in trauma-focused (TF) and non-trauma-focused (non-TF) treatment outcomes for individuals who did and did not endorse baseline cannabis use (N = 410; 70% male; 33.2% endorsed cannabis use). Propensity score-weighted mixed effects modeling evaluated main and interactive effects of treatment assignment (TF versus non-TF) and baseline cannabis use (yes/no) on attendance rates and within-treatment changes in PTSD, alcohol, and non-cannabis drug use severity. Results revealed significant improvements across outcomes among participants in all conditions, with larger PTSD symptom reductions but lower attendance among individuals receiving TF versus non-TF treatment in both cannabis groups. Participants achieved similar reductions in alcohol and drug use across all conditions. TF outperformed non-TF treatments regardless of recent cannabis use, underscoring the importance of reducing barriers to accessing TF treatments for individuals reporting cannabis use.

The Clinical Relevance of Impulsivity in Substance Use Disorder Treatment: Examining Within-treatment Changes and Relationship to Psychiatric Symptoms and Cravings in a Large Inpatient Sample.

Impulsivity is a multidimensional construct that is consistently associated with problematic substance use, but less is known about its relevance to clinical outcomes. The current study examined whether impulsivity changed over the course of addiction treatment and whether the changes were associated with changes in other clinical outcomes. Participants were patients in a large inpatient addiction medicine program (N = 817; 71.40% male). Impulsivity was assessed using a self-report measure of delay discounting (DD; i.e., overvaluation of smaller immediate rewards) and the UPPS-P, a self-report measure of impulsive personality traits. Outcomes were psychiatric symptoms including depression, anxiety, PTSD, and drug cravings. Within-subjects ANOVAs revealed significant within-treatment changes in all UPPS-P subscales, all psychiatric indicators, and craving (ps < .005), but not DD. Changes in all UPPS-P traits, except for Sensation Seeking, were significantly positively associated with changes in psychiatric symptoms and cravings over the course of treatment (all ps <.01). These findings reveal that facets of impulsive personality change across treatment and are generally related to positive changes in other clinically relevant outcomes. Evidence of change despite no explicit intervention targeting suggests that impulsive personality traits may be viable treatment targets in substance use disorder treatment.

Within-treatment changes in a novel addiction treatment program using traditional Amazonian medicine.

Aims:The therapeutic use of psychedelics is regaining scientific momentum, but similarly psychoactive ethnobotanical substances have a long history of medical (and other) uses in indigenous contexts. Here we aimed to evaluate patient outcomes in a residential addiction treatment center that employs a novel combination of Western and traditional Amazonian methods.Methods:The study was observational, with repeated measures applied throughout treatment. All tests were administered in the center, which is located in Tarapoto, Peru. Data were collected between 2014 and 2015, and the study sample consisted of 36 male inpatients who were motivated to seek treatment and who entered into treatment voluntarily. Around 58% of the sample was from South America, 28% from Europe, and the remaining 14% from North America. We primarily employed repeated measures on a psychological test battery administered throughout treatment, measuring perceived stress, craving frequency, mental illness symptoms, spiritual well-being, and physical and emotional health. Addiction severity was measured on intake, and neuropsychological performance was assessed in a subsample from intake to at least 2 months into treatment.Results:Statistically significant and clinically positive changes were found across all repeated measures. These changes appeared early in the treatment and were maintained over time. Significant improvements were also found for neuropsychological functioning.Conclusion:These results provide evidence for treatment safety in a highly novel addiction treatment setting, while also suggesting positive therapeutic effects.

A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial

BackgroundSubacromial pain syndrome (SPS) involving rotator cuff tendinopathy is a common cause of shoulder pain and disability. Evidence suggests that structured physiotherapy may be as effective as surgery in this condition with significant improvements demonstrated in trials involving scapular retraining, rotator cuff strengthening and flexibility exercises. Most published programs typically utilise isotonic concentric and/or eccentric strengthening modes. Recently, immediate analgesic effects and muscle strength gains following heavy-load isometric exercises in lower limb tendinopathy conditions have been observed. It is pertinent to ascertain whether such outcomes can be replicated in SPS/rotator cuff tendinopathy. The primary aim of this study is to establish the feasibility of undertaking a full-scale randomised controlled trial (RCT) that compares the effects of isometric, isotonic concentric and isotonic eccentric rotator cuff contractions when used as part of a semi-standardised exercise-based physiotherapy program in patients diagnosed with SPS. The secondary aim is to explore potential trends or treatment effects of the exercise intervention.MethodsThirty-six participants diagnosed with SPS will be randomised to one of three intervention groups and undergo a one-on-one exercise-based physiotherapy intervention, involving scapular and rotator cuff muscle retraining and strengthening. Each group will utilise a different mode of rotator cuff strengthening—isometric, isotonic concentric or isotonic eccentric. Rotator cuff tendon responses to isometric loading are not yet established in the literature; hence, individualised, progressive loading will be used in this pilot study in accordance with symptoms. The intervention will involve two phases: during Phase 1 (weeks 1–6) participants undertake the active group-specific physiotherapy treatment; in Phase 2 (weeks 6–12), they undertake a progressive, but no longer group-specific exercise program. To determine feasibility, an evaluation of key study parameters including (a) ease of recruitment (rate and number as well as suitability of the assessment algorithm), (b) adherence to all phases of the exercise intervention including home program compliance and logbook completion, (c) participant non-completion (drop out number and rate) and (d) adverse events (nature and number) will be undertaken. Secondary outcomes will measure immediate effects: (i) within-treatment changes in pain perception (verbal rating scale (VRS) and shoulder muscle strength (hand-held dynamometer) as well as longer-term changes: (ii) shoulder-related symptoms and disability (Western Ontario Rotator Cuff Index (WORC) and Shoulder Pain and Disability Index (SPADI)), (iii) perception of pain (11-point numerical rating scale (NRS), (iv) shoulder muscle strength (hand-held dynamometer) and (v) perceived global rating of change score. The immediate within-treatment assessment of pain and muscle strength will be undertaken in treatments 2 and 3, and the longer term measures will be collected at the primary (conclusion of Phase 1 at 6 weeks) and secondary (conclusion of Phase 2 at 12 weeks) end-points of the study.DiscussionThe findings of this pilot study will permit evaluation of this study design for a full-scale RCT.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12616001676404

Do Extremely Violent Juveniles Respond Differently to Treatment?

This study increases knowledge on effectiveness of treatment for extremely violent (EV) youth by investigating their response to multisystemic therapy (MST). Using data of a randomized controlled trial on effectiveness of MST, we investigated differences in treatment response between EV youth and not extremely violent (NEV) youth. Pre- to post-treatment comparison indicated MST was equally effective for EV and NEV youth, whereas treatment as usual was not effective for either group. Growth curves of within-treatment changes indicated EV youth responded differently to MST than NEV youth. The within-treatment change was for EV youth non-linear: Initially, they show a deterioration; however, after one month, EV juveniles respond positively to MST, indicating longer lasting, intensive programs may be effective in treating extreme violence.

The relationship between alliance and outcome: Analysis of a two-person perspective on alliance and session outcome.

Better alliance is known to predict better psychotherapy outcomes, but the interdependent and interactive effects of both therapist- and patient-reported alliance levels have yet to be systematically investigated. Using actor-partner interdependence model analysis the authors estimated actor, partner, and 2 types of interactive effects of alliance on session outcome in a sample of 241 patient-therapist dyads across 30 sessions of cognitive-behavioral and alliance-focused therapy. Findings suggest that the most robust predictors of session outcome are within-treatment changes in patient reports of the alliance, which predict both patient and therapist report on outcome. Within-treatment changes in therapist reports of the alliance, as well as differences between patients and between therapists in their average ratings of alliance levels across treatment, predict outcome as reported by the specific individual. Although alliance was found to be a significant predictor of outcome in both treatments, for therapist-reported alliance and outcome it had a stronger effect in alliance-focused therapy than in cognitive-behavioral therapy. Additionally, dyads with the highest pooled level of alliance from both partners fared best on session outcome. The results are consistent with a 2-person perspective on psychotherapy, demonstrating the importance of considering the interdependent and interactive nature of both patient and therapist alliance levels on session outcome. (PsycINFO Database Record

