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

Author(s):  
Jeannette Milgrom ◽  
Brian G. Danaher ◽  
John R. Seeley ◽  
Christopher J. Holt ◽  
Charlene Holt ◽  
...  
2015 ◽  
Vol 206 (6) ◽  
pp. 509-516 ◽  
Author(s):  
Aimee Spector ◽  
Georgina Charlesworth ◽  
Michael King ◽  
Miles Lattimer ◽  
Susan Sadek ◽  
...  

BackgroundAnxiety is common and problematic in dementia, yet there is a lack of effective treatments.AimsTo develop a cognitive–behavioural therapy (CBT) manual for anxiety in dementia and determine its feasibility through a randomised controlled trial.MethodA ten-session CBT manual was developed. Participants with dementia and anxiety (and their carers) were randomly allocated to CBT plus treatment as usual (TAU) (n= 25) or TAU (n= 25). Outcome and cost measures were administered at baseline, 15 weeks and 6 months.ResultsAt 15 weeks, there was an adjusted difference in anxiety (using the Rating Anxiety in Dementia scale) of (–3.10, 95% CI −6.55 to 0.34) for CBT compared with TAU, which just fell short of statistical significance. There were significant improvements in depression at 15 weeks after adjustment (–5.37, 95% CI −9.50 to −1.25). Improvements remained significant at 6 months. CBT was cost neutral.ConclusionsCBT was feasible (in terms of recruitment, acceptability and attrition) and effective. A fully powered RCT is now required.


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.


2019 ◽  
Vol 23 (68) ◽  
pp. 1-94 ◽  
Author(s):  
Ailsa Russell ◽  
Daisy Gaunt ◽  
Kate Cooper ◽  
Jeremy Horwood ◽  
Stephen Barton ◽  
...  

Background Co-occurring depression frequently occurs in autism. Evidence-based psychological interventions have been successfully adapted to treat co-occurring anxiety, but there is little evidence about the usefulness of adapted cognitive–behavioural therapy for depression. To the authors’ knowledge, to date there have been no randomised trials investigating the usefulness of low-intensity cognitive–behavioural therapy for depression in autism. Objectives The objectives of the study were to (1) develop a low-intensity psychological intervention for depression adapted for autism, (2) assess the feasibility and patient and therapist acceptability of the intervention, (3) estimate the rates of recruitment and retention for a full-scale randomised controlled trial and (4) identify an appropriate measure of depression to be used in a full-scale randomised controlled trial. Design The study comprised a randomised controlled trial (n = 70) with a nested qualitative evaluation (n = 21). Seventy eligible and consenting participants were randomly allocated to guided self-help or to treatment as usual. Setting Adult autism services in two NHS regions. Participants Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥ 10. People who had attended more than six sessions of cognitive–behavioural therapy in the previous 6 months were excluded. Interventions The low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision. Treatment as usual was standard NHS care for depression. Main outcome measures Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive–compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire. As this was a feasibility study also designed to identify the most appropriate measure of depression, it was not possible to specify the primary outcome measure or outcome point a priori. Results The aims of the study were met in full. The guided self-help intervention was feasible and well received by participants and coaches. The majority of allocated participants attended the intervention in full. The most practical outcome point was determined to be 16 weeks. There were differential rates of attrition across the treatment groups: 86% of the guided self-help group remained in the study at 24 weeks, compared with 54% of treatment as usual group. The qualitative study suggested that guided self-help had enhanced credibility with participants at the point of randomisation. Inter-rater reliability of the interview measure of depression was less than adequate, limiting the conclusions that can be drawn from the prespecified sensitivity to change analyses. Conclusions The intervention was feasible and well received. Although this feasibility study was not a fully powered trial, it provided some evidence that the guided self-help intervention was effective in reducing depressive symptoms. A full-scale clinical effectiveness and cost-effectiveness trial of the intervention is warranted. Future work Improvements to the intervention materials as a result of qualitative interviews. Stakeholder consultation to consider future trial design, consider strategies to improve retention in a treatment as usual arm and select a self-report measure of depression to serve as the primary outcome measure. Trial registration Current Controlled Trials ISRCTN54650760. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 68. See the NIHR Journals Library website for further project information. This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol.


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.


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.


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