Compassion-Focused Therapy for Prolonged Grief Symptoms
Condition: Prolonged Grief Symptoms
Study type: Interventional

Summary: 
      Prolonged grief disorder (PGD) is a novel diagnostic entity proposed to describe a
      psychiatric disorder that occurs after the loss of a loved one. The disorder is to be
      implemented in The International Classification of Diseases 11th Revision (ICD-11), scheduled
      for release in 2018. Failure to recognize and treat PGD may have negative effects on health,
      functional capacity and quality of life. However, very little is known about the
      characteristics and treatment of PGD in adult Danish populations although such knowledge is
      much needed before introducing the disorder in Danish health services.

      The present study aims to develop, test and disseminate a group-based treatment manual for
      PGD in bereaved partners and their adult children. People with high levels of symptoms will
      be recruited from a large-scale survey study examining frequency, predictors and prognosis of
      PGD symptoms (NCT03049007). Participants will be randomized to group-based compassion-focused
      therapy (CFT) for grief or a waitlist control group. Treatment effects will be estimated with
      prolonged grief symptoms as the primary outcome. Secondary outcomes include depressive
      symptoms, posttraumatic stress symptoms, symptoms of anxiety, and quality-of-life. The
      investigators expect that CFT will yield statistically significant effects on prolonged grief
      symptom compared with the waitlist control group. If CFT is shown to be efficacious in
      reducing prolonged grief symptoms, the investigators will conduct moderation and mediation
      analyses with the aim of identifying what works, for whom. Finally, the investigators will
      perform cost-effectiveness analyses by linking the data with healthcare utilization data from
      the Danish National registries.
    

Detailed description: 
      Aims

      Our primary hypotheses are:

      • CFT will have a statistically significant and long-term effect on PGD symptoms compared
      with the waitlist control group

      Secondary hypotheses are:

        -  Self-compassion self-criticism, rumination, and exposure to the loss will mediate the
           effects of CFT on PGD symptoms

        -  Baseline PGD symptom level will moderate the intervention effects of CFT, with higher
           symptom level predicting larger symptom improvement

        -  Gender, age, type of loss, attachment style, neuroticism, positive affect and social
           support will predict who will benefit most from treatment (moderator analyses)

        -  CFT will reduce levels of depression, anxiety, and posttraumatic stress symptoms and
           increase quality-of-life (QoL) compared with the wait-list control group

        -  Time spent on homework practice will moderate the intervention effects of CFT, with more
           time spent on homework predicting larger symptom improvement

        -  CFT is a cost-effective psychological treatment compared with the waitlist-control group

      Design

      The present project will be conducted as a randomized waitlist-controlled trial, with a 1:1
      allocation ratio and using block randomization conducted by an external biostatistician.

      Participants

      The present randomized controlled trial (RCT) recruits patients from a large survey that
      invites all bereaved partners in the Central Denmark Region and their adult children (age >
      18 years) to participate in a survey regarding trajectories of grief. This means that the
      present study recruits patients from an existing survey (NCT03049007). All bereaved partners
      and their adult children from the existing survey study with clinically relevant levels of
      PGD 11 months after their loss (min.score >= 25 on PG-13) will be invited to participate in
      the present RCT.

      Assessment points

      Assessment of all three intervention groups will be provided at five points: (1) before the
      intervention (baseline), (2) after each session (the CFT group only), (3) after the last
      intervention session (post-intervention), (4) 3 months post-intervention, and (5) 6 months
      post-intervention. In addition, data on healthcare utilization will be retrieved from the
      Danish registries concerning health care services (e.g., visit to the general practitioner,
      use of medication, number of hospitalizations).

      Sample size

      Previous studies have generally found large effects of psychological interventions for PGD
      that included cognitive techniques with effect-sizes (Cohens' d) ranging from 0.80-2.41.
      Although previous studies testing the efficacy of psychological treatments for prolonged
      grief have reported large effects, we undertake a more conservative estimate as CFT, so far,
      has not been tested in a bereaved population.

      So far, no values for minimal clinically important difference (MCID) have been established
      for the PG-13. When such indicators are missing, the general literature on interpretation of
      clinical change suggests that a change corresponding to one half standard deviation could be
      a suitable substitute (Copay et al., 2007; Norman et al. 2003). We therefore aim to be able
      to detect a clinically relevant effect of Cohen's d 0.50. A final sample of 156 participants
      (2 x 78, 1:1 allocation) will enable us, in a pre-post repeated-measures design, to detect a
      difference between CFT and the control group, with a two-sided alpha of 0.05, a pre-post
      correlation (Rho) of 0.5, a statistical power of 0.80, and an estimated dropout rate of 20%.

      Statistical analyses

      Analyses will be conducted using the statistical software IBM SPSS statistics, v.21 (IMB,
      Chicago, IL) and Stata v.13 (StataCorp, College Stadium, TX). Baseline group differences will
      be explored with t tests and χ²-tests. All main effects will be analyzed using Mixed Linear
      Models (MLMs) based on the intent-to-treat sample, comparing groups over time on all outcome
      variables. Each hypothesis will be tested in separate models.

      Intervention effects will be indicated by a statistically significant 2-way group x time
      interaction, and results will be interpreted in terms of their effect sizes. As we randomize
      the participants, we do not expect that any differences in use of alternative treatments
      prior to or during the study period will exist between study groups. However, in case of an
      imbalance on this variable, we will include it as a covariate in a second set of analyses.

      Possible mediating and moderating effects will be explored for statistically significant
      outcomes in the main analyses, using MLMs. Cost-effectiveness analyses will be investigated
      by aggregating healthcare utilization costs and by investigating the effect of CFT on
      Quality-Adjusted Life-Years (QALY).The probability of CFT being cost-effective are
      investigated by calculating Cost-Effectiveness Acceptability Curves (CEACs).
    

Intervention name(s): Compassion-Focused Therapy
Intervention type(s): Behavioral
Intervention description(s): CFT for PGD symptoms in the present project is inspired by two well-established CFT treatment manuals. The first is used for treatment of PTSD (Lee & James, 2011) and the other for treatment of anger (Kolt, 2011). The manual for CFT for PGD adopts both structure and techniques from these into an 8-week, group-based program with weekly 2 1/4-hour sessions. Each session contains elements of psychoeducation on uncomplicated and prolonged grief reactions, identifying unhelpful strategies for self-protection and facilitating use of more helpful strategies, and training an open and compassionate management of grief-related distress through CFT exercises. Between the sessions the participant will train the exercises introduced at the previous session.
Other intervention name(s): CFT for PGD symptoms
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Block randomization in REDcap (copyright by Vanderbuilt University, USA) conducted by external biostatistician
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment