Anxiety DepressionERT-ICsNCT02322905
Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial
A study testing Emotion Regulation Therapy in people with Anxiety Depression, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- Emotion Regulation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medium levels of distress (distress thermometer > 3) and at least moderate levels of worry or rumination
- Caregiver of patient with cancer
Who cannot join
- an expected survival of the patient of <6 months,
- active substance abuse (alcohol or drugs), and
- participation in other psychosocial trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer Caregiver Burden: Targeting Emotion Regulation in a Randomized Controlled Trial
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).
Read the 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.
- Conditions
- Anxiety Depression
- Being tested
- Emotion Regulation Therapy
- Keywords
- informal caregivers, caregiving, psychotherapy for caregivers, cancer, emotion regulation, distress, inflammation
- Medical subject headings
- Neoplasms, Emotional Regulation, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation TherapyBehavioural
8 sessions of ERT
| Study group | Role | What they receive |
|---|---|---|
| Emotion Regulation Therapy | Experimental | 8 sessions of Emotion Regulation Therapy. Receives: Behavioral: Emotion Regulation Therapy |
| Usual Medical Care | No intervention | No planned psychotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Caregiver Reaction Assessment and EORTC-QLQ-30
Questionnaire measuring burden in ICs and quality of life cancer patients, respectively
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Hospital Anxiety and Depression Scale (HADS)
Questionnaire measuring anxiety and depression
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Penn State Worry Questionnaire
Questionnaire measuring worry
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Rumination Response Scale - Brooding subscale only
Questionnaire measuring brooding
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Secondary outcomes (9)
Change in Difficulty in Emotion Regulation Scale
Questionnaire measuring emotion regulation
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Emotion Regulation Questionnaire
Questionnaire measuring emotion regulation
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Five Facet Mindfulness Questionnaire
Questionnaire measuring mindfulness
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Experiences Questionnaire
Questionnaire measuring psychological distancing
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in The Pittsburgh Sleep Quality Index
Questionnaire measuring sleep quality
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in quality of life - WHO-5
Questionnaire measuring quality of life
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Pro-inflammatory markers: CRP, TNFalpha, IL-1, IL-6
Serum-derived pro-inflammatory markers (only pre and post therapy)
Measured: Between-group effect at post, based on the whole treatment duration (pre-, and post-therapy).
Emotional closeness
2 items (actual and wanted emotional closeness) rated on a 0-10 scale
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Emotional attention coping (EAC)
Questionnaire measuring emotion regulation
Measured: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startAug 2015
- Primary completion25 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mia S O'Toole, MSc, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322905
- Sponsor's protocol ID
- ERT15-17
- Acronym
- ERT-ICs
- Status last verified
- Mar 2025
- First submitted
- 4 Dec 2014
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Mikkelsen MB, Elkjaer E, Mennin DS, Fresco DM, Zachariae R, Applebaum A, O'Toole MS. The impact of emotion regulation therapy on emotion differentiation in psychologically distressed caregivers of cancer patients. Anxiety Stress Coping. 2021 Jul;34(4):479-485. doi: 10.1080/10615806.2021.1929934. Epub 2021 May 28.
PubMed 34047220
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Caregiver Burden: Targeting Emotion Regulation in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02322905
- Acronym / sponsor ID
- ERT-ICs / ERT15-17
- Conditions
- Anxiety Depression
- Keywords
- informal caregivers, caregiving, psychotherapy for caregivers, cancer, emotion regulation, distress, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotion Regulation Therapy | Experimental | Behavioral: Emotion Regulation Therapy8 sessions of Emotion Regulation Therapy. |
| Usual Medical Care | No intervention | –No planned psychotherapy. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medium levels of distress (distress thermometer > 3) and at least moderate levels of worry or rumination
- Caregiver of patient with cancer
Key exclusion criteria (3 listed)
- an expected survival of the patient of <6 months,
- active substance abuse (alcohol or drugs), and
- participation in other psychosocial trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion Regulation Therapy8 sessions of ERT | Behavioural | Emotion Regulation Therapy |
Primary outcome
Change in The Caregiver Reaction Assessment and EORTC-QLQ-30
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring burden in ICs and quality of life cancer patients, respectively
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring anxiety and depression
Change in Penn State Worry Questionnaire
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring worry
Change in Rumination Response Scale - Brooding subscale only
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring brooding
9 secondary outcomes
Change in Difficulty in Emotion Regulation Scale
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Emotion Regulation Questionnaire
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Five Facet Mindfulness Questionnaire
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Experiences Questionnaire
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in The Pittsburgh Sleep Quality Index
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in quality of life - WHO-5
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Pro-inflammatory markers: CRP, TNFalpha, IL-1, IL-6
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, and post-therapy).
Emotional closeness
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Emotional attention coping (EAC)
Time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Derived from this study: PubMed 34047220Mikkelsen MB, Elkjaer E, Mennin DS, Fresco DM, Zachariae R, Applebaum A, O'Toole MS. The impact of emotion regulation therapy on emotion differentiation in psychologically distressed caregivers of cancer patients. Anxiety Stress Coping. 2021 Jul;34(4):479-485. doi: 10.1080/10615806.2021.1929934. Epub 2021 May 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mia S O'Toole, MSc principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation Therapy in people with Anxiety Depression, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Caregiver Reaction Assessment and EORTC-QLQ-30 (time frame: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.