Delayed Treatment Control Group Research Articles

A self-help behavioral activation treatment for geriatric depressive symptoms

This study investigated behavioral activation (BA) bibliotherapy as a treatment for late-life depressive symptoms. BA bibliotherapy was administered using Addis and Martell's Overcoming depression one step at a time as a stand-alone treatment that was completed by participants (N = 26) over a 4-week period [Addis, M.E., & Martell, C.R. (2004). Overcoming depression one step at a time. Oakland, CA: New Harbinger Publications, Inc.]. Results of an immediate intervention group were compared with those of a delayed treatment control group and treatment response for both groups was evaluated at 1-month follow-up. Primary outcome results showed that symptoms on a clinician-rated measure of depressive symptoms, Hamilton Rating Scale for Depression, were significantly lower at post-treatment for those who received immediate BA bibliotherapy compared with those who were in the delayed treatment control condition. However, self-reported depressive symptoms (a secondary outcome measured via the Geriatric Depression Scale), were not significantly different at this period. Because study control was lost after the delayed treatment group received the intervention, within-subjects analyses examining both treatment groups combined showed that clinician-rated depressive symptoms significantly decreased from pre-treatment to both post-treatment and 1-month follow-up. Self-reported depressive symptoms were significantly lower from pre-treatment to 1-month follow-up. These findings suggest that BA may be useful in treating mild or subthreshold depressive symptoms in an older adult population.

Instant Recess ® : A Practical Tool for Increasing Physical Activity During the School Day

An increased prevalence of overweight/obesity among children has led to school district level policies to increase physical activity (PA) among elementary school students. Interventions are needed that increase activity levels without sacrificing time spent in academics. We evaluated a policy implementation intervention for to increase in-school PA in elementary schools in Forsyth County, North Carolina, in a randomized study with a delayed intervention control group. The study included third- through fifth-grade classrooms in eight elementary schools. Instant Recess® was used to introduce 10-minute PA breaks in classrooms on schedules determined by teachers. Direct observation was used to measure activity levels, other student behaviors, and teacher behaviors related to PA in the classrooms. Twenty-eight visits to schools were made during the spring and fall semesters of 2009. At baseline 11% to 44% of intervention and control schools were engaged in classroom-based PA. PA increased from baseline to spring follow-up in intervention schools and was maintained the following fall. Control schools decreased PA from baseline to spring and increased PA once they began the intervention. Students in classrooms engaged in Instant Recess exhibited statistically significant increases in light (51%) and moderate-intensity (16%) PA and increases in time spent in on-task behavior (11%). Control schools experienced similar benefits after they began implementing Instant Recess. Instant Recess is useful for increasing PA and improving behavior among elementary school children. Additional research may be needed to understand how to create policies supporting classroom activity breaks and how to assess policy adherence.

Efficacy of a targeted cognitive–behavioral treatment program for cannabis use disorders (CANDIS*)

AimsTo examine the efficacy, 3- and 6-month follow-up effects of a psychological treatment for older adolescents and adults with DSM-IV cannabis use disorders. The program was tailored to the needs of this patient population. Experimental proceduresA randomized controlled clinical trial of 122 patients aged 16 to 44years with DSM-IV cannabis dependence as the main substance use diagnosis was conducted. Patients were randomly assigned to either Active Treatment (AT, n=90) or a Delayed Treatment Control group (DTC, n=32). Treatment consisted of 10 sessions of therapy, detailed in a strictly enforced manual. Assessments were conducted at baseline, during each therapy session, at post treatment and at follow-up assessments at 3 and 6months. ResultsThe treatment retention rate was 88%. Abstinence was achieved in 49% of AT patients and in 13% of those in DTC (p<0.001; intend-to-treat (ITT) analysis). Further, AT patients improved significantly (p<=0.001) in the frequency of cannabis use per week, addiction severity, number of disability days, and overall level of psychopathology. Program effects were maintained over a 3-month- (abstinence rate: 51%) and 6-month follow-up (45%) period. ConclusionThe treatment program is effective in obtaining abstinence as well as reducing cannabis use and improves the associated social and mental health burden.

Computerized stress management training for HIV+ women: a pilot intervention study

HIV+women have unique psychosocial stressors, but few interventions have been designed for this population. To address this gap in the literature, we developed a brief, theory-guided, computer-administered, stress management intervention for HIV+ women. To obtain initial evidence of the intervention's efficacy, we recruited 60 HIV+ female participants (70% African American) and randomized them to an immediate or delayed intervention condition. Psychological functioning, perceived stress, coping self-efficacy, and stress management knowledge were assessed at baseline and at a one month follow-up. Compared with the delayed treatment control group, women who received the intervention demonstrated improved stress management knowledge at the follow-up (p<0.01). However, depressive symptoms, psychological distress, perceived stress, and coping self-efficacy did not differ between the immediate and delayed intervention groups (ps>0.05). Computerized psychosocial interventions require continued refinement to meet the needs of HIV+ women.

