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Anxiety Self-management Intervention for Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04450862
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Information provided by (Responsible Party):
University of Sheffield

Brief Summary:
Pulmonary hypertension (PH) is a disorder of high blood pressure that impacts the heart and lungs. Approximately, 50% of individuals with PH experience anxiety or panic disorders. There is limited evidence on psychological treatments for anxiety in PH; however, results support the use of Cognitive Behavioural Therapy (CBT). Despite the prevalence and impact of anxiety in PH; there are no widely available and/or disease specific pathways, thus highlighting an unmet need in this population. This project aims to develop and pilot, using randomised control trial methodology, a self-management intervention for individuals with PH based on principles of CBT.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Pulmonary Arterial Hypertension Anxiety Anxiety Disorders Other: Cognitive Behavioural therapy self help intervention for anxiety Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development and Pilot Randomised Controlled Trial of a Self-management Intervention to Help Individuals With Pulmonary Hypertension Live Better With Anxiety
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : August 30, 2021

Arm Intervention/treatment
Experimental: Intervention arm
Participants randomised to the intervention arm will receive a CBT informed, self-help intervention for anxiety in PH. This will be based on the four factor model, which is a trans-diagnostic approach to help understanding and identify behaviour change methods (Padesky & Mooney, 1990).
Other: Cognitive Behavioural therapy self help intervention for anxiety

The intervention will involve five key components:

Psychoeducation - Increase awareness of how PH may affect emotional health, normalisation of difficulties, and discussion of how symptoms associated with anxiety may add to the burden of the disease.

Cognitions - Identify and challenge negative automatic thoughts associated with anxiety.

Coping skills - Educate and practice a range of behavioural coping methods to help participants better manage their physical symptoms associated with anxiety in PH.

Exposure - Replace avoidance of anxiety provoking situations and activities using graded exposure.

Relapse prevention - Focus on relapse prevention with implementation intentions and promotion of problem solving.

No Intervention: Control arm
A waiting-list will be used as a control condition. If the self-management intervention is found to be acceptable and not associated with any risk, then participants in the control condition will receive the intervention.

Primary Outcome Measures :
  1. Change in Generalised Anxiety Disorder-7 (GAD-7) [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]
    The Generalised Anxiety Disorder-7 (GAD-7) is a seven-item scale, self-administered screening tool and anxiety severity measure for anxiety disorders including, generalised anxiety disorder, social anxiety and panic disorder. Scores range from 0-21. A score of 0-4 indicates "no difficulties", 5-9 "mild", 10-14 "moderate" and 15-21 "severe" levels. A higher score suggests greater anxiety.

Secondary Outcome Measures :
  1. Change in Patient Health Questionnaire-9 (PHQ9) [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]
    The Patient Health Questionnaire-9 (PHQ9) is a nine-item, self-administered tool to examine severity of depression. Scores range from 0-27. A score of 0-4 indicates "no difficulties", 5-9 "mild", 10-14 "moderate", 15-19 "moderately severe" and 20 or higher "severe depression". A higher score suggests greater depression.

  2. Change in emPHasis-10 [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]
    This is a disease-specific, health-related quality of life measure asking respondents to rate ten difficulties commonly associated with PH. Scores can range form 0-50, with a higher score indicating lower quality of life.

  3. Change in Dyspnoea 12 (D12) [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]
    The Dyspnoea 12 (D12) will be used to examine participant's breathlessness severity. Total scores range from 0-36 with a higher score indicating worse functioning

  4. Change in Mastery Scale [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]
    The Mastery Scale will be used to investigate participant's perception of their own ability of coping. Total scores range from 7-49 with a higher score suggesting the individual perceives himself or herself as having a greater capacity to cope

  5. Change in Cognitive Behavioural Processes Questionnaire (CBPQ) [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]
    The Cognitive Behavioural Processes Questionnaire (CBPQ) will be used to examine participant's responses to negative cognitions, emotions and behaviours that may themselves underlie anxiety disorders. Scores range from 0-120, with higher scores suggesting lower engagement in cognitive and behavioural processes.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • • Aged 18 years or over

    • Diagnosis of pulmonary hypertension - participants will be asked to self-report this information
    • Able to complete the self-report questionnaires without help from others
    • Able to give informed consent - given that participants need to be proactive in entering the study, this will be assumed.
    • Literate in English

Exclusion Criteria:

  • • Significant risk issues (participants will be asked to self-report this information), for example, experiencing current thoughts of self-harm or suicide.

    • Received a medical intervention specifically for anxiety within the last 12 months (including pharmacological and psychological treatments).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04450862

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Contact: Gregg H Rawlings, PhD (+44) (0)114 2226610
Contact: Amrit Sinha 0114 2226650

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United Kingdom
Clinical Psychology Unit
Sheffield, South Yorkshire, United Kingdom, S1 2LT
Sponsors and Collaborators
University of Sheffield
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Principal Investigator: Gregg H Rawlings, PhD University of Sheffield
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Responsible Party: University of Sheffield Identifier: NCT04450862    
Other Study ID Numbers: 034442
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant's data will not be shared with researchers outside of the research team. Participants will be anonymised in all publications.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Anxiety Disorders
Vascular Diseases
Cardiovascular Diseases
Mental Disorders
Lung Diseases
Respiratory Tract Diseases