Glycemic and serum lipid control in patients with painful diabetic peripheral neuropathy treated with pregabalin

AimTo evaluate pregabalin effects on glycemic (hemoglobin A1c [HbA1c] and glucose) and lipid (low- and high-density lipoprotein [LDL and HDL, respectively], and total cholesterol, and triglycerides) control in patients with painful diabetic peripheral neuropathy (pDPN). MethodsData from 11 randomized, double-blind trials were pooled to assess change-from-baseline treatment differences (pregabalin or placebo) in glycemic and lipid parameters using analysis of covariance. ResultsPatients received pregabalin doses (mg/d) of 150 (n=176), 300 (n=559), 600 (n=705), 150–600 (flexible dose, n=521), or placebo (n=1050). Statistically significant mean [95% confidence interval] within-treatment (pregabalin) changes occurred in HDL (600mg/d: –1.61mg/dl [–3.17, –0.05]), total cholesterol (flexible dose: –6.03mg/dl [–11.68, –0.39]), and triglycerides (flexible dose: +15.39mg/dl [1.56, 29.23]). Statistically significant differences from placebo were found in HbA1c (300mg/d: +0.11% [0.01, 0.21]) and HDL cholesterol (300mg/d: –1.78mg/dl [–3.36, –0.19], 600mg/d: –2.53mg/dl [–4.49, –0.57]). No within- or between-treatment changes were large enough to be clinically meaningful. ConclusionNo apparent clinically meaningful effects of pregabalin on glycemic/lipid control were found in patients with pDPN.

A cluster analytic examination and external validation of psychopathic offender subtypes in a multisite sample of Canadian federal offenders.

The present study is a cluster analytic examination and validation of psychopathic offender subtypes from 4 combined samples of Canadian federally incarcerated offenders, most of whom were serving sentences for violent offenses. The men were rated on the Hare Psychopathy Checklist-Revised (PCL-R; Hare, 1991, 2003) on the basis of comprehensive file information and 314 cases were extracted using a PCL-R total cut score of 25. Cluster analysis of the 4 PCL-R facets converged at a 2-cluster solution: a primary subtype characterized by prominent interpersonal and affective features of psychopathy and a secondary subtype characterized by comparatively few interpersonal features and high scores on the remaining facets. Validation analyses found that the vast majority of primary psychopathic offenders (74.1%) were White or of non-Aboriginal descent in contrast to the secondary subtype (47.6%). Secondary psychopathic offenders tended to be actuarially higher risk, have greater criminogenic needs, and to make greater amounts of treatment change on criminogenic targets; however, contrary to expectations, within-treatment changes from a violence reduction program were significantly associated with reductions in violent recidivism for primary, but not secondary, variants. There were few differences in rates of recidivism between the groups overall; secondary variants had higher rates of sexual violence which was largely accounted for by individual differences in baseline static risk. Implications for risk assessment, treatment planning, and the classification and etiology of primary and secondary psychopathy are discussed.

