PATH vs PMR for PTSD and Depression

Recruiting at 2 trial locations

Overseen By Noni Shemenski, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Psychotropics

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for individuals with PTSD or depression following a major life event, such as a significant loss or threat. It compares Positive Processes and Transition to Health (PATH), which emphasizes positive life events and emotions, with Progressive Muscle Relaxation (PMR), which involves muscle tightening and relaxation to reduce stress. The trial aims to assess how these treatments impact PTSD and depression symptoms. Ideal participants have experienced a destabilizing event in the past five years and continue to face stress-related symptoms. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for PTSD and depression.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that your dose of psychotropic medications has been stable for the past 3 months.

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

Research has shown that both treatments, PATH and PMR, are safe based on past studies. Earlier research on PATH has been positive, indicating that this therapy might help reduce symptoms of PTSD and depression. The studies reviewed reported no serious side effects.

For PMR, studies have found it effective in promoting relaxation and improving mental health. Previous studies reported no major health issues during or immediately after the sessions. Participants also experienced better sleep and less anxiety.

Overall, existing research suggests that both PATH and PMR are well-tolerated, making them safe options for those considering joining a clinical trial for PTSD and depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Positive Processes and Transition to Health" (PATH) approach for PTSD and depression because it focuses on enhancing positive emotions and life events, which is different from standard treatments that typically target reducing negative symptoms. Unlike typical therapies that often center on managing distress, PATH emphasizes cultivating positive experiences and resilience, promoting a more balanced emotional outlook. On the other hand, Progressive Muscle Relaxation (PMR) stands out by teaching individuals to consciously relax their muscles, shifting focus from emotional processing to physical relaxation and stress reduction. While standard options like cognitive-behavioral therapy and medication focus on symptom reduction, these methods offer innovative ways to enhance well-being and resilience.

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

This trial will compare the Positive Processes and Transition to Health (PATH) program with Progressive Muscle Relaxation (PMR) for reducing symptoms of PTSD and depression. Research has shown that the PATH program, which participants in this trial may receive, can help reduce symptoms by focusing on positive experiences and emotions, thereby boosting mental health and resilience. Meanwhile, PMR, another treatment option in this trial, lowers stress and tension by tightening and relaxing different muscle groups. Studies have shown that PMR can reduce depression symptoms and improve overall well-being. Both treatments have potential for helping those with PTSD and depression, but they work in different ways. ^{1 2 3 4 6}

Who Is on the Research Team?

Norah Feeny, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

The PATH trial is for adults aged 18-65 who have experienced a significant life event causing loss or threat within the last 5 years and are dealing with PTSD or depression. Participants should show moderate symptoms in at least two of three areas: re-experiencing, avoidance, or reward deficits. Those with severe mental health conditions like bipolar disorder, psychosis, recent self-harm, substance abuse disorders, or unstable medication use cannot join.

Inclusion Criteria

You have experienced a life-altering event such as loss or threat within the past 5 years, lasting at least 3 months.

I often relive or avoid thoughts of a traumatic event and feel less pleasure in life.

Exclusion Criteria

You have engaged in severe self-injury or attempted suicide in the past three months.

I have been diagnosed with schizophrenia, delusional disorder, or an organic mental disorder.

You are currently diagnosed with a substance use disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PATH or PMR in six 60-90 minute weekly sessions, with two booster sessions for partial responders

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for changes in PTSD and depressive symptoms at 1- and 3-month follow-ups

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Positive Processes and Transition to Health
• Progressive Muscle Relaxation

Trial Overview This study tests the Positive Processes and Transition to Health (PATH) program against Progressive Muscle Relaxation (PMR) in helping individuals cope with stress-related symptoms from PTSD and depression. Each participant will receive six sessions of either PATH or PMR therapy to see which is more effective at improving mental health outcomes.

How Is the Trial Designed?

Group I: Positive Processes and Transition to Health (PATH) Experimental Treatment 1 Intervention

PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.

