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A Pilot Randomised Controlled Trial Comparing Cognitive Behaviour Therapy-Standard vs Cognitive Behaviour Therapy-Memory Reconsolidation for Inpatients with Post-Traumatic Stress Disorder

A Pilot Randomised Controlled Trial Comparing CBT-S vs CBT-MR for Inpatients with PTSD for Symptom Severity in Inpatients with PTSD

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000097640
Enrollment
70
Registered
2023-01-27
Start date
2023-02-06
Completion date
2023-12-22
Last updated
2023-02-06

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

Conditions

None listed

Brief summary

Participants with Posttraumatic Stress Disorder will engage in a 4 week inpatient program that includes individual and group cognitive behaviour therapy. This study aims to test whether trauma-focused CBT with minor modifications based upon memory reconsolidation research findings (CBT-MR) can improve patient outcomes compared with a standard trauma-focused CBT (CBT-S). Hypothesis 1 = Participants assigned to our standard trauma-focused CBT (CBT-S) will experience at least equal patient outcomes to published standard trauma-focused CBT patient outcomes. Hypothesis 2 = Participants assigned to our trauma-focused CBT modified based upon memory reconsolidation research findings (CBT-MR) will experience better patient outcomes to participants assigned to our standard trauma-focused CBT (CBT-S). Hypothesis 3 = Participants will find both version of the therapy equally acceptable in terms of similar levels of attendance, attrition from the study, and self-report of acceptability at the end of the program. Hypothesis 4 = Participants with higher levels of endocannabinoids, neuropeptides, peptides, oxytocin, and cortisol will respond significantly better to treatment compared to participants with lower levels of these analytes (in both hair and blood samples before, during, and after treatment).

Interventions

This intervention involves a 4-week inpatient program that includes group therapy and individual therapy. All participants will receive the same group therapy experience. The group therapy involves psychoeducation, motivational interviewing and cognitive behaviour therapy targeting maladaptive beliefs about emotions. The group therapy will be delivered 4 times a week over 4 weeks, with each session lasting approximately 1.5 hours. The group therapy will be delivered by a registered or probationa

This intervention involves a 4-week inpatient program that includes group therapy and individual therapy. All participants will receive the same group therapy experience. The group therapy involves psychoeducation, motivational interviewing and cognitive behaviour therapy targeting maladaptive beliefs about emotions. The group therapy will be delivered 4 times a week over 4 weeks, with each session lasting approximately 1.5 hours. The group therapy will be delivered by a registered or probationally registered psychologist with either another registered or probationally registered psychologist or mental health professional attending as a co-therapist. The groups will include between 4 to 10 participants. The participants will self-monitor attendance by rating a session attendance checklist. The individual therapy involves one of two conditions. The intervention condition is a modified version of standard prolonged exposure therapy modified according to memory reconsolidation therapy principles (CBT-MR). Each participant will receive 2 x 1.5 hour sessions a week over 4 weeks. These sessions will be administered one-on-one and face-to-face with a probationally registered or registered psychologist. Attendance will be measured using a self-rated session attendance checklist. The first session will involve developing a fear hierarchy of traumatic memories. The subsequent sessions will involve recalling the next traumatic memory on the fear hierarchy for a few minutes. The participant will then be invited to engage in detached mindfulness for the next 20 minutes. Following this, the participant will be asked to recall the traumatic memory again and will engage in imaginal exposure therapy until the participants subjective unit of distress has significantly reduced. The participant will then be advised on helpful aftercare. The individual therapy sessions will be spaced out so that there is at least one day between each session.

Sponsors

New Farm Clinic
Lead SponsorHospital

Study design

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

Eligibility

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

Inclusion criteria

>= 18 years and a diagnosis of Post-Traumatic Stress Disorder (PTSD)

Exclusion criteria

- Psychosis, due to the lack of reality testing inherent to this disorder. - Intellectual Disability or any evidence of cognitive impairment that would interfere with the course of treatment. - Complex PTSD, Borderline Personality Disorder, Narcistic Personality Disorder, or Histrionic Personality Disorder due to poor emotion regulation interfering with the ability to engage in group therapy. - Bipolar Disorder, due to the potentially confounding effects of rapid mood swings. - Alcohol Use Disorder and/or Substance Use Disorder, due to the potential to interfere with the patient’s ability to engage in exposure-based treatment and mentalise in the group CBT. - Anorexia Nervosa, because severe restrictive eating practices can reduce cognitive capacity, and reduce the effectiveness of cognitive therapy. - High Suicide Risk

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026