A Randomized Controlled Trial Evaluating the Efficacy of a Psychoeducation Program for Families of Children and Adolescents With ADHD in the United Kingdom: Results After a 6-Month Follow-Up

2016 ◽  
Vol 24 (5) ◽  
pp. 768-779 ◽  
Author(s):  
Maite Ferrin ◽  
Viviana Perez-Ayala ◽  
Samaa El-Abd ◽  
Teresa Lax-Pericall ◽  
Brian Jacobs ◽  
...  
Keyword(s):  
Group Treatment ◽  
Treatment Time ◽  
Controlled Trial ◽  
Control Group ◽  
Significant Treatment ◽  
Treatment As Usual ◽  
Time Interaction ◽  
The United Kingdom ◽  
Additional Approach

Objective: Psychoeducation forms part of the current practice for ADHD; however, its efficacy is yet to be established. Method: Sixty-nine children/adolescents with ADHD were randomly assigned for their families to receive either a well-structured psychoeducation program ( n = 35), or belong to a control group (treatment-as-usual, n = 34). Results: One-way analyses of variance showed a statistically significant Treatment × Time interaction, for ADHD total symptoms, inattention/cognition, and hyperactivity/impulsivity subdomains according to the parents, the first two with medium-large effect sizes. The effects of the intervention on the ADHD total and the inattention/cognition domain persisted after 6 months follow-up. No significant differences in teacher ratings were found; however, an improvement in clinical functioning as measured by clinicians was observed. Conclusion: This psychoeducation program has shown effectiveness in reducing ADHD symptoms when compared with treatment as usual. Psychoeducation needs to be considered as a valid and additional approach in ADHD.

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

scholarly journals Metacognitive reflection and insight therapy (MERIT) for patients with schizophrenia

2018 ◽  
Vol 49 (2) ◽  
pp. 303-313 ◽  
Author(s):  
S. de Jong ◽  
R. J. M. van Donkersgoed ◽  
M. E. Timmerman ◽  
M. aan het Rot ◽  
L. Wunderink ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Drop Out ◽  
Future Research ◽  
Control Group ◽  
Treatment As Usual ◽  
Self Reflection ◽  
Intention To Treat ◽  
Metacognitive Reflection ◽  
Secondary Outcomes

AbstractBackgroundImpaired metacognition is associated with difficulties in the daily functioning of people with psychosis. Metacognition can be divided into four domains: Self-Reflection, Understanding the Other's Mind, Decentration, and Mastery. This study investigated whether Metacognitive Reflection and Insight Therapy (MERIT) can be used to improve metacognition.MethodsThis study is a randomized controlled trial. Patients in the active condition (n = 35) received forty MERIT sessions, the control group (n = 35) received treatment as usual. Multilevel intention-to-treat and completers analyses were performed for metacognition and secondary outcomes (psychotic symptomatology, cognitive insight, Theory of Mind, empathy, depression, self-stigma, quality of life, social functioning, and work readiness).ResultsEighteen out of 35 participants finished treatment, half the drop-out stemmed from therapist attrition (N = 5) or before the first session (N = 4). Intention-to-treat analysis demonstrated that in both groups metacognition improved between pre- and post-measurements, with no significant differences between the groups. Patients who received MERIT continued to improve, while the control group returned to baseline, leading to significant differences at follow-up. Completers analysis (18/35) showed improvements on the Metacognition Assessment Scale (MAS-A) scales Self Reflectivity and metacognitive Mastery at follow-up. No effects were found on secondary outcomes.ConclusionsOn average, participants in the MERIT group were, based on MAS-A scores, at follow-up more likely to recognize their thoughts as changeable rather than as facts. MERIT might be useful for patients whose self-reflection is too limited to benefit from other therapies. Given how no changes were found in secondary measures, further research is needed. Limitations and suggestions for future research are discussed.

Evaluating Seeking Safety for Women in Prison: A Randomized Controlled Trial

2017 ◽  
Vol 29 (3) ◽  
pp. 281-290 ◽  
Author(s):  
Stephen J. Tripodi ◽  
Annelise M. Mennicke ◽  
Susan A. McCarter ◽  
Katie Ropes
Keyword(s):  
Randomized Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Post Traumatic Stress ◽  
Treatment As Usual ◽  
Seeking Safety ◽  
Randomized Controlled

Objective: This study assessed the effectiveness of Seeking Safety on depression and post-traumatic stress disorder (PTSD) with incarcerated women. Method: A randomized controlled trial ( N = 40) was used to analyze Seeking Safety’s effectiveness compared to a treatment-as-usual control group. Analyses of covariance were used to assess differences at posttest ( n = 33) and 4-month follow-up ( n = 29) while repeated measures analysis of variance was used to assess the influence of the intervention on changes over time ( n = 29). The researchers also analyzed individual participants’ scores from pretest to 4-month follow-up ( n = 29). Results: Both groups decreased their scores on the Center for Epidemiology Studies–Depression Scale and the PTSD Checklist, although improvement was greater for treatment group participants except for depression at 4-month follow-up. Conclusion: Results support the continued use of Seeking Safety as a helpful corrections-based intervention for women, but more research with larger sample sizes is needed to consider it an effective intervention.

scholarly journals Group interpersonal psychotherapy for depression in rural Uganda: 6-month outcomes

2006 ◽  
Vol 188 (6) ◽  
pp. 567-573 ◽  
Author(s):  
Judith Bass ◽  
Richard Neugebauer ◽  
Kathleen F. Clougherty ◽  
Helen Verdeli ◽  
Priya Wickramaratne ◽  
...  
Keyword(s):  
Functional Impairment ◽  
Controlled Trial ◽  
Health Benefit ◽  
Interpersonal Psychotherapy ◽  
Control Group ◽  
Depression Symptom ◽  
Treatment As Usual ◽  
Randomised Controlled

BackgroundA randomised controlled trial comparing group interpersonal psychotherapy with treatment as usual among rural Ugandans meeting symptom and functional impairment criteria for DSM–IV major depressive disorder or sub-threshold disorder showed evidence of effectiveness immediately following the intervention.AimsTo assess the long-term effectiveness of this therapy over a subsequent 6-month period.MethodA follow-up study of trial participants was conducted in which the primary outcomes were depression diagnosis, depressive symptoms and functional impairment.ResultsAt 6 months, participants receiving the group interpersonal psychotherapy had mean depression symptom and functional impairment scores respectively 14.0 points (95% CI 12.2–15.8; P < 0.0001) and 5.0 points (95% CI 3.6–6.4; P < 0.0001) lower than the control group. Similarly, the rate of major depression among those in the treatment arm (11.7%) was significantly lower than that in the control arm (54.9%) (P < 0.0001).ConclusionsParticipation in a 16-week group interpersonal psychotherapy intervention continued to confer a substantial mental health benefit 6 months after conclusion of the formal intervention.

Tablet-Based Outpatient Care for People With Dementia

GeroPsych ◽  
2019 ◽  
Vol 32 (3) ◽  
pp. 135-144 ◽  
Author(s):  
Sonia Lech ◽  
Julie L. O’Sullivan ◽  
Paul Gellert ◽  
Jan‐Niklas Voigt-Antons ◽  
Robert Greinacher ◽  
...  
Keyword(s):  
Group Treatment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Outpatient Basis ◽  
Treatment As Usual ◽  
Intention To Treat ◽  
People With Dementia ◽  
Cluster Randomized

Abstract. Most people with dementia (PwD) are treated on an outpatient basis, predominantly by general practitioners (GPs). This article provides a detailed protocol of a study aimed at developing and evaluating a tablet-based intervention to improve outpatient dementia care by fostering guideline-based treatment. A cluster-randomized controlled trial with an intervention group (tablet-based intervention) and a control group (treatment as usual plus information handbook) will be conducted. Clusters will be randomized at GP level. Primary outcome is defined as adherence to dementia guideline recommendations after 9 months. Secondary outcomes include various health outcomes assessed in PwD (e.g., quality of life) and informal caregivers (e.g., caregiver burden). Outcomes will be analyzed by an intention-to-treat analysis and using mixed models.

