[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
intervention 1
kontrol 1
Included criteria: Eligible patients (Ps) included 124 veterans referred for treatment to the Anxiety Disorders Clinic at the VA San Diego Healthcare System Medical Center, an outpatient clinic that specializes in the behavioral treatment of anxiety disorders. Participants were required to be 18-75 years of age, English speaking, and have a principal (or dual principal) DSM-IV diagnosisof panic disorder with or without agoraphobia (PD/A), generalized anxiety disorder (GAD), social anxiety disorder (SAD), specificphobia (SP), obsessive-compulsive disorder (OCD) or civilian post-traumatic stress disorder (PTSD) (e.g., non combat or military sex-ual trauma related) on the MINI International NeuropsychiatricInterview (MINI) for DSM-IV (Sheehan et al., 1998) (see Diagnostic Assessment, below).
Excluded criteria: We excluded patients with principal military-related PTSD because we were required to refer them to a specialized military PTSD clinic for treatment (which is common in many VAs). To maximize external validity, exclusion criteria were limited to active suicidal ideation, active substance use disorders within thepast 3 months, or current participation in other CBT or adapted MBSR treatments for anxiety disorders.
Pretreatment:
Intervention Characteristics
intervention 1
kontrol 1
Grad af angstsymptomer, Clinician's rating severity
Funktion, Penn State Worry Questionnaire
Frafald, alle årsager
Sponsorship source: No information
Country: USA
Setting: Outpatient clinic that specializes in the behavioral treatment o fanxiety disorders.
Authors name: Joanna J. Arch
Institution: Dept of Psychology and Neuroscience, University of Colorado Boulder
Email: E-mail addresses:Joanna.Arch@Colorado.edu
Address: Dept of Psychology and Neuroscience, University of Colorado Boulder, 345 UCB Muenzinger, Boulder, CO 80309-0345, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol 1
Kontrol 2
Included criteria: Patients met Diagnostic and statistical manual of mental disorders (4th ed., text rev.: DSM-IV-TR; American Psychiatric Association, 2000) criteria for a principal diagnosis of generalized SAD based on the Anxiety Disorders Interview Schedule for the DSM-IV. Patients met the criteria for the generalized subtype of SAD if they endorsed greather than moderate social fear in five or more distinct social situations assessed by the ADIS-IV-LPatients had to achieve a score greather than 60 on the Liebowich Social Anxiety Scale- Self report
Excluded criteria: Pharmacotherapy or psychotherapy during the past year, participation in CBT for any anxiety disorder during the last 2 years, any previous MBSR course, previous participation in long-term meditation retreats, history of regular meditatin practice of 10 min or more three or more times per week, history of neurological disorders, cardiovascular disorders, thought disorders, or bipolar disorders as well as current substance and alcohol abuse or dependence.
Intervention Characteristics
Intervention
Kontrol 1
Grad af undgåelse, Subtle Avoidance Fequency avoidance (SAFE)
Grad af angst, The Liebowitz Social Anxiety Scale (LSAS), total score
Frafald, alle årsager
Sponsorship source: No information
Country: UK
Setting: Outpatient clinic
Authors name: Philippe R Goldin
Institution: University of Calinornia
Email: pgoldin@ucdavis.edu
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol 1
Included criteria: Individuals age 18 or older were eligible if they: (a) met DSM-IV criteria for current primary GAD and designated GAD as the primary problem, and (b) scored 20 or above on the Hamilton Anxiety scale (HAM-A)
Excluded criteria: Exclusion criteria included: (1) a lifetime history of schizophrenia or any other psychosis,mental retardation, organic medical disorders, bipolar disorder, post-traumatic stress disorder or obsessive compulsive disorder, (2) alcohol or substance abuse or dependence within the past 6 months, (3) significant suicidal ideation or behaviors within past 6 months,(4) if on medication, on a stable dose for less than 4 weeks, or unwilling to remain on that dose throughout the study, (5) serious medical illness or instability, (6) concurrent psychotherapy directed toward GAD, (7) more than 4 classes of meditation training and practice (including yoga and tai-chi) in the past 2 years; (8) pregnancy or lactation, and (9)significant personality disorder likely to interfere with study participation.
