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Journal ArticleDOI

A randomized controlled trial of online versus clinic-based CBT for adolescent anxiety.

01 Oct 2011-Journal of Consulting and Clinical Psychology (American Psychological Association)-Vol. 79, Iss: 5, pp 629-642
TL;DR: Online delivery of CBT, with minimal therapist support, is equally efficacious as clinic-based, face-to-face therapy in the treatment of anxiety disorders among adolescents, with benefits of reduced therapist time and greater accessibility for families who have difficulty accessing clinic- based CBT.
Abstract: The study examined the relative efficacy of online (NET) versus clinic (CLIN) delivery of cognitive behavior therapy (CBT) in the treatment of anxiety disorders in adolescents. Participants included 115 clinically anxious adolescents aged 12 to 18 years and their parent(s). Adolescents were randomly assigned to NET, CLIN, or wait list control (WLC) conditions. The treatment groups received equivalent CBT content. Clinical diagnostic interviews and questionnaire assessments were completed 12 weeks after baseline and at 6- and 12-month follow-ups. Assessment at 12 weeks post-baseline showed significantly greater reductions in anxiety diagnoses and anxiety symptoms for both NET and CLIN conditions compared with the WLC. These improvements were maintained or further enhanced for both conditions, with minimal differences between them, at 6- and 12-month follow-ups. Seventy-eight percent of adolescents in the NET group (completer sample) no longer met criteria for the principal anxiety diagnosis at 12-month follow-up compared with 80.6 in the CLIN group. Ratings of treatment credibility from both parents and adolescents were high for NET and equivalent to CLIN. Satisfaction ratings by adolescents were equivalent for NET and CLIN conditions, whereas parents indicated slightly higher satisfaction ratings for the CLIN format. Online delivery of CBT, with minimal therapist support, is equally efficacious as clinic-based, face-to-face therapy in the treatment of anxiety disorders among adolescents. This approach offers a credible alternative to clinic-based therapy, with benefits of reduced therapist time and greater accessibility for families who have difficulty accessing clinic-based CBT.

Summary (5 min read)

A randomized controlled trial of online versus clinic-based CBT for adolescent anxiety

  • It has been well established that anxiety disorders in children can be treated efficaciously with cognitive-behavior therapy (CBT), with average remission rates of between 56% and 67% at post-treatment (Cartwright-Hatton, Roberts, Chitsabesan, Fothergill, & Harrington, 2004; James, Soler, & Weatherall, 2008; Silverman, Pina, & Viswesvaran, 2008 ).
  • Clearly, there is a need for alternative modes of treatment delivery that increase the chance that young people and their parents will seek help and participate in treatment.
  • Finally, communication applications on the internet, such as email, instant messaging, blogs and chat rooms have become a very important and familiar component of the lives of many adolescents (Subrahmanyam & Lin, 2007) .
  • Spence, Holmes, March et al. (2006) compared clinic-based group CBT, the same treatment partially delivered via the internet, and a waitlist control with anxious children.
  • Given that both parents and the young person are typically involved in the decision to seek and participate in treatment, it is important that both parties regard online CBT as a credible form of therapy.

Participants

  • The majority of adolescents were born in Australia (91%), with the remainder born in Europe, New Zealand, Asia, South Africa and the United States of America.
  • In general, parents were relatively well educated with 46% of fathers and 51% of mothers having completed a university education.
  • A proportion of adolescents also met criteria for a co-morbid disorder other than anxiety (overall 18%), including depression (2.6%), dysthymic disorder (6%), attention deficit hyperactivity disorder (9.6%), and oppositional defiant disorder (1.7%).
  • Of the 288 families who approached the study, 30 did not meet broad inclusion criteria at the telephone screen stage (e.g. outside age range, non-anxiety related difficulties, location, lack of internet access) and 258 were invited to provide informed consent and participate in the more detailed assessment to determine eligibility.
  • The remaining 115 families met all inclusion criteria, provided informed consent, and were randomly allocated to an experimental condition.

Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent versions.

