Clinical trial NCT04881643: Blended Treatment för PTSD Feasibility Study
Official title: Facilitating Implementation of Evidence-based Psychological Therapy for Posttraumatic Stress Disorder in Health Care Services Through a Digital Support - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acceptability of Health Care
Keywords: cbt
PTSD
digital support
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Research question and hypothesis

The research question is: Is blended psychological treatment for PTSD via a digital support acceptable and applicable to patients and clinicians? The hypothesis is that testing the digital support and blended delivery format in a smaller scale pilot study will bring to light how the support and treatment could be augmented to better adhere to patients and clinicians needs.

Procedure

The feasibility study will be carried out in collaboration with 2 psychiatric care units in the Stockholm region. In these clinics a handful of therapists will implement the treatment with altogether 20 PTSD patients and assess the digital support and treatment modules. A task group of 3 psychologists will develop the treatment platform and the inherent modules and work materials. The therapists will work closely with the task group and regularly provide feedback of their experiences of working with the platform. Learning obtained from the study will be utilized to improve and adjust the digital support and treatment procedure in preparation for a larger randomized study.

To enable implementation of the digital support in health care services it will be integrated into the digital health care platform Support and Treatment (SOB). SOB is a well-established national health system available to clinicians via the patient medical journals. The support will be internet-based and consist of self-help modules that incorporates similar treatment components as those found in evidence-based trauma-focused cognitive behavioural therapy (TF-CBT) protocols. The treatment modules will consist of educational texts, filmed illustrations, case examples, and relevant worksheets. The purpose of the support is to function as a treatment foundation, both for face-to-face appointments and as guided self-help.

Methodology/approach/data analysis

To be included in the study participants must meet diagnostic criteria for PTSD as their primary problem according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5), have basic reading and writing skills in Swedish, and not express acute suicidal ideation. Patients with concurrent comorbid psychiatric problems are eligible for inclusion unless another psychiatric diagnosis is assessed as primary to PTSD. Patients will be recruited from the regular flow of patients who seek treatment for psychological problems in the selected clinics.

The research question will be investigated using both qualitative and quantitative research methods. Qualitative data will be collected via semi-structured interviews with therapists and a selection of patients with the aim of exploring participant's experience of working with the program and strengths and weaknesses of the blended treatment package. Interviews will be carried out by members of the research group post-treatment. The interviews will be transcribed and thematically analyzed.

To further assess patient acceptability two questionnaires will be distributed following treatment. The Client Satisfaction Questionnaire-8 (CSQ-8) has demonstrated good psychometric properties including high reliability and construct validity. The Credibility/Expectancy Questionnaire (CEQ) is the most widely used measure of treatment credibility and expectancy in psychotherapy research. The CEQ consists of five items that are scored on a 10-point likert scale and has demonstrated high internal consistency (Cronbach's α = .84) and high test-retest reliability (r = .75 - .83). Treatment effects in terms of PTSD-symptoms, other psychiatric symptoms, general functioning and quality of life, will be measured by standardized self-rated measures with good reliability and validity. Outcome measures will be administered before, during and after therapy. Statistical analysis will be conducted to measure change over time and effect sizes (hedges g) will be calculated. Moreover, reliable change (RC) and clinically significant change (CSC) will be meassured according to the criteria established by Jacobson and Truax (22).

Significance

The purpose of this project is to increase availability to evidence-based treatment for individuals with PTSD that is effective, acceptable and resource-efficient. PTSD patients make up 2.8% (n = 10342) of the total number of psychiatric patients in the Stockholm region in 2018, according to data collected via the project "dissemination of guideline based care for PTSD". Of these, 15-20% of patients are estimated to have received evidence-based psychological treatment. This indicates that the majority of individuals suffering from PTSD are not receiving appropriate care in Stockholm. Blended treatment may be a solution to this problem and that a small scale feasibility/pilot study is a valuable first step to test the treatment and learn how it can be improved before launching a larger randomized trial. Hence the significance of this study.

Eligibility criteria: Inclusion Criteria:

* 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.

Patients who express an interest in participating receive information about the study. Patients who subsequently carry out the assessment and meet the inclusion criteria receive accurate oral and written information about what participation includes and handling of personal data and data. If the patient wants to participate and gives written consent, the person is included in the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Acceptability of treatment among patients and therapists
timeFrame: Post treatment, 12-20 weeks after enrollment
Secondary outcomes:
measure: The Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: post treatment, 8-12 weeks after enrollment
measure: The Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Week 1 of treatment
measure: The Posttraumatic stress disorder checklist 5 (PCL-5)
timeFrame: Pre-treatment, weekly, post treatment 8-12 weeks after enrollment, and 6-month follow up
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Pre-treatment, weekly, post treatment 8-12 weeks after enrollment, and 6-month follow up
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
measure: Insomnia Severity Index (ISI)
timeFrame: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
measure: Brunnsviken Brief Quality of Life Questionnaire (BBQ)
timeFrame: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
measure: World health organization disability assessment schedule (WHODAS 2.0)
timeFrame: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
measure: Negative effects questionnaire (NEQ 20)
timeFrame: Post treatment 8-12 weeks after enrollment
measure: Internet Intervention Patient Adherence Scale (IIPAS)
timeFrame: Post treatment 8-12 weeks after enrollment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References: