Group Therapy for Psychosocial Issues

(Group PM+ Trial)

Not currently recruiting at 1 trial location

Overseen By Maureen E Lyon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Suicidal, Homicidal, Psychotic, Impaired, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 7 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a group program called Rare Group Problem Management Plus, designed to help parents or guardians of children with rare conditions manage stress and other practical challenges. The program includes five weekly sessions, each lasting 90 minutes, focusing on topics like stress management and building social support. Conducted via telemedicine, participants will need a smartphone or tablet. This trial suits English or Spanish-speaking caregivers who feel distressed and care for a child with a rare disease. As an unphased trial, it offers caregivers a unique opportunity to access supportive resources tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on group therapy and does not involve medication changes.

What prior data suggests that this group therapy is safe for participants?

Research has shown that Problem Management Plus (PM+) is safe for use in different communities. PM+ is a program designed to help people manage stress and emotional problems. No serious side effects have been reported. In fact, studies have found that PM+ effectively reduces distress and anxiety over time. This program has been successfully used in various situations, such as with Syrian refugees, and many participants have continued to engage with it. While the specific version called Rare Group PM Plus is new, the overall method has a history of being well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Rare Group PM Plus because it offers a fresh approach to dealing with psychosocial issues through a structured group therapy format. Unlike traditional individual therapy or medication, this treatment involves five weekly group sessions, each focusing on different aspects like stress management, problem-solving, and enhancing social support. The group setting not only provides peer support but also encourages participants to actively engage and learn from each other's experiences, potentially leading to more lasting and meaningful improvements in mental well-being. This innovative approach has the potential to fill a gap in the current standard of care, which often doesn't emphasize the social and communal aspects of healing.

What evidence suggests that Rare Group PM Plus is effective for psychosocial issues?

Research has shown that the Rare Group Problem Management Plus (PM+) program, which participants in this trial will receive, helps people manage psychological distress. Studies have found that Group PM+ can improve physical health and reduce negative feelings like stress, anxiety, and depression. One study found it effective in easing symptoms of common mental health issues among Syrian refugees. The program focuses on managing stress, solving problems, and boosting social support. While researchers are still studying the specific effects for parents of children with rare conditions, positive results in other groups suggest it could be helpful. ^{1 2 3 6 7}

Who Is on the Research Team?

Maureen Lyon, PhD

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

This trial is for parents or guardians of children aged 1 to 17 with a rare condition. They should be able to attend weekly group sessions via telemedicine using a smartphone or tablet, which the study team can assist in providing if necessary.

Inclusion Criteria

Understands and speaks English or Spanish. Reading or health literacy is not required

Signed consent

Signed waiver of assent for child

Exclusion Criteria

Family caregiver is actively suicidal, homicidal, or psychotic

My family caregiver is younger than 18.

My child with a rare disease is older than 21.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants complete assessments before starting the Rare Group PM+ intervention

1 week

1 visit (telemedicine)

Treatment

Participants undergo the Rare Group PM+ intervention, consisting of 5 weekly sessions

5 weeks

5 visits (telemedicine)

Follow-up

Participants complete assessments within 2 weeks after completing the Rare Group PM+ intervention

2 weeks

1 visit (telemedicine)

What Are the Treatments Tested in This Trial?

Interventions

• Rare Group Problem Management Plus

Trial Overview The intervention being tested is called Rare Group Problem Management Plus, a psychoeducational program aimed at helping adults manage practical and emotional challenges through weekly group sessions over five weeks.

How Is the Trial Designed?

Group I: Rare Group PM Plus Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Travere Therapeutics, Inc.

Industry Sponsor

Trials

23

Recruited

103,000+

Published Research Related to This Trial

The Problem Management Plus (PM+) intervention significantly reduced PTSD symptoms in 738 participants compared to enhanced treatment as usual (ETAU), with only 12.5% of PM+ participants retaining a PTSD diagnosis post-treatment.

Despite the overall effectiveness of PM+, hyperarousal symptoms like sleep disturbances and concentration difficulties remained common, suggesting that future iterations of PM+ could benefit from additional strategies to address these specific issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Residual posttraumatic stress disorder symptoms after provision of brief behavioral intervention in low- and middle-income countries: An individual-patient data meta-analysis. Akhtar, A., Koyiet, P., Rahman, A., et al.[2022]

The study focused on a group therapy program specifically for male outpatients aged 20 to 40, who shared similar personality traits and psychosocial issues, such as unemployment and lack of heterosexual relationships.

