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A randomized controlled trial of Cognitive Processing Therapy for 18-35-year-olds with co-occurring post-traumatic stress and substance use disorders.

A randomized controlled trial of Cognitive Processing Therapy for 18-35-year-olds with co-occurring post-traumatic stress and substance use disorders in residential substance use treatment.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001203640
Enrollment
177
Registered
2023-11-22
Start date
2024-02-01
Completion date
2025-07-01
Last updated
2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There are disproportionately higher rates of lifetime trauma and Post-traumatic Stress Disorder (PTSD) among people with substance use disorders (SUDs), which can both precede, and occur as a consequence of substance use. Cognitive Processing Therapy (CPT) is a ‘gold-standard’ PTSD treatment, with a strong emphasis on processing and restructuring maladaptive beliefs around a traumatic event without employing exposure-based strategies. However, the effectiveness of CPT for individuals with co-occurring PTSD and SUD has not been extensively studied. The current project will be a randomized controlled parallel-group trial, which will determine the outcomes of CPT for young people with SUD/PTSD in the residential treatment setting for substance use. Participants will be randomised to receive either TAU or CPT alongside their usual residential treatment (CPT+TAU). Client outcomes on measures of substance use and PTSD, depression, anxiety symptoms will be evaluated at baseline, 1-, 3-, 6-, and 12-months follow-up.

Interventions

Cognitive processing therapy (CPT) is a 'gold-standard' cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters (Resick et al., 2016). CPT is a 12-session protocol that will be delivered by a team of trained clinicians (primarily case managers supervised by a board-approved, endorsed clinical psychologist) on an individual, twice-weekly basis, o

Cognitive processing therapy (CPT) is a 'gold-standard' cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters (Resick et al., 2016). CPT is a 12-session protocol that will be delivered by a team of trained clinicians (primarily case managers supervised by a board-approved, endorsed clinical psychologist) on an individual, twice-weekly basis, over 6 weeks, with 60-minute sessions. Sessions are delivered through telehealth (video-based) format. Session 1 - The goals for the first session of CPT are to engage the client in treatment and provide psychoeducation on the relationship between PTSD and substance use. The therapist also explains the rationale behind CPT: giving client’s tools to examine their thoughts and emotions, feeling the natural emotions arising from the trauma, and changing thoughts around trauma that are keeping client’s stuck (referred to as stuck points in CPT). Sessions 1-3 - Sessions 1-3 will focus on preparing the client for CPT and identifying stuck points that have interfered with the client’s recovery after their trauma(s), including the role of substance use. These sessions are foundational to developing the client’s association between thoughts and feelings and the client is taught to identify and self-monitor these associations. Sessions 4- 5 - The goal for these sessions are for the client to be able to label events, thoughts, and emotions and to understand the connections among them. These sessions will also introduce categorising thoughts objectively as well as challenging the client’s individual thoughts that can be related to the trauma or substance use behaviour. Sessions 6-8 - The first goal of these sessions are to teach the clients to become their own cognitive therapists based on the techniques learned thus far in therapy. Secondly, the clients are asked to identify their patterns of problematic thinking in relation to the traumatic event(s) and substance use. These sessions also begin to challenge core beliefs related to the traumatic event. Sessions 9-12 - The primary goals of the remainder of the sessions is to continue challenging the clients trauma related beliefs as well as examine the themes of Safety, Trust, Esteem, Intimacy and Power and Control related to the traumatic event. In addition, the client and therapist continue to integrate any unresolved ‘stuck points’ relevant to the index trauma. A modification which will be made at the end of treatment from the original protocol will be to add relapse prevention into the clients final sessions. Treatment fidelity of the intervention will be monitored through: a) de-identified audio recordings which will be assessed at the end of treatment by independent CPT clinicians, b) session checklists for clinicians during sessions, and c) weekly supervision of clinicians by a trained, board-approved clinical supervisor specializing in the delivery of CPT.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

1) Positive PTSD screen on the PCL-5 (+31). The PCL-5 is a measure used to assess PTSD symptomatology based on the DSM-5 criteria. This requires the client to need at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20) on the PCL-5. 2) Attendance at one of the participating Lives Lived Well residential facilities

Exclusion criteria

Following CPT protocol recommendations (Resick et al., 2016), participants will be excluded from therapy if they meet any of the following: a) non-fluent in English b) acutely suicidal c) current diagnosis of schizophrenia, currently manic bipolar, or intellectual disability d) Experienced a trauma that had occurred before the age of three (as there is an inability to remember the trauma) e) the participant's cognitive capacity is limited such that they are unable to understand the therapeutic concepts and worksheets offered.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026