  • Diagnostic status was assessed using the Anxiety Disorders Interview Schedule -Child and Parent versions (ADIS-C/P: Silverman & Albano, 1996) , administered over the telephone.
  • Assessors independent of the study and blind to treatment condition conducted the assessments.
  • A combined report was formed by the interviewer to reflect the responses provided by both the adolescent and the parent.
  • There was high inter-assessor agreement, with a kappa of 0.94 for the primary diagnosis and a correlation of .92 for the severity ratings between the initial interviewer and second, independent assessor.
  • Inter-assessor reliability for the CGAS in the present study was .91 between the initial interviewer and the independent assessor.

Secondary outcome measures (Child-and parent-reported anxiety questionnaires).

  • The Spence Children's Anxiety Scale (SCAS: Spence, 1998 Spence, , 1999) ) child (SCAS-C) and parent (SCAS-P) versions were employed to measure level of adolescent anxiety.
  • The psychometric properties of both questionnaires have been well established (Achenbach & Rescorla, 2001) .
  • Items were summed to form a total score, with higher scores representing greater treatment outcome expectancy and perceived credibility of the program.

Procedure

  • Data collection occurred across three sites from 2005-2008: The University of Queensland and Griffith University in Brisbane, Australia, and Macquarie University in Sydney, Australia.
  • Adolescents who met broad inclusion criteria, together with at least one of their parents, were then provided with information about the study and asked to provide online, informed consent, to complete a battery of online questionnaires, and to participate in diagnostic interviews.
  • Families who met all inclusion criteria following diagnostic assessment and who provided informed consent were randomly assigned to one of three treatment conditions; clinic-based treatment (CLIN), internet-based treatment (NET) or a waitlist control condition (WLC).
  • Order of random assignment was established ahead of time through a computer program and implemented by a research team member not involved in the recruitment process.
  • This study was conducted in accordance with the University of Queensland, Macquarie University and Griffith University Human Ethics Committees.

Content of the Interventions

  • Participants in the internet-based treatment condition completed BRAVE for Teenagers -ONLINE (Spence, Holmes, & Donovan, 2006) .
  • A detailed description of the BRAVE interventions has been provided elsewhere (March et al., 2009; Spence et al., 2008) , and therefore the following contains only a brief overview.
  • The intervention is based on theoretical and empirical research relating to the psychosocial determinants of child anxiety (Dadds & Roth, 2001; Rapee & Spence, 2004; Silverman & Treffers, 2001) and evidence-based, cognitive-behavioral interventions (Barrett, 1998; Rapee, Wignall, Hudson, & Schniering, 2000; Spence, Donovan, & Brechman-Toussaint, 2000) .

Sessions include explanations of CBT techniques, real-life examples to demonstrate

  • How each skill can be implemented and an opportunity for the participant to apply the technique to their own anxiety-provoking situations.
  • The content of the intervention is designed to meet the developmental and cognitive level of teenagers, with age-appropriate scenarios, examples, and activities (example situations include school exams, job interviews, dating, and oral presentations).
  • The structured nature of CBT makes it relatively straightforward to adapt session and homework content from a clinic modality to internet delivery.
  • In addition, personalised, automated computer-generated emails are sent on behalf of the online therapist to congratulate participants for completion of sessions and to provide feedback about responses to quiz tasks.
  • Finally, personalized, automated reminder emails are sent if the session is not accessed within two days of becoming available.

Clinic-based treatment (CLIN).

  • In the clinic condition, participants received the equivalent program to the online therapy in terms of content, length and number of session activities, but all sessions were conducted face-to-face with a therapist within a clinic setting.
  • BRAVE-CLINIC is a manualized individual CBT program for adolescent anxiety (Donovan, Holmes, & Spence, 2006) adapted from the child program evaluated by Spence, Holmes, March et al. (2006) .
  • Adolescents and parents received a workbook to use during the sessions and a copy of the relaxation CD.
  • The WLC did not have any form of planned contact with the project team during the 12-week period.
  • Following this period, WLC participants were offered NET treatment and subsequently ceased to be part of the study.

Power

  • Power calculations were based on chi-square tests using diagnostic status as the primary outcome measure.
  • The study was powered on the comparison between the two active treatment conditions as this comparison required the most power.

