Mental Health IssueNCT05334992
Improving Mental Health for Care Partners of Persons With AD/ADRD
A study testing Mindfulness Based Cognitive Therapy and Behavior Activation in people with Mental Health Issue and Grief, run by Texas Tech University at 1 site in United States.
Trial summary
The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Mental Health Issue, Grief, Burden, Caregiver
- What is being tested?
- Mindfulness Based Cognitive Therapy and Behavior Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be informal caregivers (e.g., spouse; child; close friend) of individuals with dementia
- Informal caregivers can be family members or close friends
- Adults (18 to 89 years old) who read, write, and speak in English
- Mental Health Diagnosis (e.g., Generalized Anxiety Disorder; Major Depressive Disorder
Who cannot join
- Formal caregivers (who are being paid to take care of the patient)
- Any informal caregivers with cognitive impairment is identified during the assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Tech University
Lubbock, Texas, 79382
Jonathan D Singer, PhD, 775-722-8066, jonsinge@ttu.edu
About this study
Official title: Reducing Pre-Death Grief, Burden, and Stress in Informal Caregivers: A Group and Individual Therapy Approach
The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia
Read the detailed description
Aim 1: Examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients.
Aim 2: Examine the effects of a modified evidence-based group therapy for informal caregivers of dementia patients.
- Conditions
- Mental Health Issue, Grief, Burden, Caregiver
- Being tested
- Mindfulness Based Cognitive Therapy, Behavior Activation
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
Also called MBCT
Individual therapy 12 to 16 weeks
Behavior ActivationBehavioural
Also called BA
Individual therapy 12 to 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Experimental | Mindfulness-Based Cognitive Therapy (MBCT) combines the ideas of cognitive therapy with meditative practices and attitudes based on the cultivation of mindfulness. The heart of this work lies in becoming acquainted with the modes of mind that often characterize mood disorders while simultaneously learning to develop a new relationship to them. Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| Behavior Activation | Experimental | BA Increase reinforcing behaviors in order to influence emotions and cognitions. Receives: Behavioral: Behavior Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Grief Scale-12 (measuring pre-death grief)
The PG-12 (range 11-55; higher scores mean higher pre-death grief), which is used to measure pre-death grief will be used to measure grief of having a loved one live with a life limiting illness and no longer be able to engage in valued activites.
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
Zarit Burden Inventory (ZBI)
Informal caregivers, usually family member, have an increase in burden or feeling they are overwhelmed by their current circumstances. The ZBI is between 0-48, higher scores indicating higher burden.
Measured: through study completion, an average of 6 months
Perceived Stress Scale
Informal caregivers, usually family members, are unpaid and have a tendency to feel tense and emotionally drained do to caregiving. Scores range from 0-40 with higher scores indicating higher rates of stress.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Feb 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Model description
- Mindfulness Based Cognitive Therapy; Behavior Activation; Group Therapy
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan D Singer, Ph.D, Principal investigator, jonsinge@ttu.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334992
- Sponsor's protocol ID
- TexasTechU
- Other IDs
- tech
- Status last verified
- Feb 2026
- First submitted
- 21 Mar 2022
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Pre-Death Grief, Burden, and Stress in Informal Caregivers: A Group and Individual Therapy Approach
- ClinicalTrials.gov ID
- NCT05334992
- Acronym / sponsor ID
- TexasTechU
- Conditions
- Mental Health Issue, Grief, Burden, Caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Apr 2022 (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.
The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia
Detailed description
Aim 1: Examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients.
Aim 2: Examine the effects of a modified evidence-based group therapy for informal caregivers of dementia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mindfulness Based Cognitive Therapy; Behavior Activation; Group Therapy
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Experimental | Behavioral: Mindfulness Based Cognitive TherapyMindfulness-Based Cognitive Therapy (MBCT) combines the ideas of cognitive therapy with meditative practices and attitudes based on the cultivation of mindfulness. The heart of this work lies in becoming acquainted with the modes of mind that often characterize mood disorders while simultaneously learning to develop a new relationship to them. |
| Behavior Activation | Experimental | Behavioral: Behavior ActivationBA Increase reinforcing behaviors in order to influence emotions and cognitions. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be informal caregivers (e.g., spouse; child; close friend) of individuals with dementia
- Informal caregivers can be family members or close friends
- Adults (18 to 89 years old) who read, write, and speak in English
- Mental Health Diagnosis (e.g., Generalized Anxiety Disorder; Major Depressive Disorder
Key exclusion criteria (2 listed)
- Formal caregivers (who are being paid to take care of the patient)
- Any informal caregivers with cognitive impairment is identified during the assessment.
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 |
|---|---|---|
| Mindfulness Based Cognitive TherapyAlso: MBCTIndividual therapy 12 to 16 weeks | Behavioural | Mindfulness Based Cognitive Therapy |
| Behavior ActivationAlso: BAIndividual therapy 12 to 16 weeks | Behavioural | Behavior Activation |
Primary outcome
Prolonged Grief Scale-12 (measuring pre-death grief)
Time frame: through study completion, an average of 6 months
The PG-12 (range 11-55; higher scores mean higher pre-death grief), which is used to measure pre-death grief will be used to measure grief of having a loved one live with a life limiting illness and no longer be able to engage in valued activites.
2 secondary outcomes
Zarit Burden Inventory (ZBI)
Time frame: through study completion, an average of 6 months
Perceived Stress Scale
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Jonathan D Singer, Ph.D principal investigator
jonsinge@ttu.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy and Behavior Activation in people with Mental Health Issue and Grief, run by Texas Tech University 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Casside Street, Ph.D ((806) 834-2285, casside.street@ttu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged Grief Scale-12 (measuring pre-death grief) (time frame: through study completion, an average of 6 months). 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 12 Feb 2026.