DepressionPhase 1/2NCT01149265
Online Support Groups for Depression and Anxiety
A Phase 1/2 study testing Online support group and Expressive writing in people with Depression and Anxiety, run by University College, London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the effectiveness of online support groups for anxiety and depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Online support group and Expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to Feb 2011
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-defined depression \& anxiety
- Resident in the UK, US or Canada
- Access to the internet
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial of an Existing Online Support Group for Depression and Anxiety
The purpose of this study is to determine the effectiveness of online support groups for anxiety and depression.
Read the detailed description
In recent years the number of online support groups for conditions like depression and anxiety has grown rapidly. Millions of people are thought to be using them around the world. This research aims to help find out whether the use of online support groups is beneficial and to learn more about what happens in these groups.
This research will compare online support groups with expressive writing. Expressive writing involves people writing about their thoughts and feelings, often upsetting ones, for a short period of time. In online support groups giving and receiving support from others can be helpful while expressive writing about emotional issues can be cathartic.
1,000 participants will be recruited online from the UK, USA and Canada and randomly assigned to either an existing online support group or to an expressive writing condition.
- Conditions
- Depression, Anxiety
- Being tested
- Online support group, Expressive writing
- 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.
Online support groupBehavioural
Expressive writing involves people writing about their thoughts and feelings, often upsetting ones, for a short period of time.
Expressive writingBehavioural
Online support groups are internet forums where like-minded people give and receive both informational and emotional support.
| Study group | Role | What they receive |
|---|---|---|
| Online support group | Experimental | Not described Receives: Behavioral: Online support group |
| Expressive writing | Active comparator | Not described Receives: Behavioral: Expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Center for Epidemiological Studies Depression Scale
Measured: Zero, three and six months
Secondary outcomes (4)
Satisfaction with Life Scale
Measured: Zero, three and six months
The Medical Outcomes Study Social Support Survey
Measured: Zero, three and six months
Generalised Anxiety Disorder Assessment
Measured: Zero, three and six months
The Illness perception questionnaire
Measured: Zero, three and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Investigators
- Chris Barker, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149265
- Sponsor's protocol ID
- UCL1376/001
- Status last verified
- Jul 2010
- First submitted
- 22 Jun 2010
- Last updated
- 21 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Dean J, Potts HW, Barker C. Direction to an Internet Support Group Compared With Online Expressive Writing for People With Depression And Anxiety: A Randomized Trial. JMIR Ment Health. 2016 May 17;3(2):e12. doi: 10.2196/mental.5133.
PubMed 27189142
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of an Existing Online Support Group for Depression and Anxiety
- ClinicalTrials.gov ID
- NCT01149265
- Acronym / sponsor ID
- UCL1376/001
- Conditions
- Depression, Anxiety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 23 Jun 2010 (estimated)
- 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 purpose of this study is to determine the effectiveness of online support groups for anxiety and depression.
Detailed description
In recent years the number of online support groups for conditions like depression and anxiety has grown rapidly. Millions of people are thought to be using them around the world. This research aims to help find out whether the use of online support groups is beneficial and to learn more about what happens in these groups.
This research will compare online support groups with expressive writing. Expressive writing involves people writing about their thoughts and feelings, often upsetting ones, for a short period of time. In online support groups giving and receiving support from others can be helpful while expressive writing about emotional issues can be cathartic.
1,000 participants will be recruited online from the UK, USA and Canada and randomly assigned to either an existing online support group or to an expressive writing condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online support group | Experimental | Behavioral: Online support group |
| Expressive writing | Active comparator | Behavioral: Expressive writing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-defined depression \& anxiety
- Resident in the UK, US or Canada
- Access to the internet
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Online support groupExpressive writing involves people writing about their thoughts and feelings, often upsetting ones, for a short period of time. | Behavioural | Online support group |
| Expressive writingOnline support groups are internet forums where like-minded people give and receive both informational and emotional support. | Behavioural | Expressive writing |
Primary outcome
The Center for Epidemiological Studies Depression Scale
Time frame: Zero, three and six months
4 secondary outcomes
Satisfaction with Life Scale
Time frame: Zero, three and six months
The Medical Outcomes Study Social Support Survey
Time frame: Zero, three and six months
Generalised Anxiety Disorder Assessment
Time frame: Zero, three and six months
The Illness perception questionnaire
Time frame: Zero, three and six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2010.
- Derived from this study: PubMed 27189142Dean J, Potts HW, Barker C. Direction to an Internet Support Group Compared With Online Expressive Writing for People With Depression And Anxiety: A Randomized Trial. JMIR Ment Health. 2016 May 17;3(2):e12. doi: 10.2196/mental.5133.
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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.
Chris Barker principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Online support group and Expressive writing in people with Depression and Anxiety, run by University College, London at 1 site in United Kingdom.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Jul 2010. 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 United Kingdom. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The Center for Epidemiological Studies Depression Scale (time frame: Zero, three and six months). 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 NCT01149265, which also lists 1 linked publication.
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 21 Jul 2010.