Goal Management Therapy for PTSD
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Approved in 2 Jurisdictions
Trial Summary
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.
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.12345
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.16789
Eligibility Criteria
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.
Trial Timeline
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
Treatment Details
Interventions
- Goal Management Therapy (Cognitive Remediation)
- Psychosocial Education (Behavioural Intervention)
Trial OverviewThe study tests Goal Management Therapy (GMT), a method to improve goal-directed behavior and executive functioning in those with PTSD, compared to psychosocial education.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Goal Management TherapyExperimental Treatment1 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 EducationActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Homewood Research InstituteGuelph, Canada
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Who Is Running the Clinical Trial?
Homewood Research InstituteLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
Homewood Health CentreCollaborator
St. Joseph's Healthcare HamiltonCollaborator
McMaster UniversityCollaborator
References
Treating posttraumatic stress disorder with metacognitive therapy: a preliminary controlled trial. [2021]Exposure, trauma-focused cognitive therapy and eye-movement desensitisation and re-processing (EMDR) are effective treatments for posttraumatic stress disorder (PTSD) producing equivalent outcomes. How might the field advance? One way is to base new treatments on PTSD maintenance mechanisms. A treatment that does this, metacognitive therapy (MCT), underwent preliminary controlled evaluation in this study.
[Attainment of generic therapy goals in a specialized group psychotherapy for phobic outpatients]. [2018]Individual therapy goals of psychotherapy patients either focus on symptom relief (disorder specific) or on improvements also in other functional areas (generic). The present study with 62 outpatients in a cognitive behavioral group psychotherapy (CBGT) investigated whether patients attain their disorder specific goals better than their generic therapy goals. Results indicated that patients reached disorder specific goals to a higher degree than the generic goals, although the group treatment specifically targeted the disorder specific goals. Implications of the results for the assessment and therapy of phobic patients are discussed.
[Establishing and changing therapeutic goals in psychiatric-psychotherapeutic treatment]. [2019]At the onset of psychotherapy, treatment goals are frequently not fully defined. They have to be set during treatment and can be changed in its course. An overview of the current literature on treatment goals from patients' and therapists' perspectives is given. Based on a case report of a patient suffering from panic disorder, the process of setting and changing goals and its influence on therapeutic technique and outcome are described. Finally, a case is made for the importance of "negotiations" between patient and therapist about treatment goals, which helps in building up a constructive therapeutic relationship and a helpful therapeutic process. The point in time of goal-setting, the achievability of treatment goals, and the patient's handling of unattained goals appear to be of particular significance.
Empirically based guidelines for goal-finding procedures in psychotherapy: Are some goals easier to attain than others? [2011]Abstract Treatment goals are either proposed by a patient or deduced from the case formulation of the therapist. To optimize goal-finding procedures in psychotherapy, therapists need an empirical point of reference to estimate the degree of goal attainment that can be expected for a specific treatment goal. To establish such an empirical basis, treatment goal categories of the primary treatment goals of 2,770 inpatients undergoing cognitive-behavioral therapy were categorized by the Bern Inventory of Treatment Goals. The levels of goal attainment were then compared with respect to 48 different goal categories. The results indicate that goal attainment differs according to treatment goal categories, even if confounding characteristics of the patient are controlled for.
Predictors of outcome during inpatient psychotherapy for posttraumatic stress disorder: a single-treatment, multi-site, practice-based study. [2022]Objective: The aims of this study were to determine the effectiveness of a routine clinical care treatment and to identify predictors of treatment outcome in PTSD inpatients. Methods: A routinely collected data set of 612 PTSD inpatients (M = 42.3 years [SD = 11.6], 75.7% female) having received trauma-focused psychotherapy was analyzed. Primary outcome was the clinical symptom severity change score, secondary outcomes were assessed using functional, anxiety, and depression change scores. Hedges g-corrected pre-post effect sizes (ES) were computed for all outcomes. Elastic net regulation as a data-driven, stability-based machine-learning approach was used to build stable clinical prediction models. Results: Hedges g ES indicated medium to large effects on all outcomes. The results of the predictor analyses suggested that a combined predictor model with sociodemographic, clinical, and psychometric variables contribute to predicting different treatment outcomes. Across the clinical and functional outcome, psychoticism, total number of diagnoses, and bronchial asthma consistently showed a stable negative predictive relationship to treatment outcome. Conclusion: Trauma-focused psychotherapy could effectively be implemented in a routine inpatient setting. Some important prognostic variables could be identified. If the proposed models of predictors are replicated, they may help personalize treatment for patients receiving routine clinical care.
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]Research suggests the use of different forms of therapy as a way of decreasing dropout rates in the treatment of post-traumatic stress disorder (PTSD). The psychotherapies to be assessed in this study are trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP) and positive psychotherapy (PPT).
An Affective Cognitive Neuroscience-Based Approach to PTSD Psychotherapy: The TARGET Model. [2020]Adaptations or alternative versions of cognitive psychotherapy for posttraumatic stress disorder (PTSD) are needed because even the most efficacious cognitive or cognitive-behavioral psychotherapies for PTSD do not retain or achieve sustained clinically significant benefits for a majority of recipients. Cognitive affective neuroscience research is reviewed which suggests that it is not just memory (or memories) of traumatic events and related core beliefs about self, the world, and relationships that are altered in PTSD but also memory (and affective information) processing A cognitive psychotherapy is described that was designed to systematically make explicit these otherwise implicit trauma-related alterations in cognitive emotion regulation and its application to the treatment of complex variants of PTSD-Trauma Affect Regulation: Guide for Education and Therapy (TARGET). TARGET provides therapists and clients with (a) a neurobiologically informed strengths-based meta-model of stress-related cognitive processing in the brain and how this is altered by PTSD and (b) a practical algorithm for restoring the executive functions that are necessary to make implicit trauma-related cognitions explicit (i.e., experiential awareness) and modifiable (i.e., planful refocusing). Results of randomized clinical trial studies and quasi-experimental effectiveness evaluations of TARGET with adolescents and adults are reviewed.
A pilot study of a 12-week model of group-based exposure therapy for veterans with PTSD. [2019]Group-based exposure therapy (GBET) is an intensive group treatment that targets posttraumatic stress disorder (PTSD) symptoms through repeated imaginal and in vivo exposure. The purpose of the present study was to assess the feasibility and acceptability of a modified 12-week course of GBET (modified from the standard 16 weeks) and to examine its effectiveness in reducing veterans' PTSD symptoms. Participants were 10 male Operation Iraqi Freedom and Vietnam-era veterans recruited from a PTSD specialty clinic at a large Veterans Affairs Medical Center. All participants were retained and demonstrated clinically significant reductions in PTSD symptoms (η(2) = .84-.87) comparable to the standard protocol. The findings from this small sample indicate that the abbreviated 12-week GBET protocol is a potentially effective treatment for PTSD.
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]We describe the rationale and procedures for a trauma-focused, present-centered, emotion self-regulation modelfor concurrent treatment of posttraumatic stress disorder (PTSD) and substance use disorders: Trauma Adaptive Recovery Group Education and Therapy (TARGET). Based on a review of the clinical and research literatures relevant to models of psychotherapy for co-occurring PTSD and addiction, we develop a conceptual model and describe a skill set that has been operationalized in TARGET. Clinical vignettes with challenging cases are provided to illustrate the application of the TARGET model in individual and group psychotherapy of co-occurring PTSD and addiction.