Goal Management Therapy for PTSD

Overseen By Heather Millman, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Homewood Research Institute

Must not be taking: Anticholinergics, Antipsychotics, Psychostimulants, Benzodiazepines

Disqualifiers: Substance dependence, Head trauma, Neurological disorder, Psychotic disorder, Bipolar, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Goal Management Therapy (GMT) for public safety personnel with PTSD, a condition that can cause distressing memories and anxiety. GMT is a program designed to improve focus and planning skills through mindfulness and practice. Participants will be compared to a group receiving psychosocial education, which includes information on brain function and lifestyle tips. The trial seeks individuals diagnosed with PTSD who can provide consent and are not currently on certain medications or have recent substance abuse issues. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance PTSD treatment options.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, such as anti-cholinergics, anti-psychotic medication, psychostimulants, and benzodiazepines, to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Goal Management Therapy (GMT) is generally well-tolerated by participants. Past studies have found that GMT helps improve symptoms in people with PTSD and cognitive issues without causing serious side effects. Participants often engage in mindfulness activities, which have been linked to improvements in PTSD symptoms such as depression.

Although specific data on negative effects isn't provided, the absence of reported serious problems suggests GMT is safe for most people. As a non-drug therapy, GMT focuses on training the brain to manage and achieve goals, typically presenting fewer risks compared to treatments involving medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Goal Management Therapy (GMT) for PTSD because it brings a unique approach to treatment, focusing on cognitive remediation and mindfulness, unlike traditional therapies that often rely on medication or talk therapy alone. GMT is designed to help patients regain control over their actions by teaching them how to manage goals and monitor their progress in real-time, addressing executive function deficits commonly seen in PTSD. This method promises a structured way to improve daily functioning and personal goal achievement for patients, offering a potentially transformative impact on their quality of life. Additionally, GMT's emphasis on real-life application and homework assignments helps reinforce the skills learned, providing patients with practical tools to manage their symptoms effectively.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Goal Management Therapy (GMT), a treatment in this trial, may benefit people with PTSD. A small initial study found that GMT improved thinking problems and reduced PTSD symptoms. Another study confirmed that GMT helped with thinking difficulties related to PTSD. GMT is a structured program designed to enhance goal-setting and decision-making, areas often impacted by PTSD. Participants learn to pause, take control of their actions, set goals, and track their progress. Overall, GMT has demonstrated potential in improving both mental processes and PTSD symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Margaret McKinnon, PhD

Principal Investigator

McMaster University, St. Joseph's Healthcare Hamilton, Homewood Research Institute

Are You a Good Fit for This Trial?

This trial is for public safety personnel who have been diagnosed with PTSD using the CAPS scale and can give written consent. It's not specified who cannot participate, so additional exclusion criteria may apply.

Inclusion Criteria

I have been diagnosed with PTSD by a professional.

You can give permission in writing to take part in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 - Treatment

Inpatients attend 6 sessions of Goal Management Therapy and 6 sessions of psychosocial education, twice per week for 3 weeks.

3 weeks

6 visits (in-person)

Phase 2 - Treatment

Outpatients attend 9 sessions of Goal Management Therapy and 9 sessions of psychosocial education, once per week for 9 weeks.

9 weeks

9 visits (in-person)

Phase 3 - Treatment and fMRI

Outpatients attend 9 sessions of Goal Management Therapy and 9 sessions of psychosocial education, with fMRI scans to investigate neurobiological changes.

9 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Goal Management Therapy
• Psychosocial Education

Trial Overview The study tests Goal Management Therapy (GMT), a method to improve goal-directed behavior and executive functioning in those with PTSD, compared to psychosocial education.

How Is the Trial Designed?

Group I: Goal Management Therapy Experimental Treatment 1 Intervention

Goal Management Therapy is a structured, short-term, present-oriented cognitive remediation program with emphasis on mindfulness and practice in planning and completion of goal-oriented behaviors. The primary objective of GMT is to train patients to interrupt ongoing behavior through the resumption of executive control in order to define goal hierarchies and monitor performance in achieving goals. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments. Phase 1: Inpatients will attend group sessions twice per week for 3 weeks, each session being 2 hours in length. Phase 2: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length. Phase 3: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length.

Group II: Psychosocial Education Active Control 1 Intervention

Psychosocial education will provide participants with educational materials (e.g., brain function, neuroplasticity) and lifestyle interventions (e.g., sleep hygiene, stress, exercise). They will be matched for length and for amount of facilitator contact with the Goal Management Therapy sessions. Phase 1: Inpatients will attend group sessions twice per week for 3 weeks, each session being 2 hours in length. Phase 2: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length. Phase 3: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length.

Goal Management Therapy is already approved in Canada, United States for the following indications:

Approved in Canada as Goal Management Therapy for:

• Post-traumatic stress disorder (PTSD) in public safety personnel

Approved in United States as Goal Management Therapy for:

• Cognitive remediation for PTSD
• Executive functioning improvement

Who Is Running the Clinical Trial?

Homewood Research Institute

Lead Sponsor

Trials

2

Recruited

140+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Homewood Health Centre

Collaborator

Trials

2

Recruited

140+

St. Joseph's Healthcare Hamilton

Collaborator

Trials

203

Recruited

26,900+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Metacognitive therapy (MCT) significantly reduced PTSD symptoms, depression, and anxiety in a study of 20 participants, with 80% achieving clinically significant recovery after an average of 6.4 sessions.

The treatment was well tolerated, with only one participant dropping out, and the positive effects were maintained during follow-ups at 3 and 6 months, suggesting MCT could be a promising new approach for PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating posttraumatic stress disorder with metacognitive therapy: a preliminary controlled trial. Wells, A., Colbear, JS.[2021]

In a study involving 62 outpatients undergoing cognitive behavioral group therapy (CBGT), patients achieved their disorder-specific therapy goals more effectively than their generic goals.

The results suggest that focusing on specific symptoms in therapy may lead to better outcomes for patients, particularly those with phobias, highlighting the importance of tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Attainment of generic therapy goals in a specialized group psychotherapy for phobic outpatients]. Trachsel, M., Itten, S., Stauffer, B., et al.[2018]

Effective psychotherapy often requires ongoing negotiations between patients and therapists to define and adjust treatment goals, which can enhance the therapeutic relationship and process.

The timing of goal-setting, the feasibility of these goals, and how patients cope with unmet goals are crucial factors that influence the success of therapy, as illustrated by a case report of a patient with panic disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Establishing and changing therapeutic goals in psychiatric-psychotherapeutic treatment]. Hasler, G., Schnyder, U.[2019]

Cognitive psychotherapy adaptations are necessary for treating PTSD, as traditional methods often fail to provide lasting benefits for most patients.

The TARGET approach offers a neurobiologically informed framework that helps therapists and clients understand and modify trauma-related cognitive processes, showing promise in randomized clinical trials and effectiveness evaluations with both adolescents and adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Affective Cognitive Neuroscience-Based Approach to PTSD Psychotherapy: The TARGET Model. Ford, J.[2020]

A randomized clinical trial involving 135 patients will compare the online efficacy of trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP), and positive psychotherapy (PPT) in reducing PTSD symptoms during the COVID-19 pandemic.

The study aims to show that all three therapies can effectively reduce PTSD symptoms, anxiety, and depression, with no significant differences expected among them, highlighting the potential for flexible online treatment options for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial to Assess the Efficacy of Online-Treatment with Trial-Based Cognitive Therapy, Mindfulness-Based Health Promotion and Positive Psychotherapy for Post-Traumatic Stress Disorder during the COVID-19 Pandemic: A Study Protocol. Duran, ÉP., Hemanny, C., Vieira, R., et al.[2022]

A study involving 2,770 inpatients undergoing cognitive-behavioral therapy found that the level of goal attainment varies significantly across different treatment goal categories.

This research highlights the importance of categorizing treatment goals to provide therapists with empirical data, helping them set realistic expectations for patient outcomes based on specific goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empirically based guidelines for goal-finding procedures in psychotherapy: Are some goals easier to attain than others? Berking, M., Grosse Holtforth, M., Jacobi, C., et al.[2011]

Trauma-focused psychotherapy for 612 PTSD inpatients showed medium to large effects on symptom severity, anxiety, and depression, indicating its effectiveness in a routine clinical setting.

Predictors such as psychoticism, total number of diagnoses, and bronchial asthma were identified as negative indicators of treatment outcomes, suggesting that these factors could help personalize therapy for better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of outcome during inpatient psychotherapy for posttraumatic stress disorder: a single-treatment, multi-site, practice-based study. Herzog, P., Voderholzer, U., Gärtner, T., et al.[2022]

A modified 12-week group-based exposure therapy (GBET) for PTSD was tested on 10 male veterans, showing that all participants completed the program and experienced significant reductions in PTSD symptoms.

The effectiveness of the 12-week GBET was comparable to the standard 16-week protocol, suggesting that a shorter treatment duration may still be beneficial for veterans with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of a 12-week model of group-based exposure therapy for veterans with PTSD. Sutherland, RJ., Mott, JM., Lanier, SH., et al.[2019]

The TARGET model is a new approach designed to treat both posttraumatic stress disorder (PTSD) and substance use disorders simultaneously, focusing on trauma and emotion self-regulation.

The model is based on extensive research and clinical literature, providing a structured skill set for therapists to use in both individual and group therapy settings, which is illustrated through real-life case examples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused, present-centered, emotional self-regulation approach to integrated treatment for posttraumatic stress and addiction: trauma adaptive recovery group education and therapy (TARGET). Ford, JD., Russo, E.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8946598/

A Pilot Randomized Controlled Trial of Goal Management ... The results of this pilot RCT show promise that GMT may be a useful intervention to improve symptoms of cognitive dysfunction, symptoms of PTSD, and symptoms ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04457271

Goal Management Training in Individuals With PTSD This study will evaluate the effect of a manualized treatment (Goal Management Training, or GMT) on the cognitive impairments associated with PTSD.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7219918/

An Open-Label Feasibility Trial Examining the ... The current study investigated the efficacy of an established cognitive remediation program, Goal Management Training (GMT), in improving cognitive functioning.

4. utppublishing.com utppublishing.com/doi/full/10.3138/jmvfh-2023-0003

Evaluating the implementation of virtual Goal Management ... In addition, previous research indicates that participation in mindfulness activities is associated with improvements in PTSD symptoms such as depression, ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/224398

Investigating the Use of Goal Management Therapy in ... This study examines the efficacy of Goal Management Therapy (GMT) - a well-established cognitive remediation strategy aimed at improving goal-directed ...

6. mdpi.com mdpi.com/2076-3425/12/7/864

A Pilot Study Assessing the Effects of Goal Management ... A pilot study assessing the effects of goal management training on cognitive functions among individuals with major depressive disorder.