Statistical Analysis

  • Primary outcomes for the investigation were clinical diagnoses (based on the ADIS-C/P), clinician severity ratings (CSR), and clinician-rated global functioning (CGAS).
  • Analyses for the continuous variables were conducted using an intention-to-treat (ITT) approach, and included all participants who were randomly assigned to conditions.
  • Mixed model, repeated measures analyses using SPSS Mixed were used separately to evaluate the continuously scaled outcome measures over time as a function of treatment condition.
  • Maximum likelihood estimation was used to determine parameter estimates.
  • The analyses first examined differences between the three experimental conditions (WLC, NET and CLIN) from baseline to the 12-week assessment point.

Baseline Comparisons

  • Initial differences between the three experimental conditions were examined for baseline demographic and treatment outcome measures.
  • No significant differences were evident for demographic variables including age, gender, family income, or parental education.

Impact of Missing Data

  • There were no significant differences in baseline levels of primary and secondary outcome variables or demographic characteristics of the child and family between participants who were retained in the study compared to those who were missing at one or more assessment occasions.
  • Dummy variables were computed for the primary outcome measures in which the number of occasions in which there was a missing value on that variable was computed.
  • There were no significant interactions between missingness and the condition by time interaction, nor with time or condition for either CSR or CGAS ratings.

Completion of Therapy Sessions

  • The average number of sessions completed by NET participants at the 12-week assessment point was 7.5 out of 10 for adolescents and 4.48 out of 5 for parents, although only 39% of adolescents and 66% of parents had completed all of their treatment sessions at this point.
  • This was not significantly different to that of CLIN families, who completed on average, 8.25 out of 10 sessions for adolescents and 4.43 out of 5 sessions for parents, with 57% of adolescents and 70% of parents completing all treatment sessions by the 12-week assessment.
  • Families in both conditions completed further sessions over the next few weeks.
  • No significant differences were evident between NET and CLIN adolescents or parents in terms of the mean number of sessions completed by 12-month follow-up.

Outcome: Baseline to 12-week Assessment Effects

  • Diagnostic status was determined on the basis of combined parent and adolescent reports on the ADIS-P and -C.
  • Diagnostic status was considered both in terms of the percentage of children who no longer met DSM-IV criteria for their primary anxiety disorder and for any anxiety disorder.
  • For the completer sample, analyses were conducted with participants for whom diagnostic data was actually available at the 12-week assessment.
  • The criterion for diagnosis free required the CSR for the primary diagnosis to be at a subclinical level (3 or lower).

Primary outcome measures -Continuous measures.

  • A linear mixed model analysis was conducted to compare the three conditions over time from baseline to the 12-week assessment for primary and secondary continuous outcome measures.
  • Results pertaining to fixed effects for intercept and slopes and effect sizes are shown in Table 3 , and indicate that both NET and CLIN conditions decreased in CSR scores significantly more than the WLC from baseline to 12-week assessment.
  • When adolescent gender was included in the model, there were no significant interaction effects between gender, condition and time.
  • A linear mixed model analysis was then used to examine differences in primary outcome measures across the four time points for the two treatment conditions.
  • There were no significant effects for condition or between condition and time for the primary outcome measures.

Outcome: Baseline to 12-week Assessment and 6-and 12-month Follow-ups

  • Follow-up data were examined only for the NET and CLIN treatment conditions, as the WLC participants were not available beyond the 12-week assessment point.
  • For the purposes of the ITT sample, missing data at 6and 12-month follow-up were replaced with the value from the previous time point at which they provided assessment data.

Clinically significant change at 6-month follow-up. The percentage of adolescents in

  • The ITT sample who no longer met DSM-IV criteria for their primary anxiety disorder continued to increase from 12-week assessment to 6-month follow-up, for both NET and CLIN conditions (see Table 1 ), suggesting that diagnostic status was further improved over time.
  • Similar improvements were evident for both treatment conditions in the completer sample.
  • Participants also continued to improve at 6-month follow-up with respect to the presence of any anxiety disorder (see Table 1 ).

Secondary outcome measures -Continuous measures.

  • There were no significant condition, or condition by time interaction effects, indicating that adolescents in both conditions showed significant and equivalent decreases in anxiety symptoms over time.
  • Table 5 shows the parameter estimates and effect sizes for the mixed model analysis and demonstrates that there were no significant differences in changes over time between the CLIN and NET conditions for the secondary outcome measures.

Satisfaction with the Program

  • Satisfaction data was collected for 40 adolescents and 41 parents in the NET condition and for 36 adolescents and 37 parents in the CLIN condition.
  • Overall, the results indicate that adolescents and parents reported moderate to high satisfaction with the treatment received, although parents in the CLIN condition reported slightly higher program satisfaction.

Discussion

  • The results of the study demonstrate the significant benefits of online delivery of CBT for the treatment of anxiety disorders amongst adolescents, with outcomes at 12 month followup being similar to those found for clinic-based therapy.
  • Furthermore, the online program was regarded as a highly credible approach by both parents and adolescents, at a level equivalent to clinic-based CBT, and produced moderate to high ratings of satisfaction with treatment.
  • Overall, the outcomes for both the CLIN and NET groups at 12-week post-baseline tended to be somewhat lower than those reported for clinic-based therapy (Cartwright-Hatton, et al., 2004; James, et al., 2008; Silverman, et al., 2008) .
  • It is feasible that both clinic and internet CBT of the length and type of content used in this study may not be sufficient to bring about significant improvements across the broad spectrum of anxiety symptoms in those young people with more complex, comorbid presentations.
  • There are, however, some limitations in the design of the study.

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Content maybe subject to copyright    Report

A randomized controlled trial of online versus clinic-based
CBT for adolescent anxiety
Author
Spence, Susan H, Donovan, Caroline L, March, Sonja, Gamble, Amanda, Anderson, Renee E,
Prosser, Samantha, Kenardy, Justin
Published
2011
Journal Title
Journal of Consulting and Clinical Psychology
DOI
https://doi.org/10.1037/a0024512
Copyright Statement
© 2011 American Psycological Association. This article may not exactly replicate the final
version published in the APA journal. It is not the copy of record. Reproduced here in
accordance with publisher policy. Please refer to the journal link for access to the definitive,
published version.
Downloaded from
http://hdl.handle.net/10072/43516
Griffith Research Online
https://research-repository.griffith.edu.au

RUNNING HEAD: ONLINE CBT FOR ADOLESCENT ANXIETY
A randomized controlled trial of online versus clinic-based CBT for adolescent anxiety
Susan H. Spence (PhD, MBA)
1
Caroline L. Donovan (PhD)
1
Sonja March (PhD)
1
Amanda Gamble (PhD)
2
Renee E. Anderson (BPsychSc Hons)
3
Samantha Prosser (BPsychSc Hons)
1
Justin Kenardy (PhD)
3 4
June 5, 2010
Author Note:
1
School of Psychology, Griffith University
2
Department of Psychology, Macquarie University
3
School of Psychology, University of Queensland
4
Centre of National Research on Disability and Rehabilitation, School of Medicine
University of Queensland
Corresponding author: Caroline L Donovan, Griffith University, QLD, Australia
TEL +61 7 3735 3401, FAX +61 7 3735 3388
Email: c.donovan@griffith.edu.au

