Group Therapy for Psychosocial Issues
(Group PM+ Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's National Research Institute
Disqualifiers: Suicidal, Homicidal, Psychotic, Impaired, others
No Placebo Group
Approved in 7 Jurisdictions
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.
12345Is 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.
678910What 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.
1112131415Eligibility 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
+1 more
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
+2 more
Trial 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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Rare Group PM PlusExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's National HospitalWashington, United States
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Who Is Running the Clinical Trial?
Children's National Research InstituteLead Sponsor
Travere Therapeutics, Inc.Industry Sponsor
References
Using written communication with patient groups to promote behavioral change in chronic mentally ill patients. [2019]Patient-managed problem-solving groups have been used in inpatient settings to increase the responsible activity of patients with chronic mental illness. In a study using a repeated measures design, staff prepared written notes describing patients' adherence to programmatic expectations and submitted them to patient-managed problem-solving groups, which recommended consequences for patients' behavior. The intervention increased the frequency of targeted behavior compared with the frequency of the behavior during baseline periods. The authors suggest that this procedure may be applied to a variety of behaviors in other treatment settings.
Clinical Case Management versus Case Management with Problem-Solving Therapy in Low-Income, Disabled Elders with Major Depression: A Randomized Clinical Trial. [2022]To test the hypotheses that (1) clinical case management integrated with problem-solving therapy (CM-PST) is more effective than clinical case management alone (CM) in reducing depressive symptoms of depressed, disabled, impoverished patients and that (2) development of problem-solving skills mediates improvement of depression.
Effects of Problem-Solving Therapy and Clinical Case Management on Disability in Low-Income Older Adults. [2018]To test the following hypotheses: (1) Clinical case management integrated with problem-solving therapy (CM-PST) is more effective than clinical case management alone (CM) in improving functional outcomes in disabled, impoverished patients and (2) improvement in depression, self-efficacy, and problem-solving skills mediates improvement of disability.
Matching clients to group therapies based on psychological readiness. [2013]In both inpatient and outpatient settings, there are diverse theoretical approaches, psychosocial programs, and formats for providing group therapies to those with psychological problems. A strategic approach for determining client readiness and "what to do when" may organize the various approaches and increase participation, the number of individuals who respond to therapy, and the extent to which individuals respond. This article describes the application of a conceptual, phase-specific model that was implemented within the outpatient and inpatient settings of a state psychiatric facility to enhance alignment between group interventions and individual psychological state. Specific psychological factors for assigning clients to three general phases, as well as the general types of interventions appropriate for each phase, are described. This heuristic model can be used to integrate the diverse approaches to group treatment currently in use and to better tailor group interventions to individuals.
[Primary psychosomatic management in general practice. Results of a German nationwide demonstration project of quality assurance]. [2008]In the frame of a national demonstration program, psychosocial care of patients with psychological and psychosomatic problems were assessed. General practitioners (n = 191) from six regions participated in the study. 1341 treatment episodes of patients with predominately psychosocial symptoms were documented. Anxiety (62%), depression (51%) and marital/family conflicts (44%) were the most frequent symptoms. Somatic treatment and psychosocial intervention were offered equally. Patients with psychosocial treatment achieved better results. Partners and family members were rarely integrated into therapy. The procedures employed to improve outcome were quality circles, family-orientated case conferences, consultation services and collaborative groups.
Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal. [2020]Psychological interventions that are brief, acceptable, effective and can be delivered by non-specialists are especially necessary in low- and middle-income countries, where mental health systems are unable to address the high level of psychosocial needs. Problem Management Plus (PM+) is a five-session intervention designed for those impaired by psychological distress while living in communities affected by adversity. Individual PM+ has demonstrated effectiveness in reducing distress in Kenya and Pakistan, and a group version of PM+ (Group PM+) was effective for conflict-affected women in Pakistan. This paper describes a feasibility and acceptability trial of locally adapted Group PM+ for women and men in an earthquake-affected region of rural Nepal.
Residual posttraumatic stress disorder symptoms after provision of brief behavioral intervention in low- and middle-income countries: An individual-patient data meta-analysis. [2022]To address shortages of mental health specialists in low- and middle-income countries, task-shifting approaches have been employed to train nonspecialists to deliver evidence-based scalable psychosocial interventions. Problem Management Plus (PM+) is a brief transdiagnostic nontrauma focused intervention for people affected by adversity. This study reports on the capacity of PM+ to address specific symptoms of posttraumatic stress disorder (PTSD).
