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Trial registered on ANZCTR


Registration number
ACTRN12611000541909
Ethics application status
Approved
Date submitted
22/05/2011
Date registered
25/05/2011
Date last updated
25/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The treatment of comorbid posttraumatic stress disorder and major depressive disorder: The utility of a combined treatment approach.
Scientific title
The utility of combining cognitive processing therapy and behavioural activation for individuals with comorbid posttraumatic stress disorder and major depressive disorders: Is there added benefit to combining treatments?
Secondary ID [1] 262228 0
Nill
Universal Trial Number (UTN)
U1111-1121-1855
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 267925 0
Depression 267926 0
Condition category
Condition code
Mental Health 268066 268066 0 0
Anxiety
Mental Health 268067 268067 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is comparing three different treatment conditions.

Arm 1: Cognitive Processing Therapy only. CPT will follow the manual written by Resick, Monson, and Chard (2007). Therapy will be administered weekly, in a one on one setting (i.e., therapist and client). Therapy will be conducted over 12 to 15 weekly sessions. Sessions will last between 60 and 90 minutes. Sessions one and two will introduce the concepts of PTSD and CPT and will involve the client writing an impact statement. The impact statement will allow the therapist and client to identify stuck points (i.e., problem areas in thinking). During session three the client will be taught to identify and label their thoughts and feelings and the relationship amongst events, thoughts and emotions. During sessions four and five the client will generate and read their trauma account to the therapist. Through Socratic questioning the therapist will begin questioning self-blame and other distorted thoughts. The therapist will continue to work through stuck points during session six. Thus, sessions one through six will aim to teach the client to challenge their thoughts of the trauma and to identify problematic cognitions. The following sessions will teach the client cognitive therapy skills and focus on topics that have been disrupted by the trauma. During session seven clients will use worksheets to develop and practice using more balanced self-statements. Sessions eight through 12 will ask the client to focus on one theme each week (i.e., safety, trust, power, esteem, intimacy) and correct overgeneralised beliefs related to the theme. Within session 11 the client will write another impact statement and this revised statement will be used in session 12 to evaluate gains made in treatment and where the client wishes to continue working. During session 12 clients will also receive information related to relapse prevention. The core therapy protocol will consist of 12 weekly sessions. However, in order to increase the clinical validity of the protocol, up to 3 additional sessions will be offered if necessary to target any residual PTSD or depressive symptoms still present after 12 weeks of treatment. This is routine clinical practice in a community setting.

Arm 2: Behavioural Activation then Cognitive Processing Therapy. Therapy will be manualised. Therapy will be administered weekly, in a one on one setting (i.e., therapist and client). The treatment will be based on the Behavioural Activation intervention for depression (Martell, Addis, & Jacobson, 2001), and CPT for PTSD (Resick, et al., 2007). Therapy will consist of 15 sessions lasting between 60 to 90 minutes each. The first five sessions will be depression focussed and utilise Behavioural Activation techniques. The first five sessions will focus on the link between behaviour and mood and involve psychoeducation, activity monitoring, and mastery and pleasure tasks (Martell et al., 2001). During session one clients will receive a treatment rationale along with information regarding PTSD and depression symptoms. During session two clients will discuss the cycle of depression and its’ relation to inactivity. Clients will be presented with a weekly activity scheduling task in which they must monitor what they do during the week and how these activities make them feel. This task aims to allow the client to become aware of their mood/anxiety levels, triggers and consequences. During session three the activity monitoring task will be reviewed and the TRAP (trigger, response, avoidance, pattern) model discussed. The therapist will then explain the importance of scheduling pleasant events and the significance of elevating activity. The client will then be assigned a pleasant event scheduling task to complete during the following week. Through the use of role plays and worksheets session four and five will then aim to teach the ACTION model and demonstrate the importance of elevating pleasant activities in everyday life. The ACTION model contains the following components:

Assess how the behaviour serves you (what outcome/consequences do you expect when you decide not to go out with friends? Why do you choose to be alone? Scared to get hurt again/embarrassment, etc.)
Choose to either avoid or activate (what will be the outcome of you going out with friends? Distraction from negative thoughts, social support, etc.)
Try out the behaviour that has been chosen (or try out a new behaviour that you find might lead to a positive outcome)
Integrate any new behaviour into a routine (make those behaviours that make you feel good part of your daily life)
Observe the outcome (continue your detective work)
Never give up!

