Chronic Conditions, MultipleNCT04978974
Implications of Stress Management Program
A study testing Stress Management Program in people with Chronic Conditions, Multiple, run by University of Gujrat at 1 site in Pakistan.
Trial summary
Previous studies indicated that patients with diabetes mellitus and hypertension had higher level of perceived stress, used maladaptive coping strategies and poor health-related quality of life. Read more about this study
- Who is it for?
- Ages 31 to 60 years
- Conditions the study is for
- Chronic Conditions, Multiple
- What is being tested?
- Stress Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 3 May 2019to 29 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with type II diabetes or hypertension with at least three months duration of illness
- had not attended any psychological intervention or stress management program earlier
Who cannot join
- Patients who had any other physical/ mental illnesses along with diabetes or hypertension
- Patients with type I diabetes
- Patients with gestational diabetes or hypertension
- Had diabetes or hypertensive condition from less than three month
- Had co morbidity of diabetes and hypertensive chronic conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress, Coping Strategies and Quality of Life Among Patients With Chronic Conditions: Implications of Stress Management Program
Previous studies indicated that patients with diabetes mellitus and hypertension had higher level of perceived stress, used maladaptive coping strategies and poor health-related quality of life. Therefore, stress management program was applied to reduce their perceived stress, improve their coping strategies, improve their health-related quality of life and psychological health of the patients with type 2 diabetes mellitus and hypertension in current study. The main objectives of the current study were to observe the effects of stress management program on perceived stress, coping strategies and health-related quality of life using pre-experimental research design. Patients with diabetes mellitus type 2 and hypertension were selected through purposive sampling technique to apply the eclectic approach of the stress management program. Total 110 patients with type 2 diabetes and hypertension completed the program from 114 patients who gave inform consent for participation in the first session. Perceived stress scale, WHOQOL and Coping strategies questionnaire were administered at the pre and post-levels of the program. Further, base line of targeted domains variables was also filled from the participants at pre, mid and post-levels to access the efficacy of the program which was formulated according to previous research data by the researcher. The stress Management program consisted of 10 session which were delivered to eight groups (diabetic and Hypertensive) in five weeks. Each session had the duration 90 minutes and two sessions were conducted in one week.
- Conditions
- Chronic Conditions, Multiple
- Being tested
- Stress Management Program
- Keywords
- Diabetes, Hypertension, Chronic Condition, Stress Management Program, Perceived Stress, Coping Strategies
- Medical subject headings
- Multiple Chronic Conditions, Diabetes Mellitus, Hypertension, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management ProgramBehavioural
Stress management program includes different techniques such as relaxation technique, psycho-education, laughing, emotional freedom technique, referenting, cognitive restructuring, rational emotive imagery, time management, anger management, assertiveness and social support
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 Diabetes mellitus and Hypertension | Experimental | patients with type 2 diabetes mellitus and hypertension were selected by using purposive sampling technique to apply stress management program Receives: Behavioral: Stress Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of stress management program as assessed using Perceived Stress Scale
Consisted of 10 items, Scoring: 0 to 1, The Higher score shows more stress
Measured: 10th session (one month and one week from first assessment)
Effects of stress management program as assessed using Health-Related Quality of Life
Consisted of 26 items, Scoring: 1 to 5, The higher score shows better HRQOL
Measured: 10th session (one month and one week from first assessment)
Effects of stress management program as assessed using Coping Strategies Questionnaire
Consisted of 62 items, Scoring: 1 to 5, The higher score shows high use of coping strategies
Measured: 10th session (one month and one week from first assessment)
Secondary outcomes (1)
Effects of stress management program as assessed using Baseline
20 targeted domains which included information about the illness, information about the causes of illness, information about the treatment of illness, efforts to control the level of illness, application of domestic tips, hopefulness, anxiety, negative thoughts, problems in daily activities, problems in social relationships, anger, appetite problems, sleep problems, concentration problems, body pain, fatigue, absent mind, unhealthy diet, loneliness and restlessness at pre, mid and post levels of stress management program. Rating scale ranges from 0-10 (0 shows there is absence of the target construct while 10 shows the high level of target construct).
