scholarly journals Role of pill-taking, expectation and therapeutic alliance in the placebo response in clinical trials for major depression

2014 ◽  
Vol 205 (6) ◽  
pp. 443-449 ◽  
Author(s):  
Andrew F. Leuchter ◽  
Aimee M. Hunter ◽  
Molly Tartter ◽  
Ian A. Cook

BackgroundPill-taking, expectations and therapeutic alliance may account for much of the benefit of medication and placebo treatment for major depressive disorder (MDD).AimsTo examine the effects of medication, placebo and supportive care on treatment outcome, and the relationships of expectations and therapeutic alliance to improvement.MethodA total of 88 participants were randomised to 8 weeks of treatment with supportive care alone or combined with double-blind treatment with placebo or antidepressant medication. Expectations of medication effectiveness, general treatment effectiveness and therapeutic alliance were measured (trial registration at ClinicalTrials.gov: NCT00200902).ResultsMedication or placebo plus supportive care were not significantly different but had significantly better outcome than supportive care alone. Therapeutic alliance predicted response to medication and placebo; expectations of medication effectiveness at enrolment predicted only placebo response.ConclusionsPill treatment yielded better outcome than supportive care alone. Medication expectations uniquely predicted placebo treatment outcome and were formed by time of enrolment, suggesting that they were shaped by prior experiences outside the clinical trial.

2018 ◽  
Vol 78 (2) ◽  
pp. 179-185 ◽  
Author(s):  
Danielle M Gerlag ◽  
Mary Safy ◽  
Karen I Maijer ◽  
Man Wai Tang ◽  
Sander W Tas ◽  
...  

ObjectivesWe explored the effects of B-cell directed therapy in subjects at risk of developing autoantibodypositive rheumatoid arthritis (RA), who never experienced inflammatory arthritis before, and explored biomarkers predictive of arthritis development.MethodsIndividuals positive for both anti-citrullinated peptide antibodies and rheumatoid factor but without arthritis were included in a randomised, double-blind, placebo-controlled study to receive a single infusion of 1000 mg rituximab or placebo.ResultsEighty-one individuals received treatment and were followed up for a mean of 29.0 (0–54) months, during which 30/81 (37%) individuals developed arthritis. The observed risk of developing arthritis in the placebo-treated group was 40%, which was decreased by 55% (HR 0.45, 95% CI 0.154 to 1.322) in the rituximab-treated group at 12 months. Rituximab treatment caused a delay in arthritis development of 12 months compared with placebo treatment at the point when 25% of the subjects had developed arthritis (p<0.0001). Erythrocyte sedimentation rate and the presence of anti-citrullinated α-enolase peptide 1 at baseline were significant predictors of arthritis development.ConclusionsA single infusion of 1000 mg rituximab significantly delays the development of arthritis in subjects at risk of developing RA, providing evidence for the pathogenetic role of B cells in the earliest, prearthritis stage of autoantibody positive RA.


Cephalalgia ◽  
2002 ◽  
Vol 22 (9) ◽  
pp. 730-739 ◽  
Author(s):  
AIM Nilsson Remahl ◽  
R Ansjön ◽  
F Lind ◽  
E Waldenlind

Sixteen patients, 12 with episodic and four with chronic cluster headache (CH) according to the International Headache Society criteria (1), participated in the study. They were randomly selected to start with one out of two different hyperbaric treatments in a double-blind, placebo-controlled, cross-over study design. Both gases were administered by mask inside a multiplace hyperbaric chamber for 70 min at 250 kPa (2.5 ATA) in two sessions 24 h apart. Active treatment was 100% oxygen (HBO treatment), while placebo treatment was 10% oxygen in nitrogen (hyperbaric normoxic placebo = sham treatment) corresponding to breathing air at sea level. All patients were decompressed on air. The patients documented the number of headache attacks and their degree of severity according to a modified VAS scale (level 0-4, where level 0 = no headache and level 4 = very severe headache). A headache index (HI = sum of (number of attacks times degree of severity)) was calculated for the run-in week prior to and the week after each separate treatment. A treatment was regarded as effective if it reduced the HI by > 50%. Blood samples were taken from the external jugular vein before and during hyperbaric treatment (after 30 and 70 min), 1 day and 1 week after each treatment for analyses of calcitonin gene-related peptide (CGRP), vasoactive intestinal peptide (VIP) and neuropeptide Y (NPY) and in a few patients also endotheline and nitrate. No difference between HBO and sham treatment on the HI or the prophylactic effect was observed in our study. However, 83% of the episodic CH patients and 25% of the chronic ones responded to either of the two treatments with at least 50% reduction of HI or remission for shorter or longer periods. This response rate exceeds an expected high placebo response due to the study procedure. Two episodic CH patients still experienced remission on follow-up 1 year after sham treatment. Five patients reported mild or moderate CH attacks during the sham treatment, and none during the HBO treatment. Changes in neuropeptides, endotheline and nitrate levels did not differ systematically when comparing the two different hyperbaric treatments or with respect to responders and non-responders. We conclude that two HBO sessions were not more effective than two sham treatments in reducing the HI and interrupting the CH period when given in a well-established cluster period or in chronic CH. The hyperbaric condition itself seems effective in reducing the HI, at least in patients with episodic CH, although a powerful placebo response can not be ruled out.


Author(s):  
Volker Tschuschke ◽  
Margit Koemeda-Lutz ◽  
Agnes von Wyl ◽  
Aureliano Crameri ◽  
Peter Schulthess

AbstractThis article investigates distances between therapists and their clients in their experience of the therapeutic alliance across the duration of the psychotherapeutic treatments in a naturalistic study. We looked at the working alliances from different vantage points—rupture, repair of ruptures, distances in the alliance impressions of both clients and therapists—and their correlation with treatment outcome. The only predictive variable of alliance ruptures was the inability of therapists to bond sufficiently with their clients regarding a sustainable working atmosphere, which could be identified through a continuous distant alliance rating by the therapists. Alliance ruptures in turn significantly predicted premature termination of treatments, whereas alliance ruptures per se did not necessarily predict treatment outcome. The paper discusses the possible role of the quality of therapists’ attachment styles as a potentially crucial variable in an effective working alliance in psychotherapy.


2020 ◽  
Vol 29 (11) ◽  
pp. 1593-1601 ◽  
Author(s):  
Patty van Benthem ◽  
Renske Spijkerman ◽  
Peter Blanken ◽  
Marloes Kleinjan ◽  
Robert R. J. M. Vermeiren ◽  
...  

Abstract We investigated the potential role of first-session therapeutic alliance ratings to serve as an early marker of treatment outcome in youth mental health and addiction treatment. The present study is among the first to incorporate both a youths’ and a therapists’ perspective of the therapeutic alliance in order to maximize predictive value of the alliance for treatment outcome. One hundred and twenty-seven adolescents participated in a multi-site prospective naturalistic clinical cohort study, with assessments at baseline and at 4 months post-baseline. Main outcome measure was favorable or unfavorable treatment outcome status at 4-month follow-up. Early therapeutic alliance had a medium and robust association with treatment outcome for youth’ (b = 1.29) and therapist’ (b = 1.12) perspectives and treatment setting. Based on the two alliance perspectives four subgroups were distinguished. Incorporating the alliance-ratings from both perspectives provided a stronger predictor of treatment outcome than using one perspective. Youth with a strong alliance according to both perspectives had an eightfold odds of favorable treatment outcome compared with youth with a weak alliance according to both perspectives. The association between therapeutic alliance and treatment outcome in youth mental health and addiction treatment may be substantially stronger than earlier assumed when both a youths’ and therapists’ perspective on alliance is considered.


2021 ◽  
Author(s):  
◽  
Elizabeth C. Ross

<p>The role of the therapeutic alliance (TA) has largely been ignored in the field of high-risk violent offender treatment. The focus on effective manualised treatment that reduces recidivism has led to improvements in treatment programme delivery, but at the cost of examining the therapy process. Considering previous research has consistently linked levels of alliance with treatment outcome in clinical and community treatment settings, it is imperative to investigate the role of the TA within high-risk violent offender treatment, because of the particularly challenging group that they represent. The aim of this thesis was to examine the relationship between the TA and treatment outcome, and the various factors that influence this relationship, within a violence prevention setting. To achieve this aim, a longitudinal study was conducted at the Rimutaka Violence Prevention Unit (RVPU) in Wellington, New Zealand, with a cohort of 70 men in treatment and their therapists, examining the TA, treatment outcome and associated variables over four time points throughout the eight month treatment programme. The results of this research are reported as four related studies. Study One explored the structure and patterns of the Working Alliance Inventory (WAI). Study One Part A was a Confirmatory Factor Analysis of the WAI, which tested the competing models of the factor structure of the WAI and explored whether rater perspective (client, therapist, observer) had an effect on the structure. It was found that a two-factor structure was the best fit for the WAI, and that all rater perspectives shared this structure. Study One Part B explored the pattern of the WAI over the four time periods of this study in order 8 to understand how the WAI changes over time, and whether this pattern differed by rater perspective. The results confirmed that changes in all rater perspectives showed a linearly increasing pattern of alliance over time. Study Two explored the client factors that affect the initial formation of the TA and examined whether these factors were specific to an "offender" or "general" client profile informed by previous research. Two client factors specific to an offender profile - motivation to change and criminal attitudes - were found to be significantly associated with the initial formation of the TA. Study Three examined the relationship between the TA and treatment outcome, and explored whether there were any factors that co-varied with or moderated this relationship. A small but significant association between alliance and outcome was found; however no significant co-varying or moderating factors were discovered. Lastly, Study Four drew together the data from Study Two and Study Three and tested whether these results fit the Revised Theory of the Therapeutic Alliance (RTTA) model (Ross, Polaschek, & Ward, 2008), or other models previously reported in the literature. Several significant models were found that partly supported the RTTA. The best of these models incorporated client motivation to change, TA and treatment outcome as measured by change in risk of violent reoffending. Overall, the results of this study support the importance of the TA and client motivation to change in violent offender treatment. The implications for these results and the clinical applications are discussed, limitations are outlined, and directions for future research are suggested.</p>


