Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

• Role of the therapeutic relationship (and different methods for evaluating that role) in the service of improved outcomes
• For individuals with serious mental illness, what facets of the therapeutic relationship (e.g., clinician or organization characteristics, including theoretical models of care) are associated with improved immediate and long term outcomes, such as functional status, quality of life, symptom profiles, patient satisfaction and the perception of having a “continuous healing relationship.”

1. What effect, if any, does the “quality” of the therapeutic relationship (or perhaps more accurately, the “therapeutic alliance” or TA) have on patient outcomes in the treatment of persons with SMI? How does the effect of the TA compare to the “specific” effect of the mental health intervention?

• Are there differences in the effect size across the different diagnostic categories that constitute SMI? (e.g., is there evidence that the TA is more difficult to develop among some patient populations?)

2. Is there a significant difference in the effect of the TA on treatment outcome with psychotherapeutic vs. psychopharmacological treatments for SMI?

• Is there evidence indicating that the impact of the TA differs with psychotherapeutic modalities? (e.g., is the effect of the TA larger for psychodynamic or interpersonal psychotherapy vs. cognitive-behavioral psychotherapy?).

3. What are the implications of #1 & #2 with regard to implementation of effective, evidence-based psychotherapeutic (or pharmacological) treatment for patients with SMI?

• If there are any significant differences in role of TA with different psychotherapy modalities or between psychotherapeutic and pharmacological treatments, what are the clinical implications of such differences for treatment recommendations in clinical practice guidelines?
• In terms of the relationship between treatment outcomes and the TA, is the TA most accurately conceptualized as a treatment mediator or mod

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

• Outcomes referred to below include quality of life, presence/absence of particularly distressing symptoms or side effects, intensity of resource use, patient satisfaction with care, treatment adherence, demoralization, hospitalization rates, and long-term adherence. Suicide rates may be relevant but are subject to many factors.
• Compare the effectiveness of various features of health professionals that support the development of a “continuous healing relationship.” – May be important to differentiate the types of health professional, as the TA may be associated with this. For instance, data on development of the TA among psychologists may not be generalizable to social workers or psychiatrists.
• Compare the qualities of the person or organization providing the care with regard to development of a “continuous healing relationship” as an assessed outcome. One nominator noted that this could/should include a variety of demographic factors as well as specific skills (e.g., training in particular therapies, ability to provide transference interpretation), identified theoretical orientation, personality traits, interpersonal qualities (e.g., empathy, warmth) for individuals and specific aspects of organizations (e.g., funding source, team vs. individual based models of care, frequency of staff turnover). This nominator also commented that patient specific factors (e.g., interpersonal style, inner- vs. outer-directedness, openness to new experiences, ability to articulate feelings, attachment style as in Ciechanowski PS Med Care. 2006 44(3):283-91) are also important to assess since some therapist characteristics (e.g., directive vs. non-directive) could be useful for some patients but not for others.
• Compare the effectiveness of recovery oriented model of care to usual care on long term functional outcomes. – Perhaps another angle into this: Compare the role of the TA (in terms of the effect size, any differences in the quality or key determinants) at variou

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

• Patients with Serious Mental Illness (SMI) including co-occurring disorders, especially chemical dependency

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

• English, non-English, and non-standard English speakers
• Age, race, gender, and language, as well as other demographic factors, should be considered in determining outcomes and how they are measured
• Disaffiliated populations e.g. people with homelessness, people in jails and prisons, some immigrant groups (refugees)
• Men vs. Women (Potential differences in role/development of TA)
• Children (to the extent that such research exists) vs. Adults (potential differences in factors associated with development of TA)
• Ethic/racial differences
• Different diagnostic categories within the domain of SMI
• According to one nominator, there may be particular subgroups that are relevant to particular questions. For example, as noted above, patients with a high degree of belief or involvement with religious or cultural healers are likely to have a very different response to involving such individuals in their care than other patients who do not share those religious or cultural models of health belief.
• In addition to religious and cultural background, factors such as age, sex, sexual orientation, race, and language may also be relevant. Some individuals may feel more comfortable or more able to establish a therapeutic relationship with a clinician who is similar in background and demographics to themselves.
• Even within the group of individuals with serious mental illness, there are varying levels of illness chronicity, residual symptoms despite optimal medications, frequency of hospitalization and adherence with treatment. These sorts of factors (as well as others) may influence the extent of effectiveness of particular treatment models (e.g. recovery oriented models). It is also important to look at patient specific factors as well as clinician specific factors in evaluation and evolution of the therapeutic relationship.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

• Decreased variation and more standardization in care for patients with SMI

– One nominator suggested rewording this to say “Improved clinical technique focusing on the therapeutic alliance with respect to people with SMI.” They noted that “more standardization” implies a cookie-cutter approach for a very person-centered intervention.

– This may or may not be a desired benefit if certain subgroups of patients are found to gain preferential benefits from particular clinician/organization characteristics or models of care.

• Better patient outcomes – Better treatment adherence – Lower treatment drop-out (and duration of time remaining in treatment) – Patient recovery and long-term functioning – Other outcomes as described previously – Long-term functioning, symptom remission and quality of life
• Improved training for mental health professionals – Increased patient satisfaction with care – Greater patient engagement/involvement in health care decision-making
• Improved patient-caregiver interaction
• Patient recovery and long-term functioning
• Improvement in treatment adherence
• Increased likelihood of shared decision making (when this is desired by the patient, which is not always the case)
• Reduced need for acute care (e.g., emergency visits, hospitalizations)
• Greater satisfaction with care – A positive therapeutic relationship may also help the clinician in mobilizing support and providing education to family members and others involved in the patient’s life, thereby enhancing those social networks.
• Optimal matching of patients to clinicians and treatment programs that are most likely to yield a productive therapeutic relationship that enhances outcomes.

Describe any health-related risks, side effects, or harms that you are concerned about.

• Patient drop-out (premature termination of treatment)
• Patient failure to follow treatment recommendations
• Exacerbation of symptoms, for instance, if patient a fails to consistently show for treatment sessions, is less engaged in treatment (from negative/poor TA); or, even harm to patient, for instance, failure to rapidly develop a TA with suicidal patient could provoke self-harm or suicide.
• The potential for increased rather than decreased symptoms, at least in some individuals, needs to be taken into consideration.

– The studies on expressed emotion offer some suggestion that high levels of emotionality, can lead to unintended consequences and worsening of symptoms, even when conveyed in a well-intentioned and ostensibly helpful manner.

– In individuals with other conditions such as anxiety disorders, it is also clear that an overwhelming progression of tasks in therapy (e.g., with exposure and response prevention) can worsen symptoms rather than diminish them.

– Anecdotal observations also suggest that the same is true for some individuals with serious mental illness.

– More serious breakdowns in the therapeutic relationship (e.g., boundary violations) also occur. Thus, the possibility of harms in the therapeutic relationship needs to be mentioned and considered along with the benefits.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Depression and other mental health disorders
• Functional limitations and disability
• Substance abuse

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Research should focus on the relationship between client and provider as central to effectiveness research (alliance). Therapeutic alliance accounts for a large degree of variance in psychotherapy treatment outcomes.

• This is true for all clinical relationships, not just psychotherapeutic ones. For example, adherence with pharmacotherapy and understanding of illness and the need for particular treatments tends to be limited in the absence of an effective therapeutic alliance. Even obtaining an accurate history may be difficult in the absence of rapport, confounding attempts at determining a diagnosis and appropriate plan of treatment. Accordingly, the role of the therapeutic relationship is an important one across settings and types of treatment in mental health as well as non-mental health settings.
• The issue of the therapeutic relationship in non-mental health settings has not been specifically noted but is also worth mentioning as individuals with serious mental illness often have significant concomitant medical, surgical and dental needs, yet are often viewed differently by those clinicians due to discriminatory ideas about individuals with mental illness. This obviously has an influence on the therapeutic relationship and a negative impact on care received as well as associated outcomes. The relative effect of the specific treatment intervention (i.e., relative amount of variance accounted for by treatment approach/modality) versus the TA has important implications for:
• Delivery of quality evidence-based mental health care for patient with SMI;
• Training of mental health professionals;
• Measurement of psychotherapy effectiveness (e.g., measures to inform evidence-based treatment by suggesting a change in therapeutic approach to improve the TA); and,
• Provision of evidence-based, patient-centered care Measurement for this factor should be part of evaluation of treatment process and outcomes.