Improving Emotion Regulation with CBT in Young Children with High Functioning Autism Spectrum Disorders: A Pilot Study

This pilot study tested the efficacy of a developmentally modified CBT for young children with Autism Spectrum Disorders (ASD) to teach emotion regulation strategies for reducing anger and anxiety, commonly noted problems in this population. Eleven 5-7 year-old children participated in a CBT-group while parents participated in psychoeducation. Children were randomly assigned to an experimental or delayed-treatment control group. From pre- to post-treatment, all children had less parent reported negativity/lability, better parent reported emotion regulation, and shorter outbursts, and also generated more coping strategies in response to vignettes. Parents also reported increases in their own confidence and their child's ability to deal with anger and anxiety. This study suggests that young children with high functioning ASD may benefit from CBT to improve regulation of anger and anxiety, and parent training may improve parental self-efficacy. Future studies are needed to make conclusions about its efficacy.

Effects of a Web-based intervention on women's breast health behaviors.

Helping women make choices to reduce cancer risk and to improve breast health behaviors is important, but the best ways to reach more people with intervention assistance is not known. To test the efficacy of a Web-based intervention designed to help women make better breast health choices, we adapted our previously tested, successful breast health intervention package to be delivered on the Internet, and then we tested it in a randomized trial. We recruited women from the general public to be randomized to either an active intervention group or a delayed intervention control group. The intervention consisted of a specialized Web site providing tailored and personalized risk information to all participants, followed by offers of additional support if needed. Follow-up at 1-year post-randomization revealed significant improvements in mammography screening in intervention women compared with control women (improvement of 13 percentage points). The intervention effects were more powerful in women who increased breast health knowledge and decreased cancer worry during intervention. These data indicate that increases in mammography can be accomplished in population-based mostly insured samples by implementing this simple, low resource intensive intervention.

Effect of Music-Based Multitask Training on Gait, Balance, and Fall Risk in Elderly People

Falls occur mainly while walking or performing concurrent tasks. We determined whether a music-based multitask exercise program improves gait and balance and reduces fall risk in elderly individuals. We conducted a 12-month randomized controlled trial involving 134 community-dwelling individuals older than 65 years, who are at increased risk of falling. They were randomly assigned to an intervention group (n = 66) or a delayed intervention control group scheduled to start the program 6 months later (n = 68). The intervention was a 6-month multitask exercise program performed to the rhythm of piano music. Change in gait variability under dual-task condition from baseline to 6 months was the primary end point. Secondary outcomes included changes in balance, functional performances, and fall risk. At 6 months, there was a reduction in stride length variability (adjusted mean difference, -1.4%; P < .002) under dual-task condition in the intervention group, compared with the delayed intervention control group. Balance and functional tests improved compared with the control group. There were fewer falls in the intervention group (incidence rate ratio, 0.46; 95% confidence interval, 0.27-0.79) and a lower risk of falling (relative risk, 0.61; 95% confidence interval, 0.39-0.96). Similar changes occurred in the delayed intervention control group during the second 6-month period with intervention. The benefit of the intervention on gait variability persisted 6 months later. In community-dwelling older people at increased risk of falling, a 6-month music-based multitask exercise program improved gait under dual-task condition, improved balance, and reduced both the rate of falls and the risk of falling. Trial Registration clinicaltrials.gov Identifier: NCT01107288.

Cerebral protection of distal ischemia postconditioning intervention on rat local cerebral ischemia injury

Objective To observe the protective effects of remote postconditioning intervention on focal cerebral ischemia/reperfusion injury. Methods Thirty-six male Vistar rats were randomly divided into 3 groups; the early intervention group after ischemia, delayed intervention group and control group, 12 rats in each group. Cerebral ischemia/reperfusion injury model of Vistar rats was created by MCAO suture method. Neurological deficit scoring was done at 1 h after embolization, then recanalization was given. The experimental groups were intervened with the early (within 30 min) and delayed (6 h later) intervention through bilateral femoral artery occlusion, a cycle of 1 min clipping/1 min recanalization for 5 times. Seventy-two h after recanalization, all animals were sacrificed by cervical dislocation after neurological deficit scoring, then brain sections were triphenyltetrazolium chloride (TTC) stained and infarction volume was calculated. Results One h after embolization, the neurological deficit scores in the two experimental group and control group were 3-4.Seventy-two h after recanalization, the neurological deficit scores in early intervention group and control group were 2-3 and 3-4 grade. Neurological functions were significantly improved. The average cerebral infarction volume in control group and early intervention group 72 h after recanalization was (40.3 ±3.2)% and (23.6 ±3.3)% respectively. The average cerebral infarct volume in experimental group was significantly reduced by about 60% as compared with control group. The neurological deficit score in delayed intervention group was 3-4 and the average infarct volume was (33.2 ± 1.9)%. As compared with control group, neurological functions were improved and infarct volume was reduced to some extent, but there was no significant. Conclusion Bilateral femoral artery intervention by repeated is-chemic adaptation after cerebral ischemia produces protective effects and the early intervention can significantly reduce local cerebral infarct volume and improve neurological functions. Key words: Ischemic postconditioning; Reperfusion injury; Cerebral protection

Bilingual dialogic book-reading intervention for preschoolers with slow expressive vocabulary development

This study examined the feasibility of using a dialogic book-reading intervention for 22–41-month-old bilingual preschool children with expressive vocabulary delays. The intervention was provided in English and Spanish concurrently to an experimental group of six children, while six other children were in a delayed treatment control group. Thirty 15-min sessions using dialogic book-reading strategies were provided in each language in the children's homes, in English by the primary investigator and in Spanish by the children's mothers, who were trained in the techniques of dialogic book-reading. Results showed that the children in the intervention group learned significantly more target words in each language following the intervention than the children in the control group. The children in the intervention group were also able to produce the acquired words at the time of a follow-up test 6 weeks after the end of the intervention. The gains in the overall vocabulary of the two groups of children did not differ significantly. The children's mothers expressed satisfaction with the program, and confirmed the benefits of dialogic book-reading for their children's learning of target words. Learning outcomes: The current paper describes a unique bilingual vocabulary intervention program for preschool children. Readers will gain an appreciation for the rationale for this intervention, and an insight in the implementation of dialogic book-reading. The main goal of the article is to provide the readers with the evaluation of the feasibility of this intervention.

Internet Treatment for Depression: A Randomized Controlled Trial Comparing Clinician vs. Technician Assistance

BackgroundInternet-based cognitive behavioural therapy (iCBT) for depression is effective when guided by a clinician, less so if unguided. Question: Would guidance from a technician be as effective as guidance from a clinician?MethodRandomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II) and the Patient Health Questionnaire-9 Item (PHQ-9). Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (p<0.001) and PHQ-9 (p<0.001) compared to the delayed treatment group but did not differ from each other. Within group effect sizes on the BDI-II were 1.27 and 1.20 for the clinician- and technician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program.ConclusionsBoth clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for depression. This form of treatment has potential to increase the capacity of existing mental health services.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12609000559213

Spelling deficits in dyslexia: evaluation of an orthographic spelling training

Orthographic spelling is a major difficulty in German-speaking children with dyslexia. The aim of the present study was to evaluate the effectiveness of an orthographic spelling training in spelling-disabled students (grade 5 and 6). In study 1, ten children (treatment group) received 15 individually administered weekly intervention sessions (60 min each). A control group (n = 4) did not receive any intervention. In study 2, orthographic spelling training was provided to a larger sample consisting of a treatment group (n = 13) and a delayed treatment control group (n = 14). The main criterion of spelling improvement was analyzed using an integrated dataset from both studies. Repeated-measures analysis of variance revealed that gains in spelling were significantly greater in the treatment group than in the control group. Statistical analyses also showed significant improvements in reading (study 1) and in a measure of participants' knowledge of orthographic spelling rules (study 2). The findings indicate that an orthographic spelling training enhances reading and spelling ability as well as orthographic knowledge in spelling-disabled children learning to spell a transparent language like German.

Effects of a Mail and Telephone Intervention on Breast Health Behaviors

This study evaluated a mail and telephone intervention to improve breast health behaviors while maintaining quality of life. Women recruited from the general public were randomized to a stepped-intensity intervention consisting of mailings, telephone calls, and counseling (if requested or appropriate given a woman's genetic risk for breast cancer) or to a delayed treatment control group. Outcomes (mammography screening and quality of life) were measured at baseline in a telephone survey and again at a 12-month follow-up period. Women in the intervention group significantly increased screening mammography uptake by 12% and quality of life by 5.3 scale points compared to control participants. Changes in knowledge of breast cancer, genetic testing, and cancer worry all significantly predicted intervention changes. This successful intervention can help women make better breast health choices without causing increased worry.

