Otherwise, we will approximate the effect estimates using an inflated standard error that incorporates the design effect Higgins Concerning studies with multiple treatment groups, we will only consider data from the comparison of interest for each of the main objectives addressed in our review.
In case of missing or unclear data, we will contact corresponding study authors or study sponsors in order to obtain key study characteristics and missing numerical outcome data when possible e. We will document all requests and correspondences. For the primary outcome, we will include all randomized participants in the analyses irrespective of how the study authors defined their ITT sample. For all other outcomes we will follow the definition of the ITT sample provided by the study authors.
We will display results visually as forest plots. We expect considerable clinical heterogeneity between studies. We will test differences between subgroups formally Bucher ; Deeks ; Song We will test dysthymia against other subtypes as dysthymia is assumed to be the most frequently mentioned subtype;. Therefore, we decided to test these approaches versus other approaches.
Evidence on the best available treatments in case of considerable differences is indispensable for guideline recommendations;. We will clearly label a priori and a posteriori analyses as such. We will perform sensitivity analyses by excluding studies with a high or unclear risk of bias separately for each of the seven domains according to the Cochrane 'Risk of bias' tool or outlying findings, or both.
We will compare results to those acquired with data from all studies in order to control for possible effects of study quality on pooled effects. The 'Summary of findings' tables will include a summary of the quality of evidence, the magnitude of effects of the according intervention, and a summary of available data on main outcomes. The BMBF grants the support of the project on the basis of the project application, but the BMBF has no influence on the study design; the data collection, analysis, and interpretation; the writing of the manuscript; or the decision to submit the paper for publication.
This register contains over 39, reference records reports of RCTs for depression, anxiety, and other common mental disorders. Rational Emotive Behavio? National Center for Biotechnology Information , U. Cochrane Database Syst Rev. Published online Nov Author information Copyright and License information Disclaimer. Sarah Liebherz, Email: ed. Corresponding author. This article has been updated. Abstract This is a protocol for a Cochrane Review Intervention.
Background Description of the condition Persistent forms of depression that last for two years or longer represent a substantial proportion of depressive disorders Boland ; Gilmer ; Keller ; Spijker Description of the intervention Overall, a large number of different interventions exist for the treatment of unipolar depression, including psychological, pharmacological, and combined psychological and pharmacological therapies.
Why it is important to do this review Research that focuses on the prevention of recurrence of depression was identified as a top priority in the recent project 'Depression: asking the right questions' MQ In summary, this systematic review may be highly relevant as: persistent depressive disorders have a high prevalence and serious personal, societal, and economic consequences; no evidence synthesis is available on continuation and maintenance treatments of persistent depressive disorders; high quality evidence synthesis is needed for clinical guideline recommendations.
Types of participants Participant characteristics We will include participants 18 years of age and older of any gender and ethnicity. Diagnosis We will include participants who have a diagnosis of persistent depressive disorder or have had this diagnosis before their last previous acute treatment.
Setting We will not place any restrictions based on setting. Types of interventions Experimental Intervention We will consider pharmacological, psychological, and combined continuation and maintenance interventions for inclusion. Thus, for example, we will not consider the general dissemination of information material in form of leaflets in waiting rooms as a psychological therapy; the intervention must consider the personal needs of the participant or a group of participants and must be individually tailored in an interpersonal process.
Comparator intervention We will include both controlled and comparative effectiveness studies. Dropout due to any reason. Hierarchy of outcome measures If more than one diagnostic definition or depression symptom rating scale, or both, are available concerning the outcome 'Relapse or recurrence rate of depression' , we will use the presented hierarchy to select measures priority starting with a fulfilment of formal diagnostic criteria, continuing with b i.
Clinical guidelines for the management of major depressive disorder in adults Kennedy Open Grey www. Handsearching As all relevant journals are included in the bibliographic databases being searched, we will not conduct any no further handsearches of journals. Reference lists We will check the reference lists of all included studies and relevant systematic reviews to identify additional studies missed from the original electronic searches e.
Correspondence We will contact the first author of each included study for information on unpublished or ongoing studies, or to request additional trial data. Data extraction and management We will use a data collection form, which has been piloted on at least one study in the review, to extract study characteristics and outcome data. Assessment of risk of bias in included studies Two review authors KM, SL, or RM will independently assess the risk of bias for each included study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions Higgins We will assess the risk of bias according to the following domains: random sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessment; incomplete outcome data; selective outcome reporting; other bias.