Understanding the determinants of the TA, such

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

• As a clinician and educator it is clear through my experience that the success of actual clinical engagement is perhaps the single most important factor in the treatment process. Without engagement, specific interventions or technologies cannot be employed successfully.
• In spite of the potential to improve patient care through a better understanding of the impact, role, and determinants of the “therapeutic alliance,” this construct has not been integrated into the current model of evidence-based care.
• Major on-going controversy within psychology/psychiatry regarding the (relative) importance of the therapeutic alliance to optimal patient care/outcomes. There is considerable variation among social scientists and practitioners in their beliefs about the effect of the treatment intervention vs. the therapeutic relationship as the primary factor affecting treatment outcome.
• The overwhelming majority of psychotherapy research has focused on the effects of specific treatment modalities/approaches, with little systematic investigation of the therapeutic alliance, which is often viewed as a “non-specific” effect or factor. Indeed, most psychotherapy research has utilized an RCT approach, which is inherently designed to evaluate specific treatment effects while “controlling” for other effects, such as the TA. As such, research on the TA as a secondary outcome from RCTs may significantly underestimate the effect of TA.
• New methodological approaches and study designs may need to be developed or utilized to characterize the true impact of the TA on patient outcomes.
• Research is needed to elucidate the role of the therapeutic alliance as a mediator or moderator of various treatment outcomes, as well as to empirically identify both modifiable (e.g., therapeutic approaches) and unmodifiable (e.g., practitioner demographic characteristics) factors, as well as interactions between the two. While (instruction to change) the modifiable factors may be targets to i

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

• The role of the therapeutic relationship, the fact that it takes time to develop such a relationship and the importance of having a stable and continuous relationship is typically underemphasized and undervalued in decisions about care authorization and time allotted for visits (e.g., particularly pharmacotherapy based treatment and general medical/surgical visits for those with serious mental illness). Models for care delivery and associated payment approaches need to appreciate that the therapeutic relationship is an essential element of appropriate diagnosis and treatment just as a CT scan or a surgical procedure would be in other areas of medicine.
• Care has become increasing fragmented throughout the health system with shifts in allowable providers based on contracts. However, fragmentation of care has become even worse for individuals with serious mental illness who do not typically have a centralized source of care but shift from one clinic to a day program to a hospital to a different clinic based on their symptoms or the location of their housing, not based upon existing therapeutic relationships. Those who were hospitalized in state mental health systems had de facto coordination of care but as such programs have been downsized without associated availability of community housing, living situations and delivery of psychiatric and medical care has become disjointed and difficult to coordinate.
• The issue of team based therapeutic alliances (see comment LF5) also has policy implications about models of care delivery. The research question relates to the comparative effectiveness of delivery of care by a team of individuals vs. delivery of care by a single individual. The roles of the therapeutic relationship with individual clinicians vs. a therapeutic relationship with “the team” (similar to the concept of an institutional transference) are specifically relevant to this topic. If team based approaches lead to a greater sense of consistency in th

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

• The relative importance of the TA and the specific treatment to patient outcome is a contentious issue in mental health care, and especially among psychologists. While some scholars/practitioners have asserted that the TA is the primary determinant of treatment outcome (e.g., most robust predictor of treatment response), others focus on the impact of the treatment intervention. This research will help clarify these factors and, ideally, provide an integrative evidence-based framework that includes the role of both factors the TA and specific treatment effects (as important sources of variance) in treatment of patients with SMI.
• This will assist psychologists and other stakeholders in appreciating the relative effects of the TA and the treatment modality, as well as the factors or clinical approaches that should be considered and possibly addressed to optimize patient care.
• Answers to these research questions will be able to inform the development of practice guideline recommendations for psychiatrists relating to the therapeutic alliance.

Describe the timeframe in which an answer to your question is needed.

As soon as possible. This topic was prioritized during a series of stakeholder meetings focused on SMI, held July-August 2010.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

• Cultural competence necessary
• Individuals with serious mental illness are a vulnerable population and such individuals often face stigmatization and discrimination within the health care system. The functional impact of their illness often leads them to be receiving disability or have income limitations that make it hard to access care or even obtain transportation to reach available care. The associated health disparities and care inequities for those with serious mental illness (including outcomes such as morbidity and mortality) are well documented elsewhere.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

• The relative importance of the TA and the specific treatment to patient outcome is a contentious issue in mental health care, and especially among psychologists. While some scholars/practitioners have asserted that the TA is the primary determinant of treatment outcome (e.g., most robust predictor of treatment response), others focus on the impact of the treatment intervention. This research will help clarify these factors and, ideally, provide an integrative evidence-based framework that includes the role of both factors the TA and specific treatment effects (as important sources of variance) in treatment of patients with SMI.
• This will assist psychologists and other stakeholders in appreciating the relative effects of the TA and the treatment modality, as well as the factors or clinical approaches that should be considered and possibly addressed to optimize patient care.
• Answers to these research questions will be able to inform the development of practice guideline recommendations for psychiatrists relating to the therapeutic alliance.

Are you making a suggestion as an individual or on behalf of an organization?

Individual

Please tell us how you heard about the Effective Health Care Program

1- The Practice Guidelines project of the American Psychiatric Association was asked for the name of someone to participate; my name was submitted; 2- Our organization was contacted by AHRQ and asked to participate; 3- AHRQ outreach; 4- Through AHRQ and CTSA activities