Does a phased approach enhance outcomes for trauma-focused cognitive therapy for complex posttraumatic stress disorder?

Not Applicable

• Conditions: Complex Post-Traumatic Stress Disorder (CPTSD); Mental and Behavioural Disorders; Post-traumatic stress disorder

• Registration Number: ISRCTN13869856
• Lead Sponsor: Queen's University Belfast

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-07
• Last Update Posted: 1 May 2023
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Aged 18 years and above
2. Willing and able to provide informed consent
3. Meets ICD-11 diagnostic criteria for CPTSD as determined by the International Trauma Interview (ITI)
4. CPTSD is the main psychological problem needing treatment
5. Willing to be randomized to a treatment arm
6. If taking psychotropic medication, the dose must be stable for at least 1 month before randomization to a treatment arm
7. If currently receiving psychological therapy for CPTSD, this treatment must have ended before being randomized to a treatment arm

Exclusion Criteria

1. History of psychosis
2. Current substance dependence
3. Acute serious suicide risk

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Complex PTSD symptom severity, as assessed by the International Trauma Questionnaire (ITQ) at 26 weeks post-randomisation.<br>2. PTSD symptom severity also measured by:<br>1.1. ITQ at 9, 17, 39 and 52 weeks<br>1.2. International Trauma Interview (ITI) at 26 and 52 weeks<br>1.3. Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) at 9, 17, 39 and 52 weeks

Secondary Outcome Measures

Name	Time	Method
1: Depression measured using the Patient Health Questionnaire (PHQ-9) at weeks 9, 17, 26, 39 and 52<br>2. Anxiety measured using the Generalized Anxiety Disorder 7-item (GAD-7) at weeks 9, 17, 26, 39 and 52<br>3. Disability measured using the Work and Social Adjustment Scale (WSAS) at weeks 9, 17, 26, 39 and 52<br>4: Well-being measured using the WHO (Five) Well-Being Index at weeks 9, 17, 26, 39 and 52<br>5. Quality of Life measured using the Endicott Quality of Life (QoL) Scale at 9, 26, 39 and 52 weeks<br>6. Credibility and outcome expectancy measured using the Borkovec and Nau’s Credibility/Expectancy (CES) Scale at 2 and 10 weeks<br>7. Attendance and adherence to interventions measured using therapist report at week 26<br>8. Drop-outs from treatment and reasons measured using [method/data source] treatment log and CTU database at 26 weeks<br>9. Patient experience of therapy measured using the IAPT Patient Experience Questionnaire (PEQ) at 26 weeks