Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy

PTSD Clinical Trial

Official title:

Evaluation of Blended CBT for PTSD in Regular Care: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy: A Randomized Controlled Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758987
• Other study ID #: 2020-07130
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: March 10, 2026

Study information

• Verified date: February 2023
• Source: Karolinska Institutet
• Contact: Sigrid Salomonsson, PhD
• Phone: 0708442283
• Email: Sigrid.salomonsson[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized Controlled Non-inferiority Trial testing if the new experimental Blended Trauma focused cognitive behavioral therapy (B-TF-CBT) for post traumatic stress disorder (PTSD), is non-inferior to gold standard control treatment Prolonged Exposure (PE).

Research question and hypothesis Can the blended treatment yield outcomes non-inferior to face-to-face TF-CBT for patients with PTSD when applied in regular health care with regards to PTSD-symptoms, depression, anxiety, sleep problems, quality of life and general functioning? The hypothesis is that the Blended TF-CBT will be non-inferior to standard face-to-face TF-CBT for patients with PTSD, directly after treatment as well as at 12-months follow up. The study will be conducted at 3-6 outpatient clinics in Region Stockholm, Sweden.

Description:

To study effects, the investigators aim to conduct a randomized controlled trial (RCT) comparing blended treatment to an evidence-based face-to-face TF-CBT protocol, Prolonged exposure.

Data will be collected concerning symptoms of PTSD with the PTSD Checklist for Diagnostic and Statistical Manual 5 (DSM-5; PCL-5) which will be the primary outcome measure. Further, symptoms of PTSD will be measured with Clinician-administered PTSD Scale for DSM-5 (CAPS-5), depression The PHQ-9, symptoms of anxiety with GAD-7 , quality of life with Work and social adjustment scale (WSAS), and sleep with the insomnia severity index (ISI). Outcome measures will be distributed before, during, after, as well as 12-months following treatment.

To analyze the data, a non-inferiority analysis will be applied for the primary outcome variable. Step one in this analysis will be to determine what difference in mean scores on the PCL-5 between the two treatments is tolerated to conclude that the interventions are equally effective (non-inferiority margin). When comparing treatment effects a one-sided t-test with a 95% confidence interval will be used to investigate whether the lower limit of the interval for the experimental treatment (blended treatment) lays outside the non-inferiority margin. If the lower limit is within the non-inferiority margin the experimental treatment is interpreted to be non-inferior to the standard treatment (TF-CBT).

The value of our non-inferiority margin will be based on the established minimum change in scores required for a reliable change on the primary outcome measure as well as the effect size (Cohen's d) seen in a previous TF-CBT study (29). As a first step to determine our non-inferiority margin the investigators made a calculation entailing the following estimates: The post treatment score on the primary measure from the reference treatment which was 15.80 with a standard deviation of 15.97 (we assumed that our treatment would yield the same post-score). 7 which is the score in between the established minimal difference on the primary outcome measure required for a reliable change (reliable change = between 5 and 10 points). 7 points on the primary outcome measure is thus the non-inferiority margin in actual scores. Appointing these figures in an effect size calculator yielded the result of 0.4. This indicates that while expecting a zero difference in effect size between the two treatments in comparison, the tolerated non-inferiority margin in Cohen's d is 0.4.

Further, to estimate the required sample size, rigorous power calculations were carried out in collaboration with an expert in statistical analysis, applying a simulation-based approach using a 2-level linear mixed-effects model, using estimates from the reference TF-CBT looking at six assessment points. Variance components that were incorporated into the analysis were random intercept, random slopes and residual variance. The power calculation showed that with 78 participants in each treatment group and a 20% dropout rate 80% power is reached, given a non-inferiority margin of 7 points and α = 0.05.

