Blended Treatment för PTSD Feasibility Study

NCT04881643 | Completed

• 1 other identifier: dnr P2020/46
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility and pilot study using within-group design with the aim of examining whether the blended psychological treatment for PTSD is acceptable for patients and therapists. 20 patients will be included and 4 therapists. Semi-structured interviews will be conducted after treatment with a selection of therapists and patients with questions regarding the helpfulness and feasibility of the treatment. Effects of the treatment will be assessed via standardized self-report outcome measures regarding PTSD, depression, anxiety, sleep, quality of life, function and patient satisfaction / acceptance. Measurements are conducted before, during, immediately after and 6 months after treatment. The study is conducted at 2 psychiatric outpatient clinics in the Stockholm Region.

Conditions

Acceptability of Health Care

Keywords

cbt; PTSD; digital support

Outcome Measures

Primary Outcomes (1)

• Acceptability of treatment among patients and therapists

  Semi-structured interviews

  Post treatment, 12-20 weeks after enrollment

Secondary Outcomes (10)

• The Client Satisfaction Questionnaire-8 (CSQ-8)

  post treatment, 8-12 weeks after enrollment

• The Credibility/Expectancy Questionnaire (CEQ)

  Week 1 of treatment

• The Posttraumatic stress disorder checklist 5 (PCL-5)

  Pre-treatment, weekly, post treatment 8-12 weeks after enrollment, and 6-month follow up

• Patient Health Questionnaire 9 (PHQ-9)

  Pre-treatment, weekly, post treatment 8-12 weeks after enrollment, and 6-month follow up

• Generalised Anxiety Disorder 7-item scale (GAD-7)

  Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up

Study Arms (1)

Blended treatment for PTSD

EXPERIMENTAL

A trauma-focused CBT where internet-based treatment is blended with face-to-face sessions with a therapist.

Behavioral: Trauma-focused cognitive behavioural therapy via a digital support

Interventions

Trauma-focused cognitive behavioural therapy via a digital support BEHAVIORAL

A blended treatment approach to PTSD, blending internet-based CBT with face-to-face sessions with a therapist

Blended treatment for PTSD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTSD according to DSM-5 criteria (American Psychiatric Association, 2013) as a primary problem
• have basic knowledge of speaking and writing in Swedish,
• not undergo other psychological treatment for PTSD during the course of the study;
• be at least 18 years old
• not be exposed to ongoing violence or threats
• if antidepressants for depression / anxiety are available, the dose must have been stable for at least 6 weeks before starting treatment.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

• Lundin J, Jansson-Frojmark M, Gustafsson-Bjorverud L, Grey N, Santoft F, Ehlers A, Carlbring P, Lundgren T, Bragesjo M, Salomonsson S. Integrating digital and in-person therapy for PTSD: feasibility and acceptability of blended trauma-focused cognitive therapy in routine care. Front Psychiatry. 2024 Sep 5;15:1447651. doi: 10.3389/fpsyt.2024.1447651. eCollection 2024.

  PMID: 39301223 DERIVED

MeSH Terms

Conditions

Patient Acceptance of Health Care; Color Vision Defects; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and PhD

Model Details: Feasibility and pilot study using within-group design. 20 patients will be included and 4 therapists. Semi-structured interviews will be conducted after treatment with a selection of therapists and patients with questions regarding the helpfulness and feasibility of the treatment. Effects of treatment patients estimate forms regarding PTSD, depression, anxiety, sleep, quality of life, function and patient satisfaction / acceptance. Measurements are performed before, during, immediately after and 6 months after treatment.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 11, 2021
• Study Start: May 20, 2021
• Primary Completion: December 4, 2022
• Study Completion: July 3, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)