Heart DiseaseNCT07262580
The Feasibility of an Intervention Targeting Sources of Meaning in Cardiac Rehabilitation
A study testing Conversation on Sources of Meaning in life with heart disease, Group based session on Sources of Meaning in life with heart disease and Dyadic Conversation on Sources of Meaning in Life with heart disease in people with Heart Disease and Mental Health Outcomes, run by University of Southern Denmark at 2 sites in Denmark.
Trial summary
Being diagnosed with heart disease can be a life-changing experience, often sparking existential questions and concerns about meaning in life. A lack of meaning in life has been found associated with increased emotional distress and decreased quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Mental Health Outcomes, Rehabilitation
- What is being tested?
- Conversation on Sources of Meaning in life with heart disease, Group based session on Sources of Meaning in life with heart disease and Dyadic Conversation on Sources of Meaning in Life with heart disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Nov 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- relative to a patient attending municipal cardiac rehabilitation
- proficiency in Danish
- Exclusion criteria, patient and relative dyadic intervention format
- as in A
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites
Center for Sundhed og Forebyggelse
Odense, Region Syddanmark, 5000
Sundhedskurser, Sundhedshus Vejle
Vejle, Region Syddanmark, 7100
About this study
Being diagnosed with heart disease can be a life-changing experience, often sparking existential questions and concerns about meaning in life. A lack of meaning in life has been found associated with increased emotional distress and decreased quality of life. Health professionals recognize that issues related to personal meaning in life are relevant but rarely address these aspects systematically in cardiac rehabilitation. This may be due to a lack of necessary tools.
The project evaluates a novel, brief and structured intervention that aims to strengthen the experience of meaningfulness and reduce or prevent emotional distress by addressing personal sources of meaning in life among patients attending cardiac rehabilitation and their relatives in Denmark. The intervention is based on the Sources of Meaning Card Method, a method developed by Peter la Cour and Tatjana Schnell to map and explore personal sources of meaning (www.somecam.org). For the current project, the method has been adapted for a cardiac rehabilitation context.
Three intervention formats are examined in a feasibility study in a municipal rehabilitation setting: 1) an individual format for patients in cardiac rehabilitation, 2) a dyadic format including a patient together with a relative, and 3) a group format for patients. Approximately 60 patients and 20 relatives are expected to participate. The study explores (a) participants' experience with and acceptability of the intervention formats; (b) changes in meaningfulness and emotional distress in a pre-post design; (c) recruitment and adherence rate, and (d) acceptability and practicality of the three formats among rehabilitation professionals.
- Conditions
- Heart Disease, Mental Health Outcomes, Rehabilitation
- Being tested
- Conversation on Sources of Meaning in life with heart disease, Group based session on Sources of Meaning in life with heart disease, Dyadic Conversation on Sources of Meaning in Life with heart disease
- Keywords
- cardiac rehabilitation, Heart disease, Sources of Meaning Card Method, Intervention, Individual intervention, Dyadic intervention, Group intervention, Sources of Meaning, Feasibility study, Pre-post design, Intervention adherence, Recruitment rate, Acceptability of interventions, Staff perspectives on acceptability and practicality, Patients and relatives
- Medical subject headings
- Heart Diseases, Adherence Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversation on Sources of Meaning in life with heart diseaseOther
The intervention uses the brief and structured Sources of Meaning Card Method (SoMeCaM; www.somecam.org), which has been adapted for use in cardiac rehabilitation. It explores personal sources of meaning in a conversation with one patient in a 1-hour session. It comprises 26 cards each including statements on a particular source of meaning. The patient prioritizes the cards, reflects on them, and identifies possibilities for change.
The conversation is facilitated by a professional (trained master students in psychology) and followed up with a phone call approximately 4 weeks after the conversation.
Group based session on Sources of Meaning in life with heart diseaseOther
The intervention is based on the brief and structured Sources of Meaning Card Method (SoMeCaM; www.somecam.org), which has been adapted for use in groups in a cardiac rehabilitation context. The method uses 26 cards, each representing a specific source of meaning. Approximately 6-10 participants are guided through a process of individually prioritizing the cards, reflecting on them and identifying potential areas for change or development in smaller groups. The group-based format enables mutual sharing and support in reflection and change processes among patients.
The workshop is facilitated by a professional (trained master students in psychology) and followed up with individual phone calls with all participants approximately 4 weeks after the conversation.
