Traumatic Brain InjuryNCT00164645
Problem Solving for Caregivers of Persons With Brain Injury
A study testing Problem Solving Therapy in people with Traumatic Brain Injury, run by Centers for Disease Control and Prevention.
Trial summary
This study was designed to evaluate a behavioral intervention program to improve medication adherence in adults with hypertension. The study was withdrawn prior to enrollment. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Problem Solving Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2005to 20 Sep 2005
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 19 years and older
Who cannot join
- None specified
- Note: The study was withdrawn prior to enrollment and no participants were enrolled.
About this study
Official title: Problem Solving for Caregivers of Patients With Traumatic Brain Injury
This study was designed to evaluate a behavioral intervention program to improve medication adherence in adults with hypertension. The study was withdrawn prior to enrollment.
Read the detailed description
The purpose of this study was to assess the effect of a behavioral intervention on medication adherence and blood pressure control in adults with hypertension. Participants were expected to receive structured counseling sessions over a 12-week period. The study was withdrawn prior to enrollment, and no participants were enrolled and no data were collected.
- Conditions
- Traumatic Brain Injury
- Being tested
- Problem Solving Therapy
- Keywords
- Caregiver Support, Cognitive Rehabilitation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyBehavioural
A structured behavioral intervention focused on teaching problem-solving skills to caregivers of patients with traumatic brain injury. The study was withdrawn prior to enrollment and no participants received the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Problem Solving Intervention | Other | Caregivers would have received a structured problem-solving intervention designed to improve coping and caregiving skills. The study was withdrawn prior to enrollment. Receives: Behavioral: Problem Solving Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver problem-solving ability as measured by the Social Problem-Solving Inventory (SPSI)
Caregiver problem-solving ability would have been assessed using the Social Problem-Solving Inventory (SPSI). Scores would have been measured at baseline and at follow-up to evaluate the effect of the intervention. The study was withdrawn prior to enrollment, and no data were collected.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study start20 Jun 2005 (estimated)
- Primary completion20 Jul 2005 (estimated)
- Study completion20 Sep 2005 (estimated)
Why it stopped: Sponsor decision to cancel study before recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164645
- Sponsor's protocol ID
- CDC-NCIPC-00019101
- Status last verified
- May 2026
- First submitted
- 12 Sep 2005
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem Solving for Caregivers of Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00164645
- Acronym / sponsor ID
- CDC-NCIPC-00019101
- Conditions
- Traumatic Brain Injury
- Keywords
- Caregiver Support, Cognitive Rehabilitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to cancel study before recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- 20 Jun 2005 (estimated)
- Primary completion
- 20 Jul 2005 (estimated)
- Study completion
- 20 Sep 2005 (estimated)
- First posted
- 14 Sep 2005 (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 was designed to evaluate a behavioral intervention program to improve medication adherence in adults with hypertension. The study was withdrawn prior to enrollment.
Detailed description
The purpose of this study was to assess the effect of a behavioral intervention on medication adherence and blood pressure control in adults with hypertension. Participants were expected to receive structured counseling sessions over a 12-week period. The study was withdrawn prior to enrollment, and no participants were enrolled and no data were collected.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Problem Solving Intervention | Other | Behavioral: Problem Solving TherapyCaregivers would have received a structured problem-solving intervention designed to improve coping and caregiving skills. The study was withdrawn prior to enrollment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 19 years and older
Key exclusion criteria (2 listed)
- None specified
- Note: The study was withdrawn prior to enrollment and no participants were enrolled.
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 TherapyA structured behavioral intervention focused on teaching problem-solving skills to caregivers of patients with traumatic brain injury. The study was withdrawn prior to enrollment and no participants received the intervention. | Behavioural | Problem Solving Intervention |
Primary outcome
Caregiver problem-solving ability as measured by the Social Problem-Solving Inventory (SPSI)
Time frame: Baseline and 12 weeks
Caregiver problem-solving ability would have been assessed using the Social Problem-Solving Inventory (SPSI). Scores would have been measured at baseline and at follow-up to evaluate the effect of the intervention. The study was withdrawn prior to enrollment, and no data were collected.
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 12 May 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy in people with Traumatic Brain Injury, run by Centers for Disease Control and Prevention.
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 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: withdrawn, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Caregiver problem-solving ability as measured by the Social Problem-Solving Inventory (SPSI) (time frame: Baseline and 12 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 12 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.