Continuous data We will analyse continuous data as mean differences MD. Studies with multiple treatment groups Concerning studies with multiple treatment groups, we will only consider data from the comparison of interest for each of the main objectives addressed in our review.
Dealing with missing data In case of missing or unclear data, we will contact corresponding study authors or study sponsors in order to obtain key study characteristics and missing numerical outcome data when possible e. We will consider the following variables: subtype of persistent depressive disorder dysthymia versus other : a possibly moderating effect of subtype would suggest that a distinction between these subtypes might be used for allocation of patients to treatments differential indication.
Sensitivity analysis We will perform sensitivity analyses by excluding studies with a high or unclear risk of bias separately for each of the seven domains according to the Cochrane 'Risk of bias' tool or outlying findings, or both. Appendices Appendix 1. Notes New. Sources of support Internal sources No sources of support supplied. Effectiveness of psychotherapy and combination treatment for chronic depression. San Antonio, Texas: Psychological Corporation, New approaches to antidepressant drug discovery: beyond monoamines.
Nature Reviews. Relapse and recurrence prevention in depression: current research and future prospects. Course and outcome of depression. Handbook of Depression. Available from www. Dunner DL. Dysthymia and double depression. Pharmacological approaches to manage persistent symptoms of major depressive disorder: rationale and therapeutic strategies.
Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence. GRADE guidelines: 1. A rating scale for depression. Phenelzine for chronic depression: a study of continuation treatment. The Cochrane Collaboration, Available from handbook. Is there a role for continuation phase cognitive therapy for depressed outpatients? Preventing recurrent depression using cognitive therapy with and without a continuation phase: a randomized clinical trial.
Time to recovery, chronicity, and levels of psychopathology in major depression. PLoS Medicine ; 5 2 :e Chronic depression: diagnosis and classification. Maintenance therapy for chronic depression. A controlled clinical trial of desipramine.
Continuation treatment of chronic depression: a comparison of nefazodone, cognitive behavioral analysis system of psychotherapy, and their combination. Chronic forms of major depression are still undertreated in the 21st century: systematic assessment of patients presenting for treatment.
Sertraline versus imipramine to prevent relapse in chronic depression. A new depression scale designed to be sensitive to change. Depression: asking the right questions. Project report.
Identifying priorities for depression research. The treatment and management of depression in adults updated edition : National Clinical Practice Guideline The other face of depression, reduced positive affect: the role of catecholamines in causation and cure. A cognitive neuropsychological model of antidepressant drug action. Initial depression severity and response to antidepressants v. Review Manager 5 RevMan 5.
Version 5. New York: Guilford, BMJ Clinical research ed. Psychotherapy, antidepressants, and their combination for chronic major depressive disorder: a systematic review.
Primary Care Evaluation of Mental Disorders. With increasing severity of depression patients may report psychotic symptoms and may also present with catatonic features. Careful history of substance intake need to be taken to evaluate the relationship of depression with substance intoxication, withdrawal and abstinence.
Many physical illnesses are known to have high rates of depression. Some of the physical illnesses commonly associated with depression are listed in Table When depression occurs in relation to physical illness attempt may be made to clearly delineate the symptoms of depression and physical illness. Further, while making the diagnosis, it maybe clearly mentioned as to which diagnostic approach [i. Further, while reviewing the treatment history of medical illnesses, medication induced depression must be kept in mind, as many medications are known to cause depression Table It is always important to take the longitudinal life course perspective into account to evaluate for previous episodes and presence of symptoms of depression amounting to dysthymia.
Evaluation of history also takes into consideration the relationship of onset of depression with change in season seasonal affective disorder , peripartum period and phase of menstrual cycle. Further, the longitudinal course approach may also take into account response to previous treatment and whether the patient achieved full remission, partial remission and did not respond to treatment.
An important aspect of diagnosis of depression is to rule out bipolar disorder. Many patients with bipolar disorder present to the clinicians during the depressive phase of illness and spontaneously do not report about previous hypomanic or manic episodes.
Careful history from the patient and other sources family members often provide important clues for the bipolar disorder. It is often useful to use standardized scales like mood disorder questionnaire to rule out bipolarity. Treating a patient of bipolar depression as unipolar disorder can increase the risk of antidepressant induced switch.
Presence of psychotic features, marked psychomotor retardation, reverse neurovegetative symptoms excessive sleep and appetite , irritability of mood, anger, family history of bipolar disorder and early age of onset need to alert the clinicians to evaluate for the possibility of bipolar disorder, before concluding that they are dealing with unipolar depression.
Area to be covered in assessment include symptom dimensions, symptom-severity, comorbid psychiatric and medical conditions, particularly comorbid substance abuse, the risk of harm to self or others, level of functioning and the socio-cultural milieu of the patient. In case patient has received treatment in the past, it is important to evaluate the information in the form of type of antidepressant used, dose of medication used, compliance with medication, reasons for poor compliance, reasons for discontinuation of medication, response to treatment, side effects experienced etc.
If the medications were changed, then the reason for change is also to be evaluated. Wherever possible, unstructured assessments need to be supplemented by ratings on appropriate standardized rating scales.
Depending on the need, investigations need to be carried out. The use of neuroimaging may be indicated in those with first-episode of depression seen in late or very late age; those have neurological signs, those having treatment resistant depression.
Besides, patients, information about the illness need to be obtained from the caregivers too and their knowledge and understanding of the illness, their attitudes and beliefs regarding treatment, the impact of the illness on them and their personal and social resources need to be evaluated.
Formulation of treatment plan involves deciding about treatment setting, medications and psychological treatments to be used. Patients and caregivers may be actively consulted while preparing the treatment plan. A practical, feasible and flexible treatment plan can be formulated to address the needs of the patients and caregivers.
Further the treatment plan can be continuously re-evaluated and modified as required. A careful assessment of the patient's risk for suicide should be done.
During history inquiry for the presence of suicidal ideation and other associated factors like presence of psychotic symptoms, severe anxiety, panic attacks and alcohol or substance abuse which increases the risk of suicide need to be evaluated.
It has been found that severity of depressive symptomatology is a strong predictor of suicidal ideation over time in elderly patients. Evaluation also includes history of past suicide attempts including the nature of those attempts. Patients also need to be asked about suicide in their family history.
During the mental status examinations besides enquiring about the suicidal ideations, it is also important to enquire about the degree to which the patient intends to act on the suicidal ideation and the extent to which the patient has made plans or begun to prepare for suicide. The availability of means for suicide be inquired about and a judgment may be made concerning the lethality of those means. Patients who are found to possess suicidal or homicidal ideation, intention or plans require close monitoring.
Measures such as hospitalization may be considered for those at significant risk. Majority of the cases of depression seen in the clinical setting are of mild to moderate severity and can be managed at the outpatient setting. However, some patients have severe depression which may be further associated with psychotic symptoms, catatonic symptoms, poor physical health status, suicidal or homicidal behaviour etc.
In such cases, careful evaluation is to be done to decide about the treatment setting and whenever necessary inpatient care may be offered. In general, the rule of thumb is that the patients may be treated in the setting that is most safe and effective.
Severely ill patients who lack adequate social support outside of a hospital setting may be considered for admission to a hospital whenever feasible. The optimal treatment setting and the patient's ability to benefit from a different level of care may be re-evaluated on an ongoing basis throughout the course of treatment.
Some of the common indications for inpatient care are shown in Table All inpatients should have accompanying family caregivers. Irrespective of the treatment modalities selected for patients, it is important for the psychiatrist to establish a therapeutic alliance with the patient.
A strong treatment alliance between patient and psychiatrist is crucial for poorly motivated, pessimistic depressed patient who are sensitive to side effect of medications. A positive therapeutic alliance always generates hope for good outcome. The successful treatment of major depressive disorder requires adequate compliance to treatment plan.
Patients with depressive disorder may be poorly motivated and unduly pessimistic over their chances of recovery with treatment. In addition, the side effect or requirements of treatment may lead to non-adherence. Patients are to be encouraged to articulate any concern regarding adherence and clinicians need to emphasize the importance of adherence for successful treatment. Simple measures which can help in improving the compliance are given in table Many patients with depression experience relapse.
Accordingly, patients as well as their families if appropriate may be educated about the risk of relapse. They can be educated to identify early signs and symptoms of new episodes. Patients can also be asked to seek adequate treatment as early in the course of a new episode as possible to decrease the likelihood of a full-blown relapse or complication.
