The Feasibility of an Intervention Targeting Sources of Meaning in Cardiac Rehabilitation

NCT07262580 | Enrolling By Invitation

• 2 other identifiers: REC610Grant no. 2023-12404
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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. 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

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

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Through study completion (approximately 1 year from study start)

Secondary Outcomes (8)

• Changes in health-related quality of life

  Baseline, 1 month post intervention and 3 months post intervention

• Changes in awareness on sources of meaning in everyday life.

  Baseline, 1 month post intervention and 3 months post intervention

• Changes in engagement in sources of meaning in everyday life

  Baseline, 1 month post intervention and 3 months post intervention

• Changes in mutual understanding (dyadic intervention arm)

  Baseline, 1 month post intervention and 3 months post intervention

• Changes in relationship quality (dyadic intervention arm)

  Baseline, 1 month post intervention and 3 months post intervention

Study Arms (3)

a) Individual intervention format

EXPERIMENTAL

1:1 conversation between a professional and a patient in rehabilitation.

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.

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.

Other: Group based session on Sources of Meaning in life with heart disease

Interventions

Conversation on Sources of Meaning in life with heart disease OTHER

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.

a) Individual intervention format

Group based session on Sources of Meaning in life with heart disease OTHER

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.

c) Group based intervention format

Dyadic Conversation on Sources of Meaning in Life with heart disease OTHER

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.

b) Dyadic (patient-relative) intervention format

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• attending municipal cardiac rehabilitation
• proficiency in Danish

You may not qualify if:

• severe psychiatric disorder
• severe cognitive impairment
• as in A
• and having a relative who would like to participate
• ≥18 years of age
• relative to a patient attending municipal cardiac rehabilitation
• proficiency in Danish
• \- as in A

Sponsors & Collaborators

• University of Southern Denmark: lead
• Danish Heart Foundation: collaborator
• Odense Municipality, Denmark: collaborator

Study Sites (2)

Center for Sundhed og Forebyggelse

Odense, Region Syddanmark, 5000, Denmark

Location

Sundhedskurser, Sundhedshus Vejle

Vejle, Region Syddanmark, 7100, Denmark

Location

Related Links

• Link to Website of the Sources of Meaning Card Method.

MeSH Terms

Conditions

Heart Diseases; Adherence Interventions

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 3, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)