scholarly journals Cognitive–behavioural therapy and short-term psychoanalytic psychotherapy versus brief psychosocial intervention in adolescents with unipolar major depression (IMPACT): a multicentre, pragmatic, observer-blind, randomised controlled trial

2017 ◽  
Vol 21 (12) ◽  
pp. 1-94 ◽  
Author(s):  
Ian M Goodyer ◽  
Shirley Reynolds ◽  
Barbara Barrett ◽  
Sarah Byford ◽  
Bernadka Dubicka ◽  
...  

BackgroundAlthough there are effective psychological treatments for unipolar major depression in adolescents, whether or not one or more of the available therapies maintain reduced depressive symptoms 1 year after the end of treatment is not known. This is a non-trivial issue because maintaining lowered depressive symptoms below a clinical threshold level reduces the risk for diagnostic relapse into the adult years.ObjectiveTo determine whether or not either of two specialist psychological treatments, cognitive–behavioural therapy (CBT) or short-term psychoanalytic psychotherapy (STPP), is more effective than a reference brief psychosocial intervention (BPI) in maintaining reduction of depression symptoms in the year after treatment.DesignObserver-blind, parallel-group, pragmatic superiority randomised controlled trial.SettingA total of 15 outpatient NHS clinics in the UK from East Anglia, north-west England and North London.ParticipantsAdolescents aged 11–17 years withDiagnostic and Statistical Manual of Mental Disorders-Fourth Edition major depression including those with suicidality, depressive psychosis and conduct disorder. Patients were randomised using stochastic minimisation controlling for age, sex and self-reported depression sum score; 470 patients were randomised and 465 were included in the analyses.InterventionsIn total, 154 adolescents received CBT, 156 received STPP and 155 received BPI. The trial lasted 86 weeks and study treatments were delivered in the first 36 weeks, with 52 weeks of follow-up.Main outcome measuresMean sum score on self-reported depressive symptoms (primary outcome) at final study assessment (nominally 86 weeks, at least 52 weeks after end of treatment). Secondary measures were change in mean sum scores on self-reported anxiety symptoms and researcher-rated Health of the Nation scales for children and adolescents measuring psychosocial function. Following baseline assessment, there were a further five planned follow-up reassessments at nominal time points of 6, 12, 52 and 86 weeks post randomisation.ResultsThere were non-inferiority effects of CBT compared with STPP [treatment effect by final follow-up = –0.578, 95% confidence interval (CI) –2.948 to 4.104;p = 0.748]. There were no superiority effects for the two specialist treatments (CBT + STPP) compared with BPI (treatment effect by final follow-up = –1.898, 95% CI –4.922 to 1.126;p = 0.219). At final assessment there was no significant difference in the mean depressive symptom score between treatment groups. There was an average 49–52% reduction in depression symptoms by the end of the study. There were no differences in total costs or quality-of-life scores between treatment groups and prescribing a selective serotonin reuptake inhibitor (SSRI) during treatment or follow-up did not differ between the therapy arms and, therefore, did not mediate the outcome.ConclusionsThe three psychological treatments differed markedly in theoretical and clinical approach and are associated with a similar degree of clinical improvement, cost-effectiveness and subsequent maintenance of lowered depressive symptoms. Both STPP and BPI offer an additional patient treatment choice, alongside CBT, for depressed adolescents attending specialist Child and Adolescent Mental Health Services. Further research should focus on psychological mechanisms that are associated with treatment response, the maintenance of positive effects, determinants of non-response and whether or not brief psychotherapies are of use in primary care and community settings.LimitationsNeither reason for SSRI prescribing or monitoring of medication compliance was controlled for over the course of the study, and the economic results were limited by missing data.Trial registrationCurrent Controlled Trials ISRCTN83033550.FundingThis project was funded by the National Institute for Heath Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 12. See the National Institute for Heath Research Journals Library website for further project information. Funding was also provided by the Department of Health. The funders had no role in the study design, patient recruitment, data collection, analysis or writing of the study, any aspect pertinent to the study or the decision to submit toThe Lancet.

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly

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.


2006 ◽  
Vol 188 (3) ◽  
pp. 250-254 ◽  
Author(s):  
Gillian Haddock ◽  
Shôn Lewis ◽  
Richard Bentall ◽  
Graham Dunn ◽  
Richard Drake ◽  
...  

BackgroundPsychological treatments have been shown to be effective in patients with psychosis. However, the studies published to date have included participants across wide age ranges, so few conclusions can be reached about the effectiveness of such treatments in relation to age.AimsTo evaluate outcomes by age in a randomised controlled trial designed to evaluate the effectiveness of cognitive-behavioural therapy (CBT), supportive counselling and treatment as usual.MethodOutcomes were evaluated in terms of symptoms, social functioning, insight and therapeutic alliance according to age at 3- and 18-month follow-up.ResultsYounger participants responded better to supportive counselling than to treatment as usual and CBTover 3 months. Older participants responded better to CBT than to supportive counselling over 18 months. Younger participants showed a greater increase in insight after CBT compared with treatment as usual and supportive counselling, and were more difficult to engage in therapy.ConclusionsYoung people may have different needs with regard to engagement in psychological treatments. Treatment providers need to take age-specific factors into account.


2020 ◽  
Author(s):  
Jeannette Milgrom ◽  
Brian G. Danaher ◽  
John R. Seeley ◽  
Christopher J. Holt ◽  
Charlene Holt ◽  
...  

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.


BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e017177 ◽  
Author(s):  
Dan Denis ◽  
Thalia C Eley ◽  
Fruhling Rijsdijk ◽  
Helena M S Zavos ◽  
Robert Keers ◽  
...  

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.


2015 ◽  
Vol 206 (1) ◽  
pp. 58-66 ◽  
Author(s):  
Steven H. Jones ◽  
Gina Smith ◽  
Lee D. Mulligan ◽  
Fiona Lobban ◽  
Heather Law ◽  
...  

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.


2014 ◽  
Vol 204 (3) ◽  
pp. 222-233 ◽  
Author(s):  
Linda Horrell ◽  
Kimberley A. Goldsmith ◽  
André T. Tylee ◽  
Ulrike H. Schmidt ◽  
Caroline L. Murphy ◽  
...  

BackgroundDespite its high prevalence, help-seeking for depression is low.AimsTo assess the effectiveness and cost-effectiveness of 1-day cognitive–behavioural therapy (CBT) self-confidence workshops in reducing depression. Anxiety, self-esteem, prognostic indicators as well as access were also assessed.MethodAn open randomised controlled trial (RCT) waiting list control design with 12-week follow-up was used (trial registration: ISRCTN26634837). A total of 459 adult participants with depression (Beck Depression Inventory (BDI) scores of 14) self-referred and 382 participants (83%) were followed up.ResultsAt follow-up, experimental and control participants differed significantly on the BDI, with an effect size of 0.55. Anxiety and self-esteem also differed. Of those who participated, 25% were GP non-consulters and 32% were from Black and minority ethnic groups. Women benefited more than men on depression scores. The intervention has a 90% chance of being considered cost-effective if a depression-free day is valued at £14.ConclusionsSelf-confidence workshops appear promising in terms of clinical effectiveness, cost-effectiveness and access by difficult-to-engage groups.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
T. A. Kuut ◽  
F. Müller ◽  
A. Aldenkamp ◽  
E. Assmann-Schuilwerve ◽  
A. Braamse ◽  
...  

Abstract Background Coronavirus disease 2019 (COVID-19) results in debilitating long-term symptoms, often referred to as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), in a substantial subgroup of patients. One of the most prevalent symptoms following COVID-19 is severe fatigue. Prompt delivery of cognitive behavioural therapy (CBT), an evidence-based treatment that has shown benefit in reducing severe fatigue in other conditions, may reduce post-COVID-19 fatigue. Based on an existing CBT protocol, a blended intervention of 17 weeks, Fit after COVID, was developed to treat severe fatigue after the acute phase of infection with SARS-CoV-2. Method The ReCOVer study is a multicentre 2-arm randomised controlled trial (RCT) to test the efficacy of Fit after COVID on severe post-infectious fatigue. Participants are eligible if they report severe fatigue 3 up to and including 12 months following COVID-19. One hundred and fourteen participants will be randomised to either Fit after COVID or care as usual (ratio 1:1). The primary outcome, the fatigue severity subscale of the Checklist Individual Strength (CIS-fatigue), is assessed in both groups before randomisation (T0), directly post CBT or following care as usual (T1), and at follow-up 6 months after the second assessment (T2). In addition, a long-term follow-up (T3), 12 months after the second assessment, is performed in the CBT group only. The primary objective is to investigate whether CBT will lead to a significantly lower mean fatigue severity score measured with the CIS-fatigue across the first two follow-up assessments (T1 and T2) as compared to care as usual. Secondary objectives are to determine the proportion of participants no longer being severely fatigued (operationalised in different ways) at T1 and T2 and to investigate changes in physical and social functioning, in the number and severity of somatic symptoms and in problems concentrating across T1 and T2. Discussion This is the first trial testing a cognitive behavioural intervention targeting severe fatigue after COVID-19. If Fit after COVID is effective in reducing fatigue severity following COVID-19, this intervention could contribute to alleviating the long-term health consequences of COVID-19 by relieving one of its most prevalent and distressing long-term symptoms. Trial registration Netherlands Trial Register NL8947. Registered on 14 October 2020.


BJPsych Open ◽  
2021 ◽  
Vol 7 (5) ◽  
Author(s):  
Mark Hayward ◽  
Katherine Berry ◽  
Stephen Bremner ◽  
Anna-Marie Jones ◽  
Sam Robertson ◽  
...  

Background Cognitive–behavioural therapy (CBT) is recommended for all patients with psychosis, but is offered to only a minority. This is attributable, in part, to the resource-intensive nature of CBT for psychosis. Responses have included the development of CBT for psychosis in brief and targeted formats, and its delivery by briefly trained therapists. This study explored a combination of these responses by investigating a brief, CBT-informed intervention targeted at distressing voices (the GiVE intervention) administered by a briefly trained workforce of assistant psychologists. Aims To explore the feasibility of conducting a randomised controlled trial to evaluate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists to patients with psychosis. Method This was a three-arm, feasibility, randomised controlled trial comparing the GiVE intervention, a supportive counselling intervention and treatment as usual, recruiting across two sites, with 1:1:1 allocation and blind post-treatment and follow-up assessments. Results Feasibility outcomes were favourable with regard to the recruitment and retention of participants and the adherence of assistant psychologists to therapy and supervision protocols. For the candidate primary outcomes, estimated effects were in favour of GiVE compared with supportive counselling and treatment as usual at post-treatment. At follow-up, estimated effects were in favour of supportive counselling compared with GiVE and treatment as usual, and GiVE compared with treatment as usual. Conclusions A definitive trial of the GiVE intervention, delivered by assistant psychologists, is feasible. Adaptations to the GiVE intervention and the design of any future trials may be necessary.


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