Types of participants
The review will consider studies that include patients 18 years of age or older, of both genders, with generalised anxiety disorder (GAD) diagnosed by the existent diagnostic criteria at the time when the study was conducted, based on the criteria of the International Classification of Diseases (ICD) or the Diagnostic Statistical Manual of mental disorders (DSM).
Types of intervention(s)
The review will consider for inclusion studies that evaluate relaxation techniques based on autogenic training, on muscular relaxation or breathing techniques, done either in a group or individually.
Studies to be included are those that compare the specified relaxation techniques with:
- Another relaxation technique
- Cognitive-behavioural therapies with or without relaxation
- Pharmacological therapy
- The absence of relaxation (either comparing with normal practice, being on a waiting list, or a placebo).
Types of outcomes
This review will consider studies that include the following outcome measures:
- Primary outcomes:
- Anxiety, measured with scales developed for that purpose.
- Quality of life, measured with scales developed for that purpose.
- Secondary outcomes:
- Use of health resources, i.e., visits to primary care health centres, visits to mental health centres, hospital admittances.
- Variation in the use of specific medications for GAD.
- Adverse effects of the intervention.
- Acceptability of the intervention.
Types of studies
The review will consider for inclusion studies that include randomised controlled clinical trials and quasi-experimental studies with a control group, developed in any setting: primary care, specialised care or non-healthcare settings.
The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilised in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Studies published in Spanish, English, Portuguese, French, and German will be considered for inclusion in this review. Studies published from inception of the database to July 31, 2012 will be considered for inclusion in this review.
The databases to be searched include:
Medline, CINAHL, Embase, PsycINFO, The Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Library, BIREME, and the clinical trial registry ClinicalTrials.gov
The principal journals on this topic in the last five years will be searched manually:
Journal of Anxiety Disorders, Archives of General Psychiatry, British Journal of Psychiatry, JAMA: the Journal of the American Medical Association, Journal of Affective Disorders, Journal of Clinical Psychiatry, Journal of Clinical Psychopharmacology, Journal of Consulting and Clinical Psychology, Journal of Psychopharmacology.
The search for unpublished studies will include:
Following the same criteria, a search of articles related to the review's objectives will be done in summaries and conference proceedings of Congresses, Meetings, and Scientific Societies. The search will be conducted in the following databases:
- OpenSIGLE (System for Information on Grey Literature in Europe)
- Dissertation Abstracts International
- Proceedings First Database
- Database for Spanish Dissertations: TESEO
- Grey Literature Report (through New York Academy of Medicine website)
- CURRENT CONTENTS
- EXPANDED ACADEMIC INDEX
- Mednar Database.
Contact with the experts
Experts on this topic will be contacted to know if there are clinical and quasi-experimental trials that are unpublished or in a data analysis or publication phase.
Initial keywords to be used will be:
“Adults”, “Anxiety Disorders”, “Relaxation”, “Relaxation Therapy”, “Muscle Relaxation”, “Autogenic Training”, “Breathing Exercises”, “Controlled Clinical Trial”, “Randomized Controlled Trial”, “Randomised Controlled Trial”, “Controlled Before and After Study”, “Test Anxiety Scale”, “Manifest Anxiety Scale”, “Quality of Life”, “Psychotropic Drugs”, “Adverse Effects”, and free language terms.
Studies will be selected independently by two reviewers. The reviewers will select the study according to its title, abstract and key words in order to determine if it meets the inclusion criteria. For this they will use a study selection sheet that contains the inclusion criteria (Appendix I). All those studies that have an affirmative response to all the criteria will be included, and those that have a negative response to any of them will be excluded. If there is doubt over any study the entire article will be reviewed. In the case of discrepancies on the selection of studies there will be a consensus meeting to discuss the criteria that each of the two reviewers took into account. In the case of non-consensus, a third researcher will be included.
