88 Participants Needed

Goal Management Therapy for PTSD

HM
Overseen ByHeather Millman, MA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study examines the efficacy of Goal Management Therapy (GMT) - a well-established cognitive remediation strategy aimed at improving goal-directed behaviors that are dependent on basic cognitive processes and on executive functioning - among public safety personnel with post-traumatic stress disorder.

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.

How is Goal Management Therapy different from other PTSD treatments?

Goal Management Therapy (GMT) is unique because it focuses on improving executive functions, which are mental skills that help with managing tasks and goals, rather than just addressing traumatic memories or emotions. This approach is different from traditional PTSD treatments that often focus on exposure to trauma-related memories or cognitive restructuring.12345

What data supports the effectiveness of the treatment Goal Management Therapy for PTSD?

The research suggests that trauma-focused psychotherapy, which includes cognitive behavioral therapy (CBT) and other similar approaches, is effective for treating PTSD, showing medium to large improvements in symptoms. This indicates that therapies focusing on specific goals, like Goal Management Therapy, may also be beneficial for PTSD.46789

Who Is on the Research Team?

MM

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Goal Management TherapyExperimental Treatment1 Intervention
Group II: Psychosocial EducationActive Control1 Intervention

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

🇨🇦
Approved in Canada as Goal Management Therapy for:
🇺🇸
Approved in United States as Goal Management Therapy for:

Find a Clinic Near You

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

Citations

Treating posttraumatic stress disorder with metacognitive therapy: a preliminary controlled trial. [2021]
[Attainment of generic therapy goals in a specialized group psychotherapy for phobic outpatients]. [2018]
[Establishing and changing therapeutic goals in psychiatric-psychotherapeutic treatment]. [2019]
Empirically based guidelines for goal-finding procedures in psychotherapy: Are some goals easier to attain than others? [2011]
Predictors of outcome during inpatient psychotherapy for posttraumatic stress disorder: a single-treatment, multi-site, practice-based study. [2022]
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. [2022]
An Affective Cognitive Neuroscience-Based Approach to PTSD Psychotherapy: The TARGET Model. [2020]
A pilot study of a 12-week model of group-based exposure therapy for veterans with PTSD. [2019]
Trauma-focused, present-centered, emotional self-regulation approach to integrated treatment for posttraumatic stress and addiction: trauma adaptive recovery group education and therapy (TARGET). [2018]
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