Supported Online Self-Help for Veterans With Depression in Primary Care

ConditionDepression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles

About this trial

Depression is disabling and affects one in five Veterans. VA's Primary Care-Mental health Integration (PCMHI) enables specialists to support medication treatment in primary care, but timely and sufficient access to psychotherapy is unattainable despite Veteran preference for psychotherapy. This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting PCMHI collaborative care models to improve uptake of peer-supported computerized cognitive behavioral therapy (cCBT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must be enrolled in the VHA and currently receiving primary care services at VA Los Angeles or San Diego

Have access to computer (mobile or desktop), internet, telephone, and email

Able to read English text on a computer screen

Score 10 or higher on the PHQ-9

Disqualifiers

Have moderate-high suicide risk (e.g. suicide flag) or active suicidality

Have other serious mental illness (e.g. bipolar disorder, psychosis)

Have medical disorder that would prevent/ interfere with participation (e.g. dementia/cognitive impairment, terminal illness)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enhanced Usual Care (EUC)

    Behavioral

    Enhanced usual care includes all the usual depression care at the VA and access to an online therapy program with no peer support sessions. The online therapy program offered consists of several modules for depression care, specifically tailored for Veterans.

  • Supported Online Self-help for Depression (SOS-Depression)

    Behavioral

    Supported Online Self-help for Depression (SOS-Depression) includes all the usual depression care at the VA and access to an online therapy program with support sessions with a peer. The online therapy program consists of several modules for depression care, specifically tailored for Veterans.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Enhanced Usual Care (EUC)Active comparator 1 intervention
Group B: Supported Online Self-help for Depression (SOS-Depression)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient Health Questionnaire (PHQ-9)

The Patient Health Questionnaire (PHQ-9) is a scale commonly used to measure and categorize depression symptoms. It is already administered as part of routine primary care at our study site. The minimum score is 0, the maximum is 27. A higher score indicates a worse outcome (i.e. more severe depression symptoms).

Time frame
3- and 6-month follow up

Secondary outcomes

1

Behavioral Activation for Depression Scale (BADS-SF)

The 9-item Behavioral Activation for Depression Scale (BADS-SF) will also be used to examine behavioral activation as an intermediary to depression symptomatology outcomes. The minimum score is 0, the maximum is 54. Higher scores indicate a better outcome (i.e., higher activation).

Time frame
3- and 6-month follow up
2

Generalized Anxiety Disorder (GAD-7)

The 7-item Generalized Anxiety Disorder (GAD-7) is among the most commonly used and best validated anxiety measures in primary care settings. The minimum score is 0, the maximum is 21. Higher scores indicate a worse outcome (i.e., more severe anxiety). For reference: scores of 0-4=minimal anxiety, 5-9=mild anxiety, 10-14=moderate anxiety, and 15-21=severe anxiety.

Time frame
3- and 6-month follow up
3

World Health Organization Disability Assessment Schedule (WHODAS 2.0)

The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version is a brief self-report measure that will be used to assess functioning and disability across multiple domains of daily life. The minimum score is 0, and the maximum score is 48. Higher scores indicate greater disability.

Time frame
3- and 6-month follow up

Other outcomes

1

Treatment Engagement

Treatment engagement will be conceptualized as the number of cCBT sessions completed. A higher number indicates more cCBT sessions completed, but isn't indicative of a better or worse outcome.

Time frame
6-months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

San Diego Veterans Healthcare System

Collaborator

VA Greater Los Angeles Healthcare System

Collaborator

Congressionally Directed Medical Research Programs

Collaborator

This trial is not recruiting at the moment. You can still explore other options: