Group Therapy for Psychosocial Issues

(Group PM+ Trial)

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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Group Therapy for Psychosocial Issues?

Research shows that problem-solving therapy, when combined with other management strategies, can improve outcomes for people with depression and disability. Additionally, patient-managed problem-solving groups have been effective in increasing responsible behavior in patients with chronic mental illness. ^{1 2 3 4 5}

Is Group Problem Management Plus (PM+) safe for humans?

Group Problem Management Plus (PM+) has been used safely in various settings, including for people affected by adversity in low- and middle-income countries. It is a brief intervention delivered by non-specialists and has been evaluated for its feasibility and acceptability, indicating it is generally safe for human use. ^{6 7 8 9 10}

What makes Group Problem Management Plus (PM+) unique compared to other treatments for psychosocial issues?

Group Problem Management Plus (PM+) is unique because it combines problem-solving strategies with group therapy, allowing participants to support each other while learning practical skills to manage their issues. This approach is cost-effective and can be particularly beneficial for those who need extended support, as it leverages the social dynamics of group settings to enhance learning and motivation. ^{11 12 13 14 15}

Research Team

Maureen Lyon, PhD

Principal Investigator

Children's National Research Institute

Eligibility Criteria

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

My family caregiver is younger than 18.

My child with a rare disease is older than 21.

Family caregiver is actively suicidal, homicidal, or psychotic

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using written communication with patient groups to promote behavioral change in chronic mentally ill patients. [2019]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effects of Problem-Solving Therapy and Clinical Case Management on Disability in Low-Income Older Adults. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

[Primary psychosomatic management in general practice. Results of a German nationwide demonstration project of quality assurance]. [2008]

6. England 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. [2020]

7. United States 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. [2022]

8. England 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. [2021]

9. England 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. [2021]

10. England 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Group psychotherapy in an HMO. [2016]

12. Switzerland pubmed.ncbi.nlm.nih.gov

[Group psychotherapy in psychiatry]. [2006]

13. United States pubmed.ncbi.nlm.nih.gov

A psychotherapeutic group for men. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

A group psychotherapy model for acute treatment settings. [2015]

15. England pubmed.ncbi.nlm.nih.gov

Group Psychotherapy in Norway. [2016]