Continuous data will be analyzed using mixed effects models or t-tests, dichotomous data using chi-square tests. In mixed effects model analysis of between-group differences, the interaction effect of group and time will be the central estimate. The investigators will also calculate effect sizes using Cohen's d based on pooled standard deviations. Remission rates will be calculated using a cut off of 38 on the PCL-5. The proportion of patients who will make a clinical significant change and reliable change according to the Jacobson and Truax algorithm will be measured. Dichotomous data of remission will also be analyzed with survival analysis where time to remission is calculated and compared between groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 10, 2026
• Est. primary completion date: March 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PTSD according to Diagnostic and Statistical Manual of mental disorders 5 as primary problem

• = 18 years

• Basic knowledge of speaking and writing Swedish

• No other psychological treatment at the same time

• No ongoing threats or violence

• If antidepressant medication, stable dose 6 weeks before starting treatment

• Have access to the internet and a computer

• Willingness/ability to participate after receiving information about what participation entails

Exclusion Criteria:

• Other diagnosis or problem is assessed as primary to PTSD

• Moderate to severe suicidal risk

• PTSD from childhood trauma that the person cannot remember

Related Conditions & MeSH terms

• CBT
• PTSD

Intervention

Behavioral:
• Blended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT)
A trauma-focused CBT where internet-based treatment is blended with face-to-face sessions with a therapist.
• Prolonged exposure
A gold standard trauma-focused CBT delivered with face-to-face sessions with a therapist.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Capio Group, Region Stockholm, Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from pre intervention to immediately post intervention
Primary	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.	Change from pre intervention to 6 months post intervention
Primary	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.	Change from pre intervention to 12 months post intervention
Secondary	Clinician-administered PTSD Scale for DSM-5 (CAPS-5)	The traumatic event.; The 20 PTSD symptoms according to DSM-5.; The onset of PTSD symptoms.; Duration of PTSD symptoms.; The degree of subjective discomfort and mental strain due to PTSD symptoms.; The degree of impairment in social, professional and other functioning due to PTSD symptoms.; The degree of symptom improvement since the previous CAPS assessment.; Reliability/validity of the client's responses (i.e. whether the responses are truthful).; Overall severity of the PTSD symptoms.; CAPS-5 contains estimates of dissociative subtypes (depersonalization and derealization) that are new to DSM-V (i.e., not included in DSM-IV criteria for PTSD).; A 0-4 scale is used for each of the 30 items: (0 = absence of symptoms, 1 = mild/subthreshold, 2 = moderate/threshold, 3= severe/markedly elevated, 4 = extreme/disabling)	1 week post intervention
Secondary	Clinician-administered PTSD Scale for DSM-5 (CAPS-5)	The traumatic event.; The 20 PTSD symptoms according to DSM-5.; The onset of PTSD symptoms.; Duration of PTSD symptoms.; The degree of subjective discomfort and mental strain due to PTSD symptoms.; The degree of impairment in social, professional and other functioning due to PTSD symptoms.; The degree of symptom improvement since the previous CAPS assessment.; Reliability/validity of the client's responses (i.e. whether the responses are truthful).; Overall severity of the PTSD symptoms.; CAPS-5 contains estimates of dissociative subtypes (depersonalization and derealization) that are new to DSM-V (i.e., not included in DSM-IV criteria for PTSD).; A 0-4 scale is used for each of the 30 items: (0 = absence of symptoms, 1 = mild/subthreshold, 2 = moderate/threshold, 3= severe/markedly elevated, 4 = extreme/disabling)	12 months post intervention
Secondary	Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.; The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV. You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.	Change from pre intervention to immediately post intervention
Secondary	Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.; The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV. You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.	Change from pre intervention to 6 months post intervention
Secondary	Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.; The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV. You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.	Change from pre intervention to 12 months post intervention
