scholarly journals Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e032649
Author(s):  
Jenny Ingram ◽  
Debbie Johnson ◽  
Sarah Johnson ◽  
Heather A O'Mahen ◽  
David Kessler ◽  
...  
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Advisory Group ◽  
Low Intensity ◽  
Cognitive Behavioural ◽  
Study Results

IntroductionOne in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our patient advisory groups requested greater treatment choice. Interpersonal counselling (IPC) is a low-intensity version of interpersonal therapy. It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage). We aim to compare CBT and IPC for pregnant women with depression in a feasibility study.Methods and analysisA two-arm non-blinded randomised feasibility study of 60 women will be conducted in two UK localities. Women with depression will be identified through midwife clinics and ultrasound scanning appointments and randomised to receive six sessions of IPC or CBT. In every other way, these women will receive usual care. Women thought to have severe depression will be referred for more intensive treatment. After 12 weeks, we will measure women’s mood, well-being, relationship satisfaction and use of healthcare. Women, their partners and staff providing treatments will be interviewed to understand whether IPC is an acceptable approach and whether changes should be introduced before applying to run a larger trial.Several groups of patients with depression during pregnancy have contributed to our study design. A patient advisory group will meet and advise us during the study.Ethics and disseminationStudy results will inform the design of a larger multicentre randomised controlled trial (RCT). Our findings will be shared through public engagement events, papers and reports to organisations within the NHS. National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN11513120.

scholarly journals Internet-assisted cognitive behavioural therapy with telephone coaching for anxious Finnish children aged 10–13 years: study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e045474
Author(s):  
Terhi Luntamo ◽  
Tarja Korpilahti-Leino ◽  
Terja Ristkari ◽  
Sanna Hinkka-Yli-Salomäki ◽  
Marjo Kurki ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Childhood Anxiety ◽  
Behavioural Therapy ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Telephone Coaching ◽  
The Impact

IntroductionChildhood anxiety is common, causes significant functional impairment and may lead to psychosocial problems by adulthood. Although cognitive behavioural therapy (CBT) is effective for treating anxiety, its availability is limited by the lack of trained CBT therapists and easily accessible local services. To address the challenges in both recognition and treatment, this study combines systematic anxiety screening in the general population with a randomised controlled trial (RCT) on internet-assisted CBT (ICBT) with telephone coaching. Child, family and intervention-related factors are studied as possible predictors or moderators, together with the COVID-19 pandemic.Methods and analysisThe study is an open two-parallel group RCT, stratified by sex, that compares ICBT with telephone coaching to an education control. Children aged 10–13 are screened at yearly school healthcare check-ups using five items from the Screen for Child Anxiety Related Disorders (SCARED) Questionnaire. The families of children who screen positive for anxiety are contacted to assess the family’s eligibility for the RCT. The inclusion criteria include scoring at least 22 points in the 41-item SCARED Questionnaire. The primary outcome is the SCARED child and parent reports. The secondary outcomes include the impact of anxiety, quality of life, comorbidity, peer relationships, perceptions of school, parental well-being and service use. Additional measures include demographics and life events, anxiety disorder diagnoses, as well as therapeutic partnerships, the use of the programme and general satisfaction among the intervention group.Ethics and disseminationThe study has been approved by the research ethics board of the Hospital District of South West Finland and local authorities. Participation is voluntary and based on informed consent. The anonymity of the participants will be protected and the results will be published in a scientific journal and disseminated to healthcare professionals and the general public.Trial registration numberClinicalTrials.gov NCT03310489, pre-results, initially released on 30 September 2017.

scholarly journals Guided self-help for depression in autistic adults: the ADEPT feasibility RCT

2019 ◽  
Vol 23 (68) ◽  
pp. 1-94 ◽  
Author(s):  
Ailsa Russell ◽  
Daisy Gaunt ◽  
Kate Cooper ◽  
Jeremy Horwood ◽  
Stephen Barton ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Full Scale ◽  
Treatment As Usual ◽  
Low Intensity ◽  
Self Help ◽  
Cognitive Behavioural ◽  
Randomised Controlled

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.

scholarly journals Telephone-supported computerised cognitive–behavioural therapy: REEACT-2 large-scale pragmatic randomised controlled trial

2017 ◽  
Vol 210 (5) ◽  
pp. 362-367 ◽  
Author(s):  
Simon Gilbody ◽  
Sally Brabyn ◽  
Karina Lovell ◽  
David Kessler ◽  
Thomas Devlin ◽  
...  
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Large Scale ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Behavioural Therapy ◽  
Telephone Support ◽  
Cognitive Behavioural ◽  
Patient Health ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

