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Effectiveness of relaxation on anxiety and quality of life in adult patients with generalised anxiety disorder: a systematic review protocol

Caja, Bermejo; Carlos, J. RN. MSN, MHN; Ángel, Martín García RN.; Laborda, García Ana RN. MHN.; María del Mar, Pérez Quintana RN; Lourdes, Díaz Rodríguez PhD. RN; Susana, Marqués Andrés RN. MSN. MHN.

JBI Database of Systematic Reviews and Implementation Reports: January 2013 - Volume 11 - Issue 1 - p 270–287
doi: 10.11124/jbisrir-2013-613
Systematic Review Protocols

Review question/objective: The primary review objective is to identify and synthesise the best available evidence on effectiveness of relaxation techniques for the improvement of anxiety levels and quality of life in adult patients 18 years of age or older with generalised anxiety disorder, within the health sector and in the community (universities, nursing homes, the workplace, etc.). The secondary review objective is to synthesise the best available evidence on what type of relaxation technique produces the greatest improvement in anxiety levels and quality of life.

Review Questions are:

Are relaxation techniques effective at reducing anxiety and improving the quality of life in adult patients with Generalised Anxiety Disorder?

What type of relaxation technique produces the greatest improvement in anxiety levels and quality of life?

Background: Anxiety is a complex emotion that is characterised by a set of responses that are physiological, cognitive, related to personal experience, and behavioural, and which are distinguished by a state of urgent quickening and alertness1. Anxiety is considered pathological if a disproportionate response is produced by the stimulus that elicits it, in terms of either its intensity and/or persistence, keeping the person in an inappropriately hyperactive state2.

According to the Diagnostic and Statistical Manual of Mental Disorders, Text Revision (DSM‐IV‐TR)3 there are twelve anxiety disorders. Generalised anxiety disorder (GAD) is characterised by the presence of symptoms of intense anxiety and worry related to a variety of occurrences or situations, with diagnostic criteria such as the presence of at least three of certain symptoms (restlessness or impatience, tendency to feel fatigued, difficulty in concentrating, irritability, muscular tension or sleep disturbances), difficulty in controlling a state of intense worry, and general deterioration or unease that last for at least six months.

GAD, as an independent disorder, is an important public health problem. Prevalence studies conducted in several countries have produced variable results. In one systematic review4 of community studies on the prevalence and incidence of anxiety disorders in adult populations conducted between 1980 and 2004 across different countries, the authors reported a global estimate of prevalence/year and prevalence/lifetime of anxiety disorders. The prevalence/year of all anxiety disorders varied between 9.7% in a study in Australia5 and 17.2% in the United States6, with the review authors reaching an estimate of 10.6% prevalence. For prevalence/lifetime, results varied between 9.2% in Korea (Lee 1987)7 and 24.9% in USA6, with a global estimate of 16.6% for the review. For GADs, results varied between 0.15% in Derry, Northern Ireland8 and 12.7% in Christchurch, New Zealand9 for prevalence/year, and between 1.9% in Basle, Switzerland10 and 31.1% in Christchurch9 for prevalence/lifetime. Global estimates for prevalence/year and prevalence/lifetime were 2.6% and 6.2%, respectively, in the review. More recent studies conducted with populations of six European countries (Belgium, France, Spain, Germany, Italy, and the Netherlands) 11 between 2001 and 2003 show a prevalence of anxiety disorders at some point in life of 13.6%, and a prevalence/year of 6.4%. As for GADs, the prevalence/lifetime and prevalence/year are 2.8% and 1.0%, respectively. Women have a higher probability of suffering from anxiety disorders than men (OR= 2.43; 95% CI: 2.06‐2.86). Regarding age, the time at which there is the highest probability of having anxiety disorders is between 18 and 24 years, with the probability decreasing with increasing age. The greatest probability of having anxiety disorders is among people who have never married (OR= 1.21; 95% CI: 1.01‐1.46), housewives (OR= 1.26; 95% CI: 1.01‐1.57), workers on sick leave (OR= 2.99; 95% CI: 1.68‐5.34), and disabled persons (OR= 2.76; 95% CI: 1.87‐4.07). Those who have at some time been married or workers in any situation other than sick leave are at the lowest risk of GAD. Generalised anxiety and major depression are the principal diagnoses related to psychological illness that are given in the physician's office to the population seeking assistance in Primary Care in Spain. More than half of the cases of anxiety disorders diagnosed in Primary Care in Spain are due to generalised anxiety12.

