Effectiveness and Acceptability of Internet-delivered Treatment for Depression, Anxiety and Stress

NCT02614443 | Completed DMC

• 1 other identifier: EAITDAS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to test the effectiveness and acceptability of internet-delivered treatment for depression, anxiety and stress in university students. These data will inform the methods for a future randomized controlled trial. The trial will establish an initial estimate of the effectiveness of these online interventions for students in terms of within-group effect sizes associated with changes in depression, anxiety and stress from pre to post-intervention and follow-up. These data will be used to estimate the sample size for a future trial to ensure that the study is sufficiently powered. A conservative estimate using the 90% upper confidence limit will be used to inform the sample size calculation of the definitive RCT. Acceptability of the intervention to participants will be assessed using data on usage and engagement with the intervention (e.g. percentage of participants completing each module, average number of log ins, average time spent per session and total time spent on the program). These data are acquired through the online SilverCloud system. Satisfaction with will be assessed through the use of a post-intervention questionnaire on satisfaction with accessing and using an online delivery format for treatment.

Conditions

Depression; Anxiety; Stress

Keywords

Depression; Anxiety; Stress; Online interventions; University students; CBT

Outcome Measures

Primary Outcomes (3)

• Change in Stress sub-scale of Depression Anxiety and Stress Scale-21 (DASS-21)

  Composed of 7-item sub-scale measuring symptoms of stress.

  Baseline, postintervention at 8 weeks and 3 month follow-up

• Change in Patient Health Questionnaire-9 (PHQ-9)

  A self-report measure of depression that has been widely used in screening, primary care, and research.

  Baseline, postintervention at 8 weeks and 3 month follow-up

• Change in Generalized Anxiety Disorder-7 (GAD-7)

  Comprises 7 items measuring symptoms and severity of GAD based on the DSM-IV diagnostic criteria for GAD.

  Baseline, postintervention at 8 weeks and 3 month follow-up

Other Outcomes (1)

• Change in The Satisfaction with Treatment (SAT) Questionnaire

  Postintervention at 8 weeks and 3 month follow-up

Study Arms (3)

Depression Condition

EXPERIMENTAL

Participants in this group will be offered the Space from Depression programme to be completed over an 8 week period. The programme is delivered through the online SilverCloud platform.

Other: Space from Depression

Anxiety Condition

EXPERIMENTAL

Participants in this group will be offered the Space from Anxiety programme to be completed over an 8 week period. The programme is delivered through the online SilverCloud platform.

Other: Space from Anxiety

Stress Condition

EXPERIMENTAL

Participants in this group will be offered the Space from Stress programme to be completed over an 8 week period. The programme is delivered through the online SilverCloud platform.

Other: Space from Stress

Interventions

Space from Depression OTHER

Delivered through the online SilverCloud platform, the program for the treatment of depression employs several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social.

Depression Condition

Space from Anxiety OTHER

Delivered through the online SilverCloud platform, the program for the treatment of anxiety employs several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social.

Anxiety Condition

Space from Stress OTHER

Delivered through the online SilverCloud platform, the program for the treatment of stress employs several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social.

Stress Condition

Eligibility Criteria

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

You may qualify if:

• Participants must be at least 18 years of age. Participants must have self-reported mild to severe symptoms of depression (5-27+) according to PHQ-9, self-reported mild to severe symptoms of anxiety (5-21+) according to GAD-7, or self-reported mild to severe symptoms of stress (15-34+) according to the stress sub-scale of DASS-21.

You may not qualify if:

• Students who currently are in face-to-face therapy at UCCS or BHS will be excluded. Students who score in the "red zone" in terms of risk of self-harm on the screening questions routinely used at UCCS will not be referred to the study. Students who score greater than 0 on the PHQ-9 self-harm item during the initial screening phase will be automatically directed to be further evaluated and alerted that a counselor will try to reach them. Based on this further evaluation, they may be recommended to seek help from their health/counseling service and may/may not be eligible to participate in the study. They will be telephoned within 1 working day and contacted by email if they cannot be reached by phone.

Sponsors & Collaborators

• Silver Cloud Health: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Derek Richards, PhD

  SilverCloud Health

  STUDY DIRECTOR

• Patricia Frazier, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Stefan G. Hofmann, PhD

  Department of Psychological and Brain Sciences, Boston University

  PRINCIPAL INVESTIGATOR

• Deborah Beidel, PhD

  UCF RESTORES, Department of Psychology, University of Central Florida

  PRINCIPAL INVESTIGATOR

• Patrick A. Palmieri, PhD

  Center for the Treatment and Study of Traumatic Stress, Summa Health System, Akron, Ohio

  PRINCIPAL INVESTIGATOR

• Jacqueline Mooney, MA

  SilverCloud Health

  PRINCIPAL INVESTIGATOR

• Christopher Bonner, MSc

  SilverCloud Health

  PRINCIPAL INVESTIGATOR

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: November 19, 2015
• First Posted: November 25, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)