NCT03271645

Brief Summary

The research will utilise an open feasibility parallel groups trial to examine the impact of novel internet-delivered cognitive behavioural therapy (CBT) interventions for stress, anxiety, and depression compared to treatment as usual (face to face counselling and psychotherapy) in an employment context. Participants will consist of employees accessing services provided by employee assistance programmes (EAP) provided at the European headquarters of a large technology organisation.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

September 11, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

August 24, 2017

Last Update Submit

September 7, 2018

Conditions

DepressionAnxietyStress

Keywords

DepressionAnxietyStressInternet-delivered interventions

Outcome Measures

Primary Outcomes (2)

  • PHQ-4

    Patient health Questionnaire

    Up to 4-months

  • PSS-4

    Perceived Stress Scale-4 (PSS-4)

    Up to 4-months

Secondary Outcomes (2)

  • Health and Work Performance Questionnaire (HPQ-SF)

    Up to 4-months

  • Satisfaction with Treatment Questionnaire (SAT)

    8 weeks

Study Arms (4)

Space from depression

EXPERIMENTAL

Space from depression is an 8 module CBT-based intervention.

Behavioral: Space from Depression

Space from Anxiety

EXPERIMENTAL

Space from anxiety CBT is an 8 module CBT-based intervention.

Behavioral: Space from Anxiety

Space from stress

EXPERIMENTAL

Space from stress CBT is an 8 module CBT-based intervention.

Behavioral: Space from Stress

Face-to-face counselling

ACTIVE COMPARATOR

Face-to-face counselling

Behavioral: Face-to-face counselling

Interventions

Space from DepressionBEHAVIORAL

The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014). The treatment comprises cognitive, emotional and behavioural components. The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.

Space from depression
Space from AnxietyBEHAVIORAL

The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014). The treatment comprises cognitive, emotional and behavioural components. The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.

Space from Anxiety
Space from StressBEHAVIORAL

The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014).The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.

Space from stress
Face-to-face counsellingBEHAVIORAL

Face-to-face counselling

Face-to-face counselling

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants will be 18+ years of age.

You may not qualify if:

  • Suicidal intent/ideation: score \>1 on PHQ-9 question 9.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multinational Technology Industry European HQ

Cork, Ireland

Location

Related Publications (8)

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND

  • American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-IV-TR). 4th ed. Washington D.C.: American Psychiatric Association.; 2000.

    BACKGROUND

  • Cohen S, Williamson G. Perceived stress in a probability sample of the United States. In: S. Spacapan, Oskamp S, editors. The social psychology of health. Newbury Park, CA: Sage; 1988.

    BACKGROUND

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

  • Kessler R, Petukhova M, McInnes K. World Health Organization Health and Work Performance Questionnaire (HPQ). HPQ Short Form (Absenteeism and Presenteeism Questions and Scoring Rules) Harvard Medical School. 2007.

    BACKGROUND

  • Kessler RC, Barber C, Beck A, Berglund P, Cleary PD, McKenas D, Pronk N, Simon G, Stang P, Ustun TB, Wang P. The World Health Organization Health and Work Performance Questionnaire (HPQ). J Occup Environ Med. 2003 Feb;45(2):156-74. doi: 10.1097/01.jom.0000052967.43131.51.

    PMID: 12625231BACKGROUND

  • Kessler RC, Ames M, Hymel PA, Loeppke R, McKenas DK, Richling DE, Stang PE, Ustun TB. Using the World Health Organization Health and Work Performance Questionnaire (HPQ) to evaluate the indirect workplace costs of illness. J Occup Environ Med. 2004 Jun;46(6 Suppl):S23-37. doi: 10.1097/01.jom.0000126683.75201.c5.

    PMID: 15194893BACKGROUND

  • Richards D, Timulak L. Satisfaction with therapist-delivered vs. self-administered online cognitive-behavioural treatments for depression symptoms in college students. British Journal of Guidance & Counselling. 2012;41(2):193-207

    BACKGROUND

Related Links

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Derek Richards, PhD

    SilverCloud Health

    PRINCIPAL INVESTIGATOR
0

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

August 24, 2017

First Posted

September 5, 2017

Study Start

September 11, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

IE(1)