Measured: base line were used in 5th (two weeks and 3 days) and 10th session (one month and one week from first assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start3 May 2019
- Primary completion3 Jan 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Conditions, MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients with chronic conditions which included type 2 diabetes and hypertension were selected through purposive sampling technique
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gujrat
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafsa Qurban, University of Gujrat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978974
- Sponsor's protocol ID
- UOG/ASRB/Psych/3/18631/011
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data confidentiality from the participants, there is no plan of IPD available
Publications
Alshayban D, Joseph R. Health-related quality of life among patients with type 2 diabetes mellitus in Eastern Province, Saudi Arabia: A cross-sectional study. PLoS One. 2020 Jan 10;15(1):e0227573. doi: 10.1371/journal.pone.0227573. eCollection 2020.
PubMed 31923232
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress, Coping Strategies and Quality of Life Among Patients With Chronic Conditions: Implications of Stress Management Program
- ClinicalTrials.gov ID
- NCT04978974
- Acronym / sponsor ID
- UOG/ASRB/Psych/3/18631/011
- Conditions
- Chronic Conditions, Multiple
- Keywords
- Diabetes, Hypertension, Chronic Condition, Stress Management Program, Perceived Stress, Coping Strategies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of GujratUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies indicated that patients with diabetes mellitus and hypertension had higher level of perceived stress, used maladaptive coping strategies and poor health-related quality of life. Therefore, stress management program was applied to reduce their perceived stress, improve their coping strategies, improve their health-related quality of life and psychological health of the patients with type 2 diabetes mellitus and hypertension in current study. The main objectives of the current study were to observe the effects of stress management program on perceived stress, coping strategies and health-related quality of life using pre-experimental research design. Patients with diabetes mellitus type 2 and hypertension were selected through purposive sampling technique to apply the eclectic approach of the stress management program. Total 110 patients with type 2 diabetes and hypertension completed the program from 114 patients who gave inform consent for participation in the first session. Perceived stress scale, WHOQOL and Coping strategies questionnaire were administered at the pre and post-levels of the program. Further, base line of targeted domains variables was also filled from the participants at pre, mid and post-levels to access the efficacy of the program which was formulated according to previous research data by the researcher. The stress Management program consisted of 10 session which were delivered to eight groups (diabetic and Hypertensive) in five weeks. Each session had the duration 90 minutes and two sessions were conducted in one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients with chronic conditions which included type 2 diabetes and hypertension were selected through purposive sampling technique
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 Diabetes mellitus and Hypertension | Experimental | Behavioral: Stress Management Programpatients with type 2 diabetes mellitus and hypertension were selected by using purposive sampling technique to apply stress management program |
Who may qualify
- Ages
- 31 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with type II diabetes or hypertension with at least three months duration of illness
- had not attended any psychological intervention or stress management program earlier
Key exclusion criteria (5 listed)
- Patients who had any other physical/ mental illnesses along with diabetes or hypertension
- Patients with type I diabetes
- Patients with gestational diabetes or hypertension
- Had diabetes or hypertensive condition from less than three month
- Had co morbidity of diabetes and hypertensive chronic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Management ProgramStress management program includes different techniques such as relaxation technique, psycho-education, laughing, emotional freedom technique, referenting, cognitive restructuring, rational emotive imagery, time management, anger management, assertiveness and social support | Behavioural | Patients with type 2 Diabetes mellitus and Hypertension |
Primary outcome
Effects of stress management program as assessed using Perceived Stress Scale
Time frame: 10th session (one month and one week from first assessment)
Consisted of 10 items, Scoring: 0 to 1, The Higher score shows more stress
Effects of stress management program as assessed using Health-Related Quality of Life
Time frame: 10th session (one month and one week from first assessment)
Consisted of 26 items, Scoring: 1 to 5, The higher score shows better HRQOL
Effects of stress management program as assessed using Coping Strategies Questionnaire
Time frame: 10th session (one month and one week from first assessment)
Consisted of 62 items, Scoring: 1 to 5, The higher score shows high use of coping strategies
1 secondary outcome
Effects of stress management program as assessed using Baseline
Time frame: base line were used in 5th (two weeks and 3 days) and 10th session (one month and one week from first assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Background: PubMed 31923232Alshayban D, Joseph R. Health-related quality of life among patients with type 2 diabetes mellitus in Eastern Province, Saudi Arabia: A cross-sectional study. PLoS One. 2020 Jan 10;15(1):e0227573. doi: 10.1371/journal.pone.0227573. eCollection 2020.
- Individual participant dataSharing planned: No. Due to data confidentiality from the participants, there is no plan of IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management Program in people with Chronic Conditions, Multiple, run by University of Gujrat at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of stress management program as assessed using Perceived Stress Scale (time frame: 10th session (one month and one week from first assessment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04978974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.