After six months of therapy, the report evaluates the characteristics of the patients, themes discussed in sessions, and the overall outcomes, highlighting the potential benefits of targeted group therapy for this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A psychotherapeutic group for men. Swenson, JR., Elliott, D.[2019]

Group psychotherapy in Norway has a well-established history and employs various approaches, indicating a structured and evolving practice in mental health care.

The integration of practice and research within the public mental health system supports the development and financing of systematic training programs for group psychotherapy, enhancing its efficacy and accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Psychotherapy in Norway. Lorentzen, S., Wilberg, T., Martinsen, EW.[2016]

The use of patient-managed problem-solving groups in inpatient settings effectively increased responsible behaviors among patients with chronic mental illness, as shown by a repeated measures design.

This intervention led to a higher frequency of targeted behaviors compared to baseline periods, suggesting its potential applicability for various behaviors in different treatment environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using written communication with patient groups to promote behavioral change in chronic mentally ill patients. Elder, AD., Zultowsky, D.[2019]

A randomized controlled trial involving 171 low-income individuals aged 60 and older with major depression showed that both clinical case management (CM) and integrated problem-solving therapy (CM-PST) significantly improved functional outcomes over 12 weeks, with benefits lasting up to 24 weeks.

Interestingly, CM was found to be just as effective as CM-PST, indicating that the additional problem-solving therapy may not be necessary for improving function in this population, while improvements in self-efficacy, problem-solving skills, and depression symptoms were key predictors of functional improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Problem-Solving Therapy and Clinical Case Management on Disability in Low-Income Older Adults. Areán, PA., Raue, PJ., McCulloch, C., et al.[2018]

Traditional group psychotherapy models are becoming less effective in inpatient settings due to shorter patient stays and rapidly changing group dynamics.

The authors propose a new model tailored for acutely ill patients that focuses on specific therapeutic factors, recommending adjustments in group structure, therapist roles, and clinical techniques to better meet the needs of these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A group psychotherapy model for acute treatment settings. Hoge, MA., McLoughlin, KA.[2015]

The pilot randomized controlled trial (RCT) will assess the feasibility of the Problem Management Plus (PM+) intervention for asylum seekers and refugees (AS&Rs) in Liverpool, UK, focusing on its delivery by trained lay therapists with lived experience of forced migration.

The study aims to recruit 105 participants to evaluate the effectiveness of PM+ in reducing anxiety and depressive symptoms, with primary outcomes measured at 3 months, and will inform the design of a larger RCT to address mental health disparities in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lay-therapist-delivered, low-intensity, psychosocial intervention for refugees and asylum seekers (PROSPER): protocol for a pilot randomised controlled trial. Rawlinson, R., Aslam, RW., Burnside, G., et al.[2021]

The Problem Management Plus (PM+) intervention was found to be largely acceptable and positively impactful for women affected by adversity in Kenya, based on qualitative interviews with 27 key informants.

A significant barrier to scaling up PM+ is the sustainability of community health volunteers, who are unsalaried, indicating a need for a more stable support system for these non-specialist providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative evaluation of a brief multicomponent intervention provided by lay health workers for women affected by adversity in urban Kenya. Van't Hof, E., Dawson, KS., Schafer, A., et al.[2022]

In a study involving 171 depressed, disabled, low-income patients aged 60 and older, both clinical case management (CM) and integrated problem-solving therapy (CM-PST) showed similar effectiveness in reducing depressive symptoms over 12 weeks, indicating that CM alone is sufficient for this population.

The development of problem-solving skills did not mediate the improvement in depression, suggesting that the benefits of CM do not rely on this specific therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Case Management versus Case Management with Problem-Solving Therapy in Low-Income, Disabled Elders with Major Depression: A Randomized Clinical Trial. Alexopoulos, GS., Raue, PJ., McCulloch, C., et al.[2022]

A phase-specific model was developed to improve the effectiveness of group therapies in both inpatient and outpatient settings by aligning interventions with individual psychological states.

