Evaluating the efficacy of additional self-compassion or cognitive therapy for treatment of post-traumatic stress disorder (PTSD) and depressive disorders

• Register: ANZCTR
• Last refreshed on: 27 August 2018
• Main ID: ACTRN12617000885392
• Date of registration: 16/06/2017
• Prospective Registration: Yes
• Primary sponsor: Zhila Javidi-Hosseinabad
• 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
• Date of first enrolment: 3/07/2017
• Target sample size: 58
• Recruitment status: Completed
• URL: http://www.anzctr.org.au/ACTRN12617000885392.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Not Applicable

Health Condition(s) or Problem(s) studied

Depressive disorders

PTSD

Intervention(s)

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 the