Towards Optimization of Traumatic Cognitive-behavioral Therapy for Treatment of Post-traumatic Stress Disorder and Related Problems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a form of cognitive behavioral therapy (CBT) in a population of individuals with PTSD and common related problems (depression, anxiety or sleep disorders, pain, psychosocial stressors, low social support, substance use disorder). Half of the participants will receive a cognitive behavioral therapy with specific modules for the treatment of related problems (CBT-E) and the other half of participants will receive therapy without specific modules (CBT-C).
The main assumption is that participants treated in the CBT-E condition will present a lower level of symptom intensity of PTSD and a higher remission rate than those in the CBT-C condition during the post-treatment assessment. As a secondary objective, an analysis of the different parameters of effectiveness of the two forms of CBT (e.g., average number of sessions required to reach remission, treatment strategies used) will be performed.
详细描述
Post-traumatic stress disorder (PTSD) will affect nearly one in ten Canadians in their lifetime and more than 75% of them will develop at least one other related problem (i.e. depression). Results from a previous study suggest that CBT offering a flexible number of sessions and support for common related problems can improve the effectiveness of CBT. However, no studies have demonstrated the superior efficacy of flexible CBT compared to CBT targeting only PTSD to individuals with PTSD and common related problems.
A randomized parallel-stratified single-blind controlled trial will be used. Randomization will be performed through www.randomized.net, a comprehensive internet-based randomization service for clinical trials, with multiple Coordinating Center users (each with their own role). A total of 134 individuals will be randomized to one of two therapy conditions. Following the initial assessment, between 8 and 32 sessions with a psychologist will be offered to participants upon achievement of remission of the diagnosis of PTSD. Discontinuation of treatment will be decided in collaboration with the participant and will be considered on the basis of achieving a non-clinical severity level of symptoms of PTSD on the PCL-5 (i.e., score <33 and absence or non-clinical level of severity of each of the symptoms). The participants will be re-evaluated 3 times after their therapy (1 week, 3 months and 6 months post-therapy) on primary and secondary measures. A 1 year post-therapy follow-up will also be provided for the primary measure only.
Planned analysis. The statistical analysis will respect the "intent-to-treat" principle: the results of all randomized participants will be included in the groups in which they were originally assigned. The significance level is fixed at .05 and bilateral tests will be used. With regards to missing data, first the type of missing data will be determined (e.g. missing completely randomly). Thereafter, a multiple imputation strategy (3 to 5 imputations) will be used to replace the data and carry out the various analysis planned. This data replacement strategy is recognized as being robust and efficient in addition to resolving uncertainty due to missing data. Generalized linear models will be used to execute group comparisons (CBT-C vs CBT-E) on the main measurements using the pre-treatment (T0) result as a covariate. The same strategy will be used for comparisons of the secondary variables and related problems. An analysis of the different parameters of effectiveness of the two forms of CBT (e.g. average number of sessions required to achieve remission, treatment strategy used) will be carried out.
Subgroup analysis. No subgroup analysis is expected. Exploratory analysis will be conducted to determine if the results are generalizable to victims of both sexes and to the two major categories of traumatic exposures characterizing the sample recruited, namely violent criminal acts and workplace accidents.
Sample size and calculations of treatment effects. Based on the treatment effect size observed in a pilot study on the effects of CBT-E, similar research, and on the use of the GPower power calculation software, the sample size required to obtain statistical power of .80 with 3 follow-ups, a significance level at .05 and bilateral testing for ANCOVA is 53 participants per group. A sample of 106 participants will allow for detections of differences in means between the two groups in terms of symptoms intensity of PTSD. It will also be adequate to verify the other assumptions and objectives of this project. Based on data from our recent studies on the efficacy of CBT-C, and the literature on similar therapies (Bradley et al., 2005), the attrition rate is estimated to be 28% for participants who will be randomized in CBT-C. For CBT-E, the attrition rate observed during a pilot project was 14% (3 dropouts out of 21 participants). Given these attrition rates, recruitment for each of the therapies to achieve the required statistical power is calculated as follows: CBT-C = 53 participants * attrition (28%) = 74; CBT-E = 53 participants * attrition (14%) = 60). Consequently, a total of 134 participants will be randomized to one of the two conditions of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exposed to a traumatic event at an adult age
- •Primary PTSD diagnosis according to the DSM-5 criteria
- •At least one PTSD related problem (depressive, anxiety or sleep disorders, pain, psychosocial stressors, inadequate social support, substance use disorder)
- •Being fluent in French.
排除标准
- •Schizophrenia diagnostic, current or past psychotic episodes, bipolar disorder, organic cerebral disorder or intellectual deficiency
- •Presence of a trouble linked to a substance developed prior to the traumatic event
- •Physical condition preventing participation in the study (e.g. cerebral trauma)
- •Presence of active suicide ideas.
研究组 & 干预措施
CBT-E
CBT-E refers to Cognitive Behavioral Therapy with specific modules. In the CBT-E condition and following the identification of the needs identified during the evaluation, additional strategies will be added to the CBT strategies for PTSD to address one or more of the seven related problem types that emerged as a result of the traumatic event: 1) major depression, 2) sleep disorders, 3) pain, 4) stressors, 5) inadequate social support, 6) substance use disorder, and 7) anxiety disorder.
干预措施: Specific Modules (Behavioral)
CBT-E
CBT-E refers to Cognitive Behavioral Therapy with specific modules. In the CBT-E condition and following the identification of the needs identified during the evaluation, additional strategies will be added to the CBT strategies for PTSD to address one or more of the seven related problem types that emerged as a result of the traumatic event: 1) major depression, 2) sleep disorders, 3) pain, 4) stressors, 5) inadequate social support, 6) substance use disorder, and 7) anxiety disorder.
干预措施: Cognitive behavioral therapy (Behavioral)
CBT-C
CBT-C refers to Cognitive Behavioral Therapy without specific modules. CBT-C participants will be offered only cognitive-behavioral intervention strategies to alleviate the symptoms of each of the PTSD diagnostic criteria.
干预措施: Cognitive behavioral therapy (Behavioral)
结局指标
主要结局
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013)
时间窗: Baseline, changes from baseline at 1 week post-treatment, 3 months post-treatment, and 6 months post-treatment
The CAPS-5 will be used to evaluate the presence 20 symptoms indicative of PTSD according to the DSM-5. This scale was designed not only to assess symptoms but also to provide indications regarding symptoms onset and duration, associated subjective distress, perceived impact of symptoms on social and professional functioning, changes in symptomology since the previous CAPS assessment and global severity of PTSD.
次要结局
- The Beck II Depression Inventory (BDI-II; Beck, Steer & Brown, 1996)(Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment)
- The Life Events Questionnaire (LEQ; Norbeck, 1984)(Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment)
- The Social Provisions Scale (SPS; Cutrona & Russel, 1987)(Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment)
- The Posttraumatic Stress Disorder Checklist Scale-version DSM-5 (PCL-5; Weathers, Litz et al., 2013)(Baseline, changes from baseline at every 4-sessions during treatment (i.e. session 4, 8 … 28 - the number of assessments during treatment will vary based on the number of sessions), 1 week, 3 months, 6 months and 1 year post-treatment.)
- The Beck Anxiety Inventory (BAI; Beck, Epstein, Brown & Steer, 1988)(Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment)
- The Inventory of Social Support in Anxious Situations (ISSAS; St-Jean-Trudel et al., 2005)(Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment)
- The Structured Clinical Interview (SCID-I; First, Spitzer, Gibbon & Williams, 1995)(Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment)
- The Health Cost Interview(Baseline, 3 months post-treatment)
- The WHOQOL - Bref (WHOQOL Group, 1998)(Baseline, every 4 weeks during treatment, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment, 1 year post-treatment)
- The Pittsburgh Sleep Quality Index (PSQI)(Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment)
- The Brief Pain Inventory (BPI; Cleeland, 1989)(Baseline, 1 week post-treatment, 3 months post-treatment, 6 months post-treatment)
研究者
Stephane Guay
Professor
Université de Montréal