scholarly journals Temperamental Development among Preterm Born Children. An RCT Follow-Up Study

Children ◽  
2020 ◽  
Vol 7 (4) ◽  
pp. 36
Author(s):  
Inger Pauline Landsem ◽  
Bjørn Helge Handegård ◽  
Stein Erik Ulvund
Keyword(s):  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Negative Emotionality ◽  
Control Group ◽  
Follow Up Study ◽  
Time Interaction ◽  
Before And After ◽  
Preterm Born ◽  
To Receive

A randomized controlled trial study recruited 146 preterm born children, either to participate in a modified version of the Mother–Infant Transaction Program (MITP-m) or to receive the usual follow-up services, before and after discharge from a neonatal intensive care unit. This follow-up study investigates whether MITP participation is associated with parental perceptions of child temperament from two to seven years. Children’s temperament was reported by mothers and fathers separately at children’s ages of 2, 3, 5, and 7 years. Parents in the MITP-m group reported lower levels of negative emotionality in their children compared to the control group. In maternal reports, a group effect (F(1, 121) = 9.7, p = 0.002) revealed a stable difference in children’s negative emotionality from two to seven years, while a group-by-time interaction related to an increasing difference was detected in reports from fathers (F(1, 94) = 4.8, p = 0.03). Another group difference appeared in fathers’ reports of children’s soothability (F(1, 100) = 14.2, p < 0.0005). MITP-m fathers seemed to perceive their children as easier to soothe at all ages as no interaction with time appeared. Parental reports on children’s sociality, shyness, and activity did not differ between the groups.

EFFECTS OF A GROUP-BASED 8-WEEK MULTICOMPONENT COGNITIVE TRAINING ON COGNITION, MOOD AND ACTIVITIES OF DAILY LIVING AMONG HEALTHY OLDER ADULTS: A ONE-YEAR FOLLOW-UP OF A RANDOMIZED CONTROLLED TRIAL

2019 ◽  
pp. 1-10
Author(s):  
P. Srisuwan ◽  
D. Nakawiro ◽  
S. Chansirikarnjana ◽  
O. Kuha ◽  
P. Chaikongthong ◽  
...  
Keyword(s):  
Older Adults ◽  
Executive Function ◽  
Activities Of Daily Living ◽  
Cognitive Training ◽  
Daily Living ◽  
Controlled Trial ◽  
Control Group ◽  
Treatment As Usual ◽  
Healthy Older Adults

ACKGROUND: Cognitive interventions have the potential to enhance cognition among healthy older adults. However, little attention has been paid to the effect of cognitive training (CT) on mood and activities of daily living (ADL). OBJECTIVES: To assess the effectiveness of a multicomponent CT using a training program of executive functions, attention, memory and visuospatial functions (TEAM-V Program) on cognition, mood and instrumental ADL. DESIGN: A randomized, single-blinded, treatment-as-usual controlled trial. SETTING: Geriatric clinic in Bangkok, Thailand. PARTICIPANTS: 77 nondemented community-dwelling older adults (mean age 65.7±4.3 years). INTERVENTION: The CT (TEAM-V) program or the treatment-as-usual controlled group. The TEAM-V intervention was conducted over 5 sessions, with a 2-week interval between each session. Of 77 participants randomized (n=40 the TEAM-V program; n=37 the control group). MEASUREMENTS: The Thai version of Montreal Cognitive Assessment (MoCA), The Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog), Thai version of Hospital Anxiety and Depression Scale (HADS) and The Chula ADL were used to assess at baseline, 6 months and 1 year. RESULTS: Compared with the control arm, the TEAM-V Program was associated with reducing anxiety (P = 0.004). Compared with the baseline, participants receiving the TEAM-V Program were associated with significantly improved general cognition (MoCA, P < 0.001), immediate recall (word recall task, P = 0.01), retrieval and retention of memory process (word recognition task, P = 0.01), attention (number cancellation part A, P < 0.001) and executive function (maze test, P = 0.02) at 1 year. No training effects on depression (P = 0.097) and IADL (P = 0.27) were detected. CONCLUSIONS: The TEAM-V Program was effective in reducing anxiety. Even though, the program did not significantly improve cognition, depression and ADL compared with the control group, global cognition, memory, attention and executive function improved in the intervention group compared with baseline. Further studies incorporating a larger sample size, longitudinal follow-up and higher-intensity CT should be conducted.

scholarly journals A Randomized Controlled Trial to Evaluate Interventions Designed to Improve University Students' Subjective Financial Wellness in the United Kingdom

2020 ◽  
Vol 31 (2) ◽  
pp. 296-312
Author(s):  
Kelly Ann Schmidtke ◽  
Antony Elliott ◽  
Krishane Patel ◽  
Derek King ◽  
Ivo Vlaev
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Future Research ◽  
Control Group ◽  
Financial Behaviors ◽  
Randomized Controlled ◽  
Financial Wellness ◽  
Subjective Perceptions ◽  
The United Kingdom

This article describes a randomized controlled trial to evaluate the effectiveness of intervention tools designed to help people save more or spend less money by enhancing their capabilities, motivations, and opportunities. The participants included 177 students from an English University who were randomly allocated to either the Control, Savings-Tool, or Savings+Habit-Tools group. Participants provided with the intervention tool(s) for 4 weeks were more likely to experience improvements in both their financial satisfaction and subjective perceptions than those in the Control group not asked to use either tool. The tools did not significantly affect financial behaviors or objective financial wellness. The discussion examines limitations of the study and discusses avenues for future research such as including a longer follow-up period.

Increasing Life-Space Mobility in Community-Dwelling Older Persons With Cognitive Impairment Following Rehabilitation: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Phoebe Ullrich ◽  
Christian Werner ◽  
Martin Bongartz ◽  
Tobias Eckert ◽  
Bastian Abel ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Older Persons ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Life Space ◽  
Home Based ◽  
Independent Life

Abstract Background Community-dwelling older persons with cognitive impairment (CI) following discharge from geriatric rehabilitation are at high risk of losing life-space mobility (LSM). Interventions to improve their LSM are, however, still lacking. The aim of this study was to evaluate the effects of a CI-specific, home-based physical training and activity promotion program on LSM. Methods Older persons with mild-to-moderate CI (Mini-Mental State Examination: 17–26 points) discharged home from rehabilitation were included in this double-blinded, randomized, placebo-controlled trial with a 12-week intervention period and 12-week follow-up period. The intervention group received a CI-specific, home-based strength, balance, and walking training supported by tailored motivational strategies. The control group received a placebo activity. LSM was evaluated by the Life-Space Assessment in Persons with Cognitive Impairment, including a composite score for LSM and 3 subscores for maximal, equipment-assisted, and independent life space. Mixed-model repeated-measures analyses were used. Results One hundred eighteen participants (82.3 ± 6.0 years) with CI (Mini-Mental State Examination: 23.3 ± 2.4) were randomized. After the intervention, the home-based training program resulted in a significant benefit in the Life-Space Assessment in Persons with Cognitive Impairment composite scores (b = 8.15; 95% confidence interval: 2.89–13.41; p = .003) and independent life-space subscores (b = 0.39; 95% confidence interval: 0.00–0.78; p = .048) in the intervention group (n = 63) compared to control group (n = 55). Other subscores and follow-up results were not significantly different. Conclusions The home-based training program improved LSM and independent life space significantly in this vulnerable population. Effects were not sustained over the follow-up. The program may represent a model for improved transition from rehabilitation to the community to prevent high risk of LSM restriction.

scholarly journals Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
S van Wessel ◽  
T Hamerlynck ◽  
V Schutyser ◽  
C Tomassetti ◽  
C Wyns ◽  
...  
Keyword(s):  
Live Birth ◽  
Financial Support ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Fertility Treatment ◽  
Control Group ◽  
Women Of Reproductive Age ◽  
Operative Hysteroscopy ◽  
Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

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