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1.
BMC Psychiatry ; 22(1): 129, 2022 02 17.
Article in English | MEDLINE | ID: mdl-35177019

ABSTRACT

BACKGROUND: We investigated the acceptability and feasibility of a new brief intervention for maternal prenatal anxiety within maternity services in London and Exeter, UK. METHODS: One hundred fourteen pregnant individuals attending their 12-week scan at a prenatal clinic with elevated symptoms of anxiety (GAD-7 score of ≥7) were randomly assigned to either the ACORN intervention + Treatment as usual (TAU) (n = 57) or to usual care only (n = 57). The ACORN intervention consisted of 3 2-h group sessions, led by a midwife and psychological therapist, for pregnant individuals and their partners. The intervention included psychoeducation about anxiety, strategies for problem-sovling and tolerating uncertainty during pregnancy, including communicating about these with others, and mindfulness exercises. RESULTS: Engagement rates with ACORN met or exceeded those in primary care services in England. In the intervention arm, 77% (n = 44) of participants attended at least one session, 51% (n = 29) were adherent, defined as attending two or more sessions. Feedback was positive, and participants in the ACORN treatment group demonstrated evidence of a larger drop in their levels of anxiety than the participants in the TAU-only group (Cohen's d = 0.42). CONCLUSION: The ACORN intervention was acceptable to pregnant individuals and their partners and resulted in reductions in anxiety. With further evaluation in a larger-scale trial with child outcomes, there is significant potential for large scale public health benefit.


Subject(s)
Crisis Intervention , Mindfulness , Anxiety/diagnosis , Anxiety/psychology , Anxiety/therapy , Anxiety Disorders , Feasibility Studies , Female , Humans , Pregnancy
2.
Trials ; 17: 156, 2016 Mar 22.
Article in English | MEDLINE | ID: mdl-27006007

ABSTRACT

BACKGROUND: National guidelines in the UK, United States of America, Canada, and Australia have recently stressed the importance of identifying and treating antenatal anxiety and depression. However, there is little research into the most effective and acceptable ways of helping women manage their symptoms of anxiety and stress during pregnancy. Research indicates the necessity to consider the unique needs and concerns of perinatal populations to ensure treatment engagement, highlighting the need to develop specialised treatments which could be integrated within routine antenatal healthcare services. This trial aims to develop a brief intervention for antenatal anxiety, with a focus on embedding the delivery of the treatment within routine antenatal care. METHODS/DESIGN: This study is a two-phase feasibility trial. In phase 1 we will develop and pilot a brief intervention for antenatal anxiety, blended with group support, to be led by midwives. This intervention will draw on cognitive behavioural principles and wider learning from existing interventions that have been used to reduce anxiety in expectant mothers. The intervention will then be tested in a pilot randomised controlled trial in phase 2. The following outcomes will be assessed: (1) number of participants meeting eligibility criteria, (2) number of participants consenting to the study, (3) number of participants randomised, (4) number of sessions completed by those in the intervention arm, and (5) number of participants completing the post-intervention outcome measures. Secondary outcomes comprise: detailed feedback on acceptability, which will guide further development of the intervention; and outcome data on symptoms of maternal and paternal anxiety and depression, maternal quality of life, quality of couple relationship, mother-child bonding, infant temperament and infant sleep. DISCUSSION: The study will provide important data to inform the design of a future full-scale randomised controlled trial of a brief intervention for anxiety during pregnancy. This will include information on its acceptability and feasibility regarding implementation within current antenatal services, which will inform whether ultimately this provision could be rolled out widely in healthcare settings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN95282830 . Registered on 29 October 2014.


Subject(s)
Anxiety/therapy , Cognitive Behavioral Therapy , Pregnancy Complications/therapy , Prenatal Care/methods , Psychotherapy, Brief , Anxiety/diagnosis , Anxiety/psychology , Body Temperature Regulation , Clinical Protocols , England , Feasibility Studies , Female , Humans , Infant, Newborn , Midwifery , Mother-Child Relations , Pilot Projects , Pregnancy , Pregnancy Complications/diagnosis , Pregnancy Complications/psychology , Psychiatric Status Rating Scales , Psychotherapy, Group , Quality of Life , Research Design , Sleep , Time Factors , Treatment Outcome
3.
Trials ; 15: 29, 2014 Jan 21.
Article in English | MEDLINE | ID: mdl-24447460

ABSTRACT

BACKGROUND: Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers. METHODS/DESIGN: COBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life. DISCUSSION: The clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN27473954.


Subject(s)
Behavior Therapy/economics , Cognitive Behavioral Therapy/economics , Depressive Disorder, Major/economics , Depressive Disorder, Major/therapy , Health Care Costs , Research Design , Behavior Therapy/methods , Clinical Protocols , Cost-Benefit Analysis , Depressive Disorder, Major/diagnosis , Depressive Disorder, Major/psychology , England , Humans , Intention to Treat Analysis , Psychiatric Status Rating Scales , Quality of Life , Quality-Adjusted Life Years , Surveys and Questionnaires , Time Factors , Treatment Outcome
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