Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial
Condition: Anxiety Depression
MeSH terms: Caregiver Burden
Study type: Interventional

Summary: 
      Informal caregivers of cancer patients report high levels of psychological distress as
      evidenced in markedly increased levels of anxiety and depression. High levels of
      psychological distress in caregivers have also been found to be associated with poorer health
      and increased levels of pro-inflammatory cytokines that are well-established risk factors for
      physical illness and stress-related mortality. Previous psychological interventions using
      cognitive methods have only produced small effect sizes and more research on how to
      effectively alleviate caregiver burden is needed. The proposed project will investigate the
      effect of Emotion Regulation Therapy (ERT) for caregivers of cancer patients. ERT is a novel
      approach specifically targeting emotion regulation with the aim of improving mental and
      physical health. The effect of ERT will be examined in a randomized controlled trial
      comparing ERT to usual medical care (UMC).
    

Detailed description: 
      PURPOSE:

      The primary purpose of the study is to test the efficacy of Emotion Regulation Therapy (ERT)
      for informal caregivers (ICs) of cancer patients. ERT is a manualized treatment for ICs and
      consists of 8 weekly sessions.

      AIMS AND HYPOTHESES:

      Intervention and mediation effects. In an RCT, the investigators will investigate the
      efficacy of an 8 session ERT for ICs on psychological and physical distress and a number of
      other health outcomes in both ICs and cancer patients. Outcomes in the ERT group will be
      compared to outcomes in a group of ICs and patients receiving usual medical care (UMC) (see
      Figure 1). ICs receiving ERT compared to ICs receiving UMC are expected to exhibit 1a)
      significant reductions in psychological distress and perceived caregiving burden, 1b)
      improvements in quality of life; and 1c) improvements in pro-inflammatory markers of
      stress/immune functioning. Likewise, patients whose ICs receive ERT are expected to report
      2a) reduced anxiety and depression, 2b) improved quality of life and 2c) less chronic
      inflammation. Due to the design, these effects will be considered following the acute
      treatment period (pre, mid and post therapy). In addition to this, gains are expected to be
      maintained over the follow-up-period. In addition, 3) improvements are exptected to be
      maintained over the follow-up period. Finally, 4) improvements in adaptive emotion regulation
      (mindfulness, acceptance, and cognitive reappraisal) are expected to mediate the effect of
      ERT.

      PARTICIPANTS AND PROCEDURES:

      ICs of cancer patients with various cancer types will be consecutively recruited from Aarhus
      University Hospital, Denmark. Staff at the Outpatient Clinic at the Department of Oncology,
      Aarhus University Hospital, Denmark, will screen ICs at the department. Initially the
      investigators wanted to include caregivers of patients with lung and colorectal cancer only.
      However, in order to be able to include caregivers at a faster pace, it was decided - after
      one month during which only two caregivers were included - to broaden the patient group.
      Furthermore, it was decided that more than one IC per patient could participate.

      After giving informed consent, participants will be randomized to Emotion Regulation Therapy
      (ERT) or usual medical care (UMC) in a ratio of 1:1 by means of computer-generated
      randomization lists. Outcome measures will be obtained pre-, mid-, and post-therapy as well
      as at 3 and 6-month follow-up. At every ERT session, ICs and clinicians will fill out a
      number of self-report the process measures. Cancer patients will be assessed pre- and post
      ERT, and at 3 and 6-months follow-up. Every IC and patient will provide blood samples before
      and after the intervention as well as at follow-ups.

      Based on a power calculation (alpha=0.0125, beta=0.90), a dropout rate of 35%, and an
      intraclass correlation between ICs of the same patient of 0.20, the inclusion of 80 ICs will
      allow for an interaction effect between group (ERT vs. UMC) and time (acute treatment, thats
      is, pre, mid and post) of a medium effect size (d=0.5) to be significant.
    

Intervention name(s): Emotion Regulation Therapy
Intervention type(s): Behavioral
Intervention description(s): 8 sessions of ERT
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: informal caregivers; caregiving; psychotherapy for caregivers; cancer; emotion regulation; distress; inflammation