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A single-center, assessor-blind, randomized, 16-week intervention, parallel-group, superiority study to compare the efficacy of combined out-patient cognitive-processing therapy and treatment-as-usual versus treatment-as-usual only in the reduction of post-traumatic stress symptoms of patients with posttraumatic stress disorders.

A single-center, assessor-blind, randomized, 16-week intervention, parallel-group, superiority study to compare the efficacy of combined out-patient cognitive-processing therapy and treatment-as-usual versus treatment-as-usual only in the reduction of post-traumatic stress symptoms of patients with posttraumatic stress disorders. - Randomized Controlled Trial of Cognitive Processing Therapy for Posttraumatic stress disorder:Safety, Power, Intimacy, Esteem, Trust to PTSD patient (SPINET)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021670
Enrollment
58
Registered
2016-04-01
Start date
2016-04-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Post-traumatic Stress Disorder

Interventions

Cognitive processing therapy with treatment-as-usual Cognitive processing therapy is a psychotherapy for PTSD(Resick et al., 2014). The twelve to sixteen weekly sessions (50 minutes for each) will

Sponsors

National Center of Neurology and Psychiatry
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (a) DSM-5 diagnosis of Post-traumatic Stress Disorder assessed by CAPS-5 (b) Ages 18 years or older, and 70 years or younger at baseline. (c) Subjects who give full consent in the participation of the study.

Exclusion criteria

Exclusion criteria: (a) No severe substance use disorders at baseline as assessed by the Mini-International Neuropsychiatric Interview (MINI) (b) No current manic episode or current psychotic disorders at baseline assessed by MINI (c) No serious suicidal ideation at baseline assessed by MINI (d) No severe or unstable physical disorders or major cognitive deficits at baseline. (e) No structured psychotherapy at baseline. (f) Other relevant reason decided by the investigators.

Design outcomes

Primary

MeasureTime frame
Post-traumatic stress symptoms assessed by Clinician Administered PTSD scale for DSM-5 diagnoses at 17-week

Secondary

MeasureTime frame
Post-traumatic stress symptoms assessed by PTSD Check List for DSM-5 at 17-week Responder status at 17-week

Countries

Japan

Contacts

Public ContactMasaya Ito

National Center of Neurology and Psychiatry National Center for Cognitive-Behavior Therapy

masaya-ito@umin.ac.jp+82-42-341-2711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026