Clinical trial NCT03068676: Internet-delivered Treatments for Depression and Anxiety in Primary Care (SUMMA)
Official title: A Pilot Study Investigating the Feasibility of Implementing Internet-delivered Treatments for Depression and Anxiety in Primary Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depressive Disorder
Anxiety Disorders
Depression
Keywords: Depression
Anxiety
Internet-delivered
CBT
Primary Care
Lead sponsor: Silver Cloud Health
Sponsor class: OTHER
Collaborators: name: Summa Health System
First posted: 2017-03-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study is an open feasibility trial with the aim of providing a description of the factors associated with the implementation of an iCBT platform into an existing treatment framework in a primary care setting. The trial will examine the factors surrounding implementation, such as the experience of primary care practitioners and the online supporters, the recruitment process, and attitudes towards the overall implementation of the interventions. Patients presenting to the primary care setting will be screened using standard depression and anxiety measures, and where appropriate, will be referred to an iCBT intervention for either depression or anxiety, with support from trained staff. Analyses will be conducted on outcome measures to examine changes in symptom severity as patients progress through the intervention. Patient satisfaction data will also be collected to establish patient acceptability of the intervention. \[Note: Recruitment is ONLY open to patients at Ohio Family Practice Center\]

Detailed description: iCBT is the delivery of a tailored structured cognitive and behaviour therapy based programme, with support, to individuals with mild to moderate symptoms of depression and anxiety. There is now a substantial body of research evidence that supports the efficacy and effectiveness of internet-delivered cognitive behaviour therapy for depression and anxiety. Historically, a number of iCBT interventions have been used in clinical practice in IAPT services. However, they have often suffered with poor engagement and consequently poor clinical outcomes. More recent developments in the field have produced more robust technological platforms, where content is delivered through a variety of media that enhance productivity, increase engagement and produce better clinical outcomes. The SilverCloud intervention has been demonstrated to be a clinical effective evidence-based cognitive behavioural treatment option.

Approximately 90% of primary care patients with depression have one or more visits to a primary care physician (PCP) over a 12-month period, whereas less than one-third see a mental health professional. It has been reported that individuals with an anxiety disorder are 3 to 5 times more likely to visit their primary care physician than those without, but their symptoms are often associated with physical causes. PCPs often do not have training in psychological therapies and therefore they do not feel competent to treat individuals presenting with depression or anxiety. Often these individuals are prescribed antidepressant or anti-anxiety medications.

The use of online programs to deliver CBT to people with mental health disorders is becoming increasingly popular. Internet-delivered CBT (iCBT) consists of programs designed for the treatment of specific disorders, such as depression and anxiety, which are delivered via the internet. These programs can be clinician-guided and/or self-administered interventions. Evidence suggests that iCBT can benefit individuals with anxiety and depression when offered in a service context that offers brief support from trained staff. Such iCBT interventions are widely-used in some European countries and the recommended length of treatment is generally 6 - 8 online sessions. A robust evidence base supporting the use and effectiveness of internet-delivered treatments for depression and anxiety has been established. Outcomes have been greater for those programs offering the additional feature of human support.

The current study will examine the feasibility of implementing an iCBT platform within a primary care setting. This objective can be further dismantled into several sub objectives:

1. Is the model of implementation (screening, recruitment, and adherence to the internet-delivered intervention) feasible?
2. Will patients experience the iCBT intervention as satisfactory within their primary care treatment?
3. What is the feedback of the Primary Care Practitioners about the implementation of the internet-delivered intervention as part of primary care?
4. What is the experience of the trained supporters who assist patients within the iCBT intervention?
5. Can an internet-delivered intervention achieve improvements in depressive and anxiety symptoms for users?
6. Can patient attitudes toward internet-delivered interventions predict treatment outcome?

Eligibility criteria: Inclusion criteria:

At least 18 years of age, Speak English, Self-report symptoms of depression or anxiety (using PHQ-9 and GAD-7 measures).

Specifically for the self-report symptoms,

participants will need to have a PHQ-9 score of 5 to 19 for the depression program or a GAD-7 score of 5 to 15 for the anxiety program.

Participants currently attending face-to-face therapy/counseling will be excluded.

Exclusion criteria

Participants who flag as a risk on the self-harm item of the PHQ-9 during routine office visit screening will not be referred to the study and will be provided treatment and/or referral services as per the clinic's standard procedure.

Primary outcomes:
measure: Patient health Questionnaire
timeFrame: At week 8
measure: Generalized Anxiety Disorder
timeFrame: At week 8
Secondary outcomes:
measure: Socio-demographic Questionnaire
timeFrame: At baseline for screening
measure: Work and Social Adjustment
timeFrame: At baseline and week 8
measure: Satisfaction with Treatment
timeFrame: At week 8
measure: Attitudes towards Psychological Online Interventions
timeFrame: At baseline and week 8
Other outcomes:
Locations:
city: Akron
country: United States
facility: Summa Health
state: Ohio
Study officials:
affiliation: SilverCloud Health
name: Derek Richards, PhD
role: STUDY_DIRECTOR
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