DepressioniCBT@WorkNCT03271645
Internet-delivered Interventions for Stress, Anxiety and Depression in the Workplace
A study testing Space from Depression, Space from Anxiety and Space from Stress in people with Depression and Anxiety, run by Silver Cloud Health at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- Space from Depression, Space from Anxiety and Space from Stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIreland
- Study dates
- 11 Sep 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants will be 18+ years of age.
Who cannot join
- Suicidal intent/ideation: score >1 on PHQ-9 question 9.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Participants will be recruited for the online intervention through either self-referral or a referral from one of the counsellors or GPs at the onsite well-being service centre. Participants in the face-to-face group will be recruited by referral from a member of the EAP; those on the waiting list for face-to-face services provided by the EAP will be approached to participate in the research. At baseline, participants in both the online and the face-to-face groups will complete sociodemographic information, the PHQ-4, PSS-4, the HPQ-SF, as well as an assessment of risk using question 9 from the PHQ-9. Eligible participants in the online intervention group will be offered one of three internet-delivered CBT interventions (Space from Stress, Space from Anxiety, Space from Depression). Participants attending the onsite EAP counselling service will receive 8 sessions of counselling.
Risk Assessment
Participants will be screened at baseline for risk. This assessment will be conducted through the response to question 9 on the PHQ-9, in which respondents are requested to indicate how often they have been bothered by "thoughts that you would be better off dead or of harming yourself in some way" rated on a 4-point Likert scale, with 0 indicated "not at all", 1 = "several days", 2 = "more than half the days", 3 = "nearly every day". Any participant who scores > 1 will be automatically prompted to answer additional questions to qualify the level of risk indicated. These questions include "Do you have any current plans to end your life?", "Have you made any actual preparations towards ending your life?" answered in a simple "yes/no" format and "how likely is it that you will act on these thoughts or plans to end your life" rated on a 0=10 scale with 0 indicating "I would never do this" and 10 indicating "I am definitely going to do this". Participants are also asked an open-ended question about their protective factors "what is stopping you from acting on these thoughts?". If any risk to self or others is highlighted, the participant will be immediately provided with crisis contact numbers (GP Out of Hours, Samaritans, Aware, Pieta House, Women's Aid, Amen) through the platform, and encouraged to contact these services directly if they feel in crisis. In addition, participants who indicate risk at baseline will be recommended that they contact the onsite GP or one of the counsellors at the onsite wellness centre. Those who exceed the cut-off score for risk ( >1 PHQ-9 Question 9) on the screening questions will not be eligible to participate in the study and will be able to access support from the onsite GP and /or the counselling team at the onsite wellness centre.
During the course of the trial, all supporters who are trained mental health practitioners will remain alert for indications of risk and will escalate concerns within the established supervision governance structure in an appropriate time frame.
During treatment, participants in both the online interventions and the face-to-face intervention will complete the PHQ-4 and PSS-4. At the end of the treatment, participants will be asked to complete the PHQ-4, PSS-4, SAT, and the HPQ-SF. These measures will also be completed at 4-months follow-up. A mixed-method approach will be used to include quantitative and qualitative analysis of symptom severity, work performance, and user satisfaction.
Each of the online interventions (Space from Depression, Space from Anxiety, Space from Stress) consists of 8 modules of internet-delivered CBT, delivered over an 8-week period. Participants will be assigned a supporter who will provide weekly post-session feedback on progress and exercises.
Support for this trial will be provided by Nuffield Health clinical support services. Nuffield Clinical Support Services is an established clinical service that provides support through Nuffield Health's Employee Assistance Programmes. The service is composed of British Association of Behavioural and Cognitive Psychotherapists (BABCP) accredited cognitive behavioural psychotherapists. They also have a small group of psychological well-being practitioners who are also British Association of Behavioural and Cognitive Psychotherapists (BABCP) accredited or currently in supervised training for accreditation. Each supporter will provide post-session feedback of between 10 and 15 minutes per participant per session.
Schedule of Assessment:
Participants will complete the primary and secondary outcome measures at baseline. Thereafter, they will complete the PHQ-4 and PSS-4 at each counselling or online review session. Once participants have completed treatment, they will be contacted to complete both the primary and secondary outcome measures. Satisfaction with treatment will be measured post-treatment at 4-month follow-up, where participants will complete the PHQ-4, PSS-4 and HPQ-SF.
