Placebo Control Conditions Research Articles

Mindfulness-based 'third wave' cognitive and behavioural therapies versus treatment as usual for depression.

This is the protocol for a review and there is no abstract. The objectives are as follows: To examine the effectiveness and acceptability of all third wave CBT approaches compared with treatment as usual/waiting list/attention placebo control conditions for acute depression.To examine the effectiveness and acceptability of different third wave CBT approaches (ACT, compassionate mind training, functional analytic psychotherapy, meta-cognitive therapy, dialectical behaviour therapy, MBCT, extended behavioural activation and meta-cognitive therapy) compared with treatment as usual/waiting list/attention placebo control conditions for acute depression.To examine the effectiveness and acceptability of all third wave CBT approaches compared with different types of comparator (standard care, no treatment, waiting list, attention placebo) for acute depression.

Behavioural therapies versus treatment as usual for depression.

This is the protocol for a review and there is no abstract. The objectives are as follows: To examine the effectiveness and acceptability of all BT approaches compared with treatment as usual/waiting list/attention placebo control conditions for acute depression.To examine the effectiveness and acceptability of different BT approaches (behavioural therapy, behavioural activation, social skills training and relaxation training) compared with treatment as usual/waiting list/attention placebo control conditions for acute depression.To examine the effectiveness and acceptability of all BT approaches compared with different types of comparator (standard care, no treatment, waiting list, attention placebo) for acute depression.

Interpersonal, cognitive analytic and other integrative therapies versus treatment as usual for depression.

This is the protocol for a review and there is no abstract. The objectives are as follows: To examine the effectiveness and acceptability of all integrative therapies compared with treatment as usual/waiting list/attention placebo control conditions for acute depression.To examine the effectiveness and acceptability of different integrative therapies (IPT, CAT, psychodynamic-interpersonal therapy, cognitive behavioural analysis system of psychotherapy and counselling) compared with treatment as usual/waiting list/attention placebo control conditions for acute depression.To examine the effectiveness and acceptability of all integrative therapies compared with different types of comparator (standard care, no treatment, waiting list, attention placebo) for acute depression.

The Last Stop

This issue contains six empirical papers (five articles and a Report from the Field) related to strategies and programs to prevent substance use, violence, sexual risk talking, and sexual assault among adolescents, youth, and emerging adults. Lopez et al. present findings from a study of family, school, and peer factors as they inter-relate to the likelihood of substance use in a sample of Hispanic adolescents in Miami. This research is promising both in terms of the implications for targets of prevention programming and for the application of ecodevelopmental theory, which might guide similar efforts with different cultural groups. Jagers and colleagues build on prior research on the Aban Aya Youth Project by comparing social development classroom curriculum, school/family/community intervention curriculum, and a health enhancement curriculum attention placebo control conditions on changes over time in violent behaviors among participating youth. Using grade 5 pretest and grades 5–8 posttest data, as well as information about youth who joined the study after baseline, to investigate the possibility of differential intervention effects. The authors present promising violence prevention findings, and they also provide important answers to dosage and developmental timing questions with their analyses of these longitudinal data.

Maternal anxiety and depression after a premature infant's discharge from the neonatal intensive care unit: explanatory effects of the creating opportunities for parent empowerment program.

Understanding the processes through which interventions work for mothers of premature infants is necessary for the advancement of science and the translation of efficacious interventions into clinical practice settings. To test a theoretical model examining the processes through which an educational-behavioral intervention program (Creating Opportunities for Parent Empowerment [COPE]) influences mothers' anxiety and depression 2 months after discharge of their premature infants from the neonatal intensive care unit (NICU). A secondary analysis was conducted using data from a randomized controlled trial with 246 mothers of low-birth-weight preterm infants who were assigned randomly to COPE or placebo control conditions. Measures included mothers' stress in the NICU, mothers' anxiety and depression, and mothers' beliefs about their infants and their role. Observers blind to study group condition also rated the quality of mother-infant interaction in the NICU. Structural equation modeling suggested that the model tested provided a reasonable fit to the data, chi2(64) = 97.67, p = .004, root mean square error of approximation = .046, comparative fit index = .97. Participation in COPE was both directly and indirectly, via associations with increased maternal beliefs and less maternal depression and anxiety in the NICU, related to mothers' decreased posthospital depression and anxiety. Participation in the COPE program also was associated with higher mother-infant interaction scores. Implementation of COPE could lessen postdischarge maternal anxiety and depression, which may improve outcomes for both mothers and preterm infants.

Design of Control‐Group Conditions in Clinical Trials of Behavioral Interventions

To review considerations in the design of placebo (attention) control conditions for community-based clinical trials of health behavior change interventions and to provide practical strategies for the design of control conditions. A well-designed control condition is an essential component of a clinical trial to foster the unambiguous interpretation of study findings. Pitfalls in the design of control conditions in clinical trials of behavioral interventions are identified and strategies to address them are offered. Types of control conditions that have been used in fall prevention trials are described, along with their strengths and weaknesses. The control condition used in the recent fall evaluation and prevention program (FEPP) was designed to overcome limitations of previous trial designs; it is provided to illustrate how to apply specific design principles. Pitfalls in the design of behavioral intervention studies may be avoided with the application of sound design principles. The FEPP active control condition can be used as a model in the design of future studies.

Mediation and moderation of psychological pain treatments: Response expectancies and hypnotic suggestibility.

The mediator role of response expectancies and the moderator role of hypnotic suggestibility were evaluated in the analogue treatment of pain. Approximately 1,000 participants were assessed for hypnotic suggestibility. Later, as part of a seemingly unrelated experiment, 188 of these individuals were randomly assigned to distraction, cognitive-behavioral package, hypnotic cognitive-behavioral package, hypnotic analgesia suggestion, placebo control, or no-treatment control conditions. Response expectancies partially mediated the effects of treatment on pain. Hypnotic suggestibility moderated treatment and was associated with the relief produced only by the hypnotic interventions. The results suggest that response expectancies are an important mechanism of hypnotic and cognitive-behavioral pain treatments and that hypnotic suggestibility is a trait variable that predicts hypnotic responding across situations, including hypnosis-based pain interventions.

Melatonin Does Not Inhibit Hypothalamic‐Pituitary‐Adrenal Activity in Waking Young Men

The pineal hormone melatonin is mainly secreted during night-time which, in humans, is the normal time of sleep. It has been proposed that, during this period, melatonin exerts an inhibitory influence on secretory activity of the hypothalamic-pituitary-adrenal (HPA) system, although there is little evidence for this view in humans. In blind humans, a single oral dose of melatonin at bed time suppressed nocturnal cortisol secretion. However, suppression could have been secondary to an improved sleep after melatonin in these experiments. In the present study, we examined whether melatonin exerts a similar inhibitory effect on HPA activity in waking subjects. Fourteen healthy young men were tested at bed time, but kept awake throughout the experimental epoch. Thirty minutes after oral ingestion of 5 mg melatonin, activity of the HPA-system was stimulated through a standard insulin-induced hypoglycaemia. Adrenocorticotrophin hormone and cortisol concentrations under basal conditions before insulin injection, as well as in response to insulin-induced hypoglycaemia, were almost identical for the melatonin and placebo control conditions (P > 0.5). However, melatonin increased plasma prolactin concentrations (P < 0.01) and reduced systolic blood pressure in the time interval following hypoglycaemia (P < 0.05). Based on a review of the literature and our results, we conclude that melatonin per se has no substantially suppressing effect on HPA secretory activity, although such an effect can be gated by sleep-related processes.

Buttock Taping Produces an Immediate Improvement in Hip Extension for Persons following Stroke

