DDBT Adapted Problem Solving Treatment for Primary Care

NCT03514394 | Completed Results

• 2 other identifiers: STUDY000042361P50MH115837-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Evidence-based psychosocial interventions are rarely used in part because of their design complexity. Although many implementation frameworks do address the importance of EBPI characteristics, adapting and modifying EBPIs to enhance usability has not been a focus. User-centered design (UCD) approaches, which have been successful in creating hardware and software tools that are accessible and compelling to use, have the potential to modify EBPIs so that they are accessible and compelling to clinicians. We hypothesize that UCD driven modifications to EBPI usability (target mechanism) will result in enhanced clinician ability to deliver EBPI elements competently, and that better competence results in better patient reported outcomes. We will modify Behavioral Activation (BA), an EBPI often used in primary care, to function as a Task Sharing model between clinicians and care managers. Our specific aims are to (1) identify usability problems clinicians and care managers encounter with BA (2) create a clinician- and care manager-driven modification of BA and (3) compare the modified Task Sharing version of BA to usual care on usability, clinician competence, and patient reported outcomes.

Conditions

Depression; PTSD

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire-9 (PHQ-9)

  9 item patient self report measure of mood, where each item as rated on a 0 (no problem) to 3 (every day) scale. Total scores range from 0 - 27. Higher scores indicate increased depression, a score of 10 or greater is considered to be clinical depression. Data points were collected from each individual multiple times across the course of the study. For comparisons we conducted a multiple case study design examining each person's individual trajectory. The means and standard deviations reported are for all available observations stratified by condition.

  Patient participants will complete the PHQ-9 at baseline and weekly for 10 weeks, single value calculated averaging across all available observations.

• Generalized Anxiety Disorder (7-item) Scale (GAD-7)

  A 7-item screener for generalized anxiety. It consists of items related to GAD. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks. Total scores range from 0 - 21. The scale is a valid screener for GAD. High scores indicate higher anxiety symptom severity. Data points were collected from each individual multiple times across the course of the study. For comparisons we conducted a multiple case study design examining each person's individual trajectory. The means and standard deviations reported are for all available observations stratified by condition.

  Patient participants will complete the GAD-7 at baseline and weekly for 10 weeks, single value calculated averaging across all available observations.

Secondary Outcomes (7)

• Acceptability Intervention Measure (AIM)

  Clinician participants will complete the AIM at baseline and 3-month follow-up.

• User Burden Scale

  Clinician participants will complete the UBS at baseline and 3-month follow-up.

• Time to Certification

  Hours toward certification will be collected over a three month period.

• Skill Drift Using the PST Adherence Checklist

  We will rate nine therapy sessions per clinician over a six month period.

• System Usability Scale

  Clinician participants will complete the SUS at baseline and 3-month follow-up

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual care administered for depression at clinic.

Behavioral: Usual Care

Modified Behavioral Activation (Task Sharing)

EXPERIMENTAL

This intervention will be a modification of Behavioral Activation (BA), which is a behavioral intervention that identifies work, social, health, or family activities that patients have stopped engaging in because of their mood. Specifically, we will introduce a Task Sharing modification, which will allow clinicians and care managers to more efficiently share the tasks involved in BA. These modifications will be based on clinician and care manager feedback from Phases 1 and 2 of this study.

Behavioral: Modified Behavioral Activation (Task Sharing)

Interventions

Usual Care BEHAVIORAL

The clinic's usual care includes counseling, substance use disorder treatment, peer support services, and some elements of traditional BA (not the modified BA).

Usual Care

Modified Behavioral Activation (Task Sharing) BEHAVIORAL

This intervention will include all core elements of Behavioral Activation (BA), which is a behavioral intervention that identifies work, social, health, or family activities that patients have stopped engaging in because of their mood. The intervention will also include a Task Sharing modification, which will allow clinicians and care managers to more efficiently share the tasks involved in BA.

Modified Behavioral Activation (Task Sharing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care patient in rural MT and WY; Speaks English; Patient Health Questionnaire - 9 \> 10.

You may not qualify if:

• none

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Big Horn Valley Health Center

Hardin, Montana, 59034, United States

Location

Related Publications (1)

• Lyon AR, Munson SA, Renn BN, Atkins DC, Pullmann MD, Friedman E, Arean PA. Use of Human-Centered Design to Improve Implementation of Evidence-Based Psychotherapies in Low-Resource Communities: Protocol for Studies Applying a Framework to Assess Usability . JMIR Res Protoc. 2019 Oct 9;8(10):e14990. doi: 10.2196/14990.

  PMID: 31599736 DERIVED

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Morgan Johnson
• Organization: University of Washington

mjohn23@uw.edu

17154161493

Study Officials

• Patricia Arean, PhD

  UWMC Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research Assistants and expert reviewers of therapy sessions will not be made aware of which condition the therapist is assigned to.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Phase 1 will consist of observation and qualitative interviews; Phase two will consist of iterative design methods; phase three is a pilot randomized clinical trial

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: May 2, 2018
• Study Start: July 1, 2019
• Primary Completion: June 25, 2021
• Study Completion: December 30, 2021
• Last Updated: July 27, 2023
• Results First Posted: August 23, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available January 2022
• Access Criteria: All interested parties may contact Dr. Renn for access to data. Dr. Renn will review all requests and facilitate data use agreements and data access.

Locations

US (1)