OPTIMA: Psychological Distress and the Effect of Intensive Group Based Cognitive Therapy in Patients With Newly Diagnosed Ischemic Heart Disease

April 21, 2022 updated by: Hanne Kruuse Rasmusen, University Hospital Bispebjerg and Frederiksberg

OPTIMA: Psychological Distress and the Effect of Intensive Group Based Cognitive Therapy in Patients With Newly Diagnosed Ischemic Heart Disease: A Randomised Controlled Trial Protocol

The overall objectives of the Optima project is to: (1) Compare the effect of standardized group based cognitive therapy and cardiac rehabilitation versus usual cardiac rehabilitation in patients with sign of psychological distress measured by a questionnaire (HADS score), (2) To investigate spontaneous variation in psychological distress with HADS over time in order to optimize time of measuring HADS. (3) To investigate if the intervention can be implemented to other cardiac rehabilitation sites with the same effect as on BFH (that it is not person dependent).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

HYPOTHESIS: There will be a significant difference in anxiety and depression score between intervention and usual care groups after intervention, in favor of the intervention group.

METHODS: Optima is a multi-center, prospective, randomized clinical trial in patients with newly diagnosed ischemic heart disease (IHD) or heart valve replacement, and concomitant significant score of psychological distress using the Hospital Anxiety and Depression Score (HADS) (HADS A(Anxiety) /D(Depression) ≥8 or HADS>15), age <65 years. Patients with HADS D≥11 and Beck Depression Inventory (BDI)>17 are evaluated by psychiatrists to offer the best treatment. 148 patients will be randomized to either intervention or control group. All patients are offered usual cardiac rehabilitation, and in addition, the intervention group is offered standardized group based cognitive therapy with the participation of maximum four patients, consisting of 5 sessions (each 2 hours) performed by a trained cardiac rehabilitation nurse. The intervention was developed on experiences from a Liaison nurse, who offered up to five individual consultations to patients with psychological distress. Together with a psychologist specialized in cognitive therapy the investigators developed a program based on cognitive behavioral methods from cognitive therapy as well as Acceptance and commitment therapy (ACT). Each session consists of specific cognitive models, which the patient can use in everyday life.

INTERVENTION: Patients are informed about the Optima program in the inclusion interview, and patients are participating in groups of maximum 4 persons. Each of the 5 session has a duration of 1,5 - 2 hours.

The psychologist have developed the content of each session, with attention to thoughts and feelings regarding the current situation after a heart-condition, and the effects on life conditions. Patients get the tools to overcoming the difficulties, they experience, f.x. anxiety and stress.

When other hospitals are joining the Optima project, the project nurse and psychologist are training the hospital staff as well as supervising.

The session are planned as follows Session 1: Identifying your values

  • What is important in my life?
  • How has my heart-condition effected my life?
  • Where do I want to be in my life? And what challenges it? Session 2: Anxiety and techniques to reduce anxiety
  • What is anxiety?
  • Anxiety and heart symptoms
  • Circle of anxiety
  • Techniques to reduce anxiety, relaxation and breathing Session 3: Consequences of own behavior and behavioral analysis
  • Behavior that reduces self-expression
  • Heart disease and behavior
  • Consequences of own behavior Session 4: Concerns and strategies for dealing with them
  • What are concerns?
  • The Worry Tree and how to use it.
  • Strategies for handling concerns. Session 5: The balance between demands and capacity
  • Thoughts about the future
  • Working life, relations and family

Sessions are followed up with two interviews after 3 and 6 months, where the following are assessed:

  • The Hospital Anxiety and Depression Scale (HADS) score
  • Heart-related Quality of Life (HeartQoL)
  • Blood samples
  • Clinical assessment: Functional Classification of Angina (CCS), New York Heart Association (NYHA) score, Blood pressure, medical status, smoking/nonsmoking, weight, physical activity (self-assessment) cardiovascular readmissions
  • Employment status
  • return to work
  • present psychosocial status

QUESTIONNAIRES: Questionnaires include validated assessment tools:

HADS: The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress. The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.

HeartQol: Heart-related Quality of Life is a disease-specific questionnaire that measures health-related quality of life in patients with heart disease. The questionnaire consists of 14 items and provides two subscales: a 10-item physical subscale and a 4-item emotional subscale, which are scored from 0 to 3. Higher scores indicating better HRQL.

Also, a questionnaire that measures present psychosocial status/situation is used. The questionnaire is based on clinical experience.

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • Cardiology department, Bispebjerg-Frederiksberg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HADS score > 8 for HADS-A or HADS-D
  • Age < 65 years
  • Able to speak and understand Danish

Exclusion Criteria:

  • Participation in rehabilitation program within the last 2 years
  • Ejection Fraction (EF) < 35%
  • Other serious comorbidity that are expected to have a serious impact on life expectancy
  • Known abuse of alcohol or euphoric drugs. Known more serious psychopathology such as schizophrenia, bipolar disorder, severe personality disorder, and treatment with psychoactive drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cardiac rehabilitation+cognitive therapy

The intervention group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively.

In addition, the intervention group follows a standardized group based cognitive therapy program with participation of maximum four patients, consisting of 5 sessions (each 2 hours) performed by a trained cardiac rehabilitation nurse.
Behavioral: Group based cognitive therapy

Patients are informed about the Optima program in the inclusion interview, and patients are participating in groups of maximum 4 persons. Each of the 5 session has a duration of 1,5 - 2 hours.

The psychologist have developed the content of each session, with attention to thoughts and feelings regarding the current situation after a heart-condition, and the effects on life conditions. Patients get the tools to overcoming the difficulties, they experience, f.x. anxiety and stress.

When other hospitals are joining the Optima project, the project nurse and psychologist are training the hospital staff as well as supervising.
NO_INTERVENTION: Cardiac rehabilitation
The control group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. .
NO_INTERVENTION: Control group without psychological distress
The control group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome of the RCT is anxiety and depression measured by HADS
Time Frame: 3 months follow-up
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress.The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.
3 months follow-up
The primary outcome of the RCT is anxiety and depression measured by HADS
Time Frame: 6 months follow-up
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress.The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.
6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL
Time Frame: 3 months follow-up
Heart-related Quality of Life (HeartQoL) is a disease-specific questionnaire that measures health-related quality of life in patients with heart disease. The questionnaire consists of 14 items and provides two subscales: a 10-item physical subscale and a 4-item emotional subscale, which are scored from 0 to 3. Higher scores indicating better HRQL.Return to work, adherence to life style interventions, and cardiovascular readmissions. A questionnaire that measures present psychosocial status/situation. The questionnaire is based on clinical experience.
3 months follow-up
Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL
Time Frame: 6 months follow-up
Heart-related Quality of Life (HeartQoL) is a disease-specific questionnaire that measures health-related quality of life in patients with heart disease. The questionnaire consists of 14 items and provides two subscales: a 10-item physical subscale and a 4-item emotional subscale, which are scored from 0 to 3. Higher scores indicating better HRQL.Return to work, adherence to life style interventions, and cardiovascular readmissions. A questionnaire that measures present psychosocial status/situation. The questionnaire is based on clinical experience.
6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Bispebjerg and Frederiksberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

April 1, 2022

Study Registration Dates

First Submitted

January 18, 2020

First Submitted That Met QC Criteria

February 2, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16042832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Valve Diseases

Clinical Trials on Group based cognitive therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe