Groups for Specific vs Mixed Diagnosis Patients of Chronic Conditions

NCT05402358 | Completed

• 1 other identifier: 274421
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Does a group programme already delivered in routine practice to patients who share a diagnosis from the same medical speciality (i.e. specific-diagnosis) show equal effectiveness when modified for patients with diagnoses from a range of medical specialities (i.e. mixed-diagnosis)? A large number of people live with a long-term condition (LTC) and the burden of living with a LTC is recognised on a societal and individual level. Links between LTCs and poorer mental health increase demand on psychological services. Consequently new initiatives try to reduce waiting times and increase the capacity of these services. Group programmes use resources efficiently and have been applied across a range of medical specialities. A clinical health psychology service has adopted a group programme based on a well evidenced psychological therapeutic approach called Acceptance and Commitment Therapy (ACT), for patients with dermatology conditions showing promising outcomes. However, the investigators want to compare whether similar outcomes can be achieved with patients from a range of specialities. The investigators conducted quantitative and qualitative research to answer the research questions a) Does an Acceptance and Commitment Therapy group intervention for specific-diagnosis groups suggest similar effectiveness in health-related quality of life, illness beliefs and psychological distress versus mixed-diagnosis groups? b) Is there a difference in feasibility and acceptability of an Acceptance and Commitment Therapy intervention between specific-diagnosis groups versus mixed-diagnosis groups? c) What are health professionals' views on the acceptability and feasibility of specific-diagnosis versus mixed-diagnosis groups and their experiences of working with patients who have attended such groups? Participants were recruited from the Clinical Health Psychology waiting list at a UK NHS Trust. Participants attended 7, two-hour weekly sessions and an 8 week follow-up 'reunion', and completed health related quality of life, illness perceptions, depression and anxiety questionnaires pre and post intervention. Patient participants and health professional participants (facilitators and referrers) were invited to attend focus groups to discuss their views and experiences.

Conditions

Diabetes; Cardiovascular Diseases; Skin Diseases; Rheumatic Diseases; Mental Health Issue

Outcome Measures

Primary Outcomes (4)

• The Patient Health Questionnaire (PHQ-9)

  Self-report measure of depression. Minimum value 0 to maximum value 27, a higher score indicating a worse outcome.

  Baseline, week 8 and 8 week follow up

• The General Anxiety Disorder Scale (GAD-7)

  Self-report measure of anxiety. Minimum value 0 to maximum value 21, a higher score indicating a worse outcome.

  Baseline, week 8 and 8 week follow up

• The Brief Illness Perception Questionnaire (BIPQ)

  Self-reported perceptions of health. Overall score is computed and higher scores indicate more negative perceptions of illness.

  Baseline, week 8 and 8 week follow up

• The RAND 36-item Health Survey 1.0

  Self-reported health-related quality of life assessing eight domains. Higher scores indicate better quality of life.

  Baseline, week 8 and 8 week follow up

Secondary Outcomes (3)

• Group attendance

  Through intervention completion, for 8 sessions

• Focus group and individual interviews with patient participants

  After intervention completion, on average 12 weeks

• Focus group and individual interviews with health professional participants

  After intervention completion, on average 12 weeks

Study Arms (2)

Specific-Diagnosis

There were four specific-diagnosis groups covering four specialities: Dermatology, Rheumatology, Diabetes and Cardiology. Participants were categorised into these groups dependent on the speciality from which the referral originated or the participants primary condition. Participants attending a specific-diagnosis group were required to have a diagnosis relating to that speciality. All participants received the Living Well with a Long-Term Condition intervention

Other: Acceptance and Commitment Therapy Group Intervention

Mixed-Diagnosis

There were four mixed-diagnosis groups; participants who do not fall into the above specialities, or had number of co-morbid conditions, or were unable to attend the specified dates for any of the four specific-diagnosis groups, were invited to attend a mixed-diagnosis group.All participants received the Living Well with a Long-Term Condition intervention

Other: Acceptance and Commitment Therapy Group Intervention

Interventions

Acceptance and Commitment Therapy Group Intervention OTHER

The intervention consists of 7, 2-hour weekly sessions. Session 1 focused on introductions, outlining sessions and sharing experiences. Session 2 introduced key techniques used in the psychological approach (ACT) including mindfulness and understanding difficult thoughts and feelings. Session 3 explored ideas of primary and secondary suffering and reviewed the workability of current coping strategies. Session 4 asked participants to clarify their own personal values. Session 5 focused on goal setting and utilising problem solving skills. Session 6 considered barriers to change including assertiveness communication skills. Session 7 reviewed topics covered over the 6 weeks previously and explored pacing and preparing for setbacks. Finally a follow up 8 weeks later brought participants back for a reunion to review progress with goals and offer an opportunity to address any ongoing issues.

Mixed-Diagnosis; Specific-Diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care clinics

You may qualify if:

• Patient participants needed to have a diagnosis of:
• A long-term condition relating to one of the four specific-diagnosis specialities (Dermatology, Rheumatology, Diabetes, or Cardiology) for the specific-diagnosis group.
• A long-term condition (from any of the hospital specialities that the General Medicine team covered) for the mixed-diagnosis group (including any of the specific-diagnosis specialities; dermatology, rheumatology, diabetes or cardiology).
• Patient participants were also required to be 18 or over, English speaking and able to give informed consent to participate.

You may not qualify if:

• they were actively engaged with another psychological therapy or receiving active input from a secondary mental health service
• they had significant substance abuse difficulties
• they had severe and/or chronic mental health problem such as personality disorder where the interpersonal difficulties themselves are the required focus of an intervention
• they had a learning disability, at such a level that specialist skills would be required to deliver an intervention

Sponsors & Collaborators

• University of Stirling: lead

Study Sites (1)

Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Skin Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Skin and Connective Tissue Diseases; Musculoskeletal Diseases; Connective Tissue Diseases

Study Officials

• Holly Martin-Smith

  University of Stirling

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Research Student

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)