Positive Processes and Transition to Health
Condition: Major Depressive Disorder; Post Traumatic Stress Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The R61 will be an open trial to determine if Positive Processes and Transition to Health
      (PATH) engages the proposed targets: unproductive processing, avoidance, and reward deficits
      in a sample of 45 adults who have experienced a destabilizing life event involving profound
      loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and
      are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, will
      examine whether patients perceive PATH as helpful and complete/adhere to treatment, and
      therapist fidelity. Patients will receive 6 sessions of PATH (with 2 boosters, if partial
      responders). Primary targets will be assessed at pre-treatment, week 4, post-treatment, and
      at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment,
      post-treatment, and at 1- and 3-month follow-ups.
    

Detailed description: 
      Evidence-based psychotherapies for posttraumatic stress disorder (PTSD) and depression
      consistently produce strong, clinically meaningful effects for many individuals. However,
      these interventions also have significant dropout rates, a large minority of individuals
      continue to have debilitating symptoms, and even those who respond may be vulnerable to
      relapse upon future stressors. More efficient and mechanistically precise interventions are
      needed. Consistent with the cross-cutting theme of studying the role of the environment in
      the NIMH Strategic Plan, the etiological role of exposure to destabilizing, stressful life
      events is common to both PTSD and depression. Not only do they share common distress-related
      triggers, symptoms, and maintaining processes, but they also commonly co-occur (upwards of
      60%). Current PTSD and depression treatments typically focus on their respective disorders
      rather than on common processes that maintain psychopathology; and, importantly, they do not
      explicitly target positive adaptive processes associated with resilience. Decades of
      experimental studies, prospective studies, and psychotherapy trials have identified
      interconnected maladaptive and adaptive processes associated with persistent psychopathology
      after stressful, destabilizing events. These maladaptive processes include: 1) unproductive
      event processing; 2) avoidance; and 3) reward sensitivity and processing deficits. These
      processes prolong negative mood, interfere with adaptive coping and processing of emotional
      material, and increase sensitivity to future stressful life events. PATH (Positive Processes
      and Transition to Health) directly targets these maladaptive processes while also teaching
      parallel adaptive skills (constructive processing, approach, and positive emotion processing
      and reward seeking). Six, 90-min sessions target individuals who have experienced a
      destabilizing life event and have persistent stressor-related symptoms. PATH utilizes life
      event processing (revisiting, meaning making), focusing repeatedly on an identified
      destabilizing life event, positive life events, and future events as a framework to identify
      maladaptive processes and teach constructive processing skills. PATH has the potential to
      reduce dropout, improve treatment engagement and outcomes, identify potential treatment
      mechanisms, and ultimately reduce the costly human and economic burden of stressor-related
      psychopathology.

      For the open trial's "Go" to be achieved and to proceed to the R33, two criteria must be met.
      The first is that at least 2 of the 3 primary targets must change via PATH. A moderate effect
      size (d = 0.60) was chosen to reflect evidence of clinically meaningful target engagement
      (see Gold et al., 2017), in line with NIMH guidelines for a preliminary signal of target
      engagement/efficacy in intervention trials. Second, at least one of the secondary measures
      must show a moderate effect (d = 0.50) from pre- to post-treatment. We included measures of
      each of the targets, as they are conceptualized as interrelated parts of a "stuck" system.
      For "Go" to an R01 after the R33, in addition to target engagement, primary outcomes of PTSD
      and depression must show clinically meaningful gains (e.g., Barth et al., 2016; Cusak et al.,
      2016).
    

Intervention name(s): Positive Processes and Transition to Health (PATH)
Intervention type(s): Behavioral
Intervention description(s): See arm/group description for details regarding this intervention
Other intervention name(s): PATH
Intervention model: Single Group Assignment
Intervention model description: All participants will receive PATH therapy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transdiagnostic intervention; ptsd; posttraumatic stress disorder; mdd; major depressive disorder; adult; therapy; mental health; destabilizing life events; stressful life events