Assessment of methodological quality
Those studies that meet the inclusion criteria will be evaluated independently by two reviewers for methodological quality prior to inclusion in the review. They will use the standardised instruments for critical appraisal from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) for randomised controlled clinical trials and quasi-experimental trials (Appendix II).
In the case of non-consensus the reviewers will discuss the criteria that each one took into account in order to achieve consensus. If consensus is not reached, a third reviewer will be consulted.
Those studies that do not meet the following three criteria will be excluded: true random allocation, blinding of the groups to assignment, and comparability at the beginning of the study. Questions concerning randomisation will not be assessed in the case of quasi-experimental studies.
Quantitative data will be extracted from papers included in the review using the standardised data extraction tool from JBI-MAStARI (Appendix III). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Other aspects will also be extracted related with diagnostic criteria used, type of professional who administers the intervention, if the intervention was carried out in a group or individually, follow-up time and duration of intervention (see Appendix IV for details).
Data extraction will be done by four researchers. The studies will be distributed in such a manner that the data from each study will be extracted by two researchers. Each researcher will extract the data independently. In case of disagreement they will have a consensus meeting to discuss the criteria taken into account by each researcher. If consensus is not reached a third researcher will be included.
A first phase will include a summary of the characteristics of the included studies. Secondly, the clinical heterogeneity of the studies included in the review will be evaluated according to the study population, the type of intervention and the outcome variables measured. Likewise, the methodological heterogeneity will be assessed taking into account the study design and quality.
Following this, an evaluation will be done of the statistical heterogeneity with the standard chi square method (statistical significance <5%) and the I2 statistic, both calculated for each of the comparisons. I2 values of 75% indicate high heterogeneity, 50% moderate heterogeneity, and 25% low heterogeneity.
A fixed effects model will be used or, if there is heterogeneity, a random effects model (DerSimonian). If the studies are homogeneous the data will be pooled in a meta-analysis.
Measurement of the effect of treatment
In the case of dichotomous variables the Relative Risk will be calculated; also for each of the comparisons and results. For continuous variables, the difference of standardised means will be calculated. 95% confidence intervals will also be calculated.
The following comparisons will be made:
- Relaxation compared to other interventions.
- Each relaxation technique compared to other interventions.
- Relaxation techniques compared with each other.
In case statistical heterogeneity is found, the source of this heterogeneity will be evaluated according to the relaxation technique that was used, the length of therapy, the setting of the study, individual or group administration of therapy, follow-up time of patients, whether elderly or adult patients, quality of the study, diagnostic criteria for GAD, design of the study or further variables to take into account.
A subgroup analysis will be conducted according to the potential subgroups that may influence heterogeneity. Sensitivity analysis will be carried out according to the quality of the included studies. The possibility of publication bias will be evaluated by means of a funnel plot. The computer program to be used is SUMARI, v. 5.0 of the Joanna Briggs Institute.
Conflicts of interest
The authors declare that there are no conflicts of interest for doing this systematic review.
This research has been funded by the Pedro Lain Entralgo Agency through the call for papers for research projects in the field of health results in Primary Care, registry number PI-2010/RS_AP10/2. We appreciate the support of Esther González María, Gema Escobar Aguilar, Teresa Sanz Cuesta and Isabel del Cura in the preparation of the systematic review. We also appreciate the support and help of the nurses at the Centro Isabel II (Parla) in making this possible.
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Appendix I: Study selection sheet
Appendix II: Critical appraisal instruments
* Questions number 1 and 2 will not be assessed in the case of quasi-experimental studies.
Appendix III: Data extraction instruments
Appendix IV: Other data to extract/collect:
1.- Language of article.
2.- Design of study.
3.- Inclusion criteria as:
- Diagnostic criteria used.
4.- Characteristics of the intervention and control group:
- Type of intervention.
- Intervention in control group.
- Duration of intervention.
- Type of professional who administers the intervention.
- Individual or group intervention.
- Follow-up time.
- Type of setting in which the intervention was performed.