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Integrating Solution Focused Interventions in Integrated Care

Primary Purpose

Depression, Diabetes Mellitus, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Solution Focused Intervention
Treatment as Usual
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Integrated care, Solution focused, Primary Care, co occurring disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Over 18 years old PHQ9>10 Exclusion Criteria: No significant co occurring mental health disorders

Sites / Locations

  • University of Georgia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control

Arm Description

The intervention group will receive 3 sessions of SFBT from a licensed therapist in addition to treatment as usual

This group will be the treatment as usual group who will receive primary care treatment without the SFBT intervention

Outcomes

Primary Outcome Measures

Solution Focused Scaling Questions
The authors utilized a solution-focused treatment manual to extract the essential ingredients of solution-focused treatment and create a scale measuring the degree to which participants 1) have experienced hope, 2) experienced connection to important people, 3) identified their strengths, 4) have hope for a "good" future, and 5) believe they could solve problems in their lives over the past two weeks. Each of these questions occurred on a 1-10 scale where 1 was "not at all" and 10 was "completely." This screening tool was provided to participants in paper format where participants self-administered the survey.
Depression outcomes
Assess efficacy of SFBT for depression. The investigator will examine differences between the treatment and control group for depression scores utilizing the patient health questionnaire (PHQ-9.)
Diabetes Outcomes
Assess efficacy of SFBT for diabetes. The investigator will examine differences between the treatment and control group for depression scores utilizing HbA1c.
Acceptability measure
Evaluate acceptability for SFBT. The Acceptability of Intervention measure (AIM) will be used to assess the acceptability of the intervention for the treatment group. The AIM measures acceptability by asking participants whether the intervention 1) met their approval, 2) is appealing to them, 3) whether they like the intervention, and 4) whether they would welcome the intervention. A 5-point Likert scale is utilized to assess each of these domains. The scale will be self-administered by participants.
Feasibility measure
Evaluate feasibility for SFBT. The Feasibility of Intervention measure (FIM) will be used to assess the feasibility of the intervention for the treatment group. The FIM assesses whether the participant believes that the intervention seems 1) implementable, 2) possible, 3) doable, and 4) easy to use. A 5-point Likert scale is utilized to assess each of these domains. The scale will be self-administered by participants.

Secondary Outcome Measures

Hypertension
Assess efficacy of SFBT for hypertension. The investigator will examine differences between the treatment and control group for depression scores utilizing blood pressure readings.

Full Information

First Posted
April 6, 2023
Last Updated
October 17, 2023
Sponsor
University of Georgia
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1. Study Identification

Unique Protocol Identification Number
NCT05838222
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
August 11, 2023 (Actual)
Study Completion Date
October 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Diabetes Mellitus, Hypertension, Anxiety Disorders
Keywords
Integrated care, Solution focused, Primary Care, co occurring disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pretest-posttest experimental design with a treatment as usual group and an intervention group
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will receive 3 sessions of SFBT from a licensed therapist in addition to treatment as usual
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This group will be the treatment as usual group who will receive primary care treatment without the SFBT intervention
Intervention Type
Behavioral
Intervention Name(s)
Solution Focused Intervention
Intervention Description
A short term, goal focused, therapeutic approach which helps patients address problems contributing to health and mental health challenges
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
The patient receives standardized care from primary care team without the SFBT intervention
Primary Outcome Measure Information:
Title
Solution Focused Scaling Questions
Description
The authors utilized a solution-focused treatment manual to extract the essential ingredients of solution-focused treatment and create a scale measuring the degree to which participants 1) have experienced hope, 2) experienced connection to important people, 3) identified their strengths, 4) have hope for a "good" future, and 5) believe they could solve problems in their lives over the past two weeks. Each of these questions occurred on a 1-10 scale where 1 was "not at all" and 10 was "completely." This screening tool was provided to participants in paper format where participants self-administered the survey.
Time Frame
4 months
Title
Depression outcomes
Description
Assess efficacy of SFBT for depression. The investigator will examine differences between the treatment and control group for depression scores utilizing the patient health questionnaire (PHQ-9.)
Time Frame
4 months
Title
Diabetes Outcomes
Description
Assess efficacy of SFBT for diabetes. The investigator will examine differences between the treatment and control group for depression scores utilizing HbA1c.
Time Frame
4 months
Title
Acceptability measure
Description
Evaluate acceptability for SFBT. The Acceptability of Intervention measure (AIM) will be used to assess the acceptability of the intervention for the treatment group. The AIM measures acceptability by asking participants whether the intervention 1) met their approval, 2) is appealing to them, 3) whether they like the intervention, and 4) whether they would welcome the intervention. A 5-point Likert scale is utilized to assess each of these domains. The scale will be self-administered by participants.
Time Frame
4 months
Title
Feasibility measure
Description
Evaluate feasibility for SFBT. The Feasibility of Intervention measure (FIM) will be used to assess the feasibility of the intervention for the treatment group. The FIM assesses whether the participant believes that the intervention seems 1) implementable, 2) possible, 3) doable, and 4) easy to use. A 5-point Likert scale is utilized to assess each of these domains. The scale will be self-administered by participants.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Hypertension
Description
Assess efficacy of SFBT for hypertension. The investigator will examine differences between the treatment and control group for depression scores utilizing blood pressure readings.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years old PHQ9>10 Exclusion Criteria: No significant co occurring mental health disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orion Mowbray, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Integrating Solution Focused Interventions in Integrated Care

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