NCT05838222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

May 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

April 6, 2023

Last Update Submit

October 17, 2023

Conditions

Keywords

Integrated careSolution focusedPrimary Careco occurring disorders

Outcome Measures

Primary Outcomes (5)

  • 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.

    4 months

  • 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.)

    4 months

  • Diabetes Outcomes

    Assess efficacy of SFBT for diabetes. The investigator will examine differences between the treatment and control group for depression scores utilizing HbA1c.

    4 months

  • 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.

    4 months

  • 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.

    4 months

Secondary Outcomes (1)

  • Hypertension

    4 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Solution Focused InterventionOther: Treatment as Usual

Control

ACTIVE COMPARATOR

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

Other: Treatment as Usual

Interventions

A short term, goal focused, therapeutic approach which helps patients address problems contributing to health and mental health challenges

Intervention Group

The patient receives standardized care from primary care team without the SFBT intervention

ControlIntervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • PHQ9\>10

You may not qualify if:

  • No significant co occurring mental health disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

Related Publications (2)

  • Cooper ZW, Johnson L. Strategies for Fidelity Monitoring a Solution-Focused Brief Intervention in a Randomized Clinical Trial. J Clin Psychol Med Settings. 2025 Sep;32(3):421-430. doi: 10.1007/s10880-025-10063-7. Epub 2025 Jan 28.

  • Cooper ZW, Mowbray O, Ali MK, Johnson LCM. Addressing depression and comorbid health conditions through solution-focused brief therapy in an integrated care setting: a randomized clinical trial. BMC Prim Care. 2024 Aug 23;25(1):313. doi: 10.1186/s12875-024-02561-8.

MeSH Terms

Conditions

DepressionDiabetes MellitusHypertensionAnxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesMental Disorders

Study Officials

  • Orion Mowbray, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pretest-posttest experimental design with a treatment as usual group and an intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean of Research

Study Record Dates

First Submitted

April 6, 2023

First Posted

May 1, 2023

Study Start

May 8, 2023

Primary Completion

August 11, 2023

Study Completion

October 2, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations