Clinical trial NCT05838222: Integrating Solution Focused Interventions in Integrated Care
Official title: Implementation and Efficacy of Solution Focused Interventions Within an Integrated Behavioral Health Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Diabetes Mellitus
Hypertension
Anxiety Disorders
Keywords: Integrated care
Solution focused
Primary Care
co occurring disorders
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pretest-posttest experimental design with a treatment as usual group and an intervention group
Primary purpose: TREATMENT

Brief summary: Integrated behavioral healthcare (IBH) emerged to address the high prevalence of psychosocial issues endemic to primary care settings coupled with primary care provider's discomfort in addressing psychosocial issues. IBH addresses the lack of psychosocial care in primary care settings by expanding the traditional healthcare team through the inclusion of a behavioral health provider (clinical social worker, licensed psychologist, etc.). The behavioral health provider utilizes evidenced based interventions to support the healthcare team with addressing a wide range of healthcare concerns. Solution Focused Brief Therapy (SFBT) provides a promising treatment approach within IBH settings due to the high productivity standards within primary care and the efficient, solution based style foundational to SFBT. In addition, SFBT is strengths based and emphasizes patient centered approaches which primary care aspires to achieve. Despite the natural fit, there is a paucity of research regarding SFBT within integrated care settings in general, and for specific disease states. The purpose of this study is to assess the efficacy of SFBT within an IBH setting in the treatment of depression while assessing for commensurate improvement with traditional healthcare markers such as A1C, blood pressure, pulse, and weight. In addition, scaling questions will be utilized to assess for increase in core SFBT constructs to include self-awareness of strengths, future hope, and increased ability to problem solve. A pre-posttest experimental design will assess the differences between those receiving SFBT and treatment as usual across symptoms of depression, SFBT core attributes, and health outcomes.

Detailed description: Integrated behavioral healthcare (IBH) emerged to address the high prevalence of psychosocial issues endemic to primary care settings coupled with primary care provider's discomfort in addressing psychosocial issue. IBH addresses the lack of psychosocial care in primary care settings by expanding the traditional healthcare team through the inclusion of a behavioral health provider (clinical social worker, licensed psychologist, etc.). The behavioral health provider utilizes evidenced based interventions to support the healthcare team with addressing a wide range of healthcare concerns. Solution Focused Brief Therapy (SFBT) provides a promising treatment approach within IBH settings due to the high productivity standards within primary care and the efficient, solution based style foundational to SFBT. In addition, SFBT is strengths based and emphasizes patient centered approaches which primary care aspires to achieve. Despite the natural fit, there is a paucity of research regarding SFBT within integrated care settings in general, and for specific disease states. The purpose of this study is to assess the efficacy of SFBT within an IBH setting in the treatment of depression while assessing for commensurate improvement with traditional healthcare markers such as A1C, blood pressure, pulse, and weight. In addition, scaling questions will be utilized to assess for increase in core SFBT constructs to include self-awareness of strengths, future hope, and increased ability to problem solve. A pre-posttest experimental design will assess the differences between those receiving SFBT and treatment as usual across symptoms of depression, SFBT core attributes, and health outcomes.

Study Aims

The purpose of this study is to examine the efficacy of SFBT in an integrated care setting for addressing depressive symptoms and health outcomes among patients with depression. The study aims are to:

Aim 1: Assess SFBT's impact on core SFBT constructs (hope, connection with important people, strengths). Measure SFBT constructs in both the control and treatment group and assess differences between the two groups

Aim 2: Assess efficacy of SFBT for depression. Examine differences between the treatment and control group for depression scores utilizing the PHQ-9.

Aim 3: Assess efficacy of treating co occurring healthcare conditions. Key outcomes of blood pressure control and HbA1c will be compared for those who have a co-occurring chronic illness such as diabetes or hypertension.

Aim 4: Evaluate implementation measures such as fidelity, acceptance, and feasibility with both patients and healthcare staff.

Method

Sample and procedure The proposed research will use a pretest-posttest experimental design where the intervention group will receive a standardized integrated care treatment protocol along with SFBT. The control group will only receive a standardized integrated care treatment protocol; in this setting access to primary care and potential referral to co located treatment. Based on an existing partnership with the Principal Investigator, participants will be recruited from a primary care clinic in the state of Georgia. Patients who have scored at or above 10 on the PHQ-9 will be considered as eligible to participate in the study. After intake and initial depression screening, any patients who have scored at or above 10 on the PHQ-9 will be considered as eligible to participate in the study. Following the consent process, participants will be randomly assigned using a random number generator process to either the SFBT treatment condition or treatment as usual condition. Individuals in the SFBT condition will receive standard integrated care protocol, plus three sessions of SFBT. The control group will only receive the standard integrated care protocol from a primary care provider. A minimum of 50 participants will be recruited into this study. A power analysis using the software G\*Power shows that a sample of 48 participants will adequately power all statistical testing processes and permit the detection of medium to small effects (d = .20), given the design of the research. To ensure effective delivery of SFBT, the co-investigator will be enrolled in a Solution Focused Online Intensive Training program provided by The Institute for Solution Focused Therapy to gain a robust foundational understanding of SFBT and to ensure fidelity of the provision of SFBT within the research process. The training is online, asynchronous and uses readings, lectures, and mock interviews with patients; participants are also tested on their knowledge via online test at the end of each module. In addition, a SFBT fidelity scale will also be used to ensure service delivery is consistent SFBT best practices. The scale will be utilized by the clinician as a self-assessment to ensure SFBT fidelity.

Measures The dependent variables within the study will be 1) Symptoms of depression, 2) SFBT attributes, 3) Health outcomes, and 4) key implementation measures. Additional demographic measures will also be examined as potential control or moderating variables. The independent variable within the study will be the receipt of SFBT or treatment as usual (TAU).

Symptoms of depression. Depression will be measured at both pretest and posttest with the PHQ-9. The PHQ-9 is a standard assessment utilized in all federally qualified health centers and many primary care clinics and is therefore already embedded in the clinic workflow. The PHQ-9 has an established history of predictive validity and acceptable sensitivity (88%) and specificity (88%).

SFBT attributes. These will be assessed at both pretest and posttest with scaled questions including hope, patient strengths, and connection to important people.

Health outcomes. These outcomes will be assessed through patient chart review at both pretest and posttest. These measures will include traditional healthcare markers such as blood pressure, weight, pulse, and A1C measurements.

Demographic measures. These measures will be collected only at baseline and will include age, gender, race, ethnicity, sexual orientation, education, income, and marital status.

Implementation variables: Feasibility, Acceptability, and Appropriateness. The Acceptability of Intervention Measure (AIM), Feasibility of Intervention Measure (FIM), and Intervention Appropriateness Measure (IAM) will be provided to both patients and providers at baseline and at the end of study to determine their perception of the intervention within the primary care setting .

Data analysis plan To assess the utilization and efficacy of SFBT within an integrated care setting, participants who receive SFBT will be compared to those who receive TAU. Given the experimental nature of the research design, a factorial design ANOVA will be utilized to examine changes within each group (SFBT vs. TAU) from pretest to posttest, and changes between groups (SFT vs. TAU) at pretest or posttest. Demographic measures will be examined to ensure adequate randomization between groups, as well as for their role in potential within-group effects associated with identified outcomes. All analyses will be completed using the statistical software packages of SAS.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* PHQ9\>10

Exclusion Criteria:

* No significant co occurring mental health disorders

Primary outcomes:
measure: Solution Focused Scaling Questions
timeFrame: 4 months
measure: Depression outcomes
timeFrame: 4 months
measure: Diabetes Outcomes
timeFrame: 4 months
measure: Acceptability measure
timeFrame: 4 months
measure: Feasibility measure
timeFrame: 4 months
Secondary outcomes:
measure: Hypertension
timeFrame: 4 months
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Orion Mowbray, PhD
role: PRINCIPAL_INVESTIGATOR
References: