Type 2 DiabetesNCT01473017
Improving Mental Health in Diabetes: A Guided Self-Help Study
A study testing CBT-based Guided Self-Help in people with Type 2 Diabetes and Anxiety, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This study employs a Randomised Controlled Trial design to investigate whether a CBT-based guided self-help intervention can improve anxiety, depression, psychological well-being, quality of life, Diabetic self-care and adherence; as compared to controls. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Anxiety, Depression
- What is being tested?
- CBT-based Guided Self-Help
- 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 siteUnited Kingdom
- Study dates
- Nov 2011to Sep 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a diagnosis of Type 2 Diabetes with mild-moderate anxiety and/or depression (scoring 8 to 15 on the HADS scale) will be recruited, provided they do not meet any one of the exclusion criteria listed below. Patients will be able to provide written informed consent.
Who cannot join
- Individuals with a history of clinically diagnosed psychotic symptoms, schizophrenia or bipolar disorder.
- Participants with a known Learning Disability or severe visual impairment.
- Participants who cannot read or write
- Participants under 18 years of age or over age 75
- Long-term hospital inpatients
- Individuals with a diagnosis of Diabetes secondary to a major physical condition (consultation will be sought from medical professionals where appropriate on an individual basis)
Trial locations and contacts
1 site in 1 country.
About this study
This study employs a Randomised Controlled Trial design to investigate whether a CBT-based guided self-help intervention can improve anxiety, depression, psychological well-being, quality of life, Diabetic self-care and adherence; as compared to controls. The study aims to recruit 42 individuals with Diabetes and mild to moderate anxiety or depression. Anxiety and depression are common in patients with Type 2 Diabetes, and has been shown to affect Diabetes control. Literature suggests that CBT can benefit individuals with Diabetes and comorbid mental ill-health, however little research has been done to date on the effect of guided self-help in this population. It is expected that this intervention will improve patient's mental health, as well as extend the limited knowledge-base on guided self-help in chronic illness.
- Conditions
- Type 2 Diabetes, Anxiety, Depression
- Being tested
- CBT-based Guided Self-Help
- Medical subject headings
- Diabetes Mellitus, Type 2, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-based Guided Self-HelpBehavioural
CBT-based booklet tailored to anxiety and/or depression in Type 2 Diabetes to enhance mood and Diabetes self-care
| Study group | Role | What they receive |
|---|---|---|
| CBT-based guided self-help | Experimental | Providing a guided self-help booklet to patients with anxiety/depression meeting criteria, with two telephone calls by a clinician to provide support with this. Receives: Behavioral: CBT-based Guided Self-Help |
| No CBT intervention | No intervention | Control group in comparison to CBT guided self-help group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and/or depression in Type 2 Diabetes
To see whether a CBT based guided self-help book improves anxiety and/or depression in participants with Type 2 Diabetes
Measured: 18 weeks
Secondary outcomes (1)
Quality of life
To see whether the intervention enhances quality of life, psychological well-being and self-reported diabetes management.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473017
- Sponsor's protocol ID
- 11/NHS/0055
- Status last verified
- Nov 2011
- First submitted
- 14 Nov 2011
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health in Diabetes: A Guided Self-Help Study
- ClinicalTrials.gov ID
- NCT01473017
- Acronym / sponsor ID
- 11/NHS/0055
- Conditions
- Type 2 Diabetes, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 17 Nov 2011 (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.
This study employs a Randomised Controlled Trial design to investigate whether a CBT-based guided self-help intervention can improve anxiety, depression, psychological well-being, quality of life, Diabetic self-care and adherence; as compared to controls. The study aims to recruit 42 individuals with Diabetes and mild to moderate anxiety or depression. Anxiety and depression are common in patients with Type 2 Diabetes, and has been shown to affect Diabetes control. Literature suggests that CBT can benefit individuals with Diabetes and comorbid mental ill-health, however little research has been done to date on the effect of guided self-help in this population. It is expected that this intervention will improve patient's mental health, as well as extend the limited knowledge-base on guided self-help in chronic illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-based guided self-help | Experimental | Behavioral: CBT-based Guided Self-HelpProviding a guided self-help booklet to patients with anxiety/depression meeting criteria, with two telephone calls by a clinician to provide support with this. |
| No CBT intervention | No intervention | –Control group in comparison to CBT guided self-help group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with a diagnosis of Type 2 Diabetes with mild-moderate anxiety and/or depression (scoring 8 to 15 on the HADS scale) will be recruited, provided they do not meet any one of the exclusion criteria listed below. Patients will be able to provide written informed consent.
Key exclusion criteria (6 listed)
- Individuals with a history of clinically diagnosed psychotic symptoms, schizophrenia or bipolar disorder.
- Participants with a known Learning Disability or severe visual impairment.
- Participants who cannot read or write
- Participants under 18 years of age or over age 75
- Long-term hospital inpatients
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 |
|---|---|---|
| CBT-based Guided Self-HelpCBT-based booklet tailored to anxiety and/or depression in Type 2 Diabetes to enhance mood and Diabetes self-care | Behavioural | CBT-based guided self-help |
Primary outcome
Anxiety and/or depression in Type 2 Diabetes
Time frame: 18 weeks
To see whether a CBT based guided self-help book improves anxiety and/or depression in participants with Type 2 Diabetes
1 secondary outcome
Quality of life
Time frame: 18 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 16 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-based Guided Self-Help in people with Type 2 Diabetes and Anxiety, run by University of Edinburgh 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 1 inclusion and 6 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 16 May 2024. 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.
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?
Anxiety and/or depression in Type 2 Diabetes (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.