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Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial.

Allen AR, Newby JM, Smith J, Andrews G - Trials (2015)

Bottom Line: The minimum sample size for each group (alpha 0.05, power 0.80 for a g of 0.47) was identified as 72, but 10 % more will be recruited to hedge against expected attrition.The IUS-12 and ERQ will be administered before lessons 1 and 4, at post-treatment and at 3-month follow-up.The waitlist control group will complete these measures at week 1, week 5 and week 11 of the waitlist period.

View Article: PubMed Central - PubMed

Affiliation: Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St Vincent's Hospital, Level 4, O'Brien Centre, St. Vincent's Hospital, 394-404 Victoria Street, Darlinghurst, NSW, Australia. adrian.allen@unsw.edu.au.

ABSTRACT

Background: This randomised controlled trial (RCT) with two parallel arms will evaluate the efficacy of an internet-delivered six-lesson 10-week cognitive behavioural therapy (iCBT) intervention for posttraumatic stress disorder (PTSD). It will also investigate the association between changes in PTSD symptoms, intolerance of uncertainty (IU) and emotion regulation.

Methods/design: Patients with PTSD will be recruited via the research arm of a not-for-profit clinical and research unit in Australia and randomised to a treatment group or waitlist control group. The minimum sample size for each group (alpha 0.05, power 0.80 for a g of 0.47) was identified as 72, but 10 % more will be recruited to hedge against expected attrition. PTSD diagnosis will be determined using the PTSD module from the Mini International Neuropsychiatric Interview version 5.0.0. The PTSD Checklist - Civilian version (PCL-C) will be used to measure PTSD symptoms (the primary outcome measure), with the Intolerance of Uncertainty Scale 12-item version (IUS-12) and the Emotion Regulation Questionnaire (ERQ) used to measure intolerance of uncertainty and emotion regulation, respectively. The PCL-C will be administered to the treatment group before each lesson of the PTSD program and at 3-month follow-up. The IUS-12 and ERQ will be administered before lessons 1 and 4, at post-treatment and at 3-month follow-up. The waitlist control group will complete these measures at week 1, week 5 and week 11 of the waitlist period. PTSD program efficacy will be determined using intent-to-treat mixed models. Maintenance of gains will be assessed at 3-month follow-up. Mediation analyses using PROCESS will be used to examine the association between change in PTSD symptoms over treatment and change in each of IU and emotion regulation ability in separate analyses.

Discussion: The current RCT seeks to replicate previous efficacy findings of iCBT for PTSD in a formally assessed PTSD sample from the general population. Findings may point to future lines of enquiry for the role of IU and emotion regulation in the mechanism of PTSD symptom change during CBT.

Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12614001213639 , registered 18 November 2014. This trial protocol is written in compliance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.

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Related in: MedlinePlus

Participant flow chart
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Fig1: Participant flow chart

Mentions: Participants will be recruited through flyers, paid print and internet advertising. Applicants will first complete online screening questionnaires about symptoms and demographic details (see Fig. 1 for a participant flow chart). Inclusion criteria are as follows: meet diagnostic criteria for PTSD; computer, internet and printer access; Australian resident; fluent in written and spoken English; willing to provide name, phone number and address, and to provide the name and address of a local general practitioner. Exclusion criteria are as follows: trauma occurrence within the past 4 weeks; non-resident of Australia; less than 18 years of age; currently receiving treatment for trauma/PTSD; frequent suicidal ideation (indicated by a score of 3 to item 9 of the Patient Health Questionnaire 9-item version (PHQ9)); regularly using illicit drugs or regularly consuming more than three standard drinks per day; psychotic disorder or taking atypical antipsychotics or benzodiazepines; if taking medication for anxiety or depression, has been taking the same dose for less than 1 month or intending to change the dose during the course of the program; currently highly dissociative (indicated by score ≥40 on the Dissociative Experiences Scale as per Spence et al. [20]); current or pending medicolegal proceedings associated with the reported trauma; applying for, or receiving, Workers Compensation associated with their trauma or PTSD. Excluded applicants will receive information on alternative services and will be encouraged to discuss their symptoms with their physician. Applicants who pass the screening phase will be telephoned for a diagnostic interview using the PTSD module from the Mini International Neuropsychiatric Interview version 5.0.0 (MINI) [39] to determine whether they meet diagnostic criteria for PTSD. All interviews will be conducted by a registered Clinical Psychologist (AA) or Clinical Trials Manager (JS) under the guidance of the Clinical Psychologist and trained in administration of the diagnostic interview. Applicants who satisfy all inclusion criteria will be informed of the study design and will complete an electronic informed consent prior to enrolling in the trial. Information from the diagnostic interview will be used for research purposes only for those participants who provide informed consent. All participants will be informed in writing that they may withdraw from the study (i.e. choose to cease program enrolment or choose for their data to be excluded from the RCT) at any time without jeopardising their relationship with St. Vincent’s Hospital or the University of New South Wales. Further, those participants randomised to the waitlist control group will be informed that should they commence a trauma-focused intervention outside of the trial, their data will be omitted from the RCT.Fig. 1


Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial.