Intervention Characteristics
Intervention
Kontrol 1
The SME course was taught in a didactic format, covering topics relevant to stress, stress physiology, effect of stress on body systems, time management techniques, sleep physiology, insomnia, optimal nutrition, effects of stress on diet, caffeine, exercise, stress hardiness, and factors that can buffer the impact of stress,such as humor, altruism, and volunteering. The course content was based on the control condition used by Dusek et al, but delivered in a group lecture format. To more closely match the yoga portion of MBSR, SME included gentle strength and posture exercises with a physical therapist for the same number of total minutes. Extra resistance bands were provided for assigned home exercises. There was no aerobic exercise in the course. The weekend Special Class included stability ball exercise instruction, a lecture on functional movement and individual postural assessments with a fitness instructor, a short massage, and a lecture from a licensed dietician. Similar to the MBSR class, participants inSME were provided 20 minute audio book recordings to listen to at home (same total number of minutes)
Skadesvirkninger (total antal SAE og AE)
Grad af angst, CGI-Illness severity
Grad af angst, HAM-A
Grad af angst, The Beck Anxiety Inventory (BAI)
Sponsorship source: This study was primarily supported by grant K23AT4432 from the National Center on Complementary and Alternative Medicine, National Institutes of Health (Hoge, P.I.). The Highland Street Foundation provided additional support including to Ms Metcalf andDrs. Simon, Bui, Marques and Pollack
Country: USA
Setting: Outpatient clinic
Authors name: Elizabeth A. Hoge
Institution: Department of Psychiatry, Massachusetts General Hospital, Boston, MA
Email: ehoge@partners.org
Address: Corresponding Author: Elizabeth Hoge, MD, Assistant Professor of Psychiatry, Center for Anxiety and Traumatic Stress Disorders,Massachusetts General Hospital, One Bowdoin Square, 6th Floor, Boston, MA 02114
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol 1
Kontrol 2
Included criteria: Inclusion criteria were: principal diagnosis of SAD,Generalized (based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., text revision [DSM-IV-TR];American Psychiatric Association, 2000assessed using the Struc-turedClinical Interview for DSM-IV[SCID-IV];First, Spitzer, Gibbon,& Williams, 1996); English fluency; and age between 18 and 65 years.
Excluded criteria: Exclusion criteria were: current major depressive disorder(MDD); current alcohol or substance abuse or dependence; lifetime psychosis; lifetime mania; current suicidal intent; and past ACT orCBT for SAD. Psychotropic medications were allowed if doses were stable in the 3 months prior to the study and there was agreement to remain stable for the study duration.
Intervention Characteristics
Intervention
Kontrol 1
Kontrol 2
Frafald, alle årsager
Funktion, Social Adjustment Scale
Funktion, Social phobia inventory
Livskvalitet, Valued Living Questionnaire (VLQ)
Sponsorship source: The authors gratefully acknowledge financial support awarded to the first author from the Ontario Mental Health Foundation and the Ministry of Research and Innovation.
Country: Canada
Setting: Outpatient clinic
Authors name: Nancy L. Kocovski
Institution: Department of Psychology, Wilfrid Laurier University, 75 University Ave., Waterloo, Ontario N2L 3C5, Canada
Email: E-mail address:nkocovski@wlu.ca
Address: Department of Psychology, Wilfrid Laurier University, 75 University Ave., Waterloo, Ontario N2L 3C5, Canada
Study design:
Study grouping:
Baseline Characteristics
intervention 1
kontrol 1
Included criteria: Patients were eligible to participate if they had a current diagnosis of DSM-IVSAD, generalized subtype, based on psychiatric interview and a structured clinical interview (Mini International Neuropsychiatric Interview (MINI),Sheehan et al., 1998) and reported at least moderately severe SAD symptoms as determined by a total score > 50 on the clinician-rated Liebowitz Social Anxiety Scale (LSAS) (Liebowitz, 1987) and a severity rating > 4 on the Clinical Global Impression (CGI)-Severity ofIllness subscale (Guy, 1976) at screening and baseline visits. Because comorbidity is common in SAD (Kessler,Chiu, Demler, & Walters, 2005), certain additional current Axis I disorders were allowed as long as they were secondary to and not clinically more prominent than the SAD. In the present study, these included dysthymia, major depression, panic disorder, agoraphobia, GAD, specific phobia and somatization disorder.
Excluded criteria: Exclusion criteria were a Hamilton Depression Rating Scale (Hamilton, 1960) score > 14 at screen visit; presence of other Axis I disorders; lifetime history of psychotic disorders or bipolar disorder; substance abuse in the past 12 months; current suicide risk; participation in any form of psychotherapy in the last 3 months; receivedCBT in the past 12 months; participated in any formal stress reduction program that includes regular meditation and yoga practices in the past 12 months; and presence of any clinically significant medical condition that would make it unsafe for the patient to participate in the study. Concurrent use of psychotropics was allowed as long as the medication type and dose remained stable for 6 weeks prior to randomization and throughout the study. Concomitant treatment with any form of psychotherapy was not permitted during the study
Intervention Characteristics
intervention 1
kontrol 1
Frafald, alle årsager
Skadesvirkninger (total antal SAE og AE)
Grad af angst, CGI-Illness severity
Funktion, The Social Interaction Scale (SIAS)
Funktion, Social Phobia Scale (SPS), mean final, SD
Livskvalitet, Quality of Life Inventory (QoLI), mean final, SD
Undgåelse, The Liebowitz Social Anxiety Scale (LSAS), total score
Undgåelse, The Liebowitz Social Anxiety Scale (LSAS),subscore avoidance
Sponsorship source: This study was funded in part by a grant from the University (Ottawa) Medical Research Fund. We wouldlike to thank Maria Pizzi, Simin Stephens, Murray Weeks, Emilie Chan and Ramona Eryzulu for researchassistance
Country: USA
Setting: Outpatient
Authors name: Diana Koszycki
Institution: Stress and Anxiety Clinical Research Unit, University of Ottawa Institute of Mental Health Research
Email: E-mail address:dkoszyck@rohcg.on.ca
Address: Stress and Anxiety Clinical Research Unit, University of Ottawa Institute of Mental Health Research, RoyalOttawa Mental Health Centre, 1145 Carling Ave., Ottawa, Ontario, Canada K1Z 7K4.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol 1
Included criteria: The sample comprised men and women age 18 years and older who were recruited via referrals from mental health services and advertisements placed in local media, the Internet, university and hospital bullet in boards, and physician offices. Individuals who inquired about the study participated in a telephone prescreen interview to confirm the presence of SAD symptoms and exclude those who were clearly ineligible to participate. After the telephone prescreen, potentially eligible participants were scheduled an appointment with the study investigators for confirmation of SAD and other eligibility criteria. To be eligible, participants needed to meet SAD criteria based on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition (SCID), with scores greater than 30 on the Liebowitz Social Phobia Scale and 4 or greater on the Clinical Global Impression-Severity (CGI-S) scale at the baseline visit.
Excluded criteria: Exclusion criteria included a lifetime history of psychosisor bipolar disorder, history of substance use disorders in the last 12 months, history of psychotic features of affective disorder, and high suicide risk. Other comorbidities were allowed so long as the SAD was the primary and predominant disorder. Participants with depressive disorders who obtained a score of 24 or greater on the Montgomery-Åsberg Depression Rating Scale at baseline visit were excluded.Consistent with previous research on MBIs for SAD, participants with an established meditation were excluded, as were those who had a regular yoga practice given theoverlap between yoga and MBIs.Concurrent use of anti-depressants, anxiolytics, hypnotics, and herbal products withpsychoactive substances was allowed as long as the medication type and dose had remained stable for 6 weeks before randomization and medication type and dose did not change after randomization. Concomitant treatment with any psychotherapy was proscribed during the study. Concomitant treatment was recorded at each assessment.
Intervention Characteristics
Intervention
Kontrol 1
Frafald, alle årsager
Skadesvirkninger (total antal SAE og AE)
Grad af angst, CGI-Illness severity
Funktion, Social Adjustment Scale
Undgåelse, The Liebowitz Social Anxiety Scale (LSAS), total score
Sponsorship source: The study was funded in part by a grant from the Institutde recherche de l'Hopital Montfort awarded to Dr. Kos-zycki. The authors would like to thank Jessie Bosse (DPsychCandidate, Psychology, Universite ́de Que ́be ́c en Outaouais)for co-facilitating one of the groups and Julie Wallis, BSc,and Eva Gue ́rin, PhD, for research assistance
Country: Canada
Setting: Outpatient clinic
Authors name: Diana Koszycki
Institution: University of Ottawa, Ottawa, Ontario, Canada
Study design:
Study grouping:
Baseline Characteristics
intervention 1
kontrol 1
Included criteria: Subjects were between 20 and 60 years of ageand fulfilled the Diagnostic and Statistical Manual ofMental Disorders, Fourth Edition(DSM-IV) criteria for generalized anxiety disorder or panic disorder with or without agoraphobia, as diagnosed by two psychiatrists using the Structured Clinical Interview for DSM-IVAxis I disorders. In all subjects, symptoms were not relieved after more than 6 months of pharmacotherapy.Written informed consent was obtained after a full description of the study had been presented to the subjects. Prior to the study, the subjects were treated with the antidepressant paroxetine (20 mg/day), sertraline (50-100 mg/day), or fluvoxamine (50-100 mg/day) and with the anxiolytic alprazolam (0.125-0.5 mg/day). Psychiatrists confirmed that acute symptoms in the patients had stabilized and had remained unchanged for the past 2 months. The medications and dosages were not altered during the study.
Excluded criteria: Exclusion criteria included any history of substance abuse or dependency, other psychiatric comorbidities, significant medical problems (such as diabetes mellitus, hypertension, tuberculosis, hepatitis, or pregnancy), and involvement in litigation or compensation.
Intervention Characteristics
intervention 1
kontrol 1
Frafald, alle årsager
Funktion, The Symptom Checklist-90-Revised (SCL-90-R)
Grad af angst, HAM-A
Sponsorship source: No information
Country: South Korea
Setting: Inpatient or outpatient at the Department of Psychiatry, PochoCHA University College of Medicine
Authors name: Sang Hyuk Lee
Institution: Department of Psychiatry, Pochon CHA University College of Medicine, Seongnam, South Korea
Email: E-mail address:ctk7089@hanmail.net
Address: Department of Psychiatry, Pochon CHA University College of Medicine, Bundang CHA Hospital, 351 Yatap-Dong,Bundang-Gu, Seongnam 463-712, South Korea
Study design: Randomized controlled trial
Study grouping:
Baseline Characteristics
intervention 1
kontrol 1
Included criteria:age 18-25 with a primary diagnosis of SP according to DSM-IV criteria (American Psychiatric Association, 2000).
Excluded criteria: Exclusion criteria comprised: psychosis, severe depression, alcohol or drug dependence, bipolar disorder, cluster A and B personality disorders, and current (but not previous) psycho-pharmacological or psychotherapeutic treatment.
Intervention Characteristics
intervention 1
kontrol 1
Frafald, alle årsager
Undgåelse, The Liebowitz Social Anxiety Scale (LSAS), total score
Grad af angst, The Beck Anxiety Inventory (BAI)
Funktion, Sheehan Disablity Scale, mean final, SD
Funktion, The Symptom Checklist-90-Revised (SCL-90-R)
Sponsorship source: No information
Country: Denmark
Setting: Outpatient clinic
Authors name: JACOB PIET
Institution: Institute of Psychology, Aarhus University, Denmark
Email: jacobpj@psy.au.dk
Address: Jacob Piet, Institute of Psychology, Aarhus University, Nobelparken, Jens Chr. Skous Vej 4, 8000 Aarhus C, Denmark.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
intervention 1
kontrol 1
Included criteria: Inclusion criteria were that patients 1) be between 18 and 65 years, and 2) fulfill diagnostic criteria for either PD/AG, SAD,or GAD.
Excluded criteria: Exclusion criteria were: 1) suicidality, 2) substance abuse and/or dependence, 3) severe mental disorder (psychosis or bipolardisorder), 4) other Axis I disorders as primary diagnosis, 5) use of anxiolytics, 6) deficits in impulse control as assessed by the MINI module for antisocial personality disorder, and 7) other concurrent treatment. These criteria allowed for the presence of comorbid Axis I symptomatology, provided that patients had anxiety disorder as a primary diagnosis.
Intervention Characteristics
intervention 1
kontrol 1
Funktion, Penn State Worry Questionnaire
Frafald, alle årsager
Skadesvirkninger (total antal SAE og AE)
Grad af angst, The Beck Anxiety Inventory (BAI)
Funktion, The Symptom Checklist-90-Revised (SCL-90-R)
Sponsorship source: No information
Country: Norway
Setting: Outpatient clinic
Authors name: Jon Vøllestad
Institution: Department of Clinical Psychology, University of Bergen, Christiesgate 12, 5015 Bergen, Norway
Email: E-mail address:jon.vollestad@psykp.uib.no
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol 1
Kontrol 2
Included criteria: (a) aged 21-65 (b) with a DSM-IV proncipal diagnosis of GAD on a structured Clinical Interview for DSM-IV (SCID) and a score of 19 or above using the Chinese version of the Beck Anxiety Inventory (BAI) at baseline;(c) could understand Cantonese;(d) were willing to attend either the MBCT or psychoeducation group sessions; (e) if they were on medications for anxiety, they needed to have been on stable doses for at least 2 months before starting the intervention.
