DepressionNCT00854984
Pilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease
A study testing Living Life to the Full in people with Depression and Diabetes Mellitus Type 2, run by University of Edinburgh at 2 sites in United Kingdom.
Trial summary
A feasibility pilot trial of the self-help, "Cognitive behavioural therapy" based "Living Life to the Full" Materials for use by patients with diabetes type 2 and / or coronary heart disease. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Depression, Diabetes Mellitus Type 2, Coronary Heart Disease
- What is being tested?
- Living Life to the Full
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Mar 2009to 30 Sep 2009
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease.
- Be aged 35 or over.
- Be attending a participating primary care practice.
- Have a depression severity scale rating indicating moderate to moderately severe depression, such as:Prime-MD-PHQ9 of 10-21; HADS-D of 8-15;BDI-2 of 23-44
Who cannot join
- Unable to provide informed consent to participate
- Already receiving psychological treatment for their depression
- Have commenced treatment with an SSRI within the past 8 weeks
- Likely to have difficulty communicating by telephone
- Likely to have difficulty completing the forms and questionnaires
- Have a serious physical disorder
Show all 9Show fewer
- Have a serious mental disorder
- Express significant suicidal thoughts (PHQ9 or BDI-2 question 9 scoring >1)
- Took part in an earlier related focus group
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Faculty of Health and Social Care, Garthdee Campus, Robert Gordon University
Aberdeen, AB10 7QG
Community Health Sciences, GP Section, University of Edinburgh
Edinburgh, EH8 9DX
About this study
Official title: Pilot Study of a Practice Nurse Supported Psychological Self-help Intervention for Patients With Diabetes or Coronary Heart Disease and Co-morbid Depression
A feasibility pilot trial of the self-help, "Cognitive behavioural therapy" based "Living Life to the Full" Materials for use by patients with diabetes type 2 and / or coronary heart disease.
Read the detailed description
Depressed mood is common in patients with chronic disease and physical disability. It adversely affects quality of life, adherence to treatment and clinical outcome. Depression is expensive to the person, their family, employers and society. Recent developments in the UK General Practitioners' Contract mean that patients with two chronic diseases (Coronary Heart Disease- CHD and Diabetes - DM) are routinely screened for depression using a simple screening tool. We propose a study using an existing self help intervention in the specific context of patients with mild to moderately severe depression identified in this way.
This RCT is the second phase of a 2 phase mixed methods study examining the feasibility of a Full RCT. The first involved focus group with patients and health practitioners.
- Conditions
- Depression, Diabetes Mellitus Type 2, Coronary Heart Disease
- Being tested
- Living Life to the Full
- Keywords
- Depression, diabetes, Coronary heart disease, CBT, Cognitive behavioural therapy
- Medical subject headings
- Depression, Diabetes Mellitus, Type 2, Coronary Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living Life to the FullBehavioural
Also called Five Areas
A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats.
| Study group | Role | What they receive |
|---|---|---|
| Self-help CBT | Experimental | A nurse supported self-help CBT intervention in addition to usual care. Receives: Behavioral: Living Life to the Full |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients.
Measured: 13 weeks
Secondary outcomes (3)
The proportion of patients would prefer or require a non-computerised treatment alternative to treatment (i.e. a book or DVD based form of the treatment).
Measured: 13 weeks
The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses.
Measured: 13 weeks
A change in depression (BDI-2), anxiety , social function (WASAS), quality of life (Euroqol 5D) or illness perception (IPQ-R) from participation in a self help programme.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study start13 Mar 2009
- Primary completion30 Sep 2009
- Study completion30 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stirling, Robert Gordon University, University of Glasgow, Chief Scientist Office of the Scottish Government
- Investigators
- Margaret Maxwell, PhD, Principal investigator, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854984
- Sponsor's protocol ID
- CZH/4/462
- Other IDs
- MREC: 08/H0405/39
- Status last verified
- May 2024
- First submitted
- 2 Mar 2009
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Practice Nurse Supported Psychological Self-help Intervention for Patients With Diabetes or Coronary Heart Disease and Co-morbid Depression
- ClinicalTrials.gov ID
- NCT00854984
- Acronym / sponsor ID
- CZH/4/462
- Conditions
- Depression, Diabetes Mellitus Type 2, Coronary Heart Disease
- Keywords
- Depression, diabetes, Coronary heart disease, CBT, Cognitive behavioural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- University of Stirling, Robert Gordon University, University of Glasgow, Chief Scientist Office of the Scottish Government
- Study start
- 13 Mar 2009 (actual)
- Primary completion
- 30 Sep 2009 (actual)
- Study completion
- 30 Sep 2009 (actual)
- First posted
- 3 Mar 2009 (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.
A feasibility pilot trial of the self-help, "Cognitive behavioural therapy" based "Living Life to the Full" Materials for use by patients with diabetes type 2 and / or coronary heart disease.
Detailed description
Depressed mood is common in patients with chronic disease and physical disability. It adversely affects quality of life, adherence to treatment and clinical outcome. Depression is expensive to the person, their family, employers and society. Recent developments in the UK General Practitioners' Contract mean that patients with two chronic diseases (Coronary Heart Disease- CHD and Diabetes - DM) are routinely screened for depression using a simple screening tool. We propose a study using an existing self help intervention in the specific context of patients with mild to moderately severe depression identified in this way.
This RCT is the second phase of a 2 phase mixed methods study examining the feasibility of a Full RCT. The first involved focus group with patients and health practitioners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help CBT | Experimental | Behavioral: Living Life to the FullA nurse supported self-help CBT intervention in addition to usual care. |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease.
- Be aged 35 or over.
- Be attending a participating primary care practice.
- Have a depression severity scale rating indicating moderate to moderately severe depression, such as:Prime-MD-PHQ9 of 10-21; HADS-D of 8-15;BDI-2 of 23-44
Key exclusion criteria (9 listed)
- Unable to provide informed consent to participate
- Already receiving psychological treatment for their depression
- Have commenced treatment with an SSRI within the past 8 weeks
- Likely to have difficulty communicating by telephone
- Likely to have difficulty completing the forms and questionnaires
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 |
|---|---|---|
| Living Life to the FullAlso: Five AreasA nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats. | Behavioural | Self-help CBT |
Primary outcome
The obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients.
Time frame: 13 weeks
3 secondary outcomes
The proportion of patients would prefer or require a non-computerised treatment alternative to treatment (i.e. a book or DVD based form of the treatment).
Time frame: 13 weeks
The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses.
Time frame: 13 weeks
A change in depression (BDI-2), anxiety , social function (WASAS), quality of life (Euroqol 5D) or illness perception (IPQ-R) from participation in a self help programme.
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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.
Margaret Maxwell, PhD principal investigator
University of Stirling
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living Life to the Full in people with Depression and Diabetes Mellitus Type 2, run by University of Edinburgh at 2 sites 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 22 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 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients. (time frame: 13 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 22 May 2024.