A Placebo-Controlled Trial of d-Fenfluramine in Bulimia Nervosa

1993 ◽  
Vol 162 (5) ◽  
pp. 597-603 ◽  
Author(s):  
Thomas A. Fahy ◽  
Ivan Eisler ◽  
Gerald F. M. Russell
Keyword(s):  
Bulimia Nervosa ◽  
Controlled Trial ◽  
Eating Behaviour ◽  
Behavioural Therapy ◽  
Carbohydrate Consumption ◽  
Cognitive Behavioural ◽  
Abnormal Eating ◽  
Food Diaries ◽  
Therapy Treatment

d-Fenfluramine is a 5-HT agonist which decreases food intake and excessive carbohydrate intake in humans. A placebo-controlled trial of d-fenfluramine (45 mg/day) was conducted in 43 patients with bulimia nervosa. The patients entered an eight-week trial of medication during which they also received cognitive-behavioural therapy. Treatment response was assessed using food diaries to record eating behaviour, and self-rating questionnaires to measure psychopathology. The drug trial, and a follow-up assessment after a further eight weeks, were completed by 39 patients. Abnormal eating behaviour and psychopathology improved significantly in both the d-fenfluramine and placebo groups during the treatment trial. The study failed to show that the addition of d-fenfluramine affords an advantage over brief psychotherapy alone. Although d-fenfluramine is effective in suppressing the overeating, excessive snacking, and excessive carbohydrate consumption which are frequently found in overweight or obese patients, this study suggests that the drug is not an effective treatment for bulimia nervosa.

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

scholarly journals Cognitive Behavioural Therapy for Nightmares for Patients with Persecutory Delusions (Nites): An Assessor-Blind, Pilot Randomized Controlled Trial

2019 ◽  
pp. 070674371984742 ◽  
Author(s):  
Bryony Sheaves ◽  
Emily A. Holmes ◽  
Stephanie Rek ◽  
Kathryn M. Taylor ◽  
Alecia Nickless ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Behavioural Therapy ◽  
Serious Adverse Events ◽  
Persecutory Delusions ◽  
Treatment As Usual ◽  
Cognitive Behavioural

Objective:Nightmares are relatively common in patients experiencing psychosis but rarely assessed or treated. Nightmares may maintain persecutory delusions by portraying fears in sensory-rich detail. We tested the potential benefits of imagery-focused cognitive behavioural therapy (CBT) for nightmares on nightmare severity and persecutory delusions.Method:This assessor-blind parallel-group pilot trial randomized 24 participants with nightmares and persecutory delusions to receive CBT for nightmares delivered over 4 weeks in addition to treatment as usual (TAU) or TAU alone. Assessments were at 0, 4 (end of treatment), and 8 weeks (follow-up). Feasibility outcomes assessed therapy uptake, techniques used, satisfaction, and attrition. The primary efficacy outcome assessed nightmare severity at week 4. Analyses were intention to treat, estimating treatment effect with 95% confidence intervals (CIs).Results:All participants offered CBT completed therapy (mean [SD], 4.8 [0.6] sessions) with high satisfaction, and 20 (83%) participants completed all assessments. Compared with TAU, CBT led to large improvements in nightmares (adjusted mean difference = −7.0; 95% CI, –12.6 to –1.3; d = –1.1) and insomnia (6.3; 95% CI, 2.6 to 10.0; d = 1.4) at week 4. Gains were maintained at follow-up. Suicidal ideation was not exacerbated by CBT but remained stable to follow-up, compared with TAU, which reduced at follow-up (6.8; 95% CI, 0.3 to 3.3; d = 0.7). CBT led to reductions in paranoia (–20.8; 95% CI, –43.2 to 1.7; d = –0.6), although CIs were wide. Three serious adverse events were deemed unrelated to participation (CBT = 2, TAU = 1).Conclusions:CBT for nightmares is feasible and may be efficacious for treating nightmares and comorbid insomnia for patients with persecutory delusions. It shows promise on paranoia but potentially not on suicidal ideation.

scholarly journals Classroom-based cognitive behavioural therapy: a large-scale non-randomised controlled trial of the ‘Journey of the Brave’

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Yuko Urao ◽  
Ikuyo Ohira ◽  
Takako Koshiba ◽  
Shin-ichi Ishikawa ◽  
Yasunori Sato ◽  
...  
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Large Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioural Therapy ◽  
Anxiety Score ◽  
Small Scale ◽  
Control Group ◽  
Cognitive Behavioural

