Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03271645 |
| Other study ID # |
iCBT@Work |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 11, 2018 |
| Est. completion date |
June 1, 2019 |
Study information
| Verified date |
September 2018 |
| Source |
Silver Cloud Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. Participants will consist of employees accessing
services provided by employee assistance programmes (EAP) provided at the European
headquarters of a large technology organisation.
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.