1817 Following stroke, weak hip extensors can lead to reduced step length of the unaffected leg and consequently a reduction in stride length and walking velocity. A strategy used clinically in neurologically-intact persons to increase hip extension is buttock taping. PURPOSE: This study investigated whether taping applied to the affected buttock of persons following stroke improved hip extension during stance phase of walking. METHODS: Fifteen persons following stroke (age 62 ± 7.2 y; time since stroke 5.2 ± 2.8 y) walked 14 m under 3 conditions (control, placebo tape, and buttock tape). Buttock taping used 3 pieces of tape to lift the buttock: the first piece of tape started from the medial aspect of the buttock crease and was pulled laterally and superiorly along the buttock crease towards the greater trochanter. The second piece was pulled superiorly from the medial aspect of the buttock crease to the top of the buttock above the gluteus maximus muscle belly. The third piece of tape was pulled firmly across from the superior end of the second piece of tape to the greater trochanter. For placebo taping, 2 pieces were applied vertically across the middle of the buttock under no tension. For each condition, subjects completed 5 trials at a self-selected and fast speed. The order of conditions was randomised, as was the speed within each condition. Hip extension, measured in quiet standing, provided a baseline reference. For each walk, subjects' hip angle, unaffected step length, affected step length, stride length and walking velocity were measured. RESULTS: Subjects' hip extension increased significantly (p<0.05) for self selected and fast walking speeds at late stance phase of walk (heel off) with buttock taping (11.1 ± 9.9; 8.1 ± 8.6, respectively) compared to placebo taping (−1.0 ± 10.5, −3.1 ± 10.3) and control conditions (−3.1 ± 6.6, −2.4 ± 5.5). Also, for both self selected and fast speeds, step length on the unaffected side and overall stride length increased significantly with buttock taping by 30 ± 15 mm compared with either the control or placebo conditions. In contrast, affected step length and walking velocity remained unchanged. Finally, there was no significant difference between the control and placebo taping condition for any of the measured variables. CONCLUSIONS: As buttock taping produced an immediate improvement in hip extension at the end of stance phase of walking, it may be a useful adjunct to current rehabilitation gait training strategies. Clinically, those stroke patients who are able to weakly activate their hip extensors but are unable to sustain their activation for the duration of the stance phase of walking are likely to benefit from this form of taping.

Light treatment of mood disorders

In 1981, seven patients with nonseasonal depression were treated with bright white light in 1982, bright artificial light was used to treat a manic-depressive patient with a seasonal mood cycle. In the last 20 years, a plethora of studies have further defined the depressive populations, who are responsive to light treatment; the optimal timing, intensity, spectral frequency, and duration of treatment; its comparison with other pharmacological interventions; predictors of response; side-effect profiles; viable placebo-control conditions; alternative devices and forms of administration; potential mechanisms and anatomical pathways mediating light's physiological effects; and its application to other disorders and subsyndromaI states. These studies have been conducted across multiple countries with surprisingly consistent results. Further work is needed, as highlighted in this review, to clarify the specific mechanism of action in subtypes of depressive disorders and differential age and gender effects. Although the majority of work in this area is relatively new, it behooves the reader to remember that Solomon, almost 3000 years ago, wrote in Ecclesiastes: "Truly the light is sweet and a pleasant thing it is for the eyes to behold the sun" (11:7).

Mediation and moderation of hypnotic and cognitive‐behavioural pain reduction

AbstractThe mediator function of response expectancies and the moderator function of hypnotic and non‐hypnotic imaginative suggestibility were evaluated in the analogue treatment of pain. One hundred and sixty‐seven participants previously assessed for hypnotic and imaginative suggestibility were randomly assigned to distraction, cognitive‐behavioural package (i.e., Stress Inoculation Training), hypnotic cognitive‐behavioural package, hypnotic analgesia suggestion, placebo control, or no‐treatment control conditions. The four ‘active’ treatments reduced pain more than the no‐treatment control condition. There was no statistical difference in effectiveness between these four treatments, but only the cognitive‐behavioural package reduced pain more than the placebo control condition. Response expectancies partially mediated the effects of treatment on pain. Imaginative suggestibility, defined as a generalized tendency to respond to imaginative suggestions delivered outside of hypnosis, moderated the effects of the cognitive‐behavioural package. Contrary to prediction, neither hypnotic suggestibility, nor hypnotizability (operationalized as hypnotic suggestibility with imaginative suggestibility statistically controlled) moderated the effects of the hypnotic treatments. Copyright © 2003 British Society of Experimental and Clinical Hypnosis

THE ROLE OF BILIRUBIN ON EXERCISE-INDUCED OXIDATIVE STRESS

Bilirubin has been considered to be useless and harmful in vivo. Previous studies have reported that the urinary excretion of biopyrrin, a biomarker of oxidative bilirubin metabolites, increases by endotoxin shock or ischemia/reperfusion. Although it has recently been suggested that bilirubin functions as a free radical scavenger in vivo, there are no studies to investigate whether urinary excretion of biopyrrin is increased by exercise. PURPOSE In this study, we investigated the effect of an acute bout of running exercise on urinary excretion of biopyrrin. METHODS Six healthy male volunteers (21.0 ± 0.6 yrs) have performed treadmill running for 30 min at an intensity corresponds to 80% maximum oxygen uptake under two conditions:N-acetyl-cysteine supplemented (NAC) and placebo control (Cont) conditions. Blood samples were obtained before and immediately after the exercise. Urine sample was collected continuously for 24 hours before and following the exercise. RESULTS Serum lactate dehydrogenase (LDH) activities in both Cont and NAC were significantly increased after the exercise compared with respective initial levels (p < 0.001). Significant increases of serum creatine phoshokinase (CPK) activities from initial levels were shown only in NAC (p < 0.05). Significant decreases in serum thiobarbituric acid reactive substances (TBARS) and increases in urinary excretion of biopyrrin from initial resting levels were observed only in Cont (p < 0.05). No significant differences were found between Cont and NAC for LDH, CPK and TBARS after exercise. However, urinary excretion of biopyrrin during 24 hours after the exercise was significantly inhibited by NAC administration (p < 0.05). CONCLUSION These results indicate that bilirubin is one of the antioxidant to scavenge free radicals generated by exercise. It is suggested that measurement of biopyrrin level in urine may be useful biomarker for predicting the degree of oxidative stress by exercise.

Urinary NItrotyrosine Content as a Marker of Peroxynitrite-induced Tolerance to Organic NItrates.

BACKGROUND: Anti-ischemic therapy with nitrovaasodilators as NO-donors is complicated by the induction of tolerance. When nitrovasodilators are metabolized to release NO there is a considerable coproduction of oxygen-derived radicals leading to a diminished cyclic GMP production and to impaired vasomotory responses. We analyzed in vivo the glyceroltrinitrate-induced generation of strong oxidative/nitrating compounds contributing to development of tolerance. METHODS AND RESULTS: In 16 patients we studied the urinary nitrotyrosine excretion during either (1) placebo control conditions, (2) 2-day nonintermittent transdermal nitroglycerin administration (0.4 mg/h), (3) 2-day nonintermittent glyceroltrinitrate administration (0.4 mg/h) along with a continuous infusion of vitamin C (55 µg/kg/min) as an antioxidant, or (4) with vitamin C but without glyceroltrinitrate (diminished urinary nitrotyrosine content of 34 +/- 18 µg/day observed). Glyceroltrinitrate administration augmented urinary nitrotyrosine from 56 +/- 24 (basal) to 186 +/- 32 µg/day (glyceroltrinitrate tolerance). Coadministration of vitamin C caused complete elimination of tolerance and a decrease in urinary nitrotyrosine to 130 +/- 28 µg/day. Glyceroltrinitrate-induced formation of oxidants was confirmed in vitro comparing glyceroltrinitrate-induced and peroxynitrite-induced tachyphylaxis in isolated perfused rabbit hearts and analyzing tolerance-induced inactivation of solbule guanylyl cyclase in cultured aortic smooth muscle cells. CONCLUSIONS: Augmented urinary nitrotyrosine excretion during glyceroltrinitrate administration reflects enhanced formation of peroxynitrite and of nitrotyrosine. Glyceroltrinitrate-induced tolerance is the result of oxidative stress and can be suppressed by additional antioxidant therapy aimed to prevent glyceroltrinitrate-induced formation and/or actions of peroxynitrite.

Current Findings Regarding the Effectiveness of Counseling: Implications for Practice

Research on the effectiveness of counseling is reviewed, and conclusions are drawn about the consequences for professional practice. The research literature clearly shows that counseling is effective in relation to no‐treatment and placebo control conditions. The effects of counseling seem to be relatively lasting. These effects are attained in relatively brief time periods, with the percentage of clients who show substantial improvement increasing as the number of counseling sessions increases. There continues to be little evidence of specific efficacy for particular techniques or counseling theories, and a small portion of clients seem to deteriorate while undergoing, and perhaps because of, counseling interventions.

Behavior therapy better than placebo treatments: Fact or artifact?

Brody's comment on our meta-analysis (Bowers & Clum, 1988) seems to suggest that the efficacy of behavior therapy has not been established relative to placebo control conditions, especially for «neurotic conditions». The comments appear directed at defending an earlier meta-analysis (Priouleau, Murdock, & Brody, 1983) that concluded that psychotherapy was not more efficacious than a placebo control. We agree with Brody regarding the need for increased use of the heteromethod approach and longer follow-up for psychotherapy studies. However, we do not agree that the 10 studies Brody selected do not support the effectiveness of behavior therapy relative to placebo controls

The television, school and family smoking prevention/ cessation project. IV. controlling for program success expectancies across experimental and control conditions

A major issue in smoking prevention research is that no study has tried to equate program success expectancies across experimental and placebo control conditions. Equivalent overall program success expectancies should be established to help rule out the effects of extra-theoretical variables which influence program outcomes. The present study tested whether an attention-placebo (information based) smoking prevention program would produce equivalent expectancies about the likelihood of program success in comparison to an experimental social influences program. To try to equate program success expectancies, the design of the two programs differed in content but was similar in procedure. Fourteen middle schools were randomly assigned to the two conditions. As hypothesized, baseline expectancies were found to predict outcome measures, even after controlling for baseline smoking intentions, ethnic group, and gender. Second, the equivalence of program expectancies at posttest was tested. Youths held equivalent overall expectancies for success across conditions. This study suggested the need to control for program expectancies in prevention research, and showed that program expectancies could be controlled for by equating process of program delivery.

ADDH and Methylphenidate Responders: Effects on Behavior Controlled by Complex Reinforcement Schedules

One of the most effective treatments for children with Attention Deficit Disorder with Hyperactivity (ADDH) has been the prescription of methylphenidate (MPH). While laboratory-based evidence indicates that MPH effects may be rate-dependent, little is known about changes evinced in operant behavior controlled by complex reinforcement schedules. The present study examined the effects of several doses of MPH on the operant key-pressing behavior of 20 children with ADDH who were favorable responders to the drug. Following a drug-free training period, each child performed the task across all doses in a randomly assigned sequence under double-blind placebo control conditions. Rate-dependent effects were found for both high- and low-rate reinforcement schedules. The strength of these effects varied across dose. These results have implications for the nature of rate-dependent phenomena in humans and investigations of treatment parameters in the pharmacotherapy of children with ADDH.

Effects of an Orientation Program on Mobile Transfer Students

A group orientation program was designed and carried out to aid the adjustment of mobile seventh and eighth grade transfer students to their new schools. Students in the treatment program were compared to others in both placebo and no-treatment control conditions on various measures of school and emotional adjustment. The measures included state measures of anxiety, depression, and hostility; a problem checklist; and orientation and attitude questionnaires. Adjustment data were collected at the beginning and end of the treatment program. It was found that transfer students in the orientation-treatment program were less anxious, depressed and hostile, reported fewer school and personal problems, had more positive attitudes towards school, and were better oriented at the end of the treatment program than transfer students in the control conditions.

On Delay and Reassessment of Retrospective Preratings

AbstractThe present study investigated to what extent retrospective preratings are affected by a follow-up assessment, 2 weeks after posttesting, and a delay of the assessment, 2 weeks after treatment. The experiment was performed within an educational training context. Subjects were psychology freshmen fulfilling a course obligation. The design consisted of an experimental, a placebo, and a no-treatment control condition. Immediately after training, posttraining instruments were administered to only half of the subjects. All subjects returned after 2 weeks and filled out the posttraining instruments. Data indicate that a 2-week time interval had no effect on readministered nor on postponed retrospective preratings. In addition, a significant mean difference between conventional and retrospective preratings was found in the experimental and the placebo control conditions. Since no-treatment control subjects did not show significant differences among conventional pre-, post-, and retrospective preratings, ...

Verbal responding under a fixed-interval schedule: effects of D-amphetamine

The purpose of this study was to characterize the effects of d-amphetamine (5–30 mg) on rate and distribution of verbal responding which was maintained under a fixed-interval (FI) schedule of reinforcement. Hired volunteer subjects simultaneously wrote and spoke narrative monologues; points were delivered under a multiple 5 min fixed-interval 1 min time out schedule for closure of a voice operated relay (VOR). Under placebo control conditions, most subjects paused for 2–4 minutes following the 1 min time out then spoke and wrote during later portions of the interval. d-Amphetamine increased both the number of words written and seconds if VOR closure in a dose-related manner. In subjects who showed typical FI response patterning, the drug generally decreased the length of early interval pausing and increased low control amounts of verbal responding which occurred early in the interval proportionately more than higher amounts of verbal responding seen during later portions of the interval. These drug effects on response patterning were generally similar to those see in infrahuman species responding under fixed-interval schedules of reinforcement.