Dyadic Conversation on Sources of Meaning in Life with heart diseaseOther
The intervention is based on the brief and structured Sources of Meaning Card Method (SoMeCaM; www.somecam.org), which has been adapted for use in dyads in a cardiac rehabilitation context. The method uses 26 cards, each representing a specific source of meaning. The dyadic format considers both the patient's and the relative's individual and shared sources of meaning in 1 session, which may enhance understanding for each other's sources of meaning and facilitate their joint daily life. They both prioritize the cards individually, reflect on them and identify possibilities for change through a talk-and-listen approach.
The conversation is facilitated by a professional (trained master students in psychology) and followed up with a phone call approximately 4 weeks after the conversation.
| Study group | Role | What they receive |
|---|---|---|
| a) Individual intervention format | Experimental | 1:1 conversation between a professional and a patient in rehabilitation. Receives: Other: Conversation on Sources of Meaning in life with heart disease |
| b) Dyadic (patient-relative) intervention format | Experimental | The patient participates together with a relative and a professional. Receives: Other: Dyadic Conversation on Sources of Meaning in Life with heart disease |
| c) Group based intervention format | Experimental | A group-based approach, where approximately 6-10 patients in rehabilitation meet for a group session. Receives: Other: Group based session on Sources of Meaning in life with heart disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' experiences with the three intervention formats
Defined as the participants' experiences with their participation in one of the three intervention formats. Explored via focus groups and semi structured interviews.
Measured: Approximately 1 month post intervention
Theoretical Framework of Acceptability (TFA) Questionnaire
Participants' acceptability of the intervention will be quantitatively assessed using the Theoretical Framework of Acceptability (TFA) Questionnaire. This scale evaluates the following seven constructs: affective attitude, burden, ethicality, opportunity costs, perceived effectiveness, self-efficacy, and intervention coherence.
Each item is rated on a 5-point Likert scale ranging from 1 to 5. Higher scores indicate greater acceptability of the intervention across the measured domains.
Measured: 1 month post intervention
Acceptability of the three intervention formats among participants
Acceptability will be explored qualitatively via focus groups and semi-structured interviews with participants enrolled in one of the three intervention formats
Measured: Approximately 1 month post intervention
Changes in symptoms of depression
The Patient Health Questionnaire 9-item depression scale (PHQ-9) will be used to assess symptoms of depression in the past two weeks. Each item is scored 0 to 3. The severity score can range from 0 to 27, with higher scores indicating more severe symptoms.
Measured: Baseline, 1 month post intervention and 3 months post intervention
Changes in symptoms of anxiety
The 7-item General Anxiety Disorder Scale (GAD-7) will be used to measure symptoms of anxiety in the past two weeks. Each item is scored 0 to 3, providing a 0 to 21 severity score, with higher scores indicating more severe symptoms.
Measured: Baseline, 1 month post intervention and 3 months post intervention
Changes related to meaning in life
Changes in participants' self-reported experience of meaning in life will be assessed using two validated subscales from the Sources of Meaning and Meaning in Life Questionnaire: the Meaningfulness and Crisis of Meaning subscales.
Each subscale consists of 5 items, scored on a Likert scale from 0 (Strongly disagree) to 5 (Strongly agree).
For the Meaningfulness subscale, higher scores indicate a stronger sense of meaning in life.
For the Crisis of Meaning subscale, higher scores indicate a stronger experience of life as empty, pointless and lacking of meaning.
Measured: Baseline, 1 month post intervention and 3 months post intervention
Recruitment rate
Recruitment rate is defined as the proportion of participants who consented to participate in the study, reported as a percentage over the recruitment period.
Measured: From study start until recruitment ends (approximately 1 year)
Intervention adherence
The proportion of participants who completed the full intervention, defined as participation in the one-session Sources of Meaning conversation (individual, patient-relative, or group-based) and the follow-up phone call. Data will be recorded by the research team.
Measured: Through study completion, approximately 1 year
Study attrition (dropout rate)
The proportion of participants who drop out from the study before completing all parts of the intervention, the 3 surveys and focus group and/or individual interview. Dropout will be assessed via administrative data.
Measured: Through study completion (approximately 15 months from study start)
Acceptability among rehabilitation professionals
Acceptability of the three intervention formats will be explored via focus groups with rehabilitation professionals involved in cardiac rehabilitation. The focus groups will address professionals' views on the interventions and perceived usefulness of the intervention in the municipal cardiac rehabilitation setting.
Measured: After study enrollment (approximately 1 year from study start)
Practicality of the intervention formats among rehabilitation professionals
Defined as the rehabilitation professionals' evaluation of whether the intervention can be successfully used in practice (municipal cardiac rehabilitation). Including factors such as time, resources, and workflow compatibility. Explored via focus group with professionals in the municipal cardiac rehabilitation.
Measured: After study enrollment (approximately 1 year from study start)
Intervention facilitators' experience with delivering the intervention
Intervention facilitators will document their experience using semi-structured worksheets with field notes completed after each intervention session. These will capture reflections on feasibility, participant responsiveness, and challenges encountered in each step of the intervention.
Measured: Through study completion (approximately 1 year from study start)
Secondary outcomes (8)
Changes in health-related quality of life
Explores changes in participants' self-reported health-related quality of life measured by EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
The EQ-5D-5L consists of 2 scales: the descriptive system (EQ-5D) and the EQ visual analogue scale (EQ VAS).
EQ-5D measures the five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each with 5 levels from 'no problems', 'slight problems', 'moderate problems', 'severe problems' to 'extreme problems'.
EQ VAS captures the participant's self-rated health on a vertical visual scale from 0-100 where 100 means: 'The best health you can imagine' and 0 means 'The worst health you can imagine'.
Higher scores indicate better self-reported health-related quality of life.
Measured: Baseline, 1 month post intervention and 3 months post intervention
Changes in awareness on sources of meaning in everyday life.
Changes in awareness on sources of meaning in everyday life will be explored using a purpose-designed self-report measure with 2 items covering awareness rated on a Likert scale ranging from 0 (Strongly disagree) to 5 (Strongly agree). Higher scores indicate greater awareness on sources of meaning in everyday life.
Measured: Baseline, 1 month post intervention and 3 months post intervention
Changes in engagement in sources of meaning in everyday life
Changes in engagement in sources of meaning in everyday life will be explored using purpose-designed self-report measure with 3 items covering engagement rated on a Likert scale ranging from 0 (Strongly disagree) to 5 (Strongly agree). Higher scores indicate greater engagement on sources of meaning
Measured: Baseline, 1 month post intervention and 3 months post intervention
Changes in mutual understanding (dyadic intervention arm)
Mutual understanding between patients and relatives in the dyadic intervention format will be assessed using the Understanding Subscale of the Perceived Partner Responsiveness Scale (PPRS) (Reis \& Carmichael, 2006).
The subscale consists of 5 items rated on a 9-point Likert scale ranging from 1 (Not at all true) to 9 (Very true). Higher scores indicate higher mutual understanding in the relationship to the other person.
Measured: Baseline, 1 month post intervention and 3 months post intervention
Changes in relationship quality (dyadic intervention arm)
Relationship quality will be assessed using the Relationship Ladder, a single-item visual analogue scale in which participants rate their perceived relationship quality on a scale from 0 (Very poor) to 10 (Excellent).
Higher scores indicate better perceived relationship quality.
Measured: Baseline, 1 month post intervention and 3 months post intervention
Intervention costs
To calculate intervention costs, information on time spent by intervention facilitators and other staff as well as material costs will be collected.
Measured: Through study completion (approximately 1 year post study start)
Reasons for dropout
Reasons for participant dropout will be collected using a voluntary purpose-designed 3-item questionnaire at the time of dropout.
Measured: At time of dropout (Up to 4 months post intervention)
Engagement in intervention
Participant's engagement in the intervention is assessed through 2 purpose-designed questions: (1) 'Thought about the conversation at home' and (2) 'Used the reflection booklet at home'. Each question has an option to elaborate the answer qualitatively.
Measured: 1 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start20 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation, Odense Municipality, Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262580
- Sponsor's protocol ID
- REC610
- Other IDs
- Grant no. 2023-12404
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of an Intervention Targeting Sources of Meaning in Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT07262580
- Acronym / sponsor ID
- REC610
- Conditions
- Heart Disease, Mental Health Outcomes, Rehabilitation
- Keywords
- cardiac rehabilitation, Heart disease, Sources of Meaning Card Method, Intervention, Individual intervention, Dyadic intervention, Group intervention, Sources of Meaning
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Heart Foundation, Odense Municipality, Denmark
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- 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.
Being diagnosed with heart disease can be a life-changing experience, often sparking existential questions and concerns about meaning in life. A lack of meaning in life has been found associated with increased emotional distress and decreased quality of life. Health professionals recognize that issues related to personal meaning in life are relevant but rarely address these aspects systematically in cardiac rehabilitation. This may be due to a lack of necessary tools.
