DepressionNCT02505178
Examining the Feasibility and Effectiveness of Case Manager Delivered Problem Solving Therapy on Late Life Depression
A study testing Problem Solving Therapy in people with Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study seeks to determine the feasibility and efficacy of a Problem Solving Therapy intervention for the treatment of late life depression (LLD). Participants diagnosed with LLD will participate in six sessions of Problem Solving Therapy, a form of talk-therapy, over a period of eight weeks. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Depression
- What is being tested?
- Problem Solving Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Oct 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are of either gender and greater than 60 years of age.
- Reside in a community setting (either independent living environment or retirement home).
- Meet diagnostic criteria for major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria.
- Have a Hamilton Depression Rating Scale (HAMD) 17-item total score of >= 8 and < 24 at baseline.
- Have a Mini Mental Status Exam score of >= 20.
- Have adequate hearing and vision to be able to participate in Problem Solving Therapy.
Who cannot join
- Have suicidal ideation requiring inpatient admission to hospital for stabilization.
- Have an unstable medical condition requiring hospital admission.
- Have a life expectancy of less than 6 months or are currently receiving palliative care.
- Have psychotic symptoms.
- Have a lifetime history of bipolar disorder or schizophrenia.
- Are currently alcohol dependent or have another substance dependence.
- Are diagnosed with moderate to severe dementia.
- Are planning admission to a long-term care facility within next 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Feasibility and Effectiveness of Case Manager Delivered Problem Solving Therapy on Late Life Depression; an Open-label Prospective Pilot Study.
This study seeks to determine the feasibility and efficacy of a Problem Solving Therapy intervention for the treatment of late life depression (LLD). Participants diagnosed with LLD will participate in six sessions of Problem Solving Therapy, a form of talk-therapy, over a period of eight weeks. A Case Manager (CM) will lead the PST. The primary outcome measure is depression severity and will be measured throughout the study at weeks 0, 4, and 8. the secondary outcome measure is quality of life and will be measured at week 0 (pre-intervention) and week 12.
Read the detailed description
In the elderly (i.e. individuals 60 years of age or older) major depressive disorder (MDD) is common occurring in 2-3% of the population and known as late life depression (LLD). LLD is both disabling and associated with a high mortality rate. Response to treatment of LLD using at least one antidepressant trial of adequate dose and duration is around 30-40%. Due to these suboptimal response rates, additional interventions should be tested and implemented to further alleviate the symptoms and severity of LLD.
It is common for individuals referred to geriatric psychiatry programs to live alone and have impaired independent mobility, which makes them more susceptible to depression as they are at a higher risk for social isolation. Best practice guidelines recommend using psychosocial therapies, which are effective in reducing symptoms of LLD, as the standard treatment for mild to moderate depression, either alone or in combination with medications. PST can be delivered to patients close to their homes making it ideal for treating seniors with limited mobility. The elderly are more likely to suffer from co-morbid conditions and be treated with multiple medications. Antidepressants are associated with serious adverse events, making psychosocial treatments especially important to the elderly who take more medications and are more likely to suffer comorbid conditions.
Problem-solving therapy (PST) is an established psychosocial therapy shown to be effective in treating depression and other mental disorders in adults of all ages. PST involves seven stages of problem resolution including a)identifying and clarifying the problem b)setting clear achievable goals c) brain-storming to generate solutions d) selecting a preferred solution and f) evaluation. Studies of PST in older adults have shown the treatment to be effective in reducing depression. PST has been successfully adapted to meet the needs of seniors with comorbid conditions and those with early dementia or cognitive impairment.
Despite the importance of psychotherapy interventions for older adults with MDD there is limited access to these treatments for seniors. At present, nurse case managers and social work case managers (CM) do not receive formal training in problem solving therapy. Since they often provide treatment for geriatric mental health outpatients, this limits access to treatments like PST. However, if CM's have formal training in PST, this treatment option can be made available to seniors that could benefit from such programs. To the best of the investigators' knowledge no study has evaluated the effects of CM trained to deliver PST for individuals with LLD in Canada, as such, this is the aim of the current investigation.
