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Trial registered on ANZCTR


Registration number
ACTRN12617000885392
Ethics application status
Approved
Date submitted
31/05/2017
Date registered
16/06/2017
Date last updated
22/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of additional self-compassion or cognitive therapy for treatment of post-traumatic stress disorder (PTSD) and depressive disorders
Scientific title
Comparison of the efficacy of behavioural therapy augmented with either self-compassion or cognitive therapy for the treatment of PTSD and depressive disorders
Secondary ID [1] 292084 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PTSD 303504 0
Depressive disorders 303505 0
Condition category
Condition code
Mental Health 302921 302921 0 0
Depression
Mental Health 302922 302922 0 0
Anxiety
Mental Health 302971 302971 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a combined therapy protocol (self-compassion with behavioural therapies).

Self-compassion: Comprise techniques that, through regular monitored practice, are designed to improve self-compassion by inter-connecting the three main affect regulation systems (i.e., contentment-soothing, threat, and drive).

Behaviour therapies: will comprise either exposure therapy (which can be carried out in real situations (in-vivo), or through imagination, for PTSD) or behavioural activation (based on encouraging the client to engage in routine jobs, pleasurable, and important/necessary activities, for depression).

Description of the 12 sessions of the Experimental (Novel) Treatment for PTSD and Depressive Disorders:

Step 1: Screening & Planning for Sessions 1 & 2 for both PTSD and Depressive Disorders:

*Baseline measures: To be scored by client in waiting room prior to screening.

*Information sheet & Consent form: To be explained by therapist, to be read by client & if agreed to be signed by client prior to screening assessment.

*Initial screening at session1: Completion of the semi structure assessment tools; Discussing, planning & management risk/safety;

*Explaining the rationale for Novel Treatment for PTSD & Depressive Disorders include: To discuss the rationales for PTSD: Exposure-Based Therapies (EBTs) & Self-Compassion (SC) based interventions; To discuss the rationales for depressive disorders: Behavioural Activation (BA) & Self-Compassion (SC) based interventions

*Psychosocial history at session 2: Establishing problem and treatment goals; Therapy contract/sessions; Discussion hierarchy of anxiety & homework (from 30 to 60 mins and to practice the task for more than 3 days per week)

Step 2: Experimental Treatment from Sessions 3 to 11 for PTSD and Depressive Disorders:

*Securing the therapeutic relationship from session 3 to 11: Safety, engagement, & signposting to psychosocial supports.

*Psychoeducation from session 3 to 4: PTSD symptoms, processes, it relation to developmental stages & other traumas; Depression symptoms, processes, it relation to developmental stages & other stressors

*Collaborating on treatment sequencing from session 3 to 11: Each session is co-operative; the client is expected to be active & to try to generate solutions.

*Structure Agenda from session 3 to 11: To review the homework; To assess progress towards client’s goals; To discuss feedback on the previous session; To focus on one or two specific related issues; To plan new homework; To checking their safety; & To organize the next session.

*Behavioural therapies (BTs) for PTSD and Depression: EBTs from session 3 to 11for PTSD with graded in-vivo exposure to trauma in relation to interceptive cues and avoidances behaviours; & graded imaginal exposure to trauma memory (i.e., written, verbal and/or recording). BA from session 3 to 11 for Depression: Describe and plan activity scheduling (AS) with client; To structure client’s day according to activities (i.e., routine, necessary & pleasurable) that are avoided; Clients are encouraged to start AS with short-term goals; & Clients learn to treat their AS, as a series of appointments with themselves.

*Self-Compassion (SC) based therapies from session 3 to 11 for PTSD: Threat/safety strategies; Formulation in Compassion Focused Therapy (CFT); Fear-based hotspots; Initial re-living identification based on shame & disgust; Building a compassionate image; Compassionate mind training; Critical voice & SC thought record sheet (therapist & client guides); Practice of meditation by Paul Gilbert and/or Kristina Neff from Mindful Self-Compassion (MSC); Developing inner qualities of inner compassion; Compassionate letter writing. SC based interventions from session 3 to 11 for Depression: Formulation in Compassion Focused Therapy (CFT); Building a compassionate image; Compassionate mind training; Critical voice & SC thought record sheets; Practice of meditation by Paul Gilbert and /or Kristina Neff from Mindful Self-Compassion (MSC); Developing inner qualities of inner compassion; Healthy emotion regulation strategies; Compassionate letter writing to self (therapist & client guides); Exercises to increase SC.

*Relapse prevention strategies from session 10 to 11 for PTSD and Depression.

Step 3: End of active treatment/ Discharge at session 12 for PTSD & Depressive Disorders:

*Review progress; Scoring the initial problem and goals; Summary & maintaining changes & gains from therapy; Blueprint & re-capping relapse prevention strategies; Follow-up sessions.

