Randomised placebo-controlled trial of moclobemide, cognitive–behavioural therapy and their combination in panic disorder with agoraphobia

1999 ◽  
Vol 174 (3) ◽  
pp. 205-212 ◽  
Author(s):  
Bernd Loerch ◽  
Mechthild Graf-Morgenstern ◽  
Martin Hautzinger ◽  
Sabine Schlegel ◽  
Christoph Hain ◽  
...  
Keyword(s):  
Panic Disorder ◽  
Cognitive Behavioural Therapy ◽  
Clinical Management ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Additional Treatment ◽  
Combined Treatments ◽  
Short Term ◽  
Cognitive Behavioural

BackgroundIn the treatment of panic disorder with agoraphobia, the efficacy of pharmacological, psychological and combined treatments has been established. Unanswered questions concern the relative efficacy of such treatments.AimsTo demonstrate that moclobemide and cognitive–behavioural therapy (CBT) are effective singly and more effective in combination.MethodFifty-five patients were randomly assigned to an eight-week treatment of: moclobemide plus CBT; moclobemide plus clinical management (‘psychological placebo’); placebo plus CBT; or placebo plus clinical management.ResultsComparisons between treatments revealed strong effects for CBT. Moclobemide with clinical management was not superior to placebo. The combination of moclobemide with CBT did not yield significantly better short-term results than CBT with placebo. The CBT results remained stable during a six-month follow-up, although a substantial proportion of patients treated with placebo plus CBT needed additional treatment.ConclusionsCBT was highly effective in the treatment of panic disorder with agoraphobia and reduced agoraphobia to levels that were comparable to those of non-clinical controls.

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

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 Are claims of non-inferiority of Internet and computer-based cognitive-behavioural therapy compared with in-person cognitive-behavioural therapy for adults with anxiety disorders supported by the evidence from head-to-head randomised controlled trials? A systematic review

2019 ◽  
Vol 53 (9) ◽  
pp. 851-865 ◽  
Author(s):  
Richard O’Kearney ◽  
Sheri Kim ◽  
Rachelle L Dawson ◽  
Alison L Calear
Keyword(s):  
Panic Disorder ◽  
Cognitive Behavioural Therapy ◽  
Randomised Controlled Trials ◽  
Behavioural Therapy ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Internet Cognitive Behavioural Therapy

Objective: This review examines the evidence from head-to-head randomised controlled trials addressing whether the efficacy of cognitive-behavioural therapy for anxiety disorders, obsessive-compulsive disorder and post-traumatic stress disorders in adults delivered by computer or online (computer- and Internet-delivered cognitive-behavioural therapy) is not inferior to in-person cognitive-behavioural therapy for reducing levels of symptoms and producing clinically significant gains at post-treatment and at follow-up. A supplementary aim is to examine the evidence for severity as a moderator of the relative efficacy of computer- and Internet-delivered cognitive-behavioural therapy and in-person cognitive-behavioural therapy. Method: PubMed, PsycINFO, Embase and Cochrane database of randomised trials were searched for randomised controlled trials of cognitive-behavioural therapy for these disorders with at least an in-person cognitive-behavioural therapy and Internet or computer cognitive-behavioural therapy arm. Results: A total of 14 randomised controlled trials (9 Internet, 5 computer) of cognitive-behavioural therapy for social anxiety disorder, panic disorder and specific phobia and 3 reports of effect moderators were included. One study showed a low risk of bias when assessed against risk of bias criteria for non-inferiority trials. The remaining studies were assessed as high or unclear risk of bias. One study found that Internet-delivered cognitive-behavioural therapy was superior and non-inferior at post-treatment and follow-up to group in-person cognitive-behavioural therapy for social anxiety disorder. One study of Internet-delivered cognitive-behavioural therapy for panic disorder showed non-inferiority to individual in-person cognitive-behavioural therapy for responder status at post-treatment and one of Internet cognitive-behavioural therapy for panic disorder for symptom severity at follow-up. Other comparisons (22 Internet, 13 computer) and for estimates pooled for Internet cognitive-behavioural therapy for social anxiety disorder, Internet cognitive-behavioural therapy for panic disorder and computer-delivered cognitive-behavioural therapy studies did not support non-inferiority. Evidence of effect moderation by severity and co-morbidity was mixed. Conclusion: There is limited evidence from randomised controlled trials which supports claims that computer- or Internet-delivered cognitive-behavioural therapy for anxiety disorders is not inferior to in-person delivery. Randomised controlled trials properly designed to test non-inferiority are needed before conclusions about the relative benefits of in-person and Internet- and computer-delivered cognitive-behavioural therapy can be made. Prospero: CRD420180961655-6

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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