The mean duration of GADs is ten years, following a chronic pattern, although there may be fluctuations13. Episodes of GAD influence the patient's quality of life by deteriorating the role functioning (educational achievement or weeks missed from work) and social interaction, as well as quality of life in general14. The level of disability is very important in anxiety disorders, with consequences at the social, work, and wellbeing levels. 59% of patients with GAD report having moderate or severe physical disability, compared to 12% of patients without mental health problems. 38% of patients perceive their disability in their occupational role as moderate or severe, compared to 7% of persons without mental health problems15. The mean disability days for these patients are higher than those of healthy subjects15. These results are similar to those of another study in a North American population, in which between 32% and 43% of patients with anxiety disorders reported that the symptoms of their anxiety made it very difficult to do their work or household chores16.

Patients with a GAD diagnosis in Primary Care in Spain generally utilise more health resources than those patients without a GAD diagnosis17, with an average of ten visits per year (SD: 9.6), compared to an average of 7.6 visits per year (SD: 8.1) for other patients. These data are similar to those from other studies that show an average of 2.9 visits in three months, compared to 1.6 visits from patients without anxiety disorders16. The patients with anxiety disorders also took a greater number of sick leave days. Regarding use of resources, total costs, and those related to use of medications, referrals, and additional testing were significantly greater than those of other patients. Direct costs per patient vary between US$645 and US$28,338 per year, with an important excess in direct costs when compared to the non‐anxious population. Indirect costs derived from sick leave at work are between US$1,196 and US$1,635 per year18.

There exist several ways of approaching GAD: psychological therapy with a cognitive‐behavioural focus, progressive relaxation, meditation, pharmacological therapy or a combination of all these therapies.

Psychological therapy

In a systematic review by Hunot et al.19, cognitive‐behavioural therapies proved to be more effective than usual practice or being on a waiting list in the reduction of symptoms in generalised anxiety, including restlessness and depression. This type of therapy also proved to be more effective than psychodynamic therapy. Support therapies did not provide conclusive proof of being more effective in the clinical improvement of patients. Finally, cognitive therapies produced a greater probability of clinically relevant changes when compared to behavioural therapies, according to criteria in DSM‐III, DSM‐IV, ICD‐9, ICD‐10 or validated diagnostic scales, even if there was no significant reduction of symptoms. Quality of life has not been sufficiently evaluated in the selected studies, and there are no data given on the effectiveness of psychological therapies with respect to this variable. The review also did not focus on relaxation techniques as a main objective or as a separate therapy.

Pharmacological therapy

Some pharmacological treatments have proven their effectiveness with GAD. This is the case with certain antidepressants20‐22 and benzodiazepines 24‐25. However, the appearance of side effects23 and their short‐term benefits26,27 make them useful only as background treatment in long‐term therapy, as is recommended in some clinical practice guidelines24.

Relaxation therapy

Other types of therapy that have been developed, such as relaxation therapy, have as their goal the relaxation of the patient. They have been used for different pathologies and health problems, including hypertension, chronic headache, fibromyalgia, etc.

There are different relaxation techniques, such as the muscle relaxation therapy developed by Jacobson28‐29, the autogenic training developed by Schulz30, or techniques based on control of breathing31. These three techniques are the most widely used32.

As Conrad33 states, the therapeutic aim of muscle relaxation is to provide relief from distress and its physiological accompaniments through reducing muscle tension in stressed and anxious people. If they learn to deactivate the muscular system, this will reduce activation in other subsystems and could inhibit the generation of negative thoughts and emotions.

Autogenic training is a relaxation technique that focuses on physical sensations such as breathing or heart rate, assisted by auto suggestion34. Its aim is to achieve a relaxation response through repetitive mental focus and adopting a passive attitude35.

Breathing exercises require the individual to maintain a slow, regular breathing that can directly influence the cardiovascular system36. Breathing training aims to reverse respiratory abnormalities associated with anxiety disorders, trying to alter the anxiogenic effects of biological challenges37.

The effectiveness of relaxation has been studied in different health settings. With cases of hypertension, relaxation has been shown to bring about small reductions in systolic and diastolic blood pressure, although the evidence is weak38.