*Outcome Measures: To be scored by client at the end of the session 12.


As part of the protocol CARD for both Novel and Standard treatments: Clients diagnosed with PTSD work in collaboration with their therapist to establish their graded exposure tasks ( for 30 to 60 mins per day for more than 3 days) for in-vivo and imaginal. As part of the agreement between the therapist and the client, each graded exposure tasks (based on low to high anxiety provoking) will be practiced by client each week and client will report the outcome of their tasks at their next session.

A set of standard self-report measures will be completed at both assessment and discharge. Also Problem and Goals statement established by client will be scored from 0 to 8 at these time points.

Hand out materials used are obtained from the clinical unit (CARD) and/or other clinical websites such as: www.cci.health.wa.gov.au/resources/consumers.cfm https://cedar.exeter.ac.uk/
https://crufad.org/for clinicians/trauma/https://crufad.org/

Two senior therapists at CARD/SALHN and they have the extensive expertise in both BTs (15 to 20 years) and the SC (10 years)

Treatment is face to face and individual

Treatment comprises 12 sessions for a duration of 3 months that includes: 2 hours for initial assessment, 1 hour for treatment sessions and 2 hours for discharged session.

Treatment is conducted through an outpatient specialist service (CARD) which is part of SA local health network (SALHN)

Each therapist has completed the Master in CBT programs as part of Flinders University
The two therapists are also from AHP3 and RN3 disciplines

The two therapists have finished their training in Compassion focused therapy, Mindful self-compassion and other relevant training in areas of Mindfulness (MBCT)

Intervention code [1] 298228 0
Treatment: Other
Intervention code [2] 298281 0
Behaviour
Comparator / control treatment
The control treatment is cognitive therapy with behavioural therapies. This is the standard protocol in the study setting.

Cognitive therapy: will comprise two components. Cognitive restructuring - a set of techniques that create awareness of distorted thoughts and teach how to modify these. Behavioural experiments - derived directly from a cognitive formulation of a problem that generates information and/or tests core beliefs.

Behaviour therapies: will comprise either exposure therapy (which can be carried out in real situations (in-vivo), or through imagination, for PTSD) or behavioural activation (based on encouraging the client to engage in routine jobs, pleasurable and important/necessary activities, for depression).

Description of 12 sessions of the Standard Treatment for PTSD and Depressive Disorders:

Step 1: Screening & Planning for Sessions 1 & 2 for PTSD and Depressive Disorders:

*Baseline measures: To be scored by client in waiting room prior to screening; Information sheet & Consent form to be explained by therapist, to be read by client & if agreed to be signed by client prior to screening assessment.

*Initial screening at session1: Completion of the semi structure assessment tools; Discussing, planning & management risk/safety.

*Rationale for treatment: To discuss the rationales for PTSD: Exposure-Based Therapies (EBTs) & Cognitive Therapy (CT); To discuss the rationales for depressive disorders: Behavioural Activation (BA) & Cognitive Therapy (CT)

*Psychosocial history at session 2: Establishing problem and treatment goals; Therapy contract/sessions; Discussion hierarchy of anxiety & homework ( from 3o to 60 mins per day for more than 3 days per week)

Step 2: Standard Treatment from Sessions 3 to 11 for PTSD and Depressive Disorders:

*Securing the therapeutic relationship from session 3 to 11: Safety, engagement, & signposting to psychosocial supports.

*Psychoeducation from session 3 to 4: PTSD symptoms, processes, it relation to developmental stages & other traumas or Depression symptoms, processes, it relation to developmental stages & other stressors

*Collaborating on treatment sequencing from session 3 to 11: each session is cooperative, the client is expected to be active & to try to generate solutions.

*Structure Agenda from session 3 to 11: Review the homework; Their progress towards the goals; Discuss feedback on the previous session; Focus on one or two specific related issues; Plan new homework; Checking their safety; Organized the next session

*Behavioural therapies (BTs) for PTSD and Depression: Exposure Based Therapies (EBTs) from session 3 to 11for PTSD: Graded in-vivo exposure to trauma in relation to interceptive cues and avoidances behaviours; Graded imaginal exposure to trauma memory (i.e., written, verbal, and/or recording). Behavioural Activation (BA) from session 3 to 11 for Depression: Describe and plan activity scheduling (AS) with client: To structure client’s day according to activities (i.e., routine, necessary & pleasurable) that are avoided; Clients are encouraged to start AS with short-term goals & learn to treat their AS, as a series of appointments with themselves.

*Cognitive Therapy (CT) for PTSD and Depressive Disorders: CT from session 3 to 11 for PTSD: Conceptualisation and strategies for trauma related to NATs; Cognitive thought diary and restructuring cognitions; Engaging in Socratic dialogue and focusing on particular themes (e.g., fear, anxiety, safety and trust); Anxiety management and distress training.. CT from session 3 to 11 for depression: Conceptualisation and strategies for depressive related to NATs; Cognitive thought diary and restructuring cognitions; Engaging in Socratic dialogue; Focusing on particular themes (e.g., sadness); Erroneous beliefs & distress training

*Relapse prevention strategies from session 10 to 11 for PTSD and Depression.

Step 3: End of active treatment/ Discharge at session 12 for PTSD & Depressive Disorders:

*Review progress; Scoring the initial problem and goals; Summary & maintaining changes & gains from therapy; Blueprint & re-capping relapse prevention strategies; Follow-up sessions

*Outcome Measures: To be scored by client at the end of the session 12.
Control group
Active

Outcomes
Primary outcome [1] 302308 0
Mean K10 score (psychological distress severity).
Timepoint [1] 302308 0
At completion of a 12-week treatment program.
Primary outcome [2] 302309 0
Mean score on PCL-C scale (PTSD symptom severity).
Timepoint [2] 302309 0
At completion of a 12-week treatment program.
Secondary outcome [1] 335430 0
Mean resilience score (CD-RISC25).
Timepoint [1] 335430 0
At completion of a 12-week treatment program.
Secondary outcome [2] 335431 0
Mean self-compassion score (Self-Compassion Scale).
Timepoint [2] 335431 0
At completion of a 12-week treatment program.

Eligibility
Key inclusion criteria
Eligible participants will have a primary diagnosis of either depressive disorders or PTSD. They will be first presentations to the study service, referred by GPs or other health care professionals.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A presenting problem incompatible with the treatment protocols being studied (e.g., unmanaged psychotic illness, active suicidality, active substance or alcohol misuse, and current domestic violence).

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)
Yes.
Allocation will involve contacting the holder of the allocation schedule who is not involved in treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Yes.
By way of simple randomisation using a randomisation table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The basic analysis will be a 2 (treatment group) x 2 (time: pre/post) ANOVA.

The required sample size was determined for the interaction between treatment group and time (the effect of key interest) using G*Power 3. For alpha = .05 and power = 80% it was determined that a 'small effect size' of Partial Eta Squared =.02 (equivalent to Cohen’s f = .14) would require 29 participants per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/07/2017
Actual
3/07/2017
Date of last participant enrolment
Anticipated
4/09/2017
Actual
28/11/2017
Date of last data collection
Anticipated
4/12/2017
Actual
28/02/2018
Sample size
Target
58
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8212 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 16271 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 296615 0
Government body
Name [1] 296615 0
Centre for Anxiety and Related Disorders, Southern Adelaide Local Health Network (SALHN)
Country [1] 296615 0
Australia
Primary sponsor type
Individual
Name
Zhila Javidi-Hosseinabad
Address
Centre for Anxiety and Related Disorders (CARD) at Flinders Medical Centre, Block G4, The Flats, Flinders Drive, Bedford Park, SA, 5042
Country
Australia
Secondary sponsor category [1] 295575 0
University
Name [1] 295575 0
Flinders University
Address [1] 295575 0
Sturt Road. Bedford Park. SA. 5042.
Country [1] 295575 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297843 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 297843 0
Ethics committee country [1] 297843 0
Australia
Date submitted for ethics approval [1] 297843 0
04/06/2015
Approval date [1] 297843 0
15/06/2015
Ethics approval number [1] 297843 0
Apllication Number: 478.11

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

Contacts
Principal investigator
Name 75250 0
Ms Zhila Javidi-Hosseinabad
Address 75250 0
Centre for Anxiety and Related Disorders (CARD) at Flinders Medical Centre. Block G4. The Flats. Flinders Drive. Bedford park. SA. 5042
Country 75250 0
Australia
Phone 75250 0
+61 8 82044112
Fax 75250 0
+61 8 82045984
Email 75250 0
Zhila.Javidi@sa.gov.au
Contact person for public queries
Name 75251 0
Zhila Javidi-Hosseinabad
Address 75251 0
Centre for Anxiety and Related Disorders (CARD) at Flinders Medical Centre. Block G4. The Flats. Flinders Drive. Bedford park. SA. 5042
Country 75251 0
Australia
Phone 75251 0
+61 8 82044112
Fax 75251 0
+61 8 82045984
Email 75251 0
Zhila.Javidi@sa.gov.au
Contact person for scientific queries
Name 75252 0
Zhila Javidi-Hosseinabad
Address 75252 0
Centre for Anxiety and Related Disorders (CARD) at Flinders Medical Centre. Block G4. The Flats. Flinders Drive. Bedford park. SA. 5042
Country 75252 0
Australia
Phone 75252 0
+61 8 82044112
Fax 75252 0
+61 8 82045984
Email 75252 0
Zhila.Javidi@sa.gov.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

Documents added manually
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