The remaining sessions will be trauma focussed. These sessions will incorporate exposure, and cognitive therapy with a focus on the themes of safety, trust, intimacy, power/control, and esteem (Resick, et al., 2007). Session six will provide the client with information about PTSD symptoms and CPT. During session seven clients will write an impact statement. In session eight clients will identify thoughts and feelings and the connection between thoughts and feelings. During sessions nine and ten clients will work through their trauma accounts and stuck points will be identified. Sessions 11 and 12 will ask clients to further work through stuck points and patterns of problematic thinking. Sessions 13 through 15 will then ask clients to work through themes of safety, trust, power, esteem, intimacy and correct overgeneralised beliefs related to the theme. Session 15 will also involve the provision of relapse prevention information.

Arm 3: Cognitive Processing Therapy than Behavioural Activation. Therapy will be administered weekly, in a one on one setting (i.e., therapist and client). This condition will follow the same procedures as the Behavioural Activation then CPT condition but the CPT and Behavioural Activation components will be presented in the reverse order. That is, the first set of 10 sessions will be trauma focused and the next five sessions will utilise Behavioural Activation techniques.
Intervention code [1] 266620 0
Treatment: Other
Intervention code [2] 266648 0
Behaviour
Comparator / control treatment
Active Treatment: Cognitive Processing Therapy (details in previous item).
Control group
Active

Outcomes
Primary outcome [1] 266802 0
Primary Outcome 1: Posttraumatic Stress Disorder Check List score (posttraumatic stress disorder symptom measure)
Timepoint [1] 266802 0
Timepoint: Pre-treatment, mid treatment, post-treatment, 6 month follow up
Primary outcome [2] 266803 0
Primary Outcome 2: Mean Depression, Anxiety and Stress Scale score (depression symptom measure)
Timepoint [2] 266803 0
Timepoint: Pre-treatment, mid treatment, post-treatment, 6 month follow up
Secondary outcome [1] 276422 0
Secondary Outcome 1: Working Alliance Inventory Score (score of therapist and client's working alliance)
Timepoint [1] 276422 0
Timepoint: Score at session 2 and Post-treatment
Secondary outcome [2] 276423 0
Secondary Outcome 2: Credibility/Expectancy Questionnaire (score regarding the credibility and expectancies of the therapy)
Timepoint [2] 276423 0
Timepoint: Score at session 1 and Post-treatment
Secondary outcome [3] 276424 0
Secondary Outcome 3: Posttraumatic Cognitions Inventory (assesses thoughts surrounding self, world and self-blame)
Timepoint [3] 276424 0
Timepoint: Pre-treatment, mid treatment, post-treatment, 6-month follow up
Secondary outcome [4] 276425 0
Secondary Outcome 4: Twenty-Item Toronto Alexithymia Scale (assesses alexithymia)
Timepoint [4] 276425 0
Timepoint: Pre-treatment, mid treatment, post-treatment, 6-month follow up
Secondary outcome [5] 276426 0
Secondary Outcome 5: Emotional Numbing Questionnaire (assesses emotional numbing)
Timepoint [5] 276426 0
Timepoint: Pre-treatment, mid treatment, post-treatment, 6-month follow up
Secondary outcome [6] 276427 0
Secondary Outcome 6: Ruminative Response Scale of the Response Style Questionnaire (assesses rumination in response to depressed mood)
Timepoint [6] 276427 0
Timepoint: Pre-treatment, mid treatment, post-treatment, 6-month follow up
Secondary outcome [7] 276428 0
Secondary Outcome 7: Stress-Reactive Rumination Scale (assesses rumination in response to trauma)
Timepoint [7] 276428 0
Timepoint: Pre-treatment, mid treatment, post-treatment, 6-month follow up
Secondary outcome [8] 276429 0
Secondary Outcome 8: Client Expressed Emotional Arousal Scale-III (assesses emotional engagement during therapy)
Timepoint [8] 276429 0
Timepoint: Session 2, session 4, session 6, session 8, session 10, session 11, session 12 and session 14