Online CBT for Adolescent Anxiety
2
Abstract
Objective: The study examined the relative efficacy of clinician-assisted, online (NET)
delivery of cognitive behavior therapy compared to clinic (CLIN) delivery of the same
program and a wait list control (WLC) in the treatment of anxiety disorders in adolescents.
Method: Participants included 115 clinically anxious adolescents aged 12 to 18 years, and
their parent(s). Adolescents were randomly assigned to NET, CLIN or WLC conditions. The
treatment groups received equivalent CBT content. Clinical diagnostic interviews and
questionnaire assessments were completed 12 weeks after baseline, and at 6- and 12-month
follow-ups.
Results: Assessment at 12 weeks post-baseline showed significantly greater reductions in
anxiety diagnoses, and anxiety symptoms for both NET and CLIN conditions compared to the
WLC. These improvements were maintained or further enhanced for both forms of therapy,
with minimal differences between them, at 6- and 12-month follow-ups. Seventy-eight percent
of adolescents in the NET group (completer sample) no longer met criteria for the principle
anxiety diagnosis at 12-month follow-up compared to 80.6% in the CLIN group. Ratings of
treatment credibility from both parents and adolescents were high for NET, and equivalent to
CLIN. Satisfaction ratings by adolescents were equivalent for NET and CLIN conditions,
whereas parents indicated slightly higher satisfaction ratings for the CLIN format.
Conclusions: Online delivery of CBT, with minimal clinician support is as efficacious as the
same therapy content delivered on a face-to-face basis within a clinic setting in the treatment of
anxiety disorders among adolescents. This approach offers a credible alternative to clinic-based
therapy, with benefits of reduced therapist time, and greater accessibility for families who have
difficulty accessing clinic-based CBT.
KEY WORDS: ADOLESCENT, ANXIETY, COGNITIVE BEHAVIOR THERAPY,
COMPUTER, ONLINE

Online CBT for Adolescent Anxiety
3
A randomized controlled trial of online versus clinic-based CBT for adolescent anxiety
It has been well established that anxiety disorders in children can be treated efficaciously with
cognitive-behavior therapy (CBT), with average remission rates of between 56% and 67% at
post-treatment (Cartwright-Hatton, Roberts, Chitsabesan, Fothergill, & Harrington, 2004;
James, Soler, & Weatherall, 2008; Silverman, Pina, & Viswesvaran, 2008). An issue of
concern, however, is that only around 25% of clinically anxious young people receive
professional help (Essau, Conradt, & Petermann, 2000; Keller et al., 1992). There are various
reasons for this, including the failure to recognize that there is a problem, lack of knowledge
about the availability of treatment, long waiting lists, lack of trained therapists, high costs of
therapy, perceived stigma of attending a mental health clinic, and time constraints on the
family (Stallard, Udwin, Goddard, & Hibbert, 2007). Clearly, there is a need for alternative
modes of treatment delivery that increase the chance that young people and their parents will
seek help and participate in treatment.
Computer-based CBT has been proposed as one way of increasing access to therapy for
mental health problems, and has now been evaluated for a number of psychological disorders,
including anxiety, with very promising results (Reger & Gahm, 2009). To date, studies have
predominantly involved adults with research into the use of such technologies with children
and adolescents still in its infancy. Computer-based therapies may be particularly appropriate
for young people. They can be accessed at any time and offer a sense of privacy and
confidentiality that is highly valued by adolescents (James, 2007; Stallard, Velleman, &
Richardson, 2010). Indeed, adolescents demonstrate a preference for text-based (email) or
online counseling over talk-based (telephone) counseling (King, Bambling, Reid, & Thomas,
2006) and a large proportion report using computers to search the web for information relating
to worries, unhappiness or other problems (Stallard et al., 2010). Finally, communication
applications on the internet, such as email, instant messaging, blogs and chat rooms have
become a very important and familiar component of the lives of many adolescents

Online CBT for Adolescent Anxiety
4
(Subrahmanyam & Lin, 2007). However, given that it is frequently parents who initiate
treatment for their child, it is also important that parents find computer-based therapy to be a
credible and acceptable form of treatment if it is to become widely adopted.
To date, there appear to be only three published randomized controlled trials evaluating
internet-based treatments for childhood anxiety, none of which have involved adolescents
(Khanna & Kendall., 2010; March, Spence, & Donovan, 2009; Spence, Holmes, March, &
Lipp, 2006). Spence, Holmes, March et al. (2006) compared clinic-based group CBT, the same
treatment partially delivered via the internet, and a waitlist control with anxious children. The
clinic and the combined clinic-internet conditions showed significantly greater reductions in
anxiety symptoms from pre- to post-treatment than the waitlist, with improvements being
maintained at 12-month follow-up. Subsequently, March et al. (2009) examined the efficacy of
the same program when delivered fully online, with only minimal therapist contact by email
and phone, in comparison to a waitlist control. Children in the internet condition showed small
but significant reductions in clinician-rated anxiety severity, global assessment of functioning,
and parent self-report measures of child anxiety compared to the wait-list at 12-week
assessment. By 6-month follow-up, 75% of children in the internet condition no longer met
criteria for their anxiety disorder. Recently, Khanna and Kendall (2010) reported a small-scale
randomized controlled trial comparing computer assisted treatment for 7-13 year old anxious
children with individual, clinic-based CBT. Both treatments were associated with significantly
greater reductions in anxiety than an attention placebo control condition. Improvements for
both treatments continued over the 3-month follow-up period, with no difference in outcome.
Research relating to the evaluation of online or computer assisted CBT has, to date,
been focused on younger children, rather than adolescents. Given the potential value of online
treatment for adolescent anxiety problems, it is particularly important to determine its efficacy.
The current study builds on previous research by comparing the efficacy of online delivery of
CBT with clinically anxious adolescents, with clinic-based treatment and a waitlist control