Excluded criteria: Participants were excluded if they: (a) were illiterate as they would have been unable to complete the self-report assessment;(b) had psychiatric and medical comorbidities that were potentially life threatening (i.e. psychosis, suicidal ideation, terminal medicalillness) or conditions expected to severely limit patient participation or adherence (such as psychosis, current substance misuse,dementia, pregnancy); (c) were currently seeing a cognitive-behavoiural therapist or psychotherapist/counsellor for any psychological problems; and (d) undertook regular meditation or yoga practice (or had previously done so).
Intervention Characteristics
Intervention
Kontrol 1
Kontrol 2
Grad af angst, The Beck Anxiety Inventory (BAI)
Funktion, Penn State Worry Questionnaire
Livskvalitet, SF 12, Mental Component Summary (MCS-12)
Livskvalitet, SF 12, Physical Component Summary (PCS-12)
Frafald, alle årsager
Sponsorship source: This study was funded by the Health and Health Services Research Fund of the Food andHealth Bureau of the HKSAR government with grant reference number 07080451. Thefunders had no role in study design, data collection and analysis, decision to publish orpreparation of the manuscript.
Country: China
Setting: Outpatient clinic
Authors name: Samuel Yeung Shan Wong
Wrong intervention
Wrong outcomes
Already included from systematic review
Wrong comparator
Wrong patient population
Wrong outcomes
Wrong outcomes
Wrong patient population
Wrong comparator
not a add-on study
Wrong study design
Wrong comparator
Wrong outcomes
Only a short synopsis
Wrong comparator
Wrong patient population
Wrong patient population
Only a short synopsis
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "A computerized random number generator created all randomization sequences, which were known to the PIs but not the blind assessors. Delays in securing VA approval for community-based MBSR therapists necessitated creating a computerized randomization of 2:1 CBT to adapted MBSR for the first third of the study. For the middle third of the study, the computer returned to assigning on a 1:1 randomization schedule. In attempt to equalize participation in both treatment conditions, for the final third of the study the computer randomized Ps 1:2 CBT to adapted MBSR. A greater number of Ps enrolled in the first than the final third of the study, however."
Judgement Comment: Computer generated allocation sequence
Judgement Comment: No information of how the allocation sequence was generated
Judgement Comment: No information of how the allocation sequence was generated
Quote: "Randomization. For the first three rounds of groups, the ratio of participants assigned to MAGT, CBGT or WAIT was equivalent. Recruitment became increasingly difficult and as such, for rounds four through six, fewer participants were assigned to WAIT (ratio of 2:2:1 for CBGT, MAGT, and WAIT, respectively) and none were assigned to WAIT for the seventh round. MINIM software (Evans, Day, & Royston; freely available on the internet) was used for the randomization procedure, which included three stratification var- iables: age (>30 or 30 years), gender (male, female), and social anxiety severity (LSAS > 75 or 75)."
Judgement Comment: No information of how the allocation sequence was generated
Quote: "After informed consent and completion of baseline assessments, eligible participants were sequentially allocated a unique participant number that determined assignment to one of the two study conditions. The treatment allocation scheduled was generated by an independent research assis- tant using a computer-based random-number generation program. Allocations were generated using permuted blocks of varying lengths to maintain close balance of the numbers of participants in each group during the trial. Participants who were randomly assigned to WL received the interven- tion after the 12-week wait period."
Judgement Comment: No information of how the allocation sequence was generated
Quote: "Randomization was carried out in blocks of 14 or 12 (for group 1 and 2 respectively) by a secretary at the institute independent of the Anxiety Clinic. Outcome measures were collected at five data points: (1) prior to therapy; (2) after participants´ first treatment (post 1), (3) after their second treatment (post 2); and at follow-ups (4) six months; and (5) 12 months after end of treatment."
Judgement Comment: No information of how the allocation sequence was generated
Quote: "simple randomisation method was used to randomly assign eligible participants to one of the three groups using the Microsoft Excel RAND function. For every batch of participants recruited, a third of the participants were randomised to the MBCT group, a third to the psychoeducation group and the rest to the control group."
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Quote: "A computerized random number generator created all randomization sequences, which were known to the PIs but not the blind assessors."
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: No information on allocation concealment
Judgement Comment: No information of allocation concealment
Judgement Comment: No information of allocation concealment
Judgement Comment: No information of allocation consealment
Quote: " After informed consent and completion of baseline as- sessments, eligible participants were sequentially allocated a unique participant number that determined assignment to one of the two study conditions. The treatment allocation scheduled was generated by an independent research assis- tant using a computer-based random-number generation program. Allocations were generated using permuted blocks of varying lengths to maintain close balance of the numbers of participants in each group during the trial. Participants who were randomly assigned to WL received the interven- tion after the 12-week wait period."
Judgement Comment: Allocations were generated by an independent research assistant.
Judgement Comment: No information of allacotion concealment
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: No information on allocation concealment
Quote: "To ensure concealment of randomisation, a biostatistician who was not part of this study pre-generated random numbers from a normal distribution."
Quote: "assigned to group A, the middle third to group B and the remaining ones to group C, where A, B and C represents the treatment the patient will receive (for example A, MBCT group; B, psycho- education group; C, control group) and only the research coordinator could decode it. The"
Quote: "rest to the control group. <b>To ensure concealment of randomisation, a biostatistician who was not part of this study pre-generated random numbers from a normal distribution. Participants were ranked in order according to their generated values. Participants ranked in the top third of the list were</b> assigned to group A, the"
Judgement Comment: Performed by a biostatician who was not part of the study.
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: Insufficient information on blinding, but is assumed to not be feasible
Judgement Comment: No information of blinding of participants and health care providers, but blinding not feasible
Judgement Comment: No information of blinding of participants and health care providers, but blinding not feasible
Judgement Comment:No information of blinding of participants and health care providers, blinding not possible
Judgement Comment: Insufficient information on blinding, but is assumed to not be feasible
Judgement Comment: No information of blinding of participants and health care providers, blinding not feasible
Judgement Comment: No information of blinding of participants and health care providers, but blinding assumes not to be possible
Judgement Comment: No information of blinding of participants and health care providers, blinding jugded not to be feasible
Judgement Comment: No information, but blinding not possible
Judgement Comment: No information of blinding of participants and health care providers, blinding not feasible
Detection bias due to knowledge of the allocated interventions by outcome assessors
Quote: "Assessors were blind to treatment condition and assessed multiple waves of patients at once (e.g., patients at pre, post, and FU), blinding the time point of the assessment. Diagnoses"
Quote: "A computerized random number generator created all randomization sequences, which were known to the PIs but not the blind assessors. Delays in"
Judgement Comment: No information of tester blinding. Selfreported outcomes not blinded
Quote: "IEs, blinded to treatment assignments, completed the assessments"
Quate: "Two clinicical psychology graduate students, blind to condition, administred the LSAS,CGI and SAD section of the CSID at posttreatment (for all groups) and follow-up (for MAGTand CBGT only)"
Judgement Comment:Self reported measurement
Quote: "Clinician-rated symptom scales were administered by the study psychiatrists who were blind to treatment allocation. Specific instructions were given to research participants for assuring blindness of raters throughout the study."
Quote: "Clinician- rated outcomes were administered by blind assessors by telephone. Blind evaluation was ensured by instructing participants not to discuss their assigned treatment with the independent evaluators. There were no reports of compromised blinding during the telephone evaluations."
Judgement Comment: Outcome assessors are blindet, no blinding for self reported outcomes
Judgement Comment: HAM-A was assessed by subject-blinded psychiatrist
No information of tester blinding
Judgement Comment: No information of tester blinding
Judgement Comment: No iformation of tester blinding, blinding not possible for patient reported outcomes
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment:Missing data are balance between groupa in numbers and reasons. Intention to treat analyses
Judgement Comment: Intention to treat analyses, dropuot low and equal distributed between the groups
Judgement Comment: 3 dropouts in the MBSR group and 11 in the SME gropu, reasons for dropout not described. Intention to treat analyses, last observation carried forward
Intention to treat analyses, last observation carried forward. High droupout rate, 40% in the CBGT group and 30% in the MAGT group. The dropout rates were not significantly different from one another. There were no reporting of reasons and numbers for each reason for dropout other tant it was stated that the most comme reason for dropout was time commitment.
