Clinical trial NCT04254315: OPTIMA: Psychological Distress and the Effect of Intensive Group Based Cognitive Therapy in Patients With Newly Diagnosed Ischemic Heart Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Heart Valve Diseases
Psychological Distress
Keywords: Group based cognitive therapy
Ischemic Heart Disease
Heart Valve Diseases
Psychological Distress
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized study with

* Intervention group
* Control group with psychological distress
* Control group without psychological distress (not part of randomization)
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome of the RCT is anxiety and depression measured by HADS
timeFrame: 3 months follow-up
measure: The primary outcome of the RCT is anxiety and depression measured by HADS
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL
timeFrame: 3 months follow-up
measure: Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL
timeFrame: 6 months follow-up
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Cardiology department, Bispebjerg-Frederiksberg Hospital
Study officials:
References:
citation: Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
citation: Damen NL, Versteeg H, Boersma E, Serruys PW, van Geuns RJ, Denollet J, van Domburg RT, Pedersen SS. Depression is independently associated with 7-year mortality in patients treated with percutaneous coronary intervention: results from the RESEARCH registry. Int J Cardiol. 2013 Sep 10;167(6):2496-501. doi: 10.1016/j.ijcard.2012.04.028. Epub 2012 May 3.
citation: van Dijk MR, Utens EM, Dulfer K, Al-Qezweny MN, van Geuns RJ, Daemen J, van Domburg RT. Depression and anxiety symptoms as predictors of mortality in PCI patients at 10 years of follow-up. Eur J Prev Cardiol. 2016 Mar;23(5):552-8. doi: 10.1177/2047487315571889. Epub 2015 Feb 9.
citation: Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510.
citation: Blumenthal JA, Sherwood A, Smith PJ, Watkins L, Mabe S, Kraus WE, Ingle K, Miller P, Hinderliter A. Enhancing Cardiac Rehabilitation With Stress Management Training: A Randomized, Clinical Efficacy Trial. Circulation. 2016 Apr 5;133(14):1341-50. doi: 10.1161/CIRCULATIONAHA.115.018926. Epub 2016 Mar 21.
citation: Zheng X, Zheng Y, Ma J, Zhang M, Zhang Y, Liu X, Chen L, Yang Q, Sun Y, Wu J, Yu B. Effect of exercise-based cardiac rehabilitation on anxiety and depression in patients with myocardial infarction: A systematic review and meta-analysis. Heart Lung. 2019 Jan;48(1):1-7. doi: 10.1016/j.hrtlng.2018.09.011. Epub 2018 Oct 23.
citation: Holdgaard A, Eckhardt-Hansen C, Lund T, Lassen CF, Sibiliz KL, Hofsten DE, Prescott E, Rasmusen HK. Intensive group-based cognitive therapy in patients with cardiac disease and psychological distress-a randomized controlled trial protocol. Trials. 2021 Jul 16;22(1):455. doi: 10.1186/s13063-021-05405-3.