ANZCTR - Registration

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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]

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

Depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

Active Treatment: Cognitive Processing Therapy (details in previous item).

Control group

Active

Outcomes

Primary outcome [1]

Primary Outcome 1: Posttraumatic Stress Disorder Check List score (posttraumatic stress disorder symptom measure)

Timepoint [1]

Timepoint: Pre-treatment, mid treatment, post-treatment, 6 month follow up

Primary outcome [2]

Primary Outcome 2: Mean Depression, Anxiety and Stress Scale score (depression symptom measure)

Timepoint [2]

Timepoint: Pre-treatment, mid treatment, post-treatment, 6 month follow up

Secondary outcome [1]

Secondary Outcome 1: Working Alliance Inventory Score (score of therapist and client's working alliance)

Timepoint [1]

Timepoint: Score at session 2 and Post-treatment

Secondary outcome [2]

Secondary Outcome 2: Credibility/Expectancy Questionnaire (score regarding the credibility and expectancies of the therapy)

Timepoint [2]

Timepoint: Score at session 1 and Post-treatment

Secondary outcome [3]

Secondary Outcome 3: Posttraumatic Cognitions Inventory (assesses thoughts surrounding self, world and self-blame)

Timepoint [3]