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References
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Reference EntryDOI
11 Jun 2013

113,134 citations

Journal ArticleDOI
TL;DR: A systematic review and meta-analysis of placebo-controlled studies examined the efficacy and tolerability of different types of antidepressants, the combination of an antidepressant and an antipsychotic, antipsychotics alone, or natural products in adults with somatoform disorders in adults to improve optimal treatment decisions.
Abstract: BACKGROUND: Somatoform disorders are characterised by chronic, medically unexplained physical symptoms (MUPS). Although different medications are part of treatment routines for people with somatoform disorders in clinics and private practices, there exists no systematic review or meta-analysis on the efficacy and tolerability of these medications. We aimed to synthesise to improve optimal treatment decisions.OBJECTIVES: To assess the effects of pharmacological interventions for somatoform disorders (specifically somatisation disorder, undifferentiated somatoform disorder, somatoform autonomic dysfunction, and pain disorder) in adults.SEARCH METHODS: We searched the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) (to 17 January 2014). This register includes relevant randomised controlled trials (RCTs) from The Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). To identify ongoing trials, we searched ClinicalTrials.gov, Current Controlled Trials metaRegister, the World Health Organization International Clinical Trials Registry Platform, and the Chinese Clinical Trials Registry. For grey literature, we searched ProQuest Dissertation {\&} Theses Database, OpenGrey, and BIOSIS Previews. We handsearched conference proceedings and reference lists of potentially relevant papers and systematic reviews and contacted experts in the field.SELECTION CRITERIA: We selected RCTs or cluster RCTs of pharmacological interventions versus placebo, treatment as usual, another medication, or a combination of different medications for somatoform disorders in adults. We included people fulfilling standardised diagnostic criteria for somatisation disorder, undifferentiated somatoform disorder, somatoform autonomic dysfunction, or somatoform pain disorder.DATA COLLECTION AND ANALYSIS: One review author and one research assistant independently extracted data and assessed risk of bias. Primary outcomes included the severity of MUPS on a continuous measure, and acceptability of treatment.MAIN RESULTS: We included 26 RCTs (33 reports), with 2159 participants, in the review. They examined the efficacy of different types of antidepressants, the combination of an antidepressant and an antipsychotic, antipsychotics alone, or natural products (NPs). The duration of the studies ranged between two and 12 weeks.One meta-analysis of placebo-controlled studies showed no clear evidence of a significant difference between tricyclic antidepressants (TCAs) and placebo for the outcome severity of MUPS (SMD -0.13; 95{\%} CI -0.39 to 0.13; 2 studies, 239 participants; I(2) = 2{\%}; low-quality evidence). For new-generation antidepressants (NGAs), there was very low-quality evidence showing they were effective in reducing the severity of MUPS (SMD -0.91; 95{\%} CI -1.36 to -0.46; 3 studies, 243 participants; I(2) = 63{\%}). For NPs there was low-quality evidence that they were effective in reducing the severity of MUPS (SMD -0.74; 95{\%} CI -0.97 to -0.51; 2 studies, 322 participants; I(2) = 0{\%}).One meta-analysis showed no clear evidence of a difference between TCAs and NGAs for severity of MUPS (SMD -0.16; 95{\%} CI -0.55 to 0.23; 3 studies, 