There is also evidence showing the effectiveness of relaxation and cognitive‐behavioural therapies in reducing the intensity and frequency of chronic headache, although not in reducing other kinds of pain39.

In a systematic review40 to evaluate the effectiveness of relaxation in patients with depression, the author states that a patient's self‐reported symptoms improved after applying relaxation techniques, compared to being on the waiting list or to no intervention. This improvement did not occur when it was the health professional who reported on the reduction of symptoms. Relaxation did not prove to be more efficient than other psychological therapies such as cognitive‐behavioural therapy, interpersonal therapy, psychodynamic therapy or support therapy. The author also points out that there are no conclusive data to assist in evaluating whether relaxation is more efficient than medication40.

Some studies have evaluated the effectiveness of relaxation in anxiety disorders in general with respect to control groups that were on a waiting list, or even when compared to other psychotherapies. In some cases the reduction of levels of anxiety was significant when compared to no intervention 41‐43. Different authors show that, when compared to other psychotherapies, the effectiveness of relaxation is equal to that of cognitive therapy44‐45, or to cognitive‐behavioural therapy46. No significant differences were observed for comparison with other therapies 47.

A search of databases which include the Joanna Briggs Institute Library of Systematic Reviews, the Cochrane Database of Systematic Reviews, PubMed, CINAHL, Prospero and DARE only found one systematic review relating to the proposed research question, published in 2008 which evaluated the effectiveness of relaxation techniques in reducing anxiety48. This review points out several limitations: the inclusion of studies done on patients with different conditions, healthy people, and patients with very different pathologies, without specifying the type of anxiety disorder; conducted over a limited time period (between 1997 and 2007 only); and done without first evaluating the methodological quality of the included studies. The authors found significant heterogeneity in a meta‐analysis of the included studies. This heterogeneity was possible due to the different relaxation techniques, subjects, and evaluation instruments included. These limitations, acknowledged by the authors, would make it necessary to do a systematic review focused on a specific population, one with GAD, and excluding other pathologies or subjects, and also with explicit diagnostic criteria in order to evaluate the methodological quality of the included studies.

Other systematic reviews focus on disorders other than generalised anxiety disorder (Stetter34, Krisanaprakornkit49, Cape50, Thorp51, Hunot19), or focus on different techniques than relaxation techniques (Gonçalves52, Hoffman 53,54, Smits55).

1. The Spanish Centre for Evidence Based Healthcare: a collaborating centre of the Joanna Briggs Institute, Institute of Health Carlos III, Madrid, Spain

2. Health Care Centre San Blas, Parla, Spain.

3. Mental Health Care Centre, Parla, Spain.

4 Health Care Centre Miraflores, Alcobendas, Spain.

5. Department of Nursing, Faculty of Health Sciences. University of Granada, Spain

6. Psychologist. Hospital of Basurto, Bilbao, Spain.

1Sociologist, Nurse Consultant of Primary Health Care Management

1,2 Anthropologist

3 Sociologist

6 Psychologist

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Inclusion criteria

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).

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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).

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Types of outcomes

This review will consider studies that include the following outcome measures:

A. Primary outcomes:

1. Anxiety, measured with scales developed for that purpose.

2. Quality of life, measured with scales developed for that purpose.

B. Secondary outcomes:

1. Use of health resources, i.e., visits to primary care health centres, visits to mental health centres, hospital admittances.

2. Variation in the use of specific medications for GAD.

3. Adverse effects of the intervention.

4. Acceptability of the intervention.

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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.

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Search strategy

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

Manual search

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:

Grey literature

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)



- 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.

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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.

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Data collection

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.

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Data synthesis

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:

1. Relaxation compared to other interventions.

2. Each relaxation technique compared to other interventions.

3. 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.

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Conflicts of interest

The authors declare that there are no conflicts of interest for doing this systematic review.

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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 Cited Here...

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Appendix II: Critical appraisal instruments

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* Questions number 1 and 2 will not be assessed in the case of quasi‐experimental studies. Cited Here...

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Appendix III: Data extraction instruments Cited Here...

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Appendix IV: Other data to extract/collect:

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1.‐ Language of article.

2.‐ Design of study.

3.‐ Inclusion criteria as:

‐ Sex.

‐ Age.

‐ 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. Cited Here...

Keywords: Adults; Anxiety Disorders; Relaxation; Relaxation Therapy; Muscle Relaxation; Autogenic Training; Breathing Exercises

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