The project evaluates a novel, brief and structured intervention that aims to strengthen the experience of meaningfulness and reduce or prevent emotional distress by addressing personal sources of meaning in life among patients attending cardiac rehabilitation and their relatives in Denmark. The intervention is based on the Sources of Meaning Card Method, a method developed by Peter la Cour and Tatjana Schnell to map and explore personal sources of meaning (www.somecam.org). For the current project, the method has been adapted for a cardiac rehabilitation context.
Three intervention formats are examined in a feasibility study in a municipal rehabilitation setting: 1) an individual format for patients in cardiac rehabilitation, 2) a dyadic format including a patient together with a relative, and 3) a group format for patients. Approximately 60 patients and 20 relatives are expected to participate. The study explores (a) participants' experience with and acceptability of the intervention formats; (b) changes in meaningfulness and emotional distress in a pre-post design; (c) recruitment and adherence rate, and (d) acceptability and practicality of the three formats among rehabilitation professionals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| a) Individual intervention format | Experimental | Other: Conversation on Sources of Meaning in life with heart disease1:1 conversation between a professional and a patient in rehabilitation. |
| b) Dyadic (patient-relative) intervention format | Experimental | Other: Dyadic Conversation on Sources of Meaning in Life with heart diseaseThe patient participates together with a relative and a professional. |
| c) Group based intervention format | Experimental | Other: Group based session on Sources of Meaning in life with heart diseaseA group-based approach, where approximately 6-10 patients in rehabilitation meet for a group session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- relative to a patient attending municipal cardiac rehabilitation
- proficiency in Danish
- Exclusion criteria, patient and relative dyadic intervention format
- as in A
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Conversation on Sources of Meaning in life with heart diseaseThe intervention uses the brief and structured Sources of Meaning Card Method (SoMeCaM; www.somecam.org), which has been adapted for use in cardiac rehabilitation. It explores personal sources of meaning in a conversation with one patient in a 1-hour session. It comprises 26 cards each including statements on a particular source of meaning. The patient prioritizes the cards, reflects on them, and identifies possibilities for change. The conversation is facilitated by a professional (trained master students in psychology) and followed up with a phone call approximately 4 weeks after the conversation. | Other | a) Individual intervention format |
| Group based session on Sources of Meaning in life with heart diseaseThe intervention is based on the brief and structured Sources of Meaning Card Method (SoMeCaM; www.somecam.org), which has been adapted for use in groups in a cardiac rehabilitation context. The method uses 26 cards, each representing a specific source of meaning. Approximately 6-10 participants are guided through a process of individually prioritizing the cards, reflecting on them and identifying potential areas for change or development in smaller groups. The group-based format enables mutual sharing and support in reflection and change processes among patients. The workshop is facilitated by a professional (trained master students in psychology) and followed up with individual phone calls with all participants approximately 4 weeks after the conversation. | Other | c) Group based intervention format |
| Dyadic Conversation on Sources of Meaning in Life with heart diseaseThe intervention is based on the brief and structured Sources of Meaning Card Method (SoMeCaM; www.somecam.org), which has been adapted for use in dyads in a cardiac rehabilitation context. The method uses 26 cards, each representing a specific source of meaning. The dyadic format considers both the patient's and the relative's individual and shared sources of meaning in 1 session, which may enhance understanding for each other's sources of meaning and facilitate their joint daily life. They both prioritize the cards individually, reflect on them and identify possibilities for change through a talk-and-listen approach. The conversation is facilitated by a professional (trained master students in psychology) and followed up with a phone call approximately 4 weeks after the conversation. | Other | b) Dyadic (patient-relative) intervention format |
Primary outcome
Participants' experiences with the three intervention formats
Time frame: Approximately 1 month post intervention
Defined as the participants' experiences with their participation in one of the three intervention formats. Explored via focus groups and semi structured interviews.
Theoretical Framework of Acceptability (TFA) Questionnaire
Time frame: 1 month post intervention
Participants' acceptability of the intervention will be quantitatively assessed using the Theoretical Framework of Acceptability (TFA) Questionnaire. This scale evaluates the following seven constructs: affective attitude, burden, ethicality, opportunity costs, perceived effectiveness, self-efficacy, and intervention coherence. Each item is rated on a 5-point Likert scale ranging from 1 to 5. Higher scores indicate greater acceptability of the intervention across the measured domains.