Quote: "Two sets of analyses were conducted: one for all randomized patients including those who did not start treatment and drop-outs (intent-to-treat (ITT) sample) and the other for the sample of patients who completed treatment and who attended at least 80% of sessions (completer sample). For patients with missing data (n = 5), the expectation-maximization (EM) method was used to impute missing values. The EM algorithm is an iterative estimation procedure that yields more reliable and unbiased estimates compared to other imputation techniques such as simple regression techniques, mean substitution and the last-observation carried forward (Graham, Hofer, & Piccinin, 1994; Schafer & Graham, 2002)."
Judgement Comment: Information of number and reasons for dropoutsIntention to treat analyses.
Quote: "Analyses were performed on the intention-to-treat (ITT) sample. Clinical and demographic characteristics were evaluated using two-sample t-tests or chi-squared tests. Continuous outcomes were analyzed using a general linear model with condition (MBI-SAD versus WL), time (base- line, week 6, and week 12), and condition by time interac- tion as fixed factors. The models were estimated using restricted maximum likelihood with a compound symmetry covariance structure to account for correlations among the repeated measures over time. The analyses were conducted using the SAS Mixed Procedure. 60 In contrast to conven- tional repeated-measures analysis of variance, this approach allowed the use of all available observations on each patient without the use of imputation procedures, such as last- observation-carried-forward methods, which are known to cause bias."
Judgement Comment: Low drop out rate.
Quote: "After the 8-week programs, the last observation carried forward method was used for intent-to-treat analysis."
Judgement Comment: Intention to treat analysis, and only 2 dropouts i the education group and 3 in the meditation group
Quote: "All outcome analyses were conducted on both the intention-to-treat (ITT) sample and on treatment completers. Except for within-group ESs, only ITT data are presented, since results from the two analyses were almost identical for the first treatment period, and the high dropout rate in the second period made completer results difficult to interpret. In the ITT analyses, which included all randomized participants, missing values were substituted by means of last observation carried forward. All data were analyzed using SPSS Version 17, and all tests performed were two- tailed with a set at 0.05."
Quote: "Treatment effect esrimated in intention-to-treat sample"
Judgement Comment: Intention to treat analyses
Quote: "To investigate significant changes over time, linear mixed models (LMM) were conducted for both primary and secondary outcomes following the intention-to-treat principle. A two-sided P-value of 0.05 or less was considered to be statistically significant. The use of LMM provided the means to include participants with incomplete data (missed 1 or 2 questionnaires) to assess the treatment effect over time (i.e. trend or group6time interaction). In our models, intervention group, time and the interactions between the inter- vention group and time were treated as fixed factors, and an unstructured covariance structure was employed. Statistical analysis of the primary and secondary outcome measures, including BAI, PSWQ, CES-D, SF-12, FFMQ as well as health service utilisation over time were made."
Judgement Comment: Few drop outs at two months, however, there are more drop outs from the usual care group.
Reporting bias due to selective outcome reporting
Judgement Comment: No reference to study protocol. Report all outcomes stated in the methods section. No reporting of quality of life and avoidance
Judgement Comment: No information of a protocol, no reporting of quality of life and function, severity of anxiety only reported with LSAS-SR.
Judgement Comment: The study is preregistred at clinicaltrials.gov. Only HAM-A and CGI-ilness severity are stated in the protocol, but the study also reports on The Beck IInventory (BAI).
Judgement Comment: No reference to a protocol, seems to report on all outcomes of interest
Judgement Comment: No reference to study protocol, but appears to report on all outcomes of interest.
Judgement Comment: Protocol at clinicaltrials.gov, appears to report on all prespecified outcomes.
Judgement Comment: There is no reference to study protocol, but the study appears to report on all outcomes of interest
Judgement Comment: No reference study protocol, but appears to report on all outcomes of interest
Judgement Comment: No information of a study protocol, but seems to report on all outcomes of interest
Judgement Comment: Reference to a protocol number, protocol not available, seems to report on all aotcomes of interest
Bias due to problems not covered elsewhere in the table
Judgement Comment: Appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: the study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to bee free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias