Research methods for clinical therapists free download

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Mental health professionals use a variety of instruments to assess mental health and wellbeing. Common purposes for psychological testing include: screening for the presence or absence of common mental health conditions; making a formal diagnosis of a mental health condition; assessment of changes in symptom severity; and monitoring client outcomes across the course of therapy.

Screening measures are often questionnaires completed by clients. Interventional studies also include studies on medical devices and studies in which surgical, physical or psychotherapeutic procedures are examined.

The diagnosis, treatment and monitoring are not performed according to a previously specified study protocol, but exclusively according to medical practice.

The aim of an interventional clinical study is to compare treatment procedures within a patient population, which should exhibit as few as possible internal differences, apart from the treatment 4 , e1. This is to be achieved by appropriate measures, particularly by random allocation of the patients to the groups, thus avoiding bias in the result.

Possible therapies include a drug, an operation, the therapeutic use of a medical device such as a stent, or physiotherapy, acupuncture, psychosocial intervention, rehabilitation measures, training or diet.

Vaccine studies also count as interventional studies in Germany and are performed as clinical studies according to the AMG. Interventional clinical studies are subject to a variety of legal and ethical requirements, including the Medicines Act and the Law on Medical Devices.

Studies with medical devices must be registered by the responsible authorities, who must also approve studies with drugs.

Drug studies also require a favorable ruling from the responsible ethics committee. For clinical studies on persons capable of giving consent, it is absolutely essential that the patient should sign a declaration of consent informed consent e2. A control group is included in most clinical studies. The selection of the control group must not only be ethically defensible, but also be suitable for answering the most important questions in the study e5.

Clinical studies should ideally include randomization, in which the patients are allocated by chance to the therapy arms. This procedure is performed with random numbers or computer algorithms 6 — 8.

Randomization ensures that the patients will be allocated to the different groups in a balanced manner and that possible confounding factors—such as risk factors, comorbidities and genetic variabilities—will be distributed by chance between the groups structural equivalence 9 , Randomization is intended to maximize homogeneity between the groups and prevent, for example, a specific therapy being reserved for patients with a particularly favorable prognosis such as young patients in good physical condition Blinding is another suitable method to avoid bias.

A distinction is made between single and double blinding. With single blinding, the patient is unaware which treatment he is receiving, while, with double blinding, neither the patient nor the investigator knows which treatment is planned. Blinding the patient and investigator excludes possible subjective even subconscious influences on the evaluation of a specific therapy e.

Thus, double blinding ensures that the patient or therapy groups are both handled and observed in the same manner. The highest possible degree of blinding should always be selected. The study statistician should also remain blinded until the details of the evaluation have finally been specified. A well designed clinical study must also include case number planning. This ensures that the assumed therapeutic effect can be recognized as such, with a previously specified statistical probability statistical power 4 , 6 , It is important for the performance of a clinical trial that it should be carefully planned and that the exact clinical details and methods should be specified in the study protocol It is, however, also important that the implementation of the study according to the protocol, as well as data collection, must be monitored.

For a first class study, data quality must be ensured by double data entry, programming plausibility tests, and evaluation by a biometrician. Many journals make this an essential condition for publication. For all the methodological reasons mentioned above and for ethical reasons, the randomized controlled and blinded clinical trial with case number planning is accepted as the gold standard for testing the efficacy and safety of therapies or drugs 4 , e1 , In contrast, noninterventional clinical studies NIS are patient-related observational studies, in which patients are given an individually specified therapy.

NIS include noninterventional therapeutic studies, prognostic studies, observational drug studies, secondary data analyses, case series and single case analyses 13 , The evaluation is often retrospective. Prognostic studies examine the influence of prognostic factors such as tumor stage, functional state, or body mass index on the further course of a disease.

Diagnostic studies are another class of observational studies, in which either the quality of a diagnostic method is compared to an established method ideally a gold standard , or an investigator is compared with one or several other investigators inter-rater comparison or with himself at different time points intra-rater comparison e1. If an event is very rare such as a rare disease or an individual course of treatment , a single-case study, or a case series, are possibilities.

A case series is a study on a larger patient group with a specific disease. The lack of a control group is a disadvantage of case series. For this reason, case series are primarily used for descriptive purposes 3. The main point of interest in epidemiological studies is to investigate the distribution and historical changes in the frequency of diseases and the causes for these.

Analogously to clinical studies, a distinction is made between experimental and observational epidemiological studies 16 , Interventional studies are experimental in character and are further subdivided into field studies sample from an area, such as a large region or a country and group studies sample from a specific group, such as a specific social or ethnic group.

One example was the investigation of the iodine supplementation of cooking salt to prevent cretinism in a region with iodine deficiency. On the other hand, many interventions are unsuitable for randomized intervention studies, for ethical, social or political reasons, as the exposure may be harmful to the subjects Observational epidemiological studies can be further subdivided into cohort studies follow-up studies , case control studies, cross-sectional studies prevalence studies , and ecological studies correlation studies or studies with aggregated data.

In contrast, studies with only descriptive evaluation are restricted to a simple depiction of the frequency incidence and prevalence and distribution of a disease within a population. The objective of the description may also be the regular recording of information monitoring, surveillance. Registry data are also suited for the description of prevalence and incidence; for example, they are used for national health reports in Germany.

In the simplest case, cohort studies involve the observation of two healthy groups of subjects over time. One group is exposed to a specific substance for example, workers in a chemical factory and the other is not exposed. It is recorded prospectively into the future how often a specific disease such as lung cancer occurs in the two groups figure 2a. The incidence for the occurrence of the disease can be determined for both groups. Moreover, the relative risk quotient of the incidence rates is a very important statistical parameter which can be calculated in cohort studies.

For rare types of exposure, the general population can be used as controls e6. All evaluations naturally consider the age and gender distributions in the corresponding cohorts. The objective of cohort studies is to record detailed information on the exposure and on confounding factors, such as the duration of employment, the maximum and the cumulated exposure. One well known cohort study is the British Doctors Study, which prospectively examined the effect of smoking on mortality among British doctors over a period of decades e7.

Cohort studies are well suited for detecting causal connections between exposure and the development of disease. On the other hand, cohort studies often demand a great deal of time, organization, and money. So-called historical cohort studies represent a special case. In this case, all data on exposure and effect illness are already available at the start of the study and are analyzed retrospectively.

For example, studies of this sort are used to investigate occupational forms of cancer. They are usually cheaper Graphical depiction of a prospective cohort study simplest case [2a] and a retrospective case control study 2b. In case control studies, cases are compared with controls.

Cases are persons who fall ill from the disease in question. Controls are persons who are not ill, but are otherwise comparable to the cases. A retrospective analysis is performed to establish to what extent persons in the case and control groups were exposed figure 2b. Possible exposure factors include smoking, nutrition and pollutant load. Care should be taken that the intensity and duration of the exposure is analyzed as carefully and in as detailed a manner as possible. If it is observed that ill people are more often exposed than healthy people, it may be concluded that there is a link between the illness and the risk factor.

Focused issues in family therapy. Cham, Switzerland: Springer. Stephens Eds. The SAGE encyclopedia of marriage, family, and couples counseling. Clinical methods in medical family therapy. Weston, I. McWhinney, C. McWilliam and T. Author : Douglas H.