Secondary	Generalized Anxiety Disorder 7-item scale (GAD-7)	The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor.; If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor.; The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.	Change from pre intervention to immediately post intervention
Secondary	Generalized Anxiety Disorder 7-item scale (GAD-7)	The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor.; If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor.; The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.	Change from pre intervention to 6 months post intervention
Secondary	Generalized Anxiety Disorder 7-item scale (GAD-7)	The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor.; If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor.; The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.	Change from pre intervention to 12 months post intervention
Secondary	Insomnia Severity Index (ISI)	A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.	Change from pre intervention to immediately post intervention
Secondary	Insomnia Severity Index (ISI)	A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.	Change from pre intervention to 6 months post intervention
Secondary	Insomnia Severity Index (ISI)	A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.	Change from pre intervention to 12 months post intervention
Secondary	The Work and Social Adjustment Scale (WSAS)	The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better.; The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely	Change from pre intervention to immediately post intervention
Secondary	The Work and Social Adjustment Scale (WSAS)	The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better.; The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely	Change from pre intervention to 6 months post intervention
Secondary	The Work and Social Adjustment Scale (WSAS)	The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better.; The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely	Change from pre intervention to 12 months post intervention
Secondary	EUROQOL 5 dimensions (EQ5D)	The EQ-5D [1] is an instrument that consists of two parts and measures health-related quality of life, regardless of disease profile. The instrument measures the general state of health within five dimensions. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'.	Change from pre intervention to immediately post intervention
Secondary	EUROQOL 5 dimensions (EQ5D)	The EQ-5D [1] is an instrument that consists of two parts and measures health-related quality of life, regardless of disease profile. The instrument measures the general state of health within five dimensions. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'.	Change from pre intervention to 6 months post intervention
Secondary	EUROQOL 5 dimensions (EQ5D)	The EQ-5D [1] is an instrument that consists of two parts and measures health-related quality of life, regardless of disease profile. The instrument measures the general state of health within five dimensions. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'.	Change from pre intervention to 12 months post intervention
Secondary	Questions about work situation	Self constructed questions regarding work, employment and sick leave to evaluate in what degree the participant has worked the last 6 months	Pre intervention
Secondary	Questions about work situation	Self constructed questions regarding work, employment and sick leave to evaluate in what degree the participant has worked the last 6 months	6 months post intervention
Secondary	Questions about work situation	Self constructed questions regarding work, employment and sick leave to evaluate in what degree the participant has worked the last 6 months	12 months post intervention
Secondary	Registry data for the cost-effectiveness analysis	From the Center for Health Data: Variables on care consumption in primary care, inpatient care and outpatient care, including ambulance transports, medication prescription; From the National Board of Health and Welfare: Assistance decision Home help & help in the home.; From the Swedish Social Insurance Agency: Sick leave	During the 12 month period post intervention
Secondary	Posttraumatic cognitions inventory (PTCI)	The Posttraumatic Cognitions Inventory measures negative PTSD-related cognitions about self, others and guilt. 36 items rated from 1 = Strongly disagree; 2 = Strongly Disagree; 3 = Disagree to some extent; 4 = Neutral; 5 = Agree to some extent; 6 = Agree to a large extent; 7 = Completely agree	Pre intervention
Secondary	Posttraumatic cognitions inventory (PTCI)	The Posttraumatic Cognitions Inventory measures negative PTSD-related cognitions about self, others and guilt. 36 items rated from 1 = Strongly disagree; 2 = Strongly Disagree; 3 = Disagree to some extent; 4 = Neutral; 5 = Agree to some extent; 6 = Agree to a large extent; 7 = Completely agree	6 weeks post intervention start
