Groups for Specific vs Mixed Diagnosis Patients of Chronic Conditions

Sponsor
University of Stirling (Other)
Overall Status
Completed
CT.gov ID
NCT05402358
Collaborator
(none)
40
1
18
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Acceptance and Commitment Therapy Group Intervention

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Acceptability and Feasibility of Groups for Specific Versus Mixed-diagnosis Patients of Long-term Conditions
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Specific-Diagnosis

Other: Acceptance and Commitment Therapy Group Intervention
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

Other: Acceptance and Commitment Therapy Group Intervention
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.

Outcome Measures

Primary Outcome Measures

  1. The Patient Health Questionnaire (PHQ-9) [Baseline, week 8 and 8 week follow up]

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

  2. The General Anxiety Disorder Scale (GAD-7) [Baseline, week 8 and 8 week follow up]

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

  3. The Brief Illness Perception Questionnaire (BIPQ) [Baseline, week 8 and 8 week follow up]

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

  4. The RAND 36-item Health Survey 1.0 [Baseline, week 8 and 8 week follow up]

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

Secondary Outcome Measures

  1. Group attendance [Through intervention completion, for 8 sessions]

    The numbers of participants recruited and retained (we will record attendance levels at group sessions)

  2. Focus group and individual interviews with patient participants [After intervention completion, on average 12 weeks]

    Explored the thoughts and feelings of participants from each group on what worked well and could be improved about all aspects of the intervention including a) the attractiveness, accessibility and acceptability of the intervention b) the group environment and ideas of being in a specific-diagnosis versus mixed-diagnosis group

  3. Focus group and individual interviews with health professional participants [After intervention completion, on average 12 weeks]

    Qualitative measure explored the thoughts and feelings of health professionals on specific-diagnosis and mixed-diagnosis groups and include the believed advantages and disadvantages and any changes noticed in patients that they have referred or worked with who complete the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patient participants needed to have a diagnosis of:
  1. A long-term condition relating to one of the four specific-diagnosis specialities (Dermatology, Rheumatology, Diabetes, or Cardiology) for the specific-diagnosis group.

  2. 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.

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Salford Royal NHS Foundation Trust Salford United Kingdom M6 8HD

Sponsors and Collaborators

  • University of Stirling

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Stirling
ClinicalTrials.gov Identifier:
NCT05402358
Other Study ID Numbers:
  • 274421
First Posted:
Jun 2, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2022