Lay-therapist-delivered, low-intensity, psychosocial intervention for refugees and asylum seekers (PROSPER): protocol for a pilot randomised controlled trial. [2021]Asylum seekers and refugees (AS&Rs) experience impaired mental health and wellbeing, related to stresses in their country of origin, experiences in transit and reception on arrival, including significant barriers to accessing mainstream services. Their contact with health care is often crisis-driven and mediated through non-governmental organisations (NGOs). Problem Management Plus (PM+) is a psychosocial intervention recommended by the World Health Organisation to address distress experienced by adults affected by humanitarian crises. We are investigating its application for the first time in a high-income country.
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]Globally, the lack of availability of psychological services for people exposed to adversities has led to the development of a range of scalable psychological interventions with features that enable better scale-up. Problem Management Plus (PM+) is a brief intervention of five sessions that can be delivered by non-specialists. It is designed for people in communities in low- and middle-income countries (LMIC) affected by any kind of adversity. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the effectiveness of individually delivered PM+. A group version of PM+ has been developed to make the intervention more scalable and acceptable. This paper describes the protocol for a cluster randomized controlled trial (c-RCT) on locally adapted Group PM+ in Nepal.
A qualitative evaluation of a brief multicomponent intervention provided by lay health workers for women affected by adversity in urban Kenya. [2022]Problem Management Plus (PM+) is a brief multicomponent intervention incorporating behavioral strategies delivered by lay health workers. The effectiveness of PM+ has been evaluated in randomized controlled trials in Kenya and Pakistan. When developing interventions for large-scale implementation it is considered essential to evaluate their feasibility and acceptability in addition to their efficacy. This paper discusses a qualitative evaluation of PM+ for women affected by adversity in Kenya.
Group psychotherapy in an HMO. [2016]Group psychotherapy is often the treatment of choice with appropriate patients, because of its clinical utility and efficacy as well as possible cost-effectiveness. Common elements of short-term group therapy are reviewed, and different forms of group therapy practiced within the HMO context are discussed. Attention is also called to the value of group therapy for providing cost-sensitive treatment to more chronically impaired psychiatric patients who may require extended supportive care. The relationship between various health care delivery structures (staff/group versus IPA/PPO models) and the provision of group treatments is emphasized, as is the importance of developing a group therapy program as part of a comprehensive mental health service.
[Group psychotherapy in psychiatry]. [2006]Psychiatry has learned to regard the human being not only as an individual but as a social being. Accordingly, group psychotherapy has come increasingly to the fore in recent years and decades. In general the term "group psychotherapy" means simultaneous psychotherapy of a number of patients by one or two therapists. Sociological-interactional-horizontal and deep psychological-motivational-vertical components combine in the therapeutic group to produce a resultant. Insight into unconscious motivations and social learning are stimulated in the therapeutic group. Through group psychotherapy, which can be administered as a treatment method alone or in combination with other therapies, inpatients and outpatients experience a framework which activates former experiences of collective life situations, e.g. in the family, and social valencies. Irrespective of the method of group psychotherapy (activity group psychotherapy, directive-suggestive group psychotherapy, group analysis, psychodrame or one of the accelerating methods) the group should always be group- and not leader-centered. Hitherto published results of group psychotherapy show that the treatment depends much more on the therapeutic commitment of the therapist (moderator, facilitator) than on the psychotherapeutic school to which the belongs.
A psychotherapeutic group for men. [2019]Little has been written on group therapy designed to treat a group of all male patients. A group of male outpatients followed in individual psychotherapy were identified who shared several personality traits and faced similar psychosocial problems. These patients were 20 to 40 years old, unmarried, the majority unemployed and lacking heterosexual relationships. This report examines characteristics of these patients, themes arising during group sessions, aspects of group composition, techniques used in therapy and the outcome of various patients after six months of therapy.
A group psychotherapy model for acute treatment settings. [2015]Traditional models of group psychotherapy have become less applicable in inpatient and partial hospital programs as the lengths of stay in these programs have decreased. Shorter lengths of stay are associated with rapid changes in group membership and high levels of symptoms among group members. The clinical objectives and clinical techniques suggested by traditional group models are simply less relevant under these conditions. In this paper the authors outline a model of group psychotherapy designed to meet the needs of acutely ill patients and accommodate to the demands of the short-term acute-care setting. Drawing on previous research that has identified the therapeutic factors that operate in these groups, the authors offer specific recommendations regarding group structure, therapist role, and clinical technique.
Group Psychotherapy in Norway. [2016]This paper gives an overview of group psychotherapy in Norway: the history, approaches in use, programs for systematic training, how group services are financed, and finally how practice and research are integrated in the public mental health system.