Abstract Background In Japan, ‘Journey of the Brave’, a cognitive behavioural therapy (CBT)-based anxiety preventive education programme, was previously developed and its effectiveness examined in two small-scale controlled trials. These studies had some limitations, including a small number of participants and not having regular classroom teachers as programme facilitators. Therefore, we conducted a large-scale controlled trial, with teachers as programme implementers. Methods Twenty-seven elementary schools participated: 1622 and 1123 children were allocated to the intervention and control groups, respectively. The intervention group received a programme comprising ten 45-min sessions, while the control group underwent the regular school curriculum. Anxiety symptoms among participants were assessed using the Spence Children’s Anxiety Scale (SCAS) at three stages (pre-intervention, post-intervention, and follow-up). Results Following primary analysis, estimated mean changes in SCAS from baseline to follow-up were − 4.91 (95% CI − 5.91, − 3.90) in the intervention group and − 2.53 (95% CI − 3.52, − 1.54) in the control group; the group difference was 2.37 (95% CI 1.42, 3.33, p < 0.0001). Children in the intervention group showed significant reduction in their anxiety score versus children in the control group. Conclusions The results showed a statistically significant anxiety score reduction in the intervention group, thus verifying the programme’s effectiveness. Trial registration The University Hospital Medical Information Network (UMIN): UMIN000032517. Registered 10 May 2018—Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037083

Internet and Face-to-Face Cognitive Behavioural Therapy for Postnatal Depression Compared to Treatment-As-Usual: A Randomised Controlled Trial of MumMoodBooster (Preprint)

2020 ◽  
Author(s):  
Jeannette Milgrom ◽  
Brian G. Danaher ◽  
John R. Seeley ◽  
Christopher J. Holt ◽  
Charlene Holt ◽  
...  
Keyword(s):  
Postnatal Depression ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Treatment As Usual ◽  
Face To Face ◽  
Cognitive Behavioural ◽  
Postnatal Women ◽  
Dsm Iv ◽  
Randomised Controlled

BACKGROUND Previous research confirms that symptoms of postnatal depression (PND) can be ameliorated through internet-delivered psychological interventions. To date, no research has examined the efficacy of such interventions compared directly to face-to-face (FTF) treatment in women clinically diagnosed with PND. OBJECTIVE We aimed to compare the efficacy of one of the first Web-based cognitive behavioural therapy (internet CBT + coach calls) interventions for PND (MumMoodBooster: MMB) with FTF-CBT in a randomised controlled trial (RCT). METHODS One hundred and sixteen postnatal women with a DSM-IV diagnosis of major or minor depression were randomised to either MMB (n = 39), FTF-CBT (n = 39) or a treatment as usual control condition (TAU, n = 38). Diagnostic status was determined at baseline and at a 21-week follow-up using the Structured Clinical Interview for the DSM-IV (SCID-IV). Severity of anxious and depressive symptoms were evaluated with the Depression Anxiety Stress Scales (DASS-21) and the Beck Depression Inventory – Revised (BDI-II) at baseline, 12 weeks (post-treatment) and at 21 weeks follow-up. RESULTS Ninety two percent of participants had a diagnosis of major depression at baseline. Rates of remission from the major or minor depressive episode at 21 weeks in both the FTF-CBT and the MMB groups were superior to TAU (Relative Risk = 0.59 and 0.68 respectively) and they were not significantly different from each other. Whilst remission rates differed between TAU and FTF-CBT, growth models showed that, in terms of symptom reduction across time, the FTF-CBT treatment was not significantly better than TAU. By comparison, MMB was statistically superior to both TAU and FTF-CBT in reducing symptoms of depression, anxiety and stress from baseline to 21 weeks follow-up (large and moderate effect sizes). Thus, after 21 weeks, symptom scores for depression and anxiety in women receiving MMB were approximately 50% lower than the average scores in both TAU and FTF-CBT. CONCLUSIONS In this RCT, MMB was at least as effective as FTF-CBT in achieving remission from a diagnosed postnatal depressive episode. MMB was superior to both TAU and FTF-CBT in encouraging and maintaining reduction of symptom severity over 21 weeks follow-up for depressed postnatal women. These findings replicate results of prior studies of MMB that showed clinically significant improvements in depressive symptoms and they provide direct empirical support that internet delivered treatment for depressed postnatal women is a viable alternative to face-to-face treatment. Advantages of internet treatment include anonymity, convenience and catering for women who would prefer not to, or cannot, access face-to-face treatments. The generalisability of results needs to be examined by future research since RCTs of internet-based versus face-to-face treatments necessarily involve a subset of people who are willing to undertake either modality of treatment. CLINICALTRIAL The protocol for this trial was registered prospectively on the Australia and New Zealand Clinical Trials Registry (trial id ACTRN12613000881730); https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364683&isReview=true.

