Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05838222 |
| Other study ID # |
00006727 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 8, 2023 |
| Est. completion date |
October 2, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
University of Georgia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