Eligibility
Key inclusion criteria
Participants will be recruited if they: (a) are fluent in English, (b) have been exposed directly or indirectly (witnessed) to trauma (motor vehicle accidents, industrial accidents, interpersonal assault etc) four or more weeks ago, (c) meet a full or sub-threshold diagnosis for Post Traumatic Stress Disorder and (d) if participants are on psychotropic medications, agree to maintain a stable course of medication for the duration of therapy.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
Exclusion criteria for research purposes comprise: inadequate comprehension of English. For clinical reasons, clients with the following presentations would not normally be offered short-term trauma-focussed therapy in any service: (a) moderate to severe traumatic brain injury, (b) uncontrolled psychosis, (c) current substance dependence, (d) already currently in an active, trauma-focussed therapy, (e) significant risk of harm (e.g. in current domestic violence situation) or (f) active suicidality.

Withdrawal criteria
As a matter of standard clinical management and ethical procedures, participants would be withdrawn if it was felt that therapy was either inappropriate or if there was a significant decline in the person’s well-being (e.g., if they required hospitalisation for self-harm concerns etc).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be recruited from Yarrow Place Rape and Sexual Assault Clinic and a variety of other sources including University campuses, general practitioner offices, police stations, hospitals and victim support services.

A proportion of participants will be recruited from Yarrow Place, a sexual assault counselling service in Adelaide. Female adult sexual assault victims who meet the criteria for PTSD and major depression will be randomly allocated to receive CPT then behavioural activation, behavioural activation and then CPT or, CPT alone. Randomisation will be stratified according to PTSD severity and age. Randomisation will be conducted by an individual external to the study and randomisation will occur using a randomisation table created by a computer. In this way personnel providing the treatment protocols will not be aware of group allocation ratios, nor will treatment allocation be influenced by the pre-treatment assessment.

Participants will be recruited from the natural referral process that occurs at Yarrow Place. When an individual makes contact with the service, potential participants who are seeking counselling for post traumatic stress disorder as a result of a sexual trauma and do not met obvious exclusion criteria, will be informed about their ability to be involved in the study by Yarrow Place staff. If a participant expresses interest in the research study they will be given the researcher’s details so that they can learn more about the study. Or alternatively, if the potential participants would prefer and if they give verbal consent to the Yarrow Place staff, they could be contacted by the researcher. Following this, a formal informed consent procedure will occur and an initial assessment will be booked. This will be the 3rd treatment trial the investigator has conducted in collaboration with Yarrow Place, thus we have good procedures in place in terms of such recruitment methods and liaising with Yarrow Place staff around recruitment issues.

Further participants will be recruited from a number of sources including local hospitals, victim support centres, police departments, mental health centres, universities, and through advertisements in local newspapers and radio (as approved by the Flinders Clinical Research Ethics Committee). These participants may have experienced a wider range of traumas (i.e., not confined to sexual traumas). These additional participants will be recruited via the following methods:

1. Relevant departments within Flinders Medical Centre (FMC) (e.g., Psychology, Psychiatry, Social Work) will be sent a letter informing them of the study. Accompanying the letter will be a copy of a handout with details of the study and how to contact the investigators which can be made available to potential participants by the FMC departments.