This model categorizes clients into three phases based on their readiness and psychological factors, which helps to tailor group interventions and potentially increases participation and therapeutic response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching clients to group therapies based on psychological readiness. Fuller, PR.[2013]

In a study involving 191 general practitioners and 1341 treatment episodes, patients receiving psychosocial interventions for issues like anxiety and depression showed better outcomes compared to those receiving only somatic treatments.

The study highlighted that while psychosocial care was effective, there was a lack of involvement of partners and family members in the therapy process, suggesting an area for improvement in treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Primary psychosomatic management in general practice. Results of a German nationwide demonstration project of quality assurance]. Fritzsche, K., Sandholzer, H., Brucks, U., et al.[2008]

The Group PM+ intervention, a brief psychological support program, was found to be feasible and acceptable for delivery by local non-specialists in an earthquake-affected region of rural Nepal, with 121 participants (83% women) showing good attendance and engagement.

While the study was not designed to measure effectiveness, preliminary results indicated that participants receiving Group PM+ experienced greater improvements in depression symptoms compared to those receiving enhanced usual care, suggesting potential benefits that warrant further investigation in a larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal. Sangraula, M., Turner, EL., Luitel, NP., et al.[2020]

The study will evaluate the effectiveness of a group version of Problem Management Plus (PM+) in reducing psychological distress among participants in Nepal, with 72 wards participating in a cluster randomized controlled trial design.

If successful, Group PM+ could provide a scalable and accessible psychological intervention for communities affected by adversity, as it is delivered by trained community psychosocial workers and focuses on practical stress management techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Group Problem Management Plus (Group-PM+) for adults affected by humanitarian crises in Nepal: study protocol for a cluster randomized controlled trial. Van't Hof, E., Sangraula, M., Luitel, NP., et al.[2021]

Group psychotherapy is an effective and cost-effective treatment option for patients, particularly beneficial for those with chronic psychiatric impairments requiring extended support.

The abstract highlights the importance of integrating group therapy into comprehensive mental health services, emphasizing its utility within different healthcare delivery models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group psychotherapy in an HMO. Hoyt, MF.[2016]

Group psychotherapy is increasingly recognized as an effective treatment method that combines social interaction and psychological insight, allowing patients to explore unconscious motivations and learn from each other in a supportive environment.

The success of group psychotherapy relies more on the therapist's commitment and facilitation skills than on the specific therapeutic approach used, highlighting the importance of a group-centered rather than leader-centered dynamic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Group psychotherapy in psychiatry]. Battegay, R.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06548022

NCT06548022 | Rare Group Problem Management Plus The World Health Organization's Group Problem Management Plus (Group PM+) intervention has been demonstrated to effectively provide psychological help for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11588643/

The effectiveness of Problem Management Plus at 1-year ... This study examined the effectiveness of PM+ in reducing symptoms of common mental disorders at 12-month follow-up among Syrian refugees in the Netherlands.

3. who.int who.int/publications/i/item/WHO-MSD-MER-18.5

Problem management plus (‎‎‎‎‎‎PM+)‎‎‎‎‎‎: individual psychological ... The manual describes a scalable psychological intervention called Problem Management Plus (PM+) for adults impaired by distress in communities who are exposed ...

4. emergency.unhcr.org emergency.unhcr.org/sites/default/files/Individual%20Psychological%20Help%20for%20Adults.pdf

PROBLEM MANAGEMENT PLUS (PM+) To ensure maximum use, the intervention is developed in such a way that it can help people with depression, anxiety and stress, whether or not exposure to ...

5. researchgate.net researchgate.net/publication/389850018_Effectiveness_of_Group_Problem_Management_Plus_Among_Individuals_Experiencing_Psychological_Distress_A_Systematic_Review_and_Meta-Analysis

Effectiveness of Group Problem Management Plus Among ... Conclusion For people who experience psychological distress, Group PM+ helps improve physical functioning and minimize negative emotions. Yet, ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/mhs2.86

Peer‐provided problem management plus (PM+) and case ... The intervention consisted of Problem Management Plus (PM+) and peer case management sessions delivered by a team of Community Psychosocial ...

7. mentalhealth.bmj.com mentalhealth.bmj.com/content/26/1/e300637

Peer-provided psychological intervention for Syrian refugees PM+ effectively reduces symptoms of CMDs among Syrian refugees. A strength was high retention at follow-up. Generalisability is limited.