DepressionNCT03092050
Group Therapy for Depressed Dementia Caregivers
A study testing Guided Imagery and Mindfulness and Facilitated Discussion in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Depression in family caregivers of relatives with Alzheimer's Disorder and related dementias is a serious public health problem. This is a randomized, controlled, single-blind pilot clinical trial of depressed caregivers, to determine the efficacy and mechanisms of group therapy for depressed dementia caregivers. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Guided Imagery and Mindfulness and Facilitated Discussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 30 Jun 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endorse clinically relevant baseline depressive symptoms Primary caregiver for a relative with dementia
Who cannot join
- Age < 45 Meditation / guided imagery practice more than twice per week Ideas of harming relative with dementia Current violence towards relative with dementia Adult Protective Services report on file Primary psychiatric disorder other than unipolar major depression Cognitive impairment on the part of the caregiver (Mini Mental State Examination score less than 24) Unstable medical illness Planned surgery Active drug or alcohol abuse Inability to understand written and oral English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Group Therapy for Depressed Caregivers of Alzheimer's Disorder and Related Dementias
Depression in family caregivers of relatives with Alzheimer's Disorder and related dementias is a serious public health problem. This is a randomized, controlled, single-blind pilot clinical trial of depressed caregivers, to determine the efficacy and mechanisms of group therapy for depressed dementia caregivers.
Read the detailed description
The trial was designed to measure clinical outcomes including depressive symptoms and other secondary outcomes of caregivers of persons living with dementia. It also included magnetic resonance imagery scanning at baseline (prior to study group) and post group to identify candidate mechanisms of effects.
Notes related to outcome measurement. On 05.10.2017 (prior to participant enrollment), all secondary outcomes were approved by the UCSF IRB #16-20163. It was noted in the IRB that the primary outcome timepoint was to be obtained 4 weeks after the first group session. Due to magnetic resonance imaging scanning scheduling constraints, which occurred at the same time as the 4 weeks visit, the outcome could not be exactly four weeks post the first group session but was collected approximately at this time.
On 05.10.2017 (prior to participant enrollment), three-month post group secondary outcomes were also approved.
- Conditions
- Depression
- Being tested
- Guided Imagery and Mindfulness, Facilitated Discussion
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery and MindfulnessBehavioural
This is a behavioral intervention using guided imagery and mindfulness techniques.
Facilitated DiscussionBehavioural
This is a behavioral intervention that involves discussion and group support.
| Study group | Role | What they receive |
|---|---|---|
| Facilitated Discussion | Active comparator | Weekly facilitated discussion for 4 weeks Receives: Behavioral: Facilitated Discussion |
| Guided Imagery and mindfulness | Experimental | Weekly guided imagery and mindfulness for 4 weeks Receives: Behavioral: Guided Imagery and Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
Self reported depression symptoms (Quick Inventory of Depression Symptoms)
Measured: approximately 4 weeks post initial group session
Secondary outcomes (10)
Depression symptoms - moderate term
Self reported depression symptoms
Measured: approximately 3 months post initial group session
Depression symptoms - clinician rated
Hamilton Depression Rating Scale
Measured: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Caregiver burden
Caregiver Burden Scale self rated questionnaire
Measured: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Anxiety symptoms
State Trait Anxiety Inventory - Trait
Measured: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Mindfulness
Five Factor Mindfulness Questionnaire
Measured: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Positive and Negative Affect
Positive and Negative Affect Scale
Measured: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Well-Being
Mental Health Continuum Short Form
Measured: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Stress
Perceived Stress Scale
Measured: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Resilience
Connors Davidson Resilience Scale
Measured: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Connectedness to Nature
Connectedness to Nature Scale
Measured: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Mar 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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 Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm randomized controlled trial. During the conduct of the trial, the investigators noted that due to staffing constraints, participant availability, and funding limitations, it would not be feasible to complete a crossover study. This was due to the fact that the investigators were unable to offer crossover group therapy visits at the same time as the initial group sessions. Rather, groups with new participants had to be prioritized and scheduled during the most accessible time slots. Times that the investigators could offer for crossover groups were often inaccessible to participants. Thus, the investigators determined that in the context of this pilot trial, it was not feasible to conduct a full crossover trial due to accessibility. The trial design was therefore updated to parallel (in accordance with the initial funding application).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Felipe A Jain, Massachusetts General Hospital
- Investigators
- Felipe Jain, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092050
- Sponsor's protocol ID
- MIT001
- Other IDs
- R21AG051970
- Status last verified
- Sep 2022
- First submitted
- 10 Mar 2017
- Last updated
- 6 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Therapy for Depressed Caregivers of Alzheimer's Disorder and Related Dementias
- ClinicalTrials.gov ID
- NCT03092050
- Acronym / sponsor ID
- MIT001
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Mar 2017 (actual)
- 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.
Depression in family caregivers of relatives with Alzheimer's Disorder and related dementias is a serious public health problem. This is a randomized, controlled, single-blind pilot clinical trial of depressed caregivers, to determine the efficacy and mechanisms of group therapy for depressed dementia caregivers.
Detailed description
The trial was designed to measure clinical outcomes including depressive symptoms and other secondary outcomes of caregivers of persons living with dementia. It also included magnetic resonance imagery scanning at baseline (prior to study group) and post group to identify candidate mechanisms of effects.
Notes related to outcome measurement. On 05.10.2017 (prior to participant enrollment), all secondary outcomes were approved by the UCSF IRB #16-20163. It was noted in the IRB that the primary outcome timepoint was to be obtained 4 weeks after the first group session. Due to magnetic resonance imaging scanning scheduling constraints, which occurred at the same time as the 4 weeks visit, the outcome could not be exactly four weeks post the first group session but was collected approximately at this time.
On 05.10.2017 (prior to participant enrollment), three-month post group secondary outcomes were also approved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 arm randomized controlled trial. During the conduct of the trial, the investigators noted that due to staffing constraints, participant availability, and funding limitations, it would not be feasible to complete a crossover study. This was due to the fact that the investigators were unable to offer crossover group therapy visits at the same time as the initial group sessions. Rather, groups with new participants had to be prioritized and scheduled during the most accessible time slots. Times that the investigators could offer for crossover groups were often inaccessible to participants. Thus, the investigators determined that in the context of this pilot trial, it was not feasible to conduct a full crossover trial due to accessibility. The trial design was therefore updated to parallel (in accordance with the initial funding application).
| Arm | Type | Receives |
|---|---|---|
| Facilitated Discussion | Active comparator | Behavioral: Facilitated DiscussionWeekly facilitated discussion for 4 weeks |
| Guided Imagery and mindfulness | Experimental | Behavioral: Guided Imagery and MindfulnessWeekly guided imagery and mindfulness for 4 weeks |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Endorse clinically relevant baseline depressive symptoms Primary caregiver for a relative with dementia
Key exclusion criteria (1 listed)
- Age < 45 Meditation / guided imagery practice more than twice per week Ideas of harming relative with dementia Current violence towards relative with dementia Adult Protective Services report on file Primary psychiatric disorder other than unipolar major depression Cognitive impairment on the part of the caregiver (Mini Mental State Examination score less than 24) Unstable medical illness Planned surgery Active drug or alcohol abuse Inability to understand written and oral English.
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 |
|---|---|---|
| Guided Imagery and MindfulnessThis is a behavioral intervention using guided imagery and mindfulness techniques. | Behavioural | Guided Imagery and mindfulness |
| Facilitated DiscussionThis is a behavioral intervention that involves discussion and group support. | Behavioural | Facilitated Discussion |
Primary outcome
Depression symptoms
Time frame: approximately 4 weeks post initial group session
Self reported depression symptoms (Quick Inventory of Depression Symptoms)
10 secondary outcomes
Depression symptoms - moderate term
Time frame: approximately 3 months post initial group session
Depression symptoms - clinician rated
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Caregiver burden
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Anxiety symptoms
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Mindfulness
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Positive and Negative Affect
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Well-Being
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Stress
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Resilience
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
Connectedness to Nature
Time frame: approximately 4 weeks post initial group session and approximately 3 months post initial group session
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 6 Sep 2022.
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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.
Felipe Jain, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery and Mindfulness and Facilitated Discussion in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
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 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: finished, as of the sponsor's last update on 6 Sep 2022. 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 States. 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?
Depression symptoms (time frame: approximately 4 weeks post initial group session). 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 6 Sep 2022.