Anxiety Self-management Intervention for Pulmonary Hypertension

NCT04450862 | Unknown

• 1 other identifier: 034442
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Hypertension; Pulmonary Arterial Hypertension; Anxiety; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Generalised Anxiety Disorder-7 (GAD-7)

  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.

  pre intervention, post intervention (4 weeks after) and 1 month follow up

Secondary Outcomes (5)

• Change in Patient Health Questionnaire-9 (PHQ9)

  pre intervention, post intervention (4 weeks after) and 1 month follow up

• Change in emPHasis-10

  pre intervention, post intervention (4 weeks after) and 1 month follow up

• Change in Dyspnoea 12 (D12)

  pre intervention, post intervention (4 weeks after) and 1 month follow up

• Change in Mastery Scale

  pre intervention, post intervention (4 weeks after) and 1 month follow up

• Change in Cognitive Behavioural Processes Questionnaire (CBPQ)

  pre intervention, post intervention (4 weeks after) and 1 month follow up

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

Cognitive Behavioural therapy self help intervention for anxiety OTHER

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sheffield: lead

Study Sites (2)

Clinical Psychology Unit

Sheffield, South Yorkshire, S1 2LT, United Kingdom

RECRUITING

Clinical Psychology Unit

Sheffield, United Kingdom

RECRUITING

Related Publications (3)

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Yorke J, Corris P, Gaine S, Gibbs JS, Kiely DG, Harries C, Pollock V, Armstrong I. emPHasis-10: development of a health-related quality of life measure in pulmonary hypertension. Eur Respir J. 2014 Apr;43(4):1106-13. doi: 10.1183/09031936.00127113. Epub 2013 Nov 14.

  PMID: 24232702 BACKGROUND

• Yorke J, Moosavi SH, Shuldham C, Jones PW. Quantification of dyspnoea using descriptors: development and initial testing of the Dyspnoea-12. Thorax. 2010 Jan;65(1):21-6. doi: 10.1136/thx.2009.118521. Epub 2009 Dec 8.

  PMID: 19996336 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Anxiety Disorders

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Study Officials

• Gregg H Rawlings, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregg H Rawlings, PhD

CONTACT

(+44) (0)114 2226610; ghrawlings1@sheffield.ac.uk

Amrit Sinha

CONTACT

0114 2226650; a.sinha@sheffield.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 30, 2020
• Study Start: August 5, 2020
• Primary Completion: April 1, 2021
• Study Completion: August 30, 2021
• Last Updated: November 10, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)