Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05838222
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2023-04-06
Brief Title:
Integrating Solution Focused Interventions in Integrated Care
Sponsor:
University of Georgia
Organization:
University of Georgia
Study Overview
Official Title:
Implementation and Efficacy of Solution Focused Interventions Within an Integrated Behavioral Health Setting
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Integrated behavioral healthcare IBH emerged to address the high prevalence of psychosocial issues endemic to primary care settings coupled with primary care providers 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 providers 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 SFBTs 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 GPower 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
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 SFBTs 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 GPower 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None