AnxietyGroup PM+NCT06548022

Rare Group Problem Management Plus

A study testing Rare Group Problem Management Plus in people with Anxiety and Depressive Symptoms, run by Children's National Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Participants are being asked to be in the study if they are the parent or legal guardian of a child (>1 year or <18 years old) with a rare condition. The group based psychoeducational intervention is called Rare Group Problem Management Plus. Rare Group PM Plus may help adults with practical and emotional problems. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Anxiety, Depressive Symptoms, Post-traumatic Stress Disorder
What is being tested?: Rare Group Problem Management Plus
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 5 Feb 2024to 30 Nov 2025
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 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

• Family caregiver aged 18 years or older of a child with a rare disease from infancy to age 21 years.
Understands and speaks English or Spanish. Reading or health literacy is not required.
Signed consent.
Signed waiver of assent for child.

Who cannot join

Family caregiver is under the age of 18 years.
Child with the rare disease is over the age of 21 years.
Family caregiver is actively suicidal, homicidal, or psychotic.
Family caregiver is impaired (cognitively or by drugs or alcohol).
Family caregiver has a low level of distress.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's National Hospital
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Participants are being asked to be in the study if they are the parent or legal guardian of a child (>1 year or <18 years old) with a rare condition.

The group based psychoeducational intervention is called Rare Group Problem Management Plus.

Rare Group PM Plus may help adults with practical and emotional problems. It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes)

Participants will complete assessments before they start Rare Group PM+. Participants will also complete the same assessments within a few weeks of completing Rare Group PM+. Assessments should only take one hour.

Study visits are by Telemedicine. Participants will need a smart phone or tablet. If they do not have a smart phone or tablet, the study team will help with this.

Participants will not receive any materials or money or medication.

Read the detailed description

Participants are being asked to be in the study because they are the parent or legal guardian of a child (infancy up to 21 years old) with a rare condition.

The group based psychoeducational intervention is called Rare Group Problem Management (PM) Plus intervention.

Rare Group PM Plus may help adults with practical and emotional problems It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes)

Investigators will be recruiting for 3 groups of 10 families each, for a total of 30 families who will participate in this study from Children's National Hospital.

There are 7 study visits.

Study Timeline:

Study visit 1: Assessment-Before Group PM+ Study visit 2: Session 1-Managing Stress Study visit 3: Session 2-Managing Problems Study visit 4: Session 3-Get Going, Keep Doing Study visit 5: Session 4-Strengthening Social Support Study Visit 6: Session 5-Staying Well and Looking Forward Study Visit 7: Assessment within 2 weeks after complete Group PM+

Sessions will occur over Zoom Telehealth and facilitated by a licensed clinical psychologist and a genetic counselor trainee.

Investigators will use chi-square tests and Fisher's exact test to measure changes from baseline to 2 weeks post-intervention. Investigators will also collect qualitative data on what participants liked about the intervention, what they did not like, and what they think will improve the intervention.

Conditions: Anxiety, Depressive Symptoms, Post-traumatic Stress Disorder, Problems Psychosocial
Being tested: Rare Group Problem Management Plus
Keywords: rare disease, pediatric, family caregiver, psychoeducation, group intervention
Medical subject headings: Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Rare Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rare Group Problem Management PlusBehavioural
The World Health Organization's Group Problem Management Plus (Group PM+) intervention has been demonstrated to effectively provide psychological help for adults impaired by distress in communities exposed to adversity. Investigators will test an adapted model for use on-line and with family caregivers of children with rare diseases. Managing Stress. Teaching participants a brief stress management strategy will help them better manage problems related to anxiety and stress. Managing Problems. This is a strategy to apply in situations where a participant is experiencing practical problems (e.g. conflict in the family). Get Going, Keep Doing. This strategy targets depression and inactivity. Strengthening Social Support. Individuals with emotional problems can be isolated from supportive people and organizations. Strengthening social support promotes well-being. Staying Well and Looking Forward. This is a review, ends with a closing ceremony.