Data analysis:
The feasibility of Internet-delivered interventions for stress, anxiety and depression as part of the organization's EAP will be evaluated based on participant recruitment, enrollment and retention rates.
Effectiveness over time of Internet-delivered interventions for the treatment of stress, anxiety and depression will be determined independently using linear mixed models. Stress severity will be measured using PSS-4 scores, depression and anxiety severity using PHQ-4 scores. In addition, sociodemographic characteristics will be assessed at baseline and factors significantly associated with treatment groups incorporated in the analysis model if required.
The impact of an internet-delivered intervention on workplace absence and job performance will be determined through the collection of HPQ-SF measures pre-treatment, immediately post-treatment and at 4-month follow-up. HPQ-SF absenteeism and presenteeism scores will be analysed using repeated measures ANOVA to detect differences at each time point.
Employee satisfaction with an internet-delivered intervention will be assessed in the Satisfaction with Treatment Questionnaire. Quantitative and qualitative measures of satisfaction will be summarised using descriptive statistics.
Internet-delivered intervention group:
Registered employees of the company will be eligible to participate in this study and will be recruited through the services their EAP provide. Participants may also be referred to the internet-delivered intervention by their general practitioner or other mental health professionals within the EAP. Interested participants will be able to log on to the SilverCloud Platform, where they can read the participant information sheet. Participants in the face-to-face group will be given a hard copy of the participant information sheet. This will detail what is involved with the study, the procedure, and how to proceed. Should participants agree to take part in the research, they will be requested to indicate their informed consent digitally. Participants will then complete the baseline measures. Participants excluded at this stage based on their risk assessment scores will be directed to the appropriate services within the EAP, for example, to the GP or face-to-face counselling services.
Using computer algorithms to score screening instruments at baseline, participants will be automatically provided with feedback on their measures (e.g. your scores indicate you may be experiencing moderate symptoms of depression). This feedback consists of informing the participant of their overall score for each measure and highlight the individual as the expert in their own life. All participants in the Internet-delivered intervention group will make an informed decision on choosing one of the three programmes, based on the combination of scores from the depression, anxiety, and stress scales. Participants will then self-select one of the three programmes: Space from Depression, Space from Anxiety, Space from Stress.
Each participant in the Internet-delivered intervention group will be assigned a supporter who will monitor participant's progress throughout the trial. Once a participant begins their chosen programme, they will receive a message from their supporter at their first log-in. This message welcomes them to the programme, highlights aspects of it and encourages them in the use of it. Weekly, supporters will log in and review participants progress, leaving feedback for them and responding to the work they have completed. Supporters will be BABCP accredited cognitive behavioural psychotherapists and psychological well-being practitioners who are also BABCP accredited or currently in supervised training for accreditation, provided by Nuffield Health EAP clinical support services. Each supporter will provide post-session feedback of between 10 and 15 minutes per participant per session.
Face to face counselling/psychotherapy group:
Once the trial starts, those beginning face-to-face services will be approached to participate in the research by a member of the EAP. Those who wish to participate will then sign a paper/ digital on iPad consent form and will complete measures at baseline and post-treatment, as per the schedule of assessment. Risk will be monitored by the clinician responsible for the participant.
The study is an open feasibility trial that uses standard instruments to assess symptoms of anxiety, depression and stress and adjustment psychopathology. It does this using reliable and valid instruments, including:
Patient Health Questionnaire (PHQ-4) a self-report measure of depression and anxiety that has been widely used in screening, primary care, and research. The PHQ-4 items reflect the diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR).
Perceived Stress Scale (PSS-4): a self-report measure of non-specific perceived stress. Based on Lazarus's transactional model of stress respondents rate how unpredictable, uncontrollable, and overloaded they appraise their life to be. Items are answered on a 5-point Likert scale (0= never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often) referring to the past month.
Health and Work Performance Questionnaire - Short Form: a brief self-report measure designed to estimate the workplace costs of health difficulties in two domains: absenteeism and reduced job performance. Validation studies have demonstrated significant correlations between self-reported HPQ scores and archival pay roll and performance assessments. The HPQ has been demonstrated to be valid, reliable and sensitive to change and recommended for use in Internet-delivered environments.
Satisfaction with Treatment (SAT) Questionnaire: includes nine quantitative items rated on a scale from 0 to 4 (e.g., How did this online treatment compare to previous treatments? 0 = 'Much better' to 4 = 'Not at all good'). The Satisfaction with Treatment questionnaire also contains two qualitative questions asking participants to describe what they liked most and least about the Internet-delivered intervention.
- Conditions
- Depression, Anxiety, Stress
- Being tested
- Space from Depression, Space from Anxiety, Space from Stress, Face-to-face counselling
- Keywords
- Depression, Anxiety, Stress, Internet-delivered interventions
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Space from DepressionBehavioural
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 AnxietyBehavioural
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 StressBehavioural
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.
Face-to-face counsellingBehavioural
Face-to-face counselling
| Study group | Role | What they receive |
|---|---|---|
| Space from depression | Experimental | Space from depression is an 8 module CBT-based intervention. Receives: Behavioral: Space from Depression |
| Space from Anxiety | Experimental | Space from anxiety CBT is an 8 module CBT-based intervention. Receives: Behavioral: Space from Anxiety |
| Space from stress | Experimental | Space from stress CBT is an 8 module CBT-based intervention. Receives: Behavioral: Space from Stress |
| Face-to-face counselling | Active comparator | Face-to-face counselling Receives: Behavioral: Face-to-face counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-4
Patient health Questionnaire
Measured: Up to 4-months
PSS-4
Perceived Stress Scale-4 (PSS-4)
Measured: Up to 4-months
Secondary outcomes (2)
Health and Work Performance Questionnaire (HPQ-SF)
Health and Work Performance Questionnaire
Measured: Up to 4-months
Satisfaction with Treatment Questionnaire (SAT)
Satisfaction with Treatment Questionnaire (SAT)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start11 Sep 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Why it stopped: logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silver Cloud Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derek Richards, PhD, Principal investigator, SilverCloud Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271645
- Sponsor's protocol ID
- iCBT@Work
- Acronym
- iCBT@Work
- Status last verified
- Sep 2018
- First submitted
- 24 Aug 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11556941American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-IV-TR). 4th ed. Washington D.C.: American Psychiatric Association.; 2000.
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.
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.
PubMed 6668417Kessler 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.
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.
PubMed 12625231Kessler 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.
PubMed 15194893Richards 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Interventions for Stress, Anxiety and Depression in the Workplace
- ClinicalTrials.gov ID
- NCT03271645
- Acronym / sponsor ID
- iCBT@Work / iCBT@Work
- Conditions
- Depression, Anxiety, Stress
- Keywords
- Depression, Anxiety, Stress, Internet-delivered interventions
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: logistics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Silver Cloud HealthUniversity, hospital or other
- Study start
- 11 Sep 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be recruited for the online intervention through either self-referral or a referral from one of the counsellors or GPs at the onsite well-being service centre. Participants in the face-to-face group will be recruited by referral from a member of the EAP; those on the waiting list for face-to-face services provided by the EAP will be approached to participate in the research. At baseline, participants in both the online and the face-to-face groups will complete sociodemographic information, the PHQ-4, PSS-4, the HPQ-SF, as well as an assessment of risk using question 9 from the PHQ-9. Eligible participants in the online intervention group will be offered one of three internet-delivered CBT interventions (Space from Stress, Space from Anxiety, Space from Depression). Participants attending the onsite EAP counselling service will receive 8 sessions of counselling.
Risk Assessment
Participants will be screened at baseline for risk. This assessment will be conducted through the response to question 9 on the PHQ-9, in which respondents are requested to indicate how often they have been bothered by "thoughts that you would be better off dead or of harming yourself in some way" rated on a 4-point Likert scale, with 0 indicated "not at all", 1 = "several days", 2 = "more than half the days", 3 = "nearly every day". Any participant who scores > 1 will be automatically prompted to answer additional questions to qualify the level of risk indicated. These questions include "Do you have any current plans to end your life?", "Have you made any actual preparations towards ending your life?" answered in a simple "yes/no" format and "how likely is it that you will act on these thoughts or plans to end your life" rated on a 0=10 scale with 0 indicating "I would never do this" and 10 indicating "I am definitely going to do this". Participants are also asked an open-ended question about their protective factors "what is stopping you from acting on these thoughts?". If any risk to self or others is highlighted, the participant will be immediately provided with crisis contact numbers (GP Out of Hours, Samaritans, Aware, Pieta House, Women's Aid, Amen) through the platform, and encouraged to contact these services directly if they feel in crisis. In addition, participants who indicate risk at baseline will be recommended that they contact the onsite GP or one of the counsellors at the onsite wellness centre. Those who exceed the cut-off score for risk ( >1 PHQ-9 Question 9) on the screening questions will not be eligible to participate in the study and will be able to access support from the onsite GP and /or the counselling team at the onsite wellness centre.
During the course of the trial, all supporters who are trained mental health practitioners will remain alert for indications of risk and will escalate concerns within the established supervision governance structure in an appropriate time frame.
During treatment, participants in both the online interventions and the face-to-face intervention will complete the PHQ-4 and PSS-4. At the end of the treatment, participants will be asked to complete the PHQ-4, PSS-4, SAT, and the HPQ-SF. These measures will also be completed at 4-months follow-up. A mixed-method approach will be used to include quantitative and qualitative analysis of symptom severity, work performance, and user satisfaction.
Each of the online interventions (Space from Depression, Space from Anxiety, Space from Stress) consists of 8 modules of internet-delivered CBT, delivered over an 8-week period. Participants will be assigned a supporter who will provide weekly post-session feedback on progress and exercises.
Support for this trial will be provided by Nuffield Health clinical support services. Nuffield Clinical Support Services is an established clinical service that provides support through Nuffield Health's Employee Assistance Programmes. The service is composed of British Association of Behavioural and Cognitive Psychotherapists (BABCP) accredited cognitive behavioural psychotherapists. They also have a small group of psychological well-being practitioners who are also British Association of Behavioural and Cognitive Psychotherapists (BABCP) accredited or currently in supervised training for accreditation. Each supporter will provide post-session feedback of between 10 and 15 minutes per participant per session.
Schedule of Assessment:
Participants will complete the primary and secondary outcome measures at baseline. Thereafter, they will complete the PHQ-4 and PSS-4 at each counselling or online review session. Once participants have completed treatment, they will be contacted to complete both the primary and secondary outcome measures. Satisfaction with treatment will be measured post-treatment at 4-month follow-up, where participants will complete the PHQ-4, PSS-4 and HPQ-SF.
Data analysis:
The feasibility of Internet-delivered interventions for stress, anxiety and depression as part of the organization's EAP will be evaluated based on participant recruitment, enrollment and retention rates.
Effectiveness over time of Internet-delivered interventions for the treatment of stress, anxiety and depression will be determined independently using linear mixed models. Stress severity will be measured using PSS-4 scores, depression and anxiety severity using PHQ-4 scores. In addition, sociodemographic characteristics will be assessed at baseline and factors significantly associated with treatment groups incorporated in the analysis model if required.
The impact of an internet-delivered intervention on workplace absence and job performance will be determined through the collection of HPQ-SF measures pre-treatment, immediately post-treatment and at 4-month follow-up. HPQ-SF absenteeism and presenteeism scores will be analysed using repeated measures ANOVA to detect differences at each time point.
Employee satisfaction with an internet-delivered intervention will be assessed in the Satisfaction with Treatment Questionnaire. Quantitative and qualitative measures of satisfaction will be summarised using descriptive statistics.
Internet-delivered intervention group:
Registered employees of the company will be eligible to participate in this study and will be recruited through the services their EAP provide. Participants may also be referred to the internet-delivered intervention by their general practitioner or other mental health professionals within the EAP. Interested participants will be able to log on to the SilverCloud Platform, where they can read the participant information sheet. Participants in the face-to-face group will be given a hard copy of the participant information sheet. This will detail what is involved with the study, the procedure, and how to proceed. Should participants agree to take part in the research, they will be requested to indicate their informed consent digitally. Participants will then complete the baseline measures. Participants excluded at this stage based on their risk assessment scores will be directed to the appropriate services within the EAP, for example, to the GP or face-to-face counselling services.
Using computer algorithms to score screening instruments at baseline, participants will be automatically provided with feedback on their measures (e.g. your scores indicate you may be experiencing moderate symptoms of depression). This feedback consists of informing the participant of their overall score for each measure and highlight the individual as the expert in their own life. All participants in the Internet-delivered intervention group will make an informed decision on choosing one of the three programmes, based on the combination of scores from the depression, anxiety, and stress scales. Participants will then self-select one of the three programmes: Space from Depression, Space from Anxiety, Space from Stress.
