A randomised controlled trial of cognitive behaviour therapy in adolescents with major depression treated by selective serotonin reuptake inhibitors. The ADAPT trial.
ABSTRACT To determine if, in the short term, depressed adolescents attending routine NHS Child and Adolescent Mental Health Services (CAMHS), and receiving ongoing active clinical care, treatment with selective serotonin reuptake inhibitors (SSRIs) plus cognitive behaviour therapy (CBT) compared with SSRI alone, results in better healthcare outcomes.
A pragmatic randomised controlled trial (RCT) was conducted on depressed adolescents attending CAMHS who had not responded to a psychosocial brief initial intervention (BII) prior to randomisation.
Six English CAMHS participated in the study.
A total of 208 patients aged between 11 and 17 years were recruited and randomised.
All participants received active routine clinical care in a CAMHS outpatient setting and an SSRI and half were offered CBT.
The duration of the trial was a 12-week treatment phase, followed by a 16-week maintenance phase. Follow-up assessments were at 6, 12 and 28 weeks. The primary outcome measure was the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA). Secondary outcome measures were self-report depressive symptoms, interviewer-rated depressive signs and symptoms, interviewer-rated psychosocial impairment and clinical global impression of response to treatment. Information on resource use was collected in interview at baseline and at the 12- and 28-week follow-up assessments using the Child and Adolescent Service Use Schedule (CA-SUS).
Of the 208 patients randomised, 200 (96%) completed the trial to the primary end-point at 12 weeks. By the 28-week follow-up, 174 (84%) participants were re-evaluated. Overall, 193 (93%) participants had been assessed at one or more time points. Clinical characteristics indicated that the trial was conducted on a severely depressed group. There was significant recovery at all time points in both arms. The findings demonstrated no difference in treatment effectiveness for SSRI + CBT over SSRI only for the primary or secondary outcome measures at any time point. This lack of difference held when baseline and treatment characteristics where taken into account (age, sex, severity, co-morbid characteristics, quality and quantity of CBT treatment, number of clinic attendances). The SSRI + CBT group was somewhat more expensive over the 28 weeks than the SSRI-only group (p=0.057) and no more cost-effective. Over the trial period there was on average a decrease in suicidal thoughts and self-harm compared with levels recorded at baseline. There was no significant increase in disinhibition, irritability and violence compared with levels at baseline. Around 20% (n=40) of patients in the trial were non-responders. Of these, 17 (43%) showed no improvement by 28 weeks and 23 (57%) were considered minimally (n=10) or moderately to severely worse (n=13).
For moderately to severely depressed adolescents who are non-responsive to a BII, the addition of CBT to fluoxetine plus routine clinical care does not improve outcome or confer protective effects against adverse events and is not cost-effective. SSRIs (mostly fluoxetine) are not likely to result in harmful adverse effects. The findings are broadly consistent with existing guidelines on the treatment of moderate to severe depression. Modification is advised for those presenting with moderate (6-8 symptoms) to severe depressions (>8 symptoms) and in those with either overt suicidal risk and/or high levels of personal impairment. In such cases, the time allowed for response to psychosocial interventions should be no more than 2-4 weeks, after which fluoxetine should be prescribed. Further research should focus on evaluating the efficacy of specific psychological treatments against brief psychological intervention, determining the characteristics of patients with severe depression who are non-responsive to fluoxetine, relapse prevention in severe depression and improving tools for determining treatment responders and non-responders.
Full-textDOI: · Available from: Sarah Byford, May 07, 2015
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ABSTRACT: Background: Major depressive disorder (MDD) causes a massive disease burden worldwide. Cognitive behavioural therapy (CBT) is an important treatment approach for depression. Cost-utility analysis (CUA) is a method to support decisions on efficient allocation of resources in health policy. The objective of our study was to systematically review CUA of CBT in the treatment of patients suffering from MDD. Methods: We conducted a systematic literature search in Medline, Embase, PsycINFO and National Health Service Economic Evaluation Database (NHS EED) to identify CUA of CBT for MDD. Cost data were inflated to the year 2011 and converted into USD using purchasing power parities (USD PPP) to ensure comparability of the data. Quality assessment of CUA was performed. Results: Twenty-two studies were included in this systematic review. No study employed a time horizon of more than 5 years. In most studies, individual and group CBT as well as CBT for maintenance showed acceptable incremental cost-utility ratios (<50,000 USD PPP/quality-adjusted life year). The CUA results of CBT for children and adolescents and of computerized CBT were inconsistent. Discussion: We found consistent evidence that individualized CBT is cost-effective from the perspective of a third-party payer for short-term treatment and for relapse prevention of MDD in the adult population. © 2014 S. Karger AG, Basel.Psychotherapy and Psychosomatics 12/2014; 84(1):6-21. DOI:10.1159/000365150 · 9.37 Impact Factor
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ABSTRACT: Following horrific or life-threatening events approximately 10 to 15% of young children develop post traumatic stress disorder (PTSD). The symptoms of this disorder are distressing - nightmares, flashbacks, anger outbursts and disturbed play. These symptoms cause major disruption to a child's functioning and, if left untreated, can persist for many years. As yet, there are no established empirically-validated treatments for PTSD in young children. Trauma-focused cognitive behaviour therapy (TF-CBT) is a psychological intervention that is effective in treating the disorder in older children (8 to 12 years), adolescents and adults. This study examines TF-CBT adapted for children aged between 3 and 8 years. This protocol describes a two-arm exploratory randomised controlled trial comparing TF-CBT to treatment as usual (TAU) in children aged 3 to 8 years with a principal diagnosis of PTSD following a single-event discrete trauma. Using a half-crossover design, 44 participants will be randomly allocated to receive the intervention or to receive TAU. Those allocated to TAU will be offered TF-CBT at the end of the 'treatment' period (approximately 12 weeks) if still indicated. The primary outcome is PTSD diagnosis according to DSM-5 criteria for children 6 years and younger at post-treatment. Secondary outcomes include effects on co-morbid diagnoses and changes in emotion and trauma symptoms at each of the follow-up points (post-treatment, 3-months, 12-months). Additionally, broader efficacy will be considered with regard to treatment feasibility, acceptability and service utilisation. The key targets of the intervention are trauma memory, the interpretation of the meaning of the event, and the management of symptoms. This is the first European trial to examine the efficacy of TF-CBT in alleviating PTSD in very young children. As well as providing much-needed data on the utility of the intervention, this exploratory trial will also allow us to gather important information about the feasibility of delivering the treatment in UK National Health Service (NHS) settings, and its acceptability to the children and their families. This study will highlight aspects of the intervention that need improvement or modification in preparation for a full-scale evaluation in a larger sample. ISRCTN35018680 , registered on 18 November 2013.Trials 03/2015; 16(1):116. DOI:10.1186/s13063-015-0632-2 · 2.12 Impact Factor
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ABSTRACT: Few cost-utility studies of child and adolescent mental health services (CAMHS) use quality adjusted life years (a combination of utility weights and time in health state) as the outcome to enable comparison across disparate programs and modalities. Part of the solution to this problem involves embedding preference-based health-related quality of life (PBHRQOL) utility instruments, which generate utility weights, in clinical practice and research. The Child Health Utility (CHU9D) is a generic PBHRQOL instrument developed specifically for use in young people. The purpose of this study was to assess the suitability of the CHU9D as a routine outcome measure in CAMHS clinical practice. Two hundred caregivers of children receiving community mental health services completed the CHU9D alongside a standardised child and adolescent mental health measure (the Strengths and Difficulties Questionnaire - SDQ) during a telephone interview. We investigated face validity, practicality, internal consistency, and convergent validity of the CHU9D. In addition, we compared the utility weights obtained in this group with utility weights from other studies of child and adolescent mental health populations. Participants found the CHU9D easy and quick to complete. It demonstrated acceptable internal consistency, and correlated moderately with the SDQ. It was able to discriminate between children in the abnormal range and those in the non-clinical/borderline range as measured by the SDQ. Three CHU9D items without corollaries in the SDQ (sleep, schoolwork, daily routine) were found to be significant predictors of the SDQ total score and may be useful clinical metrics. The mean utility weight of this sample was comparable with clinical subsamples from other CHU9D studies, but was significantly higher than mean utility weights noted in other child and adolescent mental health samples. Initial validation suggests further investigation of the CHU9D as a routine outcome measure in CAMHS is warranted. Further investigation should explore test-retest reliability, sensitivity to change, concordance between caregiver and child-completed forms, and the calibration of the utility weights. Differences between utility weights generated by the CHU9D and other utility instruments in this population should be further examined by administering a range of PBHRQOL instruments concurrently in a mental health group.Health and Quality of Life Outcomes 12/2015; 13(22). DOI:10.1186/s12955-015-0218-4 · 2.10 Impact Factor