BackgroundComputerised cognitive–behavioural therapy (cCBT) for depression has the potential to be efficient therapy but engagement is poor in primary care trials.AimsWe tested the benefits of adding telephone support to cCBT.MethodWe compared telephone-facilitated cCBT (MoodGYM) (n = 187) to minimally supported cCBT (MoodGYM) (n = 182) in a pragmatic randomised trial (trial registration: ISRCTN55310481). Outcomes were depression severity (Patient Health Questionnaire (PHQ)-9), anxiety (Generalized Anxiety Disorder Questionnaire (GAD)-7) and somatoform complaints (PHQ-15) at 4 and 12 months.ResultsUse of cCBT increased by a factor of between 1.5 and 2 with telephone facilitation. At 4 months PHQ-9 scores were 1.9 points lower (95% CI 0.5–3.3) for telephone-supported cCBT. At 12 months, the results were no longer statistically significant (0.9 PHQ-9 points, 95% CI −0.5 to 2.3). There was improvement in anxiety scores and for somatic complaints.ConclusionsTelephone facilitation of cCBT improves engagement and expedites depression improvement. The effect was small to moderate and comparable with other low-intensity psychological interventions.

scholarly journals Assessing telephone-delivered cognitive–behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial

Gut ◽  
2019 ◽  
pp. gutjnl-2018-317805 ◽  
Author(s):  
Hazel Anne Everitt ◽  
Sabine Landau ◽  
Gilly O’Reilly ◽  
Alice Sibelli ◽  
Stephanie Hughes ◽  
...  
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Social Adjustment ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Clinical Effectiveness ◽  
Behavioural Therapy ◽  
Treatment As Usual ◽  
Cognitive Behavioural ◽  
Randomised Controlled

ObjectiveTo evaluate the clinical effectiveness of two modes of cognitive–behavioural therapy (CBT) for IBS compared with treatment as usual (TAU) in refractory IBS.DesignA three-arm randomised controlled trial assessing telephone-delivered CBT (TCBT), web-based CBT (WCBT) with minimal therapist support, and TAU. Blinding participants and therapists was not possible. Chief investigator, assessors and statisticians were blinded. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and South of England between May 2014 to March 2016. Co-primary outcomes were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS) at 12 months.Results558/1452 (38.4%) patients screened for eligibility were randomised: 76% female: 91% white: mean age 43 years. (391/558) 70.1% completed 12 months of follow-up. Primary outcomes: Compared with TAU (IBS-SSS 205.6 at 12 months), IBS-SSS was 61.6 (95% CI 33.8 to 89.5) points lower (p<0.001) in TCBT and 35.2 (95% CI 12.6 to 57.8) points lower (p=0.002) in WCBT at 12 months. Compared with TAU (WSAS score 10.8 at 12 months) WSAS was 3.5 (95% CI 1.9 to 5.1) points lower (p<0.001) in TCBT and 3.0 (95% CI 1.3 to 4.6) points lower (p=0.001) in WCBT. All secondary outcomes showed significantly greater improvement (p≤0.002) in CBT arms compared with TAU. There were no serious adverse reactions to treatment.ConclusionBoth CBT interventions were superior to TAU up to 12 months of follow-up.Trial registration numberISRCTN44427879.

scholarly journals Towards a conceptual framework of the working alliance in a blended low-intensity cognitive behavioural therapy intervention for depression in primary mental health care: a qualitative study

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036299
Author(s):  
Asmae Doukani ◽  
Caroline Free ◽  
Daniel Michelson ◽  
Ricardo Araya ◽  
Jesús Montero-Marin ◽  
...  
Keyword(s):  
Conceptual Framework ◽  
Working Alliance ◽  
Cognitive Behavioural Therapy ◽  
Patient Involvement ◽  
Comparative Method ◽  
Well Being ◽  
Behavioural Therapy ◽  
Low Intensity ◽  
Cognitive Behavioural ◽  
Therapy Intervention

ObjectivesTo examine and adapt a conceptual framework of the working alliance (WA) in the context of a low-intensity blended (psychological well-being practitioner (PWP) plus computerised program) cognitive behavioural therapy intervention (b-CBT) for depression.DesignPatient involvement was enlisted to collaboratively shape the design of the project from the onset, before data collection. In-depth semi-structured interviews were carried out with participants who experienced b-CBT as part of the E-compared trial. A thematic analysis was conducted using a constant comparative method informed by grounded theory.SettingRecruitment was carried out in four psychological primary care services across the UK.ParticipantsNineteen trial participants with major depressive disorder who completed at least one computerised program and face-to-face session with a PWP in the b-CBT arm were recruited to the study.ResultsQualitative interviews that were guided by WA theory and patient involvement, revealed four themes: (1) a healthcare provider (PWP and computerised program) with good interpersonal competencies for building a working relationship with the client (‘bond’); (2) collaborative efforts between the client and the provider to appropriately identify what the client hopes to achieve through therapy (‘goals’); (3) the selection of acceptable therapeutic activities that address client goals and the availability of responsive support (‘task’) and (4) the promotion of active engagement and autonomous problem solving (‘usability heuristics’). Participants described how the PWP and computerised program uniquely and collectively contributed to different WA needs.ConclusionsThis study is the first to offer a preliminary conceptual framework of WA in b-CBT for depression, and how such demands can be addressed through blended PWP-computerised program delivery. These findings can be used to promote WA in technological design and clinical practice, thereby promoting engagement to b-CBT interventions and effective deployment of practitioner and program resources.Trial registration numberISRCTN12388725.

Sign in / Sign up

Export Citation Format

Share Document