Acceptability of the three intervention formats among participants
Time frame: Approximately 1 month post intervention
Acceptability will be explored qualitatively via focus groups and semi-structured interviews with participants enrolled in one of the three intervention formats
Changes in symptoms of depression
Time frame: Baseline, 1 month post intervention and 3 months post intervention
The Patient Health Questionnaire 9-item depression scale (PHQ-9) will be used to assess symptoms of depression in the past two weeks. Each item is scored 0 to 3. The severity score can range from 0 to 27, with higher scores indicating more severe symptoms.
Changes in symptoms of anxiety
Time frame: Baseline, 1 month post intervention and 3 months post intervention
The 7-item General Anxiety Disorder Scale (GAD-7) will be used to measure symptoms of anxiety in the past two weeks. Each item is scored 0 to 3, providing a 0 to 21 severity score, with higher scores indicating more severe symptoms.
Changes related to meaning in life
Time frame: Baseline, 1 month post intervention and 3 months post intervention
Changes in participants' self-reported experience of meaning in life will be assessed using two validated subscales from the Sources of Meaning and Meaning in Life Questionnaire: the Meaningfulness and Crisis of Meaning subscales. Each subscale consists of 5 items, scored on a Likert scale from 0 (Strongly disagree) to 5 (Strongly agree). For the Meaningfulness subscale, higher scores indicate a stronger sense of meaning in life. For the Crisis of Meaning subscale, higher scores indicate a stronger experience of life as empty, pointless and lacking of meaning.
Recruitment rate
Time frame: From study start until recruitment ends (approximately 1 year)
Recruitment rate is defined as the proportion of participants who consented to participate in the study, reported as a percentage over the recruitment period.
Intervention adherence
Time frame: Through study completion, approximately 1 year
The proportion of participants who completed the full intervention, defined as participation in the one-session Sources of Meaning conversation (individual, patient-relative, or group-based) and the follow-up phone call. Data will be recorded by the research team.
Study attrition (dropout rate)
Time frame: Through study completion (approximately 15 months from study start)
The proportion of participants who drop out from the study before completing all parts of the intervention, the 3 surveys and focus group and/or individual interview. Dropout will be assessed via administrative data.
Acceptability among rehabilitation professionals
Time frame: After study enrollment (approximately 1 year from study start)
Acceptability of the three intervention formats will be explored via focus groups with rehabilitation professionals involved in cardiac rehabilitation. The focus groups will address professionals' views on the interventions and perceived usefulness of the intervention in the municipal cardiac rehabilitation setting.
Practicality of the intervention formats among rehabilitation professionals
Time frame: After study enrollment (approximately 1 year from study start)
Defined as the rehabilitation professionals' evaluation of whether the intervention can be successfully used in practice (municipal cardiac rehabilitation). Including factors such as time, resources, and workflow compatibility. Explored via focus group with professionals in the municipal cardiac rehabilitation.
Intervention facilitators' experience with delivering the intervention
Time frame: Through study completion (approximately 1 year from study start)
Intervention facilitators will document their experience using semi-structured worksheets with field notes completed after each intervention session. These will capture reflections on feasibility, participant responsiveness, and challenges encountered in each step of the intervention.
8 secondary outcomes
Changes in health-related quality of life
Time frame: Baseline, 1 month post intervention and 3 months post intervention
Changes in awareness on sources of meaning in everyday life.
Time frame: Baseline, 1 month post intervention and 3 months post intervention
Changes in engagement in sources of meaning in everyday life
Time frame: Baseline, 1 month post intervention and 3 months post intervention
Changes in mutual understanding (dyadic intervention arm)
Time frame: Baseline, 1 month post intervention and 3 months post intervention
Changes in relationship quality (dyadic intervention arm)
Time frame: Baseline, 1 month post intervention and 3 months post intervention
Intervention costs
Time frame: Through study completion (approximately 1 year post study start)
Reasons for dropout
Time frame: At time of dropout (Up to 4 months post intervention)
Engagement in intervention
Time frame: 1 month post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Link to Website of the Sources of Meaning Card Method.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversation on Sources of Meaning in life with heart disease, Group based session on Sources of Meaning in life with heart disease and Dyadic Conversation on Sources of Meaning in Life with heart disease in people with Heart Disease and Mental Health Outcomes, run by University of Southern Denmark at 2 sites 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 5 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Participants' experiences with the three intervention formats (time frame: Approximately 1 month post intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2026.