OPTIMA: Psychological Distress and the Effect of Intensive Group Based Cognitive Therapy in Patients With Newly Diagnosed Ischemic Heart Disease
Condition: Ischemic Heart Disease; Heart Valve Diseases; Psychological Distress
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Heart Valve Diseases; Ischemia
Study type: Interventional

Summary: 
      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).
    

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.
    

Intervention name(s): Group based cognitive therapy
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized study with
Intervention group
Control group with psychological distress
Control group without psychological distress (not part of randomization)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Group based cognitive therapy; Ischemic Heart Disease; Heart Valve Diseases; Psychological Distress