Internet-delivered Treatments for Depression and Anxiety in Primary Care (SUMMA)

NCT03068676 | Terminated

• 1 other identifier: SUMMA-PC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. \[Note: Recruitment is ONLY open to patients at Ohio Family Practice Center\]

Conditions

Depressive Disorder; Anxiety Disorders; Depression

Keywords

Depression; Anxiety; Internet-delivered; CBT; Primary Care

Outcome Measures

Primary Outcomes (2)

• Patient health Questionnaire

  The PHQ-9 is a self-report measure of depression that has been widely used in screening, primary care, and research. The PHQ-9 items reflect the diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) (American Psychiatric Association \[APA\], 2000). Summed scores range from 0-27; larger scores reflect a greater severity of depressive symptoms. The PHQ-9 discriminated well between depressed and nondepressed individuals using the clinical cut-off of total score ≥10, with good sensitivity (88.0%) and specificity (88.0%) (Kroenke et al., 2001; R. Spitzer et al., 1999).

  At week 8

• Generalized Anxiety Disorder

  The GAD-7 (Spitzer, Krownke, Williams, \& Lowe, 2006) comprises 7 items measuring symptoms and severity of GAD based on the DSM-IV diagnostic criteria for GAD. The GAD-7 has good internal consistency (.89) and good convergent validity with other anxiety scales. Higher scores indicate greater severity of symptoms. The GAD-7 is increasingly used in large-scale studies as a generic measure of changes in anxiety symptomatology, using a cut-off score of 8 (Richards \& Suckling, 2009).

  At week 8

Secondary Outcomes (4)

• Socio-demographic Questionnaire

  At baseline for screening

• Work and Social Adjustment

  At baseline and week 8

• Satisfaction with Treatment

  At week 8

• Attitudes towards Psychological Online Interventions

  At baseline and week 8

Study Arms (2)

Space from depression

EXPERIMENTAL

Space from Depression is an eight-module online CBT-based intervention for depression, composed of cognitive and behavioral components including self-monitoring and thought recording, behavioral activation, cognitive restructuring, and challenging core beliefs. Each module follows a structured format that incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other users are incorporated into the presentation of the material.

Behavioral: Space from Depression

Space from Anxiety

EXPERIMENTAL

Space from Anxiety is an eight-module online CBT-based intervention for depression, composed of cognitive and behavioral components including self-monitoring and thought recording, behavioral activation, cognitive restructuring, and challenging core beliefs. Each module follows a structured format that incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other users are incorporated into the presentation of the material.

Behavioral: Space from Anxiety

Interventions

Space from Depression BEHAVIORAL

internet-delivered CBT

Space from depression

Space from Anxiety BEHAVIORAL

internet-delivered CBT

Space from Anxiety

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silver Cloud Health: lead
• Summa Health System: collaborator

Study Sites (1)

Summa Health

Akron, Ohio, 44310, United States

Location

Related Publications (30)

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MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Derek Richards, PhD

  SilverCloud Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 3, 2017
• Study Start: February 8, 2017
• Primary Completion: February 8, 2018
• Study Completion: February 9, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)