2. Participants from other sources will be recruited through the use of the same letter/handout (e.g., GP’s, community noticeboards, police stations and victim services agencies). Approval will be sought from the relevant organisations if this is required before the advertisements are posted in waiting rooms etc.

3. FMC Website – Information regarding the study will be posted on the website.

4. Generic pamphlet – because the Investigator is currently conducting three treatment outcome studies, a generic pamphlet summarising the research treatment studies being undertaken by the Investigator’s Posttraumatic Stress Disorder Research Unit at Flinders University has been developed. Accordingly this pamphlet will also be used for recruitment at clinical services that see a range of clients that might fit criteria for any of these studies.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are allocated to treatment condition based on block randomisation. The randomisation spreadsheet is held by an individual unrelated to the study. After participants complete their pre-treatment assessment, the individual is contacted and the participant’s condition is then disclosed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4024 0
5001
Recruitment postcode(s) [2] 4025 0
5042
Recruitment postcode(s) [3] 4026 0
5063
Recruitment postcode(s) [4] 4027 0
5110
Recruitment postcode(s) [5] 4028 0
5117
Recruitment postcode(s) [6] 4029 0
5108
Recruitment postcode(s) [7] 4030 0
5043
Recruitment postcode(s) [8] 4031 0
5052
Recruitment postcode(s) [9] 4032 0
5043
Recruitment postcode(s) [10] 4033 0
5041
Recruitment postcode(s) [11] 4034 0
5046
Recruitment postcode(s) [12] 4035 0
5039
Recruitment postcode(s) [13] 4036 0
5043

Funding & Sponsors
Funding source category [1] 267118 0
University
Name [1] 267118 0
Flinders University - Research student maintenance fund
Country [1] 267118 0
Australia
Primary sponsor type
Individual
Name
Samantha Angelakis
Address
Samantha Angelakis
School of Psychology
Flinders University
GPO Box 2100, Adelaide, SA, 5001
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 264196 0
None
Name [1] 264196 0
Address [1] 264196 0
Country [1] 264196 0
Other collaborator category [1] 252014 0
Individual
Name [1] 252014 0
Dr Reg Nixon
Address [1] 252014 0
School of Psychology
Flinders University
GPO Box 2100 Adelaide, SA 5001
Australia
Country [1] 252014 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267100 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 267100 0
Ethics committee country [1] 267100 0
Australia
Date submitted for ethics approval [1] 267100 0
09/07/2010
Approval date [1] 267100 0
01/10/2010
Ethics approval number [1] 267100 0
1/10/0283
Ethics committee name [2] 267101 0
Conditional approval from Children, Youth And Women's Health Service (CYWHS) Human Research Ethics Committee (HREC)
Ethics committee address [2] 267101 0
Ethics committee country [2] 267101 0
Australia
Date submitted for ethics approval [2] 267101 0
20/04/2011
Approval date [2] 267101 0
Ethics approval number [2] 267101 0
14/04/2366

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32643 0
Address 32643 0
Country 32643 0
Phone 32643 0
Fax 32643 0
Email 32643 0
Contact person for public queries
Name 15890 0
Samantha Angelakis
Address 15890 0
Samantha Angelakis
School of Psychology
Flinders University
Bedford Park, South Australia, 5042
GPO Box 2100 Adelaide
Australia
Country 15890 0
Australia
Phone 15890 0
+61 8 8201 2370
Fax 15890 0
+61 8201 3877
Email 15890 0
samantha.angelakis@flinders.edu.au
Contact person for scientific queries
Name 6818 0
Samantha Angelakis
Address 6818 0
Samantha Angelakis
School of Psychology
Flinders University
Bedford Park, South Australia, 5042
GPO Box 2100 Adelaide
Australia
Country 6818 0
Australia
Phone 6818 0
+61 8 8201 2370
Fax 6818 0
+61 8 8201 3877
Email 6818 0
samantha.angelakis@flinders.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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