2012 ◽  
Vol 1 (2) ◽  
pp. 137-148 ◽  
Author(s):  
Tarra Rawdon ◽  
Rick L. Sharp ◽  
Mack Shelley ◽  
Jerry R. Thomas

This paper is a meta-analysis of the role of nutritional supplements in strength training focusing on the effects of placebo treatments. We address specifically the results from meta-analysis of 334 fi.ndings from 37 studies of the effect of nutritional supplements and physical fitness interventions on strength, stamina, and endurance outcomes, controlling for main effects of the group on which the results were obtained (placebo, treatment, control, for pretest or posttest), with covariates for age, gender, randomization, double-blind procedures, study duration, training load, training frequency, and training status. Finding show that there are significant placebo effects accounting for a substantial portion of the effect size typically associated with treatment interventions. In addition to produce the best evaluations of treatment effects, both control and placebo groups should be included in a double-blind research design using participants who are well familiarized with the study procedures.


2021 ◽  
Author(s):  
◽  
Elizabeth C. Ross

<p>The role of the therapeutic alliance (TA) has largely been ignored in the field of high-risk violent offender treatment. The focus on effective manualised treatment that reduces recidivism has led to improvements in treatment programme delivery, but at the cost of examining the therapy process. Considering previous research has consistently linked levels of alliance with treatment outcome in clinical and community treatment settings, it is imperative to investigate the role of the TA within high-risk violent offender treatment, because of the particularly challenging group that they represent. The aim of this thesis was to examine the relationship between the TA and treatment outcome, and the various factors that influence this relationship, within a violence prevention setting. To achieve this aim, a longitudinal study was conducted at the Rimutaka Violence Prevention Unit (RVPU) in Wellington, New Zealand, with a cohort of 70 men in treatment and their therapists, examining the TA, treatment outcome and associated variables over four time points throughout the eight month treatment programme. The results of this research are reported as four related studies. Study One explored the structure and patterns of the Working Alliance Inventory (WAI). Study One Part A was a Confirmatory Factor Analysis of the WAI, which tested the competing models of the factor structure of the WAI and explored whether rater perspective (client, therapist, observer) had an effect on the structure. It was found that a two-factor structure was the best fit for the WAI, and that all rater perspectives shared this structure. Study One Part B explored the pattern of the WAI over the four time periods of this study in order 8 to understand how the WAI changes over time, and whether this pattern differed by rater perspective. The results confirmed that changes in all rater perspectives showed a linearly increasing pattern of alliance over time. Study Two explored the client factors that affect the initial formation of the TA and examined whether these factors were specific to an "offender" or "general" client profile informed by previous research. Two client factors specific to an offender profile - motivation to change and criminal attitudes - were found to be significantly associated with the initial formation of the TA. Study Three examined the relationship between the TA and treatment outcome, and explored whether there were any factors that co-varied with or moderated this relationship. A small but significant association between alliance and outcome was found; however no significant co-varying or moderating factors were discovered. Lastly, Study Four drew together the data from Study Two and Study Three and tested whether these results fit the Revised Theory of the Therapeutic Alliance (RTTA) model (Ross, Polaschek, & Ward, 2008), or other models previously reported in the literature. Several significant models were found that partly supported the RTTA. The best of these models incorporated client motivation to change, TA and treatment outcome as measured by change in risk of violent reoffending. Overall, the results of this study support the importance of the TA and client motivation to change in violent offender treatment. The implications for these results and the clinical applications are discussed, limitations are outlined, and directions for future research are suggested.</p>


Sign in / Sign up

Export Citation Format

Share Document