177 participants; I(2) = 42{\%}; low-quality evidence). There was also no difference between NGAs and other NGAs for severity of MUPS (SMD -0.16; 95{\%} CI -0.45 to 0.14; 4 studies, 182 participants; I(2) = 0{\%}).Finally, one meta-analysis comparing selective serotonin reuptake inhibitors (SSRIs) with a combination of SSRIs and antipsychotics showed low-quality evidence in favour of combined treatment for severity of MUPS (SMD 0.77; 95{\%} CI 0.32 to 1.22; 2 studies, 107 participants; I(2) = 23{\%}).Differences regarding the acceptability of the treatment (rate of all-cause drop-outs) were neither found between NGAs and placebo (RR 1.01, 95{\%} CI 0.64 to 1.61; 2 studies, 163 participants; I(2) = 0{\%}; low-quality evidence) or NPs and placebo (RR 0.85, 95{\%} CI 0.40 to 1.78; 3 studies, 506 participants; I(2) = 0{\%}; low-quality evidence); nor between TCAs and other medication (RR 1.48, 95{\%} CI 0.59 to 3.72; 8 studies, 556 participants; I(2) =14{\%}; low-quality evidence); nor between antidepressants and the combination of an antidepressant and an antipsychotic (RR 0.80, 95{\%} CI 0.25 to 2.52; 2 studies, 118 participants; I(2) = 0{\%}; low-quality evidence). Percental attrition rates due to adverse effects were high in all antidepressant treatments (0{\%} to 32{\%}), but low for NPs (0{\%} to 1.7{\%}).The risk of bias was high in many domains across studies. Seventeen trials (65.4{\%}) gave no information about random sequence generation and only two (7.7{\%}) provided information about allocation concealment. Eighteen studies (69.2{\%}) revealed a high or unclear risk in blinding participants and study personnel; 23 studies had high risk of bias relating to blinding assessors. For the comparison NGA versus placebo, there was relatively high imprecision and heterogeneity due to one outlier study. Although we identified 26 studies, each comparison only contained a few studies and small numbers of participants so the results were imprecise.AUTHORS' CONCLUSIONS: The current review found very low-quality evidence for NGAs and low-quality evidence for NPs being effective in treating somatoform symptoms in adults when compared with placebo. There was some evidence that different classes of antidepressants did not differ in efficacy; however, this was limited and of low to very low quality. These results had serious shortcomings such as the high risk of bias, strong heterogeneity in the data, and small sample sizes. Furthermore, the significant effects of antidepressant treatment have to be balanced against the relatively high rates of adverse effects. Adverse effects produced by medication can have amplifying effects on symptom perceptions, particularly in people focusing on somatic symptoms without medical causes. We can only draw conclusions about short-term efficacy of the pharmacological interventions because no trial included follow-up assessments. For each of the comparisons where there were available data on acceptability rates (NGAs versus placebo, NPs versus placebo, TCAs versus other medication, and antidepressants versus a combination of an antidepressant and an antipsychotic), no clear differences between the intervention and comparator were found.Future high-quality research should be carried out to determine the effectiveness of medications other than antidepressants, to compare antidepressants more thoroughly, and to follow-up participants over longer periods (the longest follow up was just 12 weeks). Another idea for future research would be to include other outcomes such as functional impairment or dysfunctional behaviours and cognitions as well as the classical outcomes such as symptom severity, depression, or anxiety.

11,458 citations

Journal ArticleDOI
Sinead Brophy1, Helen Davies1, Sopna Mannan1, Huw Brunt, Rhys Williams1 
TL;DR: Two studies show SU leading to earlier insulin dependence and a meta-analysis of four studies with considerable heterogeneity showed poorer metabolic control if SU is prescribed for patients with LADA compared to insulin.
Abstract: Background Latent autoimmune diabetes in adults (LADA) is a slowly developing type 1 diabetes. Objectives To compare interventions used for LADA. Search methods Studies were obtained from searches of electronic databases, supplemented by handsearches, conference proceedings and consultation with experts. Date of last search was December 2010. Selection criteria Randomised controlled trials (RCT) and controlled clinical trials (CCT) evaluating interventions for LADA or type 2 diabetes with antibodies were included. Data collection and analysis Two authors independently extracted data and assessed risk of bias. Studies were summarised using meta-analysis or descriptive methods. Main results Searches identified 13,306 citations. Fifteen publications (ten studies) were included, involving 1019 participants who were followed between three months to 10 years (1060 randomised). All studies had a high risk of bias. Sulphonylurea (SU) with insulin did not improve metabolic control significantly more than insulin alone at three months (one study, n = 15) and at 12 months (one study, n = 14) of treatment and follow-up. SU (with or without metformin) gave poorer metabolic control compared to insulin alone (mean difference in glycosylated haemoglobin A1c (HbA1c) from baseline to end of study, for insulin compared to oral therapy: -1.3% (95% confidence interval (CI) -2.4 to -0.1; P = 0.03, 160 participants, four studies, follow-up/duration of therapy: 12, 30, 36 and 60 months; however, heterogeneity was considerable). In addition, there was evidence that SU caused earlier insulin dependence (proportion requiring insulin at two years was 30% in the SU group compared to 5% in conventional care group (P < 0.001); patients classified as insulin dependent was 64% (SU group) and 12.5% (insulin group, P = 0.007). No intervention influenced fasting C-peptide, but insulin maintained stimulated C-peptide better than SU (one study, mean difference 7.7 ng/ml (95% CI 2.9 to 12.5)). In a five year follow-up of GAD65 (glutamic acid decarboxylase formulated with aluminium hydroxide), improvements in fasting and stimulated C-peptide levels (20 μg group) were maintained after five years. Short term (three months) follow-up in one study (n = 74) using Chinese remedies did not demonstrate a significant difference in improving fasting C-peptide levels compared to insulin alone (0.07 µg/L (95% CI -0.05 to 0.19). One study using vitamin D with insulin showed steady fasting C-peptide levels in the vitamin D group but declining fasting C-peptide levels (368 to 179 pmol/L, P = 0.006) in the insulin alone group at 12 months follow-up. Comparing studies was difficult as there was a great deal of heterogeneity in the studies and in their selection criteria. There was no information regarding health-related quality of life, complications of diabetes, cost or health service utilisation, mortality and limited evidence on adverse events (studies on oral agents or insulin reported no adverse events in terms of severe hypoglycaemic episodes). Authors' conclusions Two studies show SU leading to earlier insulin dependence and a meta-analysis of four studies with considerable heterogeneity showed poorer metabolic control if SU is prescribed for patients with LADA compared to insulin. One study showed that vitamin D with insulin may protect pancreatic beta cells in LADA. Novel treatments such as GAD65 in certain doses (20 μg) have been suggested to maintain fasting and stimulated C-peptide levels. However, there is no significant evidence for or against other lines of treatment of LADA.

6,882 citations

Journal ArticleDOI
TL;DR: The findings indicate that the CGAS can be a useful measure of overall severity of disturbance and is recommended to both clinicians and researchers as a complement to syndrome-specific scales.
Abstract: • We evaluated the Children's Global Assessment Scale (CGAS), an adaptation of the Global Assessment Scale for adults. Our findings indicate that the CGAS can be a useful measure of overall severity of disturbance. It was found to be reliable between raters and across time. Moreover, it demonstrated both discriminant and concurrent validity. Given these favorable psychometric properties and its relative simplicity, the CGAS is recommended to both clinicians and researchers as a complement to syndrome-specific scales.

3,281 citations


"A randomized controlled trial of on..." refers background or methods in this paper

  • ...The CGAS has demonstrated good inter-rater reliability (r = .84) and test-retest reliability (r = .85) (Dyrborg et al., 2000; Rey, Starling, Wever, Dossetor, & Plapp, 1995; Schaffer et al., 1983)....

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  • ...The blind assessor also completed the Children's Global Assessment Scale (CGAS: Schaffer et al., 1983)....

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  • ...Scores ranging between 81 and 100 on the CGAS represent normal levels of functioning, scores of 61-80 indicate slight disability, moderate disability is represented by scores between 41 and 60, and scores of 1-40 indicate serious disability (Schaffer et al., 1983)....

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