scholarly journals Sleep Treatment Outcome Predictors (STOP) Pilot Study: a protocol for a randomised controlled trial examining predictors of change of insomnia symptoms and associated traits following cognitive–behavioural therapy for insomnia in an unselected sample

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e017177 ◽  
Author(s):  
Dan Denis ◽  
Thalia C Eley ◽  
Fruhling Rijsdijk ◽  
Helena M S Zavos ◽  
Robert Keers ◽  
...  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Cognitive Behavioural ◽  
Ethical Approval ◽  
Unselected Sample ◽  
Randomised Controlled

IntroductionCognitive–behavioural therapy for insomnia (CBT-I) leads to insomnia symptom improvements in a substantial proportion of patients. However, not everyone responds well to this treatment, and it is unclear what determines individual differences in response. The broader aim of this work is to examine to what extent response to CBT-I is due to genetic and environmental factors. The purpose of this pilot study is to examine feasibility of a design to test hypotheses focusing on an unselected sample, that is, without selection on insomnia complaints, in order to plan a larger behavioural genetics study where most participants will likely not have an insomnia disorder.Methods and analysisA two parallel-group randomised controlled trial is being conducted across three London universities. Female students (minimum age 18 years) enrolled on a psychology programme at one of the three sites were invited to participate. The target number of participants to be recruited is 240. Following baseline assessments, participants were randomly allocated to either the treatment group, where they received weekly sessions of digital CBT-I for 6 weeks, or the control group, where they completed an online puzzle each week for 6 weeks. Follow-up assessments have taken place mid-intervention (3 weeks) and end of intervention (6 weeks). A 6-month follow-up assessment will also occur. Primary outcomes will be assessed using descriptive statistics and effect size estimates for intervention effects. Secondary outcomes will be analysed using multivariate generalised estimating equation models.Ethics and disseminationThe study received ethical approval from the Research Ethics and Integrity subcommittee, Goldsmiths, University of London (application reference: EA 1305). DNA sample collection for the BioResource received ethical approval from the NRES Committee South Central—Oxford (reference number: 15/SC/0388). The results of this work shall be published in peer-reviewed journals.Trial registration numberNCT03062891; Results.

scholarly journals Recovery-focused cognitive–behavioural therapy for recent-onset bipolar disorder: Randomised controlled pilot trial

2015 ◽  
Vol 206 (1) ◽  
pp. 58-66 ◽  
Author(s):  
Steven H. Jones ◽  
Gina Smith ◽  
Lee D. Mulligan ◽  
Fiona Lobban ◽  
Heather Law ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Behavioural Therapy ◽  
Personal Recovery ◽  
Recent Onset ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite evidence for the effectiveness of structured psychological therapies for bipolar disorder no psychological interventions have been specifically designed to enhance personal recovery for individuals with recent-onset bipolar disorder.AimsA pilot study to assess the feasibility and effectiveness of a new intervention, recovery-focused cognitive–behavioural therapy (CBT), designed in collaboration with individuals with recent-onset bipolar disorder intended to improve clinical and personal recovery outcomes.MethodA single, blind randomised controlled trial compared treatment as usual (TAU) with recovery-focused CBT plus TAU (n = 67).ResultsRecruitment and follow-up rates within 10% of pre-planned targets to 12-month follow-up were achieved. An average of 14.15 h (s.d. = 4.21) of recovery-focused CBT were attended out of a potential maximum of 18 h. Compared with TAU, recovery-focused CBT significantly improved personal recovery up to 12-month follow-up (Bipolar Recovery Questionnaire mean score 310.87, 95% CI 75.00–546.74 (s.e. = 120.34), P = 0.010, d=0.62) and increased time to any mood relapse during up to 15 months follow-up (χ2 = 7.64, P<0.006, estimated hazard ratio (HR) = 0.38, 95% CI 0.18–0.78). Groups did not differ with respect to medication adherence.ConclusionsRecovery-focused CBT seems promising with respect to feasibility and potential clinical effectiveness. Clinical- and cost-effectiveness now need to be reliably estimated in a definitive trial.

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