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Behavioral Intervention

PATH vs PMR for PTSD and Depression

N/A

Recruiting

Led By Norah Feeny, PhD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Elevated target: Scores of at least moderate (1 or higher) on at least 2 of the 3 target mechanisms: re- experiencing or ruminative processing of the destabilizing event (PSS-I items: 1, 2, 3, 4 or QIDS-C item 11), avoidance (PSS-I items 6, 7, 8), or reward deficits (PSS-I items 12, 13, or QIDS-C item 13)

Between the ages of 18 and 65

Must not have

Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by DSM-5

Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline score at 6 weeks (immediately post treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help 135 people w/ PTSD & depression by studying 2 treatments: PATH & PMR, to see which is more effective. Targets assessed before, during & after treatment, plus 2 boosters if needed.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves psychological therapies rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing traumatic events during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently diagnosed with severe depression or bipolar disorder.

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I cannot or will not stop my current psychotherapy.

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My mental health medication dose has been stable for the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline score at 6 weeks (immediately post treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline score at 6 weeks (immediately post treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline score at 6 weeks (immediately post treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Affective Updating Task

Idiographic Behavioral Approach Task

Probabilistic Reward Task

Secondary study objectives

Behavioral Activation for Depression Scale

Posttraumatic Cognitions Inventory

Snaith-Hamilton Pleasure Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Positive Processes and Transition to Health (PATH)Experimental Treatment1 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 Control1 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.

0 / 6Eligibility criteria met