Group II: Progressive Muscle Relaxation (PMR) Active Control 1 Intervention

PMR will be adapted from Berstein, Borkoveck, and Hazlett- Stevens (2000). PMR will be conducted in six, 60-90 min individual weekly sessions with a study therapist. Muscle groups are tightened and then relaxed with the attention of the patient focused on the contrast between tension and relaxation. Through regular practice, the person becomes more aware of tension in the body and can induce relaxation as needed (Field, 2009). During the six sessions of training, patients will be encouraged to practice PMR and learn how to deliberately induce physical relaxation to reduce stress and mental tension. Sessions will move from relaxation of 16-muscle groups to 7 muscle groups, 4 muscle groups, and finally to relaxation by recall. Patients will be instructed to practice daily, if possible, but at least two or three times a week, and to integrate the practice into their daily life. They will be provided with audio recordings and homework reporting forms to assist their home PMR exercises.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 53 adults with PTSD undergoing cognitive processing therapy (CPT), dropout rates were significantly higher (39.7%) compared to written exposure therapy (6.4%), indicating a need to address factors influencing treatment retention.

The research identified that higher levels of physiological distress and cognitive emotional processing were associated with lower dropout rates, while avoidance behaviors predicted higher dropout, suggesting that targeting these factors early in treatment could improve engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of dropout in cognitive processing therapy for PTSD: An examination of in-session treatment processes. Shayani, DR., Canale, CA., Sloan, DM., et al.[2023]

In individuals with PTSD, the periaqueductal gray (PAG) shows stronger functional connectivity with the default mode network (DMN) during trauma-related stimulus processing compared to healthy individuals, indicating altered brain function associated with self-related processes.

The study found that the PAG has increased excitatory connectivity to key areas of the DMN (precuneus and medial prefrontal cortex) in PTSD patients, suggesting that these changes may contribute to the clinical symptoms experienced during trauma-related processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The hijacked self: Disrupted functional connectivity between the periaqueductal gray and the default mode network in posttraumatic stress disorder using dynamic causal modeling. Terpou, BA., Densmore, M., Théberge, J., et al.[2021]

The study evaluated a new psychophysiological measure, psychophysiological reactivity to script-driven imagery (SDI-PR), in diagnosing PTSD, involving 36 participants over an initial visit and a follow-up after 6 months.

SDI-PR demonstrated strong stability and convergent validity with the established Clinician-Administered PTSD Scale (CAPS), suggesting it could serve as a reliable adjunctive tool for diagnosing PTSD by capturing underlying physiological responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychophysiological assessment of PTSD: a potential research domain criteria construct. Bauer, MR., Ruef, AM., Pineles, SL., et al.[2019]

In a randomized controlled trial of written exposure treatment for PTSD, initial physiological arousal was linked to treatment outcomes, indicating that how a person reacts physically at the start can influence their recovery.

However, changes in physiological arousal during and between therapy sessions did not correlate with treatment gains, suggesting that self-reported feelings of arousal may be more important for understanding the effectiveness of exposure therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of Change in Written Exposure Treatment of Posttraumatic Stress Disorder. Wisco, BE., Baker, AS., Sloan, DM.[2022]

In a study of 47 veterans with PTSD, Mindfulness-Based Stress Reduction (MBSR) did not show reliable effects on PTSD or depression symptoms compared to treatment as usual, although it did improve mental health-related quality of life immediately after treatment.

Veterans who attended at least 4 MBSR classes experienced medium to large improvements in depression, mental health-related quality of life, and mindfulness skills, suggesting that participation in MBSR may lead to meaningful benefits for some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of participation in a mindfulness program for veterans with posttraumatic stress disorder: a randomized controlled pilot study. Kearney, DJ., McDermott, K., Malte, C., et al.[2021]

The 3MDR intervention effectively engages veterans with treatment-resistant PTSD by facilitating the processing of traumatic memories, leading to positive changes such as increased self-understanding and emotional regulation, even if not all participants experienced symptom improvement.

Veterans reported unique aspects of 3MDR, such as walking towards trauma-related images, which contributed to their treatment experience, suggesting that the intervention may provide benefits beyond just reducing PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived treatment processes and effects of interactive motion-assisted exposure therapy for veterans with treatment-resistant posttraumatic stress disorder: a mixed methods study. van Gelderen, MJ., Nijdam, MJ., Dubbink, GE., et al.[2021]

In a study of 390 PTSD patients treated with sertraline or paroxetine over 12 weeks, both medications showed better outcomes than placebo, but individual responses varied based on factors like gender and trauma history.

The research identified three distinct response classes among patients: fast responders, those with low pretreatment symptom severity, and those with high pretreatment severity, suggesting that longer time since trauma may enhance treatment benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and trajectories of treatment response to SSRIs in patients suffering from PTSD. Nøhr, AK., Eriksson, H., Hobart, M., et al.[2022]

A study of 2686 veterans with PTSD revealed five distinct treatment response trajectories, indicating that severity of PTSD at intake significantly influences treatment outcomes, with some experiencing minimal change and others showing substantial improvement.

Depression and guilt were identified as key predictors of treatment response, suggesting that addressing these issues before starting PTSD therapy could enhance treatment effectiveness, especially for those with severe PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key patterns and predictors of response to treatment for military veterans with post-traumatic stress disorder: a growth mixture modelling approach. Phelps, AJ., Steel, Z., Metcalf, O., et al.[2018]

In a study involving 20 PTSD patients and 20 matched trauma-exposed controls, it was found that both groups exhibited similar functional and anatomical connectivity patterns in the default mode network (DMN), suggesting that these brain mechanisms are affected by trauma regardless of PTSD diagnosis.

The study revealed that the integrity of specific brain regions in the DMN correlated strongly with the severity of PTSD symptoms, indicating that both anatomical and functional connectivity are important in understanding the disorder, and that trauma type and timing can further influence these connectivity patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical and functional connectivity in the default mode network of post-traumatic stress disorder patients after civilian and military-related trauma. Reuveni, I., Bonne, O., Giesser, R., et al.[2022]

In a study of 215 breast cancer patients undergoing chemotherapy, higher levels of posttraumatic stress symptoms (PTSS), particularly hyperarousal, were linked to increased sleep disturbance and fatigue over time.

The findings suggest that addressing PTSS and sleep disturbances early in cancer treatment could help prevent fatigue, highlighting the importance of early intervention in managing these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do posttraumatic stress symptoms predict trajectories of sleep disturbance and fatigue in patients with breast cancer? A parallel-process latent growth model. Shim, EJ., Jeong, D., Jung, D., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06093906

Positive Processes and Transition to Health (PATH) Evidence-based psychotherapies for posttraumatic stress disorder (PTSD) and depression consistently produce strong, clinically meaningful effects for many ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06093906/positive-processes-and-transition-to-health-path?state=DE&city=Neward

Positive Processes and Transition to Health (PATH) This study will examine Positive Processes and Transition to Health (PATH)'s impact on stressor-related psychopathology in comparison to Progressive Muscle ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06900712

NCT06900712 | Positive Processes and Transition to Health This study will be an open trial to determine if PATH-SS reduces stressor-related symptoms of PTSD and/or depression after sexual assault in a sample of 45 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10174277/

Positive Affect Processes and Posttraumatic Stress ... Findings suggest that PPMT may relate to improved PTSD symptoms; and that positive affect levels/dysregulation may be worthwhile targets for future ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38866094/

A protocol for a pragmatic comparative effectiveness trial ... This protocol paper describes a pragmatic trial that compares outcomes of primary care patients randomized to initially receive a brief trauma-focused ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9188831/

The relationship between post-traumatic stress and positive ... Out of 653 participants, 39.8% received a provisional PTSD diagnosis; 33.4% reported flourishing, 57.7% moderate, and 8.9% languishing mental ...