Study groups in NCT06548022
Study group	Role	What they receive
Rare Group PM Plus	Experimental	Rare Group PM Plus consists of 5 weekly sessions. Each session lasts 90 minutes. Session 1: Managing Stress Session 2: Managing Problems Session 3: Get Going, Keep Doing Session 4: Strengthening Social Support Session 5: Staying Well and Looking Forward Receives: Behavioral: Rare Group Problem Management Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability
As measured by retention at 2 weeks post-intervention assessment
Measured: 2 weeks post-intervention (Session 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 202430 Nov 2025

First posted12 Aug 2024
Study start5 Feb 2024
Primary completion25 Jun 2025
Study completion30 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies 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: Not applicable
Intervention model: Single group
Model description: Single group, pre/post-test design.
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06548022
Sponsor's protocol ID: IRBear Protocol # 1049
Acronym: Group PM+
Status last verified: Mar 2026
First submitted: 29 Jul 2024
Last updated: 30 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No individual participant data will be available to other researchers for this development and adaptation study.

Publications

Bogart KR, Irvin VL. Health-related quality of life among adults with diverse rare disorders. Orphanet J Rare Dis. 2017 Dec 7;12(1):177. doi: 10.1186/s13023-017-0730-1.
PubMed 29212508
Bogart KR, Dermody SS. Relationship of rare disorder latent clusters to anxiety and depression symptoms. Health Psychol. 2020 Apr;39(4):307-315. doi: 10.1037/hea0000840. Epub 2019 Dec 19.
PubMed 31855040
Rothrock NE, Amtmann D, Cook KF. Development and validation of an interpretive guide for PROMIS scores. J Patient Rep Outcomes. 2020 Feb 28;4(1):16. doi: 10.1186/s41687-020-0181-7.
PubMed 32112189
Uhlenbusch N, Lowe B, Harter M, Schramm C, Weiler-Normann C, Depping MK. Depression and anxiety in patients with different rare chronic diseases: A cross-sectional study. PLoS One. 2019 Feb 20;14(2):e0211343. doi: 10.1371/journal.pone.0211343. eCollection 2019.
PubMed 30785907
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
Saunders R, Moinian D, Stott J, Delamain H, Naqvi SA, Singh S, Wheatley J, Pilling S, Buckman JEJ. Measurement invariance of the PHQ-9 and GAD-7 across males and females seeking treatment for common mental health disorders. BMC Psychiatry. 2023 Apr 28;23(1):298. doi: 10.1186/s12888-023-04804-x.
PubMed 37118684
Lai X, Jiang Y, Sun Y, Zhang Z, Wang S. Prevalence of depression and anxiety, and their relationship to social support among patients and family caregivers of rare bone diseases. Orphanet J Rare Dis. 2023 Jan 26;18(1):18. doi: 10.1186/s13023-022-02611-3.
PubMed 36703212
Xiao SY. et al. The theoretical basis and applications of Social Support Rating Scale (SSRS). Journal of Clinical Psychiatry. 1994;4:98-100.
Kenny T, et al. The importance of psychological support for parents and caregivers of children with a rare disease diagnosis. Rare Disease and Orphan Drugs Journal. 2022;1(2):7.
Anderson M, Elliott EJ, Zurynski YA. Australian families living with rare disease: experiences of diagnosis, health services use and needs for psychosocial support. Orphanet J Rare Dis. 2013 Feb 11;8:22. doi: 10.1186/1750-1172-8-22.
PubMed 23398775
Scharping M, Brennenstuhl H, Garbade SF, Wild B, Posset R, Zielonka M, Kolker S, Haun MW, Opladen T. Unmet Needs of Parents of Children with Urea Cycle Disorders. Children (Basel). 2022 May 12;9(5):712. doi: 10.3390/children9050712.
PubMed 35626889
Lyon ME, Fraser JL, Thompkins JD, Clark H, Brodie N, Detwiler K, Torres C, Guerrera MF, Younge T, Aoun S, Trujillo Rivera EA. Advance Care Planning for Children With Rare Diseases: A Pilot RCT. Pediatrics. 2024 Jun 1;153(6):e2023064557. doi: 10.1542/peds.2023-064557.
PubMed 38699801
Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D. Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med. 2002 Winter;24(1):49-58. doi: 10.1207/S15324796ABM2401_06.
PubMed 12008794
Cooper B, Kinsella GJ, Picton C. Development and initial validation of a family appraisal of caregiving questionnaire for palliative care. Psychooncology. 2006 Jul;15(7):613-22. doi: 10.1002/pon.1001.
PubMed 16287207
Toledano-Toledano F, Moral de la Rubia J, Dominguez-Guedea MT, Nabors LA, Barcelata-Eguiarte BE, Rocha-Perez E, Luna D, Leyva-Lopez A, Rivera-Rivera L. Validity and Reliability of the Beck Anxiety Inventory (BAI) for Family Caregivers of Children with Cancer. Int J Environ Res Public Health. 2020 Oct 23;17(21):7765. doi: 10.3390/ijerph17217765.
PubMed 33114144

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rare Group Problem Management Plus
ClinicalTrials.gov ID: NCT06548022
Acronym / sponsor ID: Group PM+ / IRBear Protocol # 1049
Conditions: Anxiety, Depressive Symptoms, Post-traumatic Stress Disorder, Problems Psychosocial
Keywords: rare disease, pediatric, family caregiver, psychoeducation, group intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Children's National Research InstituteUniversity, hospital or other
Collaborators: Travere Therapeutics, Inc.
Study start: 5 Feb 2024 (actual)
Primary completion: 25 Jun 2025 (actual)
Study completion: 30 Nov 2025 (actual)
First posted: 12 Aug 2024 (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.

Participants are being asked to be in the study if they are the parent or legal guardian of a child (>1 year or <18 years old) with a rare condition.

The group based psychoeducational intervention is called Rare Group Problem Management Plus.

Study visits are by Telemedicine. Participants will need a smart phone or tablet. If they do not have a smart phone or tablet, the study team will help with this.

Participants will not receive any materials or money or medication.

Detailed description

Participants are being asked to be in the study because they are the parent or legal guardian of a child (infancy up to 21 years old) with a rare condition.

The group based psychoeducational intervention is called Rare Group Problem Management (PM) Plus intervention.

Investigators will be recruiting for 3 groups of 10 families each, for a total of 30 families who will participate in this study from Children's National Hospital.

There are 7 study visits.

Study Timeline:

Sessions will occur over Zoom Telehealth and facilitated by a licensed clinical psychologist and a genetic counselor trainee.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single group, pre/post-test design.

Arm	Type	Receives
Rare Group PM Plus	Experimental	Behavioral: Rare Group Problem Management PlusRare Group PM Plus consists of 5 weekly sessions. Each session lasts 90 minutes. Session 1: Managing Stress Session 2: Managing Problems Session 3: Get Going, Keep Doing Session 4: Strengthening Social Support Session 5: Staying Well and Looking Forward

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

• Family caregiver aged 18 years or older of a child with a rare disease from infancy to age 21 years.

Key exclusion criteria (5 listed)

Family caregiver is under the age of 18 years.
Child with the rare disease is over the age of 21 years.
Family caregiver is actively suicidal, homicidal, or psychotic.
Family caregiver is impaired (cognitively or by drugs or alcohol).
Family caregiver has a low level of distress.

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
Rare Group Problem Management PlusThe World Health Organization's Group Problem Management Plus (Group PM+) intervention has been demonstrated to effectively provide psychological help for adults impaired by distress in communities exposed to adversity. Investigators will test an adapted model for use on-line and with family caregivers of children with rare diseases. Managing Stress. Teaching participants a brief stress management strategy will help them better manage problems related to anxiety and stress. Managing Problems. This is a strategy to apply in situations where a participant is experiencing practical problems (e.g. conflict in the family). Get Going, Keep Doing. This strategy targets depression and inactivity. Strengthening Social Support. Individuals with emotional problems can be isolated from supportive people and organizations. Strengthening social support promotes well-being. Staying Well and Looking Forward. This is a review, ends with a closing ceremony.	Behavioural	Rare Group PM Plus

Primary outcome

Acceptability
Time frame: 2 weeks post-intervention (Session 5)
As measured by retention at 2 weeks post-intervention assessment

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 30 Mar 2026.
Background: PubMed 29212508Bogart KR, Irvin VL. Health-related quality of life among adults with diverse rare disorders. Orphanet J Rare Dis. 2017 Dec 7;12(1):177. doi: 10.1186/s13023-017-0730-1.
Background: PubMed 31855040Bogart KR, Dermody SS. Relationship of rare disorder latent clusters to anxiety and depression symptoms. Health Psychol. 2020 Apr;39(4):307-315. doi: 10.1037/hea0000840. Epub 2019 Dec 19.
Background: PubMed 32112189Rothrock NE, Amtmann D, Cook KF. Development and validation of an interpretive guide for PROMIS scores. J Patient Rep Outcomes. 2020 Feb 28;4(1):16. doi: 10.1186/s41687-020-0181-7.
Background: PubMed 30785907Uhlenbusch N, Lowe B, Harter M, Schramm C, Weiler-Normann C, Depping MK. Depression and anxiety in patients with different rare chronic diseases: A cross-sectional study. PLoS One. 2019 Feb 20;14(2):e0211343. doi: 10.1371/journal.pone.0211343. eCollection 2019.
Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Background: PubMed 37118684Saunders R, Moinian D, Stott J, Delamain H, Naqvi SA, Singh S, Wheatley J, Pilling S, Buckman JEJ. Measurement invariance of the PHQ-9 and GAD-7 across males and females seeking treatment for common mental health disorders. BMC Psychiatry. 2023 Apr 28;23(1):298. doi: 10.1186/s12888-023-04804-x.
Background: PubMed 36703212Lai X, Jiang Y, Sun Y, Zhang Z, Wang S. Prevalence of depression and anxiety, and their relationship to social support among patients and family caregivers of rare bone diseases. Orphanet J Rare Dis. 2023 Jan 26;18(1):18. doi: 10.1186/s13023-022-02611-3.
BackgroundXiao SY. et al. The theoretical basis and applications of Social Support Rating Scale (SSRS). Journal of Clinical Psychiatry. 1994;4:98-100.
BackgroundKenny T, et al. The importance of psychological support for parents and caregivers of children with a rare disease diagnosis. Rare Disease and Orphan Drugs Journal. 2022;1(2):7.
Background: PubMed 23398775Anderson M, Elliott EJ, Zurynski YA. Australian families living with rare disease: experiences of diagnosis, health services use and needs for psychosocial support. Orphanet J Rare Dis. 2013 Feb 11;8:22. doi: 10.1186/1750-1172-8-22.
Background: PubMed 35626889Scharping M, Brennenstuhl H, Garbade SF, Wild B, Posset R, Zielonka M, Kolker S, Haun MW, Opladen T. Unmet Needs of Parents of Children with Urea Cycle Disorders. Children (Basel). 2022 May 12;9(5):712. doi: 10.3390/children9050712.
Background: PubMed 38699801Lyon ME, Fraser JL, Thompkins JD, Clark H, Brodie N, Detwiler K, Torres C, Guerrera MF, Younge T, Aoun S, Trujillo Rivera EA. Advance Care Planning for Children With Rare Diseases: A Pilot RCT. Pediatrics. 2024 Jun 1;153(6):e2023064557. doi: 10.1542/peds.2023-064557.
Individual participant dataSharing planned: No. No individual participant data will be available to other researchers for this development and adaptation study.

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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.

Maureen Lyon, PhD principal investigator

Children's National Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rare Group Problem Management Plus in people with Anxiety and Depressive Symptoms, run by Children's National Research Institute 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 5 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 30 Mar 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?

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?

Acceptability (time frame: 2 weeks post-intervention (Session 5)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06548022, which also lists 31 linked publications.

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 30 Mar 2026.