A Randomized Controlled Study of Parent-assisted Children’s Friendship Training with Children having Autism Spectrum Disorders

This study evaluated Children’s Friendship Training (CFT), a manualized parent-assisted intervention to improve social skills among second to fifth grade children with autism spectrum disorders. Comparison was made with a delayed treatment control group (DTC). Targeted skills included conversational skills, peer entry skills, developing friendship networks, good sportsmanship, good host behavior during play dates, and handling teasing. At post-testing, the CFT group was superior to the DTC group on parent measures of social skill and play date behavior, and child measures of popularity and loneliness, At 3-month follow-up, parent measures showed significant improvement from baseline. Post-hoc analysis indicated more than 87% of children receiving CFT showed reliable change on at least one measure at post-test and 66.7% after 3 months follow-up.

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study

Estimates of insomnia in breast cancer patients are high, with reports of poor sleep lasting years after completion of cancer treatment. This randomized controlled crossover pilot study looked at the effects of individual cognitive behavioral therapy for insomnia (IND-CBT-I) on sleep in breast cancer survivors. Twenty-one participants were randomly assigned to either a treatment group (six weekly IND-CBT-I sessions followed by six weeks of follow up) or a delayed treatment control group (no treatment for six weeks followed by six weekly IND-CBT-I sessions). Of these, 14 participants completed the pilot study (six in the treatment group and eight in the delayed treatment control group). Self-rated insomnia was significantly improved in the treatment group compared to the waiting period in the delayed treatment control group. The pooled pre-post-IND-CBT-I analyses revealed improvements in self-rated insomnia, sleep quality, and objective measures of sleep. These preliminary results suggest that IND-CBT-I is appropriate for improving sleep in breast cancer survivors. Individual therapy in a clinic or private practice may be a more practical option for this population as it is more easily accessed and readily available in an outpatient setting.

Changing Parent’s Mindfulness, Child Management Skills and Relationship Quality With Their Youth: Results From a Randomized Pilot Intervention Trial

We evaluated the efficacy of a mindful parenting program for changing parents' mindfulness, child management practices, and relationships with their early adolescent youth and tested whether changes in parents' mindfulness mediated changes in other domains. We conducted a pilot randomized trial with 65 families and tested an adapted version of the Strengthening Families Program: For Parent and Youth 10-14 that infused mindfulness principles and practices against the original program and a delayed intervention control group. Results of pre-post analyses of mother and youth-report data showed that the mindful parenting program generally demonstrated comparable effects to the original program on measures of child management practices and stronger effects on measures of mindful parenting and parent-youth relationship qualities. Moreover, mediation analyses indicated that the mindful parenting program operated indirectly on the quality of parent-youth relationships through changes in mindful parenting. Overall, the findings suggest that infusing mindful parenting activities into existing empirically validated parenting programs can enhance their effects on family risk and protection during the transition to adolescence.

The Effects of a Computer-Tailored Message on Secondary Prevention in Type 2 Diabetes: A Randomized Trial

The purpose of this study was to test the effect of computer-generated, tailored feedback on the quality of chronic disease management for type 2 diabetes when provided to a patient prior to a scheduled physician visit. A stand-alone computer application was developed to provide tailored feedback aimed at empowering patients to engage more actively in their diabetes management. Adults with type 2 diabetes (n = 203) were randomly assigned to groups receiving either efficacy (positive) messages (n = 68), risk (negative) messages (n = 67), or to a delayed treatment control group (n = 68). The intervention was delivered prior to a patient's visit with his or her physician so that patients would have the opportunity to discuss the messages at the clinical appointment. Although there were no significant differences in the percentage of participants who received intensified care or routine tests between the control and intervention groups, we learned that more directive messaging may be needed to help patients effectively manage their diabetes. Patients may benefit from directive feedback, providing them with specific questions to ask their physician that can lead to improved care, rather than receiving general and educational informational messages.

The StrongWomen–Healthy Hearts Program: Reducing Cardiovascular Disease Risk Factors in Rural Sedentary, Overweight, and Obese Midlife and Older Women

We tested a community-based intervention designed to reduce cardiovascular disease risk in sedentary midlife and older women who were overweight or obese. In a randomized controlled trial conducted in 8 counties in Arkansas and Kansas, counties were assigned to the intervention (a 12-week twice-weekly heart health program) group or to the delayed-intervention control group. Ten to fifteen women were selected from each site, and participants' weight, waist circumference, diet, physical activity, and self-efficacy were measured before and after the intervention. Data were analyzed with multiple regressions. Compared with the control group, participants in the intervention group had a significant decrease in body weight (-2.1 kg; 95% confidence interval [CI] = -3.2, -1.0), waist circumference (-2.3 in; 95% CI = -4.2, -0.5), and energy intake (-390 kcal/day; 95% CI = -598, -183); an increase in activity (+1637 steps/day; 95% CI = 712, 2562); and an increase in self-efficacy for dietary and physical activity behaviors. Our results suggest that a community-based program can improve self-efficacy, increase physical activity, and decrease energy intake, resulting in decreased waist circumference and body weight among at-risk women.

Effects of an exercise intervention using Dance Dance Revolution on endothelial function and other risk factors in overweight children

To determine whether an exercise intervention using an active video game (Dance Dance Revolution [DDR]) is effective in improving endothelial dysfunction (EDF) and other risk factors in overweight children. Thirty-five children (Body mass index > or = 85(th) percentile, mean age 10.21+/-1.67 years, 17 females) with EDF were assessed for flow-mediated dilation (FMD), lipids, insulin, glucose, NO(2)+NO(3), asymmetric dimethylarginine, symmetric dimethylarginine, l-arginine, height, weight, aerobic fitness, and blood pressure. In a subsample, tumor necrosis factor alpha, interleukin-6, C-reactive protein, and adiponectin were also assessed. Subjects were randomly assigned to 12-weeks of aerobic exercise (EX) using DDR or to a non-exercising delayed-treatment control group (DTC). EX had significant improvements in FMD ( 5.56+/-5.04% compared with 0.263+/-4.54%, p=0.008), exercise time on the graded exercise test (53.59+/-91.54 compared with -12.83+/-68.10 seconds, p=0.025), mean arterial pressure (MAP) (-5.62+/-7.03 compared with -1.44+/-2.16 mmHg, p=0.05), weight (0.91+/-1.53 compared with 2.43+/-1.80 kg, p=0.017) and peak VO(2) (2.38+/-3.91 compared with -1.23+/-3.18 mg/kg/min, p=0.005) compared with the DTC. Thirteen EX subjects achieved normal EDF while ten did not. These groups differed at baseline with regard to total cholesterol (TC) and low-density lipoprotein (LDL). Twelve weeks of DDR-use improved FMD, aerobic fitness, and MAP in overweight children. Improvements occurred without changes in inflammatory markers or nitric oxide production. The results document the need to explore relationships between obesity, endothelial function, inflammation, lipids, exercise intensity, and gender in a larger sample of overweight children.

Parent-Assisted Social Skills Training to Improve Friendships in Teens with Autism Spectrum Disorders

This study examines the efficacy of a manualized parent-assisted social skills intervention in comparison with a matched Delayed Treatment Control group to improve friendship quality and social skills among teens 13-17 years of age with autism spectrum disorders. Targeted skills included conversational skills, peer entry and exiting skills, developing friendship networks, good sportsmanship, good host behavior during get-togethers, changing bad reputations, and handling teasing, bullying, and arguments. Results revealed, in comparison with the control group, that the treatment group significantly improved their knowledge of social skills, increased frequency of hosted get-togethers, and improved overall social skills as reported by parents. Possibly due to poor return rate of questionnaires, social skills improvement reported by teachers was not significant. Future research should provide follow-up data to test the durability of treatment.

Effects of the Diabetes Manual 1:1 structured education in primary care

To determine the effects of the Diabetes Manual on glycaemic control, diabetes-related distress and confidence to self-care of patients with Type 2 diabetes. A cluster randomized, controlled trial of an intervention group vs. a 6-month delayed-intervention control group with a nested qualitative study. Participants were 48 urban general practices in the West Midlands, UK, with high population deprivation levels and 245 adults with Type 2 diabetes with a mean age of 62 years recruited pre-randomization. The Diabetes Manual is 1:1 structured education designed for delivery by practice nurses. Measured outcomes were HbA(1c), cardiovascular risk factors, diabetes-related distress measured by the Problem Areas in Diabetes Scale and confidence to self-care measured by the Diabetes Management Self-Efficacy Scale. Outcomes were assessed at baseline and 26 weeks. There was no significant difference in HbA(1c) between the intervention group and the control group [difference -0.08%, 95% confidence interval (CI) -0.28, 0.11]. Diabetes-related distress scores were lower in the intervention group compared with the control group (difference -4.5, 95% CI -8.1, -1.0). Confidence to self-care Scores were 11.2 points higher (95% CI 4.4, 18.0) in the intervention group compared with the control group. The patient response rate was 18.5%. In this population, the Diabetes Manual achieved a small improvement in patient diabetes-related distress and confidence to self-care over 26 weeks, without a change in glycaemic control. Further study is needed to optimize the intervention and characterize those for whom it is more clinically and psychologically effective to support its use in primary care.