Each participant in the Internet-delivered intervention group will be assigned a supporter who will monitor participant's progress throughout the trial. Once a participant begins their chosen programme, they will receive a message from their supporter at their first log-in. This message welcomes them to the programme, highlights aspects of it and encourages them in the use of it. Weekly, supporters will log in and review participants progress, leaving feedback for them and responding to the work they have completed. Supporters will be BABCP accredited cognitive behavioural psychotherapists and psychological well-being practitioners who are also BABCP accredited or currently in supervised training for accreditation, provided by Nuffield Health EAP clinical support services. Each supporter will provide post-session feedback of between 10 and 15 minutes per participant per session.
Face to face counselling/psychotherapy group:
Once the trial starts, those beginning face-to-face services will be approached to participate in the research by a member of the EAP. Those who wish to participate will then sign a paper/ digital on iPad consent form and will complete measures at baseline and post-treatment, as per the schedule of assessment. Risk will be monitored by the clinician responsible for the participant.
The study is an open feasibility trial that uses standard instruments to assess symptoms of anxiety, depression and stress and adjustment psychopathology. It does this using reliable and valid instruments, including:
Patient Health Questionnaire (PHQ-4) a self-report measure of depression and anxiety that has been widely used in screening, primary care, and research. The PHQ-4 items reflect the diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR).
Perceived Stress Scale (PSS-4): a self-report measure of non-specific perceived stress. Based on Lazarus's transactional model of stress respondents rate how unpredictable, uncontrollable, and overloaded they appraise their life to be. Items are answered on a 5-point Likert scale (0= never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often) referring to the past month.
Health and Work Performance Questionnaire - Short Form: a brief self-report measure designed to estimate the workplace costs of health difficulties in two domains: absenteeism and reduced job performance. Validation studies have demonstrated significant correlations between self-reported HPQ scores and archival pay roll and performance assessments. The HPQ has been demonstrated to be valid, reliable and sensitive to change and recommended for use in Internet-delivered environments.
Satisfaction with Treatment (SAT) Questionnaire: includes nine quantitative items rated on a scale from 0 to 4 (e.g., How did this online treatment compare to previous treatments? 0 = 'Much better' to 4 = 'Not at all good'). The Satisfaction with Treatment questionnaire also contains two qualitative questions asking participants to describe what they liked most and least about the Internet-delivered intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Space from depression | Experimental | Behavioral: Space from DepressionSpace from depression is an 8 module CBT-based intervention. |
| Space from Anxiety | Experimental | Behavioral: Space from AnxietySpace from anxiety CBT is an 8 module CBT-based intervention. |
| Space from stress | Experimental | Behavioral: Space from StressSpace from stress CBT is an 8 module CBT-based intervention. |
| Face-to-face counselling | Active comparator | Behavioral: Face-to-face counsellingFace-to-face counselling |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants will be 18+ years of age.
Key exclusion criteria (1 listed)
- Suicidal intent/ideation: score >1 on PHQ-9 question 9.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Space from DepressionThe 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. | Behavioural | Space from depression |
| Space from AnxietyThe 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. | Behavioural | Space from Anxiety |
| Space from StressThe 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. | Behavioural | Space from stress |
| Face-to-face counsellingFace-to-face counselling | Behavioural | Face-to-face counselling |
Primary outcome
PHQ-4
Time frame: Up to 4-months
Patient health Questionnaire
PSS-4
Time frame: Up to 4-months
Perceived Stress Scale-4 (PSS-4)
2 secondary outcomes
Health and Work Performance Questionnaire (HPQ-SF)
Time frame: Up to 4-months
Satisfaction with Treatment Questionnaire (SAT)
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Background: PubMed 11556941Kroenke 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.
- BackgroundAmerican Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-IV-TR). 4th ed. Washington D.C.: American Psychiatric Association.; 2000.
- BackgroundCohen 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: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundKessler 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: PubMed 12625231Kessler 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.
- Background: PubMed 15194893Kessler 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.
- BackgroundRichards 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
- SilverCloud websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Richards, PhD principal investigator
SilverCloud Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Space from Depression, Space from Anxiety and Space from Stress in people with Depression and Anxiety, run by Silver Cloud Health at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PHQ-4 (time frame: Up to 4-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03271645, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.