Allen AR, Newby JM, Smith J, Andrews G - Trials (2015)

Participant flow chart
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4666048&req=5

Fig1: Participant flow chart
Mentions: Participants will be recruited through flyers, paid print and internet advertising. Applicants will first complete online screening questionnaires about symptoms and demographic details (see Fig. 1 for a participant flow chart). Inclusion criteria are as follows: meet diagnostic criteria for PTSD; computer, internet and printer access; Australian resident; fluent in written and spoken English; willing to provide name, phone number and address, and to provide the name and address of a local general practitioner. Exclusion criteria are as follows: trauma occurrence within the past 4 weeks; non-resident of Australia; less than 18 years of age; currently receiving treatment for trauma/PTSD; frequent suicidal ideation (indicated by a score of 3 to item 9 of the Patient Health Questionnaire 9-item version (PHQ9)); regularly using illicit drugs or regularly consuming more than three standard drinks per day; psychotic disorder or taking atypical antipsychotics or benzodiazepines; if taking medication for anxiety or depression, has been taking the same dose for less than 1 month or intending to change the dose during the course of the program; currently highly dissociative (indicated by score ≥40 on the Dissociative Experiences Scale as per Spence et al. [20]); current or pending medicolegal proceedings associated with the reported trauma; applying for, or receiving, Workers Compensation associated with their trauma or PTSD. Excluded applicants will receive information on alternative services and will be encouraged to discuss their symptoms with their physician. Applicants who pass the screening phase will be telephoned for a diagnostic interview using the PTSD module from the Mini International Neuropsychiatric Interview version 5.0.0 (MINI) [39] to determine whether they meet diagnostic criteria for PTSD. All interviews will be conducted by a registered Clinical Psychologist (AA) or Clinical Trials Manager (JS) under the guidance of the Clinical Psychologist and trained in administration of the diagnostic interview. Applicants who satisfy all inclusion criteria will be informed of the study design and will complete an electronic informed consent prior to enrolling in the trial. Information from the diagnostic interview will be used for research purposes only for those participants who provide informed consent. All participants will be informed in writing that they may withdraw from the study (i.e. choose to cease program enrolment or choose for their data to be excluded from the RCT) at any time without jeopardising their relationship with St. Vincent’s Hospital or the University of New South Wales. Further, those participants randomised to the waitlist control group will be informed that should they commence a trauma-focused intervention outside of the trial, their data will be omitted from the RCT.Fig. 1

Bottom Line: The minimum sample size for each group (alpha 0.05, power 0.80 for a g of 0.47) was identified as 72, but 10 % more will be recruited to hedge against expected attrition.The IUS-12 and ERQ will be administered before lessons 1 and 4, at post-treatment and at 3-month follow-up.The waitlist control group will complete these measures at week 1, week 5 and week 11 of the waitlist period.

View Article: PubMed Central - PubMed

Affiliation: Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St Vincent's Hospital, Level 4, O'Brien Centre, St. Vincent's Hospital, 394-404 Victoria Street, Darlinghurst, NSW, Australia. adrian.allen@unsw.edu.au.

ABSTRACT

Background: This randomised controlled trial (RCT) with two parallel arms will evaluate the efficacy of an internet-delivered six-lesson 10-week cognitive behavioural therapy (iCBT) intervention for posttraumatic stress disorder (PTSD). It will also investigate the association between changes in PTSD symptoms, intolerance of uncertainty (IU) and emotion regulation.

Methods/design: Patients with PTSD will be recruited via the research arm of a not-for-profit clinical and research unit in Australia and randomised to a treatment group or waitlist control group. The minimum sample size for each group (alpha 0.05, power 0.80 for a g of 0.47) was identified as 72, but 10 % more will be recruited to hedge against expected attrition. PTSD diagnosis will be determined using the PTSD module from the Mini International Neuropsychiatric Interview version 5.0.0. The PTSD Checklist - Civilian version (PCL-C) will be used to measure PTSD symptoms (the primary outcome measure), with the Intolerance of Uncertainty Scale 12-item version (IUS-12) and the Emotion Regulation Questionnaire (ERQ) used to measure intolerance of uncertainty and emotion regulation, respectively. The PCL-C will be administered to the treatment group before each lesson of the PTSD program and at 3-month follow-up. The IUS-12 and ERQ will be administered before lessons 1 and 4, at post-treatment and at 3-month follow-up. The waitlist control group will complete these measures at week 1, week 5 and week 11 of the waitlist period. PTSD program efficacy will be determined using intent-to-treat mixed models. Maintenance of gains will be assessed at 3-month follow-up. Mediation analyses using PROCESS will be used to examine the association between change in PTSD symptoms over treatment and change in each of IU and emotion regulation ability in separate analyses.

Discussion: The current RCT seeks to replicate previous efficacy findings of iCBT for PTSD in a formally assessed PTSD sample from the general population. Findings may point to future lines of enquiry for the role of IU and emotion regulation in the mechanism of PTSD symptom change during CBT.

Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12614001213639 , registered 18 November 2014. This trial protocol is written in compliance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.

Show MeSH
Related in: MedlinePlus