- Conditions
- Depression
- Being tested
- Problem Solving Therapy
- Keywords
- Depression, Depressive Disorder, Depressive Disorder, Major, Mental Disorders, Mood Disorders, Behavioural Symptoms, Problem Solving Therapy
- Medical subject headings
- Depression, Depressive Disorder, Depressive Disorder, Major, Mental Disorders, Mood Disorders, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyOther
PST is a minimally invasive treatment. The five sessions of CM implemented PST will involve psychotherapy also known as talk therapy between the CM's and study participants in a group setting. Psychogeriatric interdisciplinary staff (CM's) i.e. psychiatric nurses, social workers who have been previously trained in PST will function in the roles of facilitator, cofacilitator and scribe. The roles can be shared amongst the professionals to build capacity in each role or maintained over time if so desired. Sessions will be approximately one-and-a-half to two hours in length and conducted at the Cherry Hill Mall library in London.
| Study group | Role | What they receive |
|---|---|---|
| Problem Solving Therapy | Experimental | Study participation will involve 9 study visits over a total of 12 weeks. This includes 5 sessions of Case Manager implemented PST over a period of 8 weeks (week 1, 3, 5, 7, and 9) and 4 assessment visits (baseline, week 4, week 8, and week 12). Receives: Other: Problem Solving Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression symptoms
Depression in study participants will be self rated on the Patient Health Questionnaire (PHQ-9)
Measured: Baseline, week 4, and week 8
Secondary outcomes (3)
Change in Quality of Life
Participants will complete a Short Form-12 to assess the change in their quality of life.
Measured: Baseline and week 12
Change in Depression Symptoms- Clinician Rated
Hamilton scale for Depression-17 item (HAM-D 17), as rated by a clinician trained to complete this scale
Measured: Baseline, Week 4 and Week 8
Change in Depression Symptoms- Overall improvement
Clinical Global Impression- CGI, as rated by a clinician trained to complete this scale
Measured: Baseline, Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2018 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: Substantial changes were made to the study protocol and a new ethics application will be submitted.
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.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, Queen's University
- Responsible party
- Principal investigator, Akshya Vasudev, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505178
- Sponsor's protocol ID
- 106856
- Status last verified
- Mar 2018
- First submitted
- 19 Jul 2015
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Feasibility and Effectiveness of Case Manager Delivered Problem Solving Therapy on Late Life Depression; an Open-label Prospective Pilot Study.
- ClinicalTrials.gov ID
- NCT02505178
- Acronym / sponsor ID
- 106856
- Conditions
- Depression
- Keywords
- Depression, Depressive Disorder, Depressive Disorder, Major, Mental Disorders, Mood Disorders, Behavioural Symptoms, Problem Solving Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Substantial changes were made to the study protocol and a new ethics application will be submitted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, Queen's University
- Study start
- Aug 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 22 Jul 2015 (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 seeks to determine the feasibility and efficacy of a Problem Solving Therapy intervention for the treatment of late life depression (LLD). Participants diagnosed with LLD will participate in six sessions of Problem Solving Therapy, a form of talk-therapy, over a period of eight weeks. A Case Manager (CM) will lead the PST. The primary outcome measure is depression severity and will be measured throughout the study at weeks 0, 4, and 8. the secondary outcome measure is quality of life and will be measured at week 0 (pre-intervention) and week 12.
Detailed description
In the elderly (i.e. individuals 60 years of age or older) major depressive disorder (MDD) is common occurring in 2-3% of the population and known as late life depression (LLD). LLD is both disabling and associated with a high mortality rate. Response to treatment of LLD using at least one antidepressant trial of adequate dose and duration is around 30-40%. Due to these suboptimal response rates, additional interventions should be tested and implemented to further alleviate the symptoms and severity of LLD.
It is common for individuals referred to geriatric psychiatry programs to live alone and have impaired independent mobility, which makes them more susceptible to depression as they are at a higher risk for social isolation. Best practice guidelines recommend using psychosocial therapies, which are effective in reducing symptoms of LLD, as the standard treatment for mild to moderate depression, either alone or in combination with medications. PST can be delivered to patients close to their homes making it ideal for treating seniors with limited mobility. The elderly are more likely to suffer from co-morbid conditions and be treated with multiple medications. Antidepressants are associated with serious adverse events, making psychosocial treatments especially important to the elderly who take more medications and are more likely to suffer comorbid conditions.
Problem-solving therapy (PST) is an established psychosocial therapy shown to be effective in treating depression and other mental disorders in adults of all ages. PST involves seven stages of problem resolution including a)identifying and clarifying the problem b)setting clear achievable goals c) brain-storming to generate solutions d) selecting a preferred solution and f) evaluation. Studies of PST in older adults have shown the treatment to be effective in reducing depression. PST has been successfully adapted to meet the needs of seniors with comorbid conditions and those with early dementia or cognitive impairment.
Despite the importance of psychotherapy interventions for older adults with MDD there is limited access to these treatments for seniors. At present, nurse case managers and social work case managers (CM) do not receive formal training in problem solving therapy. Since they often provide treatment for geriatric mental health outpatients, this limits access to treatments like PST. However, if CM's have formal training in PST, this treatment option can be made available to seniors that could benefit from such programs. To the best of the investigators' knowledge no study has evaluated the effects of CM trained to deliver PST for individuals with LLD in Canada, as such, this is the aim of the current investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Problem Solving Therapy | Experimental | Other: Problem Solving TherapyStudy participation will involve 9 study visits over a total of 12 weeks. This includes 5 sessions of Case Manager implemented PST over a period of 8 weeks (week 1, 3, 5, 7, and 9) and 4 assessment visits (baseline, week 4, week 8, and week 12). |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are of either gender and greater than 60 years of age.
- Reside in a community setting (either independent living environment or retirement home).
- Meet diagnostic criteria for major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria.
- Have a Hamilton Depression Rating Scale (HAMD) 17-item total score of >= 8 and < 24 at baseline.
- Have a Mini Mental Status Exam score of >= 20.
Key exclusion criteria (8 listed)
- Have suicidal ideation requiring inpatient admission to hospital for stabilization.
- Have an unstable medical condition requiring hospital admission.
- Have a life expectancy of less than 6 months or are currently receiving palliative care.
- Have psychotic symptoms.
- Have a lifetime history of bipolar disorder or schizophrenia.
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 |
|---|---|---|
| Problem Solving TherapyPST is a minimally invasive treatment. The five sessions of CM implemented PST will involve psychotherapy also known as talk therapy between the CM's and study participants in a group setting. Psychogeriatric interdisciplinary staff (CM's) i.e. psychiatric nurses, social workers who have been previously trained in PST will function in the roles of facilitator, cofacilitator and scribe. The roles can be shared amongst the professionals to build capacity in each role or maintained over time if so desired. Sessions will be approximately one-and-a-half to two hours in length and conducted at the Cherry Hill Mall library in London. | Other | Problem Solving Therapy |
Primary outcome
Change in depression symptoms
Time frame: Baseline, week 4, and week 8
Depression in study participants will be self rated on the Patient Health Questionnaire (PHQ-9)
3 secondary outcomes
Change in Quality of Life
Time frame: Baseline and week 12
Change in Depression Symptoms- Clinician Rated
Time frame: Baseline, Week 4 and Week 8
Change in Depression Symptoms- Overall improvement
Time frame: Baseline, Week 4 and Week 8
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 9 Mar 2018.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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 Problem Solving Therapy in people with Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 6 inclusion and 8 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 9 Mar 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 Canada. 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?
Change in depression symptoms (time frame: Baseline, week 4, and week 8). 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 9 Mar 2018.