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Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients

Primary Purpose

Depression, Anxiety, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Attention Training Technique
Sponsored by
Vestre Viken Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Established coronary heart disease as main somatic disease >=8 on either HADS-anxiety or depression subscale Age 18 - 65 years The ability to understand and speak Norwegian language, Willingness and ability to give informed consent. Exclusion Criteria: Current or past neurological illness Traumatic brain injury Current alcohol and/or substance dependency disorders Psychotic disorders Bipolar disorders Developmental disorders Mental retardation Cognitive impairment which precludes informed consent/ability to participate Acute suicidality Life-expectancy less than 12 months Concurrent psychological intervention for emotional distress Antidepressant or anxiolytic medication initiated during previous 8 weeks

Sites / Locations

  • Hospital of Vestfold
  • Vestre Viken Trust Drammen hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Attention Training Techniqe

Wait-list control

Arm Description

The treatment manual will consist of up to six weekly group sessions with 45-90 minutes duration.

The wait-list control condition will not receive any psychological intervention during the six weeks waiting period. Subsequently, this group will also receive the intervention if the study entry criteria is still fulfilled

Outcomes

Primary Outcome Measures

Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale score
Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale scores within and between the two treatment arms. Scores range 0-21, higher scores indicate more symptoms
Differences in proportion with Hospital Anxiety and Depression -anxiety and Hospital Anxiety and Depression-depression subscale scores <8
Differences in proportion with Hospital Anxiety and Depression -anxiety subscale and Hospital Anxiety and Depression -depression subscale scores <8 within and between the two treatment arms. Scores >=8 indicate signicant symptoms

Secondary Outcome Measures

Changes in rumination scores
Changes in rumination scores assessed by the Ruminative Response scale within and between the two treatment arms. Scores range from 22-88, higher scores indicate more symptoms
Changes in worry scores
Changes in worry scores assessed by the Penn State Worry Questionnaire within and between the two treatment arms. Scores range 16-80, higher scores indicate more symptoms
Changes in Positive Beliefs about Rumination Scale scores
Changes in Positive Beliefs about Rumination scores assessed by the Positive Beliefs about Rumination Questionnaire within and between the two treatment arms. Scores range 9-36, higher scores indicate stronger beliefs
Changes in Negative Beliefs about Rumination Scale scores
Changes in Negative Beliefs about Rumination scores assessed by the Negative Beliefs about Rumination Questionnaire within and between the two treatment arms. Scores range 13-52, higher scores indicate stronger beliefs
Changes in Metacognitions Questionnaire-30 scores
Changes in Metacognitions assessed by the Metacognitions Questionnaire-30 within and between the two treatment arms. Scores range 0-21, higher scores indicate more symptoms . Scores range 30-120, higher scores indicate stronger beliefs
Changes in type d personality and its traits negative affectivity and social inhibition
Changes in type d personality and its traits negative affectivity and social inhibition assessed by the Distressed Scale (DS)-14 within and between the two treatment arms. Scores range 0-28, higher scores indicate more symptoms
Changes in quality of life
Changes in quality of life assessed by the Short Form (SF) 12 within and between the two treatment arms. Scores range 1-100, lower scores indicate lower quality of life
Changes in Bergen Insomnia Scale scores
Changes in Bergen Insomnia Scale scores assessed by the Bergen Insomnia Scale within and between the two treatment arms. Scores range 0-42, higher scores indicate more symptoms
Changes in C-reactive Protein (CRP)
Changes in C-reactive Protein (CRP) measured in blood within and between the two treatment arms. Values range 0 to >20, higher values indicate more subclinical inflammation

Full Information

First Posted
November 2, 2022
Last Updated
May 2, 2023
Sponsor
Vestre Viken Hospital Trust
Collaborators
Oslo University Hospital, University of Oslo, The Hospital of Vestfold
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1. Study Identification

Unique Protocol Identification Number
NCT05621408
Brief Title
Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients
Official Title
Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients -a Randomized Controlled Trial With 6 Months Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vestre Viken Hospital Trust
Collaborators
Oslo University Hospital, University of Oslo, The Hospital of Vestfold