Secondary	Posttraumatic cognitions inventory (PTCI)	The Posttraumatic Cognitions Inventory measures negative PTSD-related cognitions about self, others and guilt. 36 items rated from 1 = Strongly disagree; 2 = Strongly Disagree; 3 = Disagree to some extent; 4 = Neutral; 5 = Agree to some extent; 6 = Agree to a large extent; 7 = Completely agree	immediately post intervention
Secondary	Posttraumatic cognitions inventory (PTCI)	The Posttraumatic Cognitions Inventory measures negative PTSD-related cognitions about self, others and guilt. 36 items rated from 1 = Strongly disagree; 2 = Strongly Disagree; 3 = Disagree to some extent; 4 = Neutral; 5 = Agree to some extent; 6 = Agree to a large extent; 7 = Completely agree	6 months post intervention
Secondary	Posttraumatic cognitions inventory (PTCI)	The Posttraumatic Cognitions Inventory measures negative PTSD-related cognitions about self, others and guilt. 36 items rated from 1 = Strongly disagree; 2 = Strongly Disagree; 3 = Disagree to some extent; 4 = Neutral; 5 = Agree to some extent; 6 = Agree to a large extent; 7 = Completely agree	12 months post intervention
Secondary	The Response to Intrusions Questionnaire (RIQ)	A 19-item inventory that assesses the use of dysfunctional cognitive and behavioral strategies in response to intrusions of the trauma. Each item is self-rated from 0-3 and summarized. Lower scores indicating less intrusions.	Pre intervention
Secondary	The Response to Intrusions Questionnaire (RIQ)	A 19-item inventory that assesses the use of dysfunctional cognitive and behavioral strategies in response to intrusions of the trauma. Each item is self-rated from 0-3 and summarized. Lower scores indicating less intrusions.	6 weeks post intervention start
Secondary	The Response to Intrusions Questionnaire (RIQ)	A 19-item inventory that assesses the use of dysfunctional cognitive and behavioral strategies in response to intrusions of the trauma. Each item is self-rated from 0-3 and summarized. Lower scores indicating less intrusions.	Immediately post intervention
Secondary	The Response to Intrusions Questionnaire (RIQ)	A 19-item inventory that assesses the use of dysfunctional cognitive and behavioral strategies in response to intrusions of the trauma. Each item is self-rated from 0-3 and summarized. Lower scores indicating less intrusions.	6 months post intervention
Secondary	The Response to Intrusions Questionnaire (RIQ)	A 19-item inventory that assesses the use of dysfunctional cognitive and behavioral strategies in response to intrusions of the trauma. Each item is self-rated from 0-3 and summarized. Lower scores indicating less intrusions.	12 months post intervention
Secondary	The internet intervention Patient Adherence Scale (iiPAS)	A tool to measure adherence in internet-delivered behavioral interventions. 7 items rated from 0-4 and summarized. Lower scores indicating less adherence to treatment.	6 weeks post intervention start
Secondary	The internet intervention Patient Adherence Scale (iiPAS)	A tool to measure adherence in internet-delivered behavioral interventions. 7 items rated from 0-4 and summarized. Lower scores indicating less adherence to treatment.	Immediately post intervention
Secondary	Client Satisfaction Questionnaire (CSQ-8)	Self rated questionnaire to rate satisfaction with treatment. 8 items rated from 1-4 and summarized. Lower scores indicating less satisfaction. Scale ranging from 0-32	Immediately post intervention
Secondary	Negative Effects Questionnaire (NEQ)	self-rating form to measure negative effects of psychological treatment The NEQ consists of 20 statements that are answered on a 0-4 Likert scale. Furthermore, there is an open question to try to capture such negative effects that are not included in the self-report form, but which may be of theoretical or clinical relevance. In addition, the respondent is asked to answer whether the negative effects experienced were due to the treatment they underwent or other circumstances. The scale ranges from 0-80, higher scores indicate more negative effects. However the scale is more descriptive than designed to calculate negative effects	Immediately post intervention
Secondary	credibility/expectancy questionnaire	The Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000) is the most widely used measure of treatment credibility and expectancy in psychotherapy research, and is a revision of the original scale developed by Borkovec and Nau (1972). This updated version contains 6 items rated on a 1-9 or a 0%-100% scale, depending upon the item. This revised scale, which was used in the present study, has been subjected to factor analysis, with results indicating that the items load onto two distinct factors of credibility and expectancy (Devilly & Borkovec, 2000). The first three items of the scale load onto the credibility factor and the final three items load onto the expectancy factor. Credibility scale ranges from 0-9 higher ratings indicate more credibility. Expectancy scale ranges from 0-100 higher ratings indicate more expectancy of treatment effect.	Two weeks post intervention start