Violent Offenders’ Within-Treatment Change in Anger, Criminal Attitudes, and Violence Risk: Associations with Violent Recidivism

This study aimed to examine the recidivist outcomes for a group of incarcerated violent offenders, based on whether they achieved pre-post raw psychometric change, reliable change, and/or clinically significant change (CSC) following treatment completion. Participants included 42 adult male violent offenders (age range 21 to 67 years) who participated in a medium- or high-intensity, group-based violent offender treatment program offered within prisons, operated by Corrections Victoria. These men were followed in the community for an average of 3.9 years post-release, and were assessed on four risk-related variables pre- and post-treatment: General Criminal Thinking (GCT), Trait Anger (T-Ang), Anger Expression/Out (AX/O), and Overall Violence Risk (OVR). Mean levels of GCT and OVR significantly reduced following treatment; no significant changes in T-Ang and AX/O were observed. Although a small proportion of offenders achieved reliable and/or CSC, within-treatment changes were not predictive of violent recidivism. This article describes, critiques, and tests methods of intra-individual within-treatment change and provides a blueprint for future analyses linking intra-individual change and violent reoffending.

Within-treatment changes in dynamic criminogenic risk factors among incarcerated sexual and violent offenders

Im Bereich der Evaluation von Straftaterbehandlung dominiert nach wie vor die Legalbewahrung in den Jahren nach Entlassung als wichtigstes Erfolgskriterium. Auch wenn Metaanalysen positive Effekte in Bezug auf die Ruckfalligkeit zeigen, ist oft unklar, inwieweit sich die in der Behandlung bearbeiteten kriminogenen Risikofaktoren tatsachlich verandert haben. Kaum untersucht wurde bisher auch, ob sich mogliche Veranderungen dieser Merkmale zwischen verschiedenen Deliktgruppen unterscheiden. Diese beiden Fragestellungen werden in der vorliegenden Studie anhand von auf Selbsteinschatzung beruhenden Pra-Post-Erhebungen kriminogener Merkmale an sozialtherapeutisch behandelten sowie im Regelvollzug verbliebenen Sexual- und Gewaltstraftatern untersucht. Die Analysen belegten prosoziale Verbesserungen einiger kriminogener Merkmale wie z. B. Selbstkontrolle, Erregbarkeit oder Neurotizismus, diese Verbesserungen unterschieden sich jedoch selten zwischen den in der Sozialtherapie und den im Regelvollzug untergebrachten Probanden. Auch hinsichtlich der Unterscheidung Sexual- vs. Gewaltstraftater ergaben sich kaum differenzielle Veranderungen, jedoch fanden sich signifikante Interaktionen zwischen Vollzugs- und Deliktart bei den Merkmalen Selbstkontrolle, Aggressivitat und Neurotizismus. Wahrend sozialtherapeutisch behandelte Gewaltstraftater starkere Veranderungen in prosozialer Richtung zeigten als Gewaltstraftater des Regelvollzugs, ergab sich bei Sexualstraftatern der entgegengesetzte Trend. Mogliche Erklarungsansatze fur diese Ergebnisse werden diskutiert. Insgesamt sind umfassendere Strategien der Evaluation notwendig, um die durch Straftaterbehandlung beabsichtigten Veranderungen zu messen und darauf aufbauend die Interventionen optimieren zu konnen.

Mechanisms of Change in Cognitive Processing Therapy and Prolonged Exposure Therapy for PTSD: Preliminary Evidence for the Differential Effects of Hopelessness and Habituation

The present study examined two potential mechanisms of change, hopelessness cognitions and habituation, in a randomized controlled trial of cognitive processing therapy (CPT) and prolonged exposure therapy (PE) for posttraumatic stress disorder (PTSD). Participants were 171 adult women with a current primary diagnosis of sexual assault related PTSD. The potential mechanisms were examined by evaluating the intraindividual change in hopelessness within the course of both treatments and subjective units distress (SUDS) ratings (a proxy for habituation) within the course of PE. The effects of intraindividual change in the proposed mechanisms were then examined on within-treatment changes in PTSD symptoms. Findings indicated that the participants assigned to the CPT treatment had significantly greater pre-post reductions in hopelessness than those assigned to PE and that the changes in hopelessness predicted changes in PTSD symptoms (R2 = .24). Intraindividual changes in SUDS ratings for participants in the PE treatment condition also predicted changes in PTSD symptoms and did so independently of the effect of changes in hopelessness. Future research should examine these mechanisms using more intensive methods of data collection that would permit the demonstration of temporality of change.

Effects of Valsartan Alone Versus Valsartan/Simvastatin Combination on Ambulatory Blood Pressure, C-Reactive Protein, Lipoproteins, and Monocyte Chemoattractant Protein–1 in Patients With Hyperlipidemia and Hypertension

Angiotensin receptor blockers have been hypothesized to have synergistic effects with statins. We evaluated the effects of valsartan alone or combined with simvastatin on blood pressure (BP) and indexes of inflammation and oxidant stress in hypertensive patients with hyperlipidemia. In this double-blind trial, 404 patients were randomized to 12 weeks valsartan 160 mg (V) or valsartan 160 mg plus simvastatin 20 mg (V/S20) or 80 mg (V/S80). Twenty-four-hour mean ambulatory BP and biochemical marker measurements were recorded at baseline and study end. There were no statistically significant between-treatment differences for least-square mean reductions from baseline in systolic BP (V, -9.22; V/S20, -9.25; V/S80, -9.58 mm Hg; p <0.0001 for all within-treatment changes vs baseline). Plasma high-sensitivity C-reactive protein decreased with the combinations but not with V alone (least-square mean median change from baseline, -0.16, -0.20, -0.70 mg/L; p = 0.0001 for V/S80 vs baseline; p = 0.045 for V/S20 vs baseline; p = 0.0023 for V/S80 vs V/S20; p = 0.0045 for V/S80 vs V). Monocyte chemoattractant protein-1 was reduced by V, with no evidence for additional lowering with V/S combinations. In conclusion, addition of simvastatin to valsartan did not incrementally lower BP. However, V/S80 was superior to V and V/S20 in reducing high-sensitivity C-reactive protein.

An Exploratory Open Label Trial of Tegaserod in Non-Erosive GERD Patients with Incomplete Response to PPIʼs

Purpose: Forty to 50% of patients treated with PPI's for non-erosive GERD (NERD) have persistent upper gastrointestinal symptoms. A previous study has shown that tegaserod improves variables of mechanical hypersensitivity and symptoms in patients with functional heartburn, suggesting tegaserod may be useful in symptomatic NERD. Aim: To determine if addition of tegaserod (6mg BID) to a prescribed PPI regimen improves: (1) Global GERD assessments and (2) occurrence, frequency, severity and distress of 10 upper gastrointestinal symptoms. Methods: This 4-week open-label, randomized, two-center, parallel-group pilot study followed a 4-week screening and 2-week baseline period. NERD patients on stable PPI's for at least 30 days with persistent symptoms were eligible. Treatments were: PPI + tegaserod 6 mg bid (Teg) or PPI alone in a 2:1 allocation. Patients completed weekly and end of treatment global symptom assessments. A GERD Symptom Assessment Questionnaire (GSAQ) was completed at screening and after treatment. A Global Composite Index Score (GCIS) was calculated from the GSAQ. Within-treatment changes from baseline were evaluated using paired t-tests. Between treatment comparisons employed analyses of covariance for continuous parameters, van Elteren's test for ordinal parameters, and Cochran-Mantel-Haenszel tests for dichotomous parameters. Results: Forty-one patients were evaluated (Age 21–63 yrs; 20 Males, 21 Females; n = 27 Teg + PPI; n = 14 PPI). Between treatment comparisons of global GERD assessments vs. pre-study were significant for Teg + PPI at week 1 (p = 0.02) and week 3 (p = 0.03). Occurrence of heartburn/acid reflux, regurgitation, abdominal bloating and nausea were improved at the final visit by Teg + PPI vs PPI alone (all p < 0.05). Frequency, severity and bothersomeness of regurgitation and nausea were improved at the final visit by Teg + PPI vs PPI alone (all p < 0.05). Teg+ PPI improved the GCIS from baseline to the final visit (p = 0.0002). Tegaserod was well tolerated, with no serious adverse events reported. Conclusions: Tegaserod in combination with a PPI significantly improved several global and individual symptom assessments in NERD patients with incomplete relief from PPI's. Data from this trial justifies investigation of the potential utility of tegaserod in patients with NERD.

The interpretation of negative social events in social phobia: changes during treatment and relationship to outcome

Catastrophic interpretations of negative social events are considered to be an important factor underlying social phobia. This study investigated the extent to which these interpretative biases change during cognitive-behavioural treatment for social phobia, and examined whether within-treatment changes in different types of interpretations predict longer-term treatment outcome. Results showed that treatment was associated with decreases in various types of maladaptive interpretations of negative social events, but that social phobia symptoms 3 months after treatment were independently predicted only by within-treatment reductions in the degree to which individuals personally believed that negative social events were indicative of unfavourable self-characteristics. These findings are discussed in relation to cognitive models of the maintenance of social anxiety, and implications for treatment are considered.

Losartan versus valsartan in the treatment of patients with mild to moderate essential hypertension: data from a multicenter, randomized, double-blind, 12-week trial

Background: Losartan, the first of the angiotensin II receptor blockers (ARBs) to be introduced, has been studied extensively in comparison with other classes of antihypertensive agents. Less research has been conducted on the efficacy and tolerability of losartan compared with that of other ARBs. Objective: This randomized, multicenter, double-blind, parallel-group equivalence study was conducted to compare the antihypertensive efficacy and tolerability of a once-daily regimen of losartan with that of valsartan. Methods: Patients ≥21 years of age with mild to moderate hypertension, defined as a trough sitting diastolic blood pressure (SiDBP) between 95 and 115 mm Hg, were randomized to receive once-daily losartan (50 mg) or valsartan (80 mg) for 12 weeks. At the end of the sixth treatment week, patients in both groups with trough SiDBP ≥90 mm Hg had their dose doubled for the remainder of the treatment period. Analysis of variance was used to compare treatment groups with respect to change in mean trough SiDBP from baseline to week 12. Within-treatment changes were analyzed using the paired t test. With at least 220 patients per treatment group, the study had 90% power to place a 90% CI on the difference between losartan and valsartan in SiDBP within the equivalence interval of ±2.5 mm Hg. Results: A total of 495 patients were randomized, 247 to the losartan group and 248 to the valsartan group; 456 patients completed the study. Adjusted mean change from baseline values for trough SiDBP at the end of 12 weeks of treatment were significantly different ( P < 0.001) from zero in both the losartan group (−9.9 mm Hg) and the valsartan group (−10.1 mm Hg). At week 12, losartan was as effective as valsartan in lowering SiDBP, with a between-group difference of 0.2 mm Hg (90% CI, −1.3 to 1.7; P = 0.827). At week 6, the difference in SiDBP between groups was −1.3 mm Hg (90% CI, −2.7 to 0.0; P = 0.106). A similar pattern of results was obtained at weeks 6 and 12 for sitting systolic blood pressure. The percentage of patients reaching the SiDBP goal at week 6 (46% [112/241] losartan; 42% [103/245] valsartan) and week 12 (57% [139/243] losartan; 59% [145/245] valsartan) was not significantly different between the treatment groups. Both losartan and valsartan were similarly well tolerated. Over the 12 weeks, the laboratory profiles of the 2 drugs were similar except for serum uric acid levels, which decreased from 6.0 to 5.7 mg/dL in the losartan group and increased from 5.9 to 6.0 mg/dL in the valsartan group ( P = 0.001 for between-treatment difference). Conclusions: At starting and titrated doses, losartan and valsartan are similarly effective in reducing blood pressure in patients with mild to moderate hypertension. Losartan, but not valsartan, was associated with a decrease in serum uric acid levels.