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Anxiety and depression are associated with work disability, lower participation rate in cardiac rehabilitation and unfavourable life style changes following a coronary heart disease (CHD) event. The prevalence of clinically significant symptoms of depression and anxiety in CHD patients has been estimated to 30-50%. Furthermore, depression and anxiety are associated with a significant increased risk of subsequent major adverse cardiovascular events and mortality in CHD patients. Psychological interventions for anxiety and depression in CHD patients have demonstrated small and uncertain effects of symptoms, and no effect on cardiovascular outcomes. Therefore, testing the effectiveness of specific psychological interventions that may affect central mechanisms for cardiovascular outcomes, has been requested. The Attention training (ATT) Study is a randomized controlled trial comparing group-attention training to wait-list control in 64 patients who experience significant anxiety and depression after a CHD event. It will also be explored whether reduction in psychological symptoms is correlated with changes in biological markers with a potential link to cardiovascular outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Attention Training Techniqe
Arm Type
Experimental
Arm Description
The treatment manual will consist of up to six weekly group sessions with 45-90 minutes duration.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
The wait-list control condition will not receive any psychological intervention during the six weeks waiting period. Subsequently, this group will also receive the intervention if the study entry criteria is still fulfilled
Intervention Type
Behavioral
Intervention Name(s)
Attention Training Technique
Intervention Description
Attention Training Technique is a six weeks psychological intervention provided by trained professionals
Primary Outcome Measure Information:
Title
Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale score
Description
Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale scores within and between the two treatment arms. Scores range 0-21, higher scores indicate more symptoms
Time Frame
Up to six weeks and six months after randomization
Title
Differences in proportion with Hospital Anxiety and Depression -anxiety and Hospital Anxiety and Depression-depression subscale scores <8
Description
Differences in proportion with Hospital Anxiety and Depression -anxiety subscale and Hospital Anxiety and Depression -depression subscale scores <8 within and between the two treatment arms. Scores >=8 indicate signicant symptoms
Time Frame
Up to six weeks and six months after randomization
Secondary Outcome Measure Information:
Title
Changes in rumination scores
Description
Changes in rumination scores assessed by the Ruminative Response scale within and between the two treatment arms. Scores range from 22-88, higher scores indicate more symptoms
Time Frame
Up to six weeks and six months after randomization
Title
Changes in worry scores
Description
Changes in worry scores assessed by the Penn State Worry Questionnaire within and between the two treatment arms. Scores range 16-80, higher scores indicate more symptoms
Time Frame
Up to six weeks and six months after randomization
Title
Changes in Positive Beliefs about Rumination Scale scores
Description
Changes in Positive Beliefs about Rumination scores assessed by the Positive Beliefs about Rumination Questionnaire within and between the two treatment arms. Scores range 9-36, higher scores indicate stronger beliefs
Time Frame
Up to six weeks and six months after randomization
Title
Changes in Negative Beliefs about Rumination Scale scores
Description
Changes in Negative Beliefs about Rumination scores assessed by the Negative Beliefs about Rumination Questionnaire within and between the two treatment arms. Scores range 13-52, higher scores indicate stronger beliefs
Time Frame
Up to six weeks and six months after randomization
Title
Changes in Metacognitions Questionnaire-30 scores
Description
Changes in Metacognitions assessed by the Metacognitions Questionnaire-30 within and between the two treatment arms. Scores range 0-21, higher scores indicate more symptoms . Scores range 30-120, higher scores indicate stronger beliefs
Time Frame
Up to six weeks and six months after randomization
Title
Changes in type d personality and its traits negative affectivity and social inhibition
Description
Changes in type d personality and its traits negative affectivity and social inhibition assessed by the Distressed Scale (DS)-14 within and between the two treatment arms. Scores range 0-28, higher scores indicate more symptoms
Time Frame
Up to six weeks and six months after randomization
Title
Changes in quality of life
Description
Changes in quality of life assessed by the Short Form (SF) 12 within and between the two treatment arms. Scores range 1-100, lower scores indicate lower quality of life
Time Frame
Up to six weeks and six months after randomization
Title
Changes in Bergen Insomnia Scale scores
Description
Changes in Bergen Insomnia Scale scores assessed by the Bergen Insomnia Scale within and between the two treatment arms. Scores range 0-42, higher scores indicate more symptoms
Time Frame
Up to six weeks and six months after randomization
Title
Changes in C-reactive Protein (CRP)
Description
Changes in C-reactive Protein (CRP) measured in blood within and between the two treatment arms. Values range 0 to >20, higher values indicate more subclinical inflammation
Time Frame
Up to six weeks and six months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established coronary heart disease as main somatic disease >=8 on either HADS-anxiety or depression subscale Age 18 - 65 years The ability to understand and speak Norwegian language, Willingness and ability to give informed consent. Exclusion Criteria: Current or past neurological illness Traumatic brain injury Current alcohol and/or substance dependency disorders Psychotic disorders Bipolar disorders Developmental disorders Mental retardation Cognitive impairment which precludes informed consent/ability to participate Acute suicidality Life-expectancy less than 12 months Concurrent psychological intervention for emotional distress Antidepressant or anxiolytic medication initiated during previous 8 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Munkhaugen, MD,PhD
Phone
+4797524194
Email
johmun@vestreviken.no
First Name & Middle Initial & Last Name or Official Title & Degree
Toril Dammen, MD,PhD
Phone
+4790163433
Email
toril.dammen@medisin.uio.no
Facility Information:
Facility Name
Hospital of Vestfold
City
Tønsberg
State/Province
Vestfold And Telemark County
ZIP/Postal Code
3103
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kari H Peersen, MD, PhD
Email
kari.peersen@siv.no
Facility Name
Vestre Viken Trust Drammen hospital
City
Drammen
State/Province
Viken County
ZIP/Postal Code
3004
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John D Munkhaugen, MD, PhD
Phone
+4797524194
Email
johmun@vestreviken.no
First Name & Middle Initial & Last Name & Degree
Toril Dammen, MD, PhD
Phone
+4790163433
Email
toril.dammen@medisin.uio.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients

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