Acceptability of Health CareNCT04881643
Blended Treatment för PTSD Feasibility Study
A study testing Trauma-focused cognitive behavioural therapy via a digital support in people with Acceptability of Health Care, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acceptability of Health Care
- What is being tested?
- Trauma-focused cognitive behavioural therapy via a digital support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- 20 May 2021to 3 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Acceptability of Health Care
- Being tested
- Trauma-focused cognitive behavioural therapy via a digital support
- Keywords
- cbt, PTSD, digital support
- Medical subject headings
- Patient Acceptance of Health Care, Color Vision Defects, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-focused cognitive behavioural therapy via a digital supportBehavioural
A blended treatment approach to PTSD, blending internet-based CBT with face-to-face sessions with a therapist
| Study group | Role | What they receive |
|---|---|---|
| Blended treatment for PTSD | Experimental | A trauma-focused CBT where internet-based treatment is blended with face-to-face sessions with a therapist. Receives: Behavioral: Trauma-focused cognitive behavioural therapy via a digital support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of treatment among patients and therapists
Semi-structured interviews
Measured: Post treatment, 12-20 weeks after enrollment
Secondary outcomes (10)
The Client Satisfaction Questionnaire-8 (CSQ-8)
Self rated satisfaction of treatment. Minimum value 8, maximum value 32 where higher values indicate greater satisfaction with the treatment.
Measured: post treatment, 8-12 weeks after enrollment
The Credibility/Expectancy Questionnaire (CEQ)
Self rated Credibility of treatment. Minimum value 3, maximum value 27 for each factor, where higher values indicate greater Credibility/Expectancy of the treatment.
Measured: Week 1 of treatment
The Posttraumatic stress disorder checklist 5 (PCL-5)
Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.
Measured: Pre-treatment, weekly, post treatment 8-12 weeks after enrollment, and 6-month follow up
Patient Health Questionnaire 9 (PHQ-9)
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
Measured: Pre-treatment, weekly, post treatment 8-12 weeks after enrollment, and 6-month follow up
Generalised Anxiety Disorder 7-item scale (GAD-7)
Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.
Measured: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
Insomnia Severity Index (ISI)
Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.
Measured: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
Brunnsviken Brief Quality of Life Questionnaire (BBQ)
Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
Measured: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
World health organization disability assessment schedule (WHODAS 2.0)
Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.
Measured: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
Negative effects questionnaire (NEQ 20)
Self rated negative effects of treatment. Minimum value 0, maximum value 80, where higher values indicate more negative effects.
Measured: Post treatment 8-12 weeks after enrollment
Internet Intervention Patient Adherence Scale (IIPAS)
Therapist-rated questionnaire regarding patient adherence to an internet-delivered psychological treatment. The scale consists of 5 items rated from 0-4 with higher ratings indicating greater adherence. Total range of scale is 0-20.
Measured: Post treatment 8-12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start20 May 2021
- Primary completion4 Dec 2022
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acceptability of Health CareStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sigrid Salomonsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881643
- Sponsor's protocol ID
- dnr P2020/46
- Status last verified
- Mar 2024
- First submitted
- 3 May 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lundin J, Rozental A, Bjorverud-Gustafsson L, Jansson-Frojmark M, Carlbring P, Lundgren T, Salomonsson S. Doing the groundwork at home, working through it together: patient experiences of blended cognitive therapy for PTSD in routine care. Eur J Psychotraumatol. 2026 Dec;17(1):2727212. doi: 10.1080/20008066.2026.2727212. Epub 2026 Sep 30.
PubMed 42812108Lundin 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.
PubMed 39301223
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Implementation of Evidence-based Psychological Therapy for Posttraumatic Stress Disorder in Health Care Services Through a Digital Support - A Feasibility Study
- ClinicalTrials.gov ID
- NCT04881643
- Acronym / sponsor ID
- dnr P2020/46
- Conditions
- Acceptability of Health Care
- Keywords
- cbt, PTSD, digital support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 4 Dec 2022 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blended treatment for PTSD | Experimental | Behavioral: Trauma-focused cognitive behavioural therapy via a digital supportA trauma-focused CBT where internet-based treatment is blended with face-to-face sessions with a therapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-focused cognitive behavioural therapy via a digital supportA blended treatment approach to PTSD, blending internet-based CBT with face-to-face sessions with a therapist | Behavioural | Blended treatment for PTSD |
Primary outcome
Acceptability of treatment among patients and therapists
Time frame: Post treatment, 12-20 weeks after enrollment
Semi-structured interviews
10 secondary outcomes
The Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: post treatment, 8-12 weeks after enrollment
The Credibility/Expectancy Questionnaire (CEQ)
Time frame: Week 1 of treatment
The Posttraumatic stress disorder checklist 5 (PCL-5)
Time frame: Pre-treatment, weekly, post treatment 8-12 weeks after enrollment, and 6-month follow up
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Pre-treatment, weekly, post treatment 8-12 weeks after enrollment, and 6-month follow up
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
Insomnia Severity Index (ISI)
Time frame: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
Brunnsviken Brief Quality of Life Questionnaire (BBQ)
Time frame: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
World health organization disability assessment schedule (WHODAS 2.0)
Time frame: Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up
Negative effects questionnaire (NEQ 20)
Time frame: Post treatment 8-12 weeks after enrollment
Internet Intervention Patient Adherence Scale (IIPAS)
Time frame: Post treatment 8-12 weeks after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Derived from this study: PubMed 42812108Lundin J, Rozental A, Bjorverud-Gustafsson L, Jansson-Frojmark M, Carlbring P, Lundgren T, Salomonsson S. Doing the groundwork at home, working through it together: patient experiences of blended cognitive therapy for PTSD in routine care. Eur J Psychotraumatol. 2026 Dec;17(1):2727212. doi: 10.1080/20008066.2026.2727212. Epub 2026 Sep 30.
- Derived from this study: PubMed 39301223Lundin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-focused cognitive behavioural therapy via a digital support in people with Acceptability of Health Care, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of treatment among patients and therapists (time frame: Post treatment, 12-20 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04881643, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.