Treatment options for management of depression can be broadly be divided into antidepressants, electroconvulsive therapy ECT and psychosocial interventions. Other less commonly used treatment or treatments used in patients with treatment resistant depression include repetitive transcranial magnetic stimulation rTMS , light therapy, transcranial direct stimulation, vagal nerve stimulation, deep brain stimulation and sleep deprivation treatment.
In many cases benzodiazepines are used as adjunctive treatment, especially during the initial phase of treatment. Additionally in some cases, lithium and thyroid supplements may be used as an augmenting agent when patient is not responding to antidepressants.
Large numbers of antidepressants Table-6 are available for management of depression and in general all the antidepressants have been shown to have nearly equal efficacy in the management of depression. Antidepressant medication may be used as initial treatment modality for patients with mild, moderate, or severe depressive episode. The selection of antidepressant medications may be based on patient specific and drug specific factors, as given in Table In general, because of the side effect and safety profile, selective serotonin reuptake inhibitors SSRIs are considered to be the first line antidepressants.
Other preferred options include tricyclic antidepressants, mirtazapine, bupropion, and venlafaxine. Usually the medication must be started in the lower doses and the doses must be titrated, depending on the response and the side effects experienced.
Patients who have started taking an antidepressant medication should be carefully monitored to assess the response to pharmacotherapy as well as the emergence of side effects and safety.
Factors to consider when determining the frequency of monitoring include severity of illness, patient's co-operation with treatment, the availability of social support and the presence of comorbid general medical problems. Visits may be kept frequent enough to monitor and address suicidality and to promote treatment adherence. Improvement with pharmacotherapy can be observed after weeks of treatment. If at least a moderate improvement is not observed in this time period, reappraisal and adjustment of the pharmacotherapy should be considered.
A specific, effective psychotherapy may be considered as an initial treatment modality for patients with mild to moderate depressive disorder. Clinical features that may suggest the use of a specific psychotherapy include the presence of significant psychosocial stressors, intrapsychic conflict and interpersonal difficulties. Patient's preference for psychotherapeutic approaches is an important factor that may be considered in the decision to use psychotherapy as the initial treatment modality.
Pregnancy, lactation, orthe wish to become pregnant may also be an indication for psychotherapy as an initial treatment. Various psychotherapeutic interventions which may be considered based on feasibility, expertise available and affordability are shown in Table Cognitive behavioral therapy CBT and interpersonal therapy are the psychotherapeutic approaches that have the best documented efficacy in the literature for management of depression.
When psychodynamic psychotherapy is used as specific treatment, in addition to symptom relief it is frequently with broader long term goals. The psychiatrist should take into account multiple factors when determining the frequency of sessions for individual patients, including the specific type and goals of psychotherapy, the frequency necessary to create and maintain a therapeutic relationship, the frequency of visits required to ensure treatment adherence, and the frequency necessary to monitor and address suicidality.
The frequency of outpatient visits during the acute phase generally varies from once a week in routine cases to as often as several times a week.
Regardless of the type of psychotherapy selected, the patient's response to treatment should be carefully monitored. For a given patient, time spent and frequency of visit may be decided by the psychiatrist. Education concerning depression and its treatments can be provided to all patients.
When appropriate, education can also be provided to involved family members. Specific educational elements may be helpful in some circumstances, e. Education regarding available treatment options will help patients make informed decisions, anticipate side effects and adhere to treatments. Another important aspect of providing education is informing the patient and especially family about the lag period of onset of action of antidepressants.
Important components of psychoeducation are given in Table There is class of patients who may require the combination of pharmacotherapy and psychotherapy. In general, the same issues that influence the choice of medication or psychotherapy when used alone should be considered when choosing treatments for patients receiving combined therapy.
Management of depression can be broadly divided into three phases, i. Maintenance phase of treatment is usually considered when patient has recurrent depressive disorder. The goal of acute phase treatment is to achieve remission, as presence of residual symptoms increase the risk of chronic depression, poor quality of life and also impairs recovery from physical illness.
Treatment generally results in improvement in quality of life and better functional capacity. In acute phase psychiatrist may choose between several initial treatment modalities, including pharmacotherapy, psychotherapy, the combination of medication and psychotherapy, or ECT.
Selection of an initial treatment modality is usually influenced by both clinical e. Antidepressant medication may be used as initial treatment modality for patients with mild, moderate, or severe major depressive disorder. Clinical features that may suggest that medication are the preferred treatment modality includes history of prior positive response to antidepressant medication, severity of symptoms, significant sleep and appetite disturbance, agitation, or anticipation of the need for maintenance therapy.
The initial selection of an antidepressant medication is largely be based on the anticipated side effects, the safety or tolerability of these side effects for individual patients, patient preference and comorbid physical illnesses.
Dose and duration of antidepressants: Once an antidepressant medication has been selected, it can be started initially at lower doses and careful monitoring to be done to assess the response to pharmacotherapy as well as the emergence of side effects, clinical conditions, and safety. Factors to consider when determining the frequency of monitoring include severity of illness, patient's cooperation and presence with treatment, and availability of social support andpresence of comorbid general medical problems.
Visits may be frequent enough to monitor and address suicidality and to promote treatment adherence. If at least a moderate improvement is not observed in this time period, reappraisal and adjustment of the pharmacotherapy maybe considered. In the initial phase, depending on the symptom severity and type of symptoms, such as presence of insomnia or anxiety, benzodiazepines or other hypnotics may be used for short duration.
If after weeks of treatment, if a moderate improvement is not observed, then a thorough review and reappraisal of the diagnosis, complicating conditions and issues, and treatment plan may be conducted. Maximizing the initial treatment regimen is perhaps the most conservative strategy.
While using the higher therapeutic doses, patients are to be closely monitored for an increase in the severity of side effects or emergence of newer side effects. Switching to a different antidepressant medication is a common strategy for treatment-refractory patients, especially those who have not shown at least partial response to the initial medication regimen. There is no consensus about switching and patients can be switched to an antidepressant medication from the same pharmacologic class e.
Some expert suggests that while switching, a drug with a different or broader mechanism of action may be chosen. Augmentation of antidepressant medications may be helpful, particularly for patients who have had a partial response to initial antidepressant monotherapy.
Options include adding a second antidepressant medication from a different pharmacologic class, or adding another adjunctive medication such as lithium, psychostimulants, modafinil, thyroid hormone, an anticonvulsant etc. Adding, changing, or increasing the intensity of psychotherapy may be considered for patients who do not respond to medication treatment.
Following any change in treatment, close monitoring need to be done. If at least a moderate level of improvement in depressive symptoms is not seen after an additional 4—8 weeks of treatment, another thorough review need to be done.
This reappraisal may include verifying the patient's diagnosis and adherence; identifying and addressing clinical factors that may be preventing improvement, such as the presence of comorbid general medical conditions or psychiatric conditions e.
If no new information is uncovered to explain the patient's lack of adequate response, depending on the severity of depression, ECT maybe considered. Choice of a specific psychotherapy: Out of the various psychotherapeutic interventions used for management of depression, there is robust level of evidence for use of CBT.
The major determinants of type of psychotherapy are patient preference and the availability of clinicians with appropriate training and expertise in specific psychotherapeutic approaches. Other clinical factors which will influence the type of psychotherapy include the severity of the depression. Psychotherapy is usually recommended for patients with depression who are experiencing stressful life events, interpersonal conflicts, family conflicts, poor social support and comorbid personality issues.
The optimal frequency of psychotherapy may be based on specific type and goals of the psychotherapy, the frequency necessary to create and maintain a therapeutic relationship, the frequency of visits required to ensure treatment adherence, and the frequency necessary to monitor and address suicidality.
Other factors which would also determine the frequency of psychotherapy visits include the severity of illness, the patient's cooperation with treatment, the availability of social supports, cost, geographic accessibility, and presence of comorbid general medical problems.
Besides the use of specific psychotherapy, all patients and their caregivers may receive psychoeducation about the illness. Role of Yoga and Meditation in management of depression: Studies related to role of traditional therapies like meditation, Yoga and other techniques have been mostly published in documents of various organizations propagating that particular technique. The goal of continuation phase is to maintain the gains achieved in the acute phase of treatment and prevent relapse of symptoms.
The treatment algorithm to be followed is shown in figure Patients who have been treated with antidepressants in the acute phase need to be maintained on same dose of these agents for weeks to prevent relapse total period of month from initiation of treatment.
There are evidences to support the use of specific psychotherapy in continuation phase to prevent relapse. The use of other somatic modalities e. The frequency of visit during the continuation phase may be determined by patient's clinical condition as well as the specific treatment being provided.
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