Taylor 2006.
Methods | Randomised controlled trial; randomisation ratio: 1:1:1 | |
Participants |
Inclusion criteria: type 2 diabetes for at least 6 months Exclusion criteria: — Diagnostic criteria: psychological well‐being through the Well‐Being Questionnaire (WBQ‐12) and a diabetes‐specific well‐being measure through an administration of the PAID 1 scale; self‐care behavioural assessment of the 4 leading behaviours linked to successful diabetes management; and social support |
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Interventions |
Number of study centres: at least 3 Treatment before study: — Titration period: no Intervention 1: cognitive‐behavioural therapy (CBT). A total of 30 minutes was allocated to cognitive‐behavioural education and 20 minutes to small‐group interaction (teams) for practicing problem‐solving techniques on selected topics. In the final 25 minutes of the session, the team group reported to the class their thoughts on the topic and solutions to the dilemma situations. Topics presented over the course of 5 weeks included the following: week 1 ‐ mind‐behaviour connection: thoughts (cognitions) can raise your blood sugar; week 2 ‐ become an ANT (automatic negative thoughts) terminator!; week 3 ‐ transform one's stress into results and relaxation; week 4 ‐ coping, one's action plan for successful mood management; week 5 ‐ healthy habits for living well with diabetes. Participants were given a Diabetes Research and Wellness Diary and asked to document the self‐care behaviour that they chose on the questionnaire to monitor Intervention 2: expressive writing. This expressive writing programme followed a similar format of the CBT programme. The first 30 minutes focused on the health habit of the week, followed by 20 minutes of small group interaction (teams) for brainstorming ideas and problem‐solving situations related to the featured self‐management skill. The final 20 minutes followed the expressive writing protocol described below. Participants were instructed to follow the research assistant to an assigned quiet chair or bench located at different parts throughout the building and grounds. Once seated and comfortable, participants were instructed to write about a stressful event that had happened to them, noting details about the event, and describing their feelings or emotions at that time. They were asked to keep writing as thoughts came into their mind and to not worry about spelling or grammar. This group programme was designed to educate participants about the 5 behavioural skills required to manage their diabetes. A workbook was written and corresponded to the following weekly schedule, allowing participants to read the material and write down any information that they found helpful. The topics presented each week were: week 1 ‐ progress not perfection: healthy habits; week 2 ‐ focus on fitness and energising one's days; week 3 ‐ make nutrition come alive; week 4 ‐ the learning gap: balancing stress; week 5 ‐ healthy habits for life: communicating with your health professionals. Participants were given a Diabetes Research and Wellness Diary and asked to document the self‐care behaviour that they chose on the questionnaire to monitor Control: control group (wait‐list). Participants were given a Diabetes Research and Wellness Diary and asked to document the self‐care behaviour that they chose on the questionnaire to monitor |
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Outcomes | Outcomes reported in abstract of publication: well‐being; stress; energy levels; mood; awareness | |
Study details |
Run‐in period: no Trial terminated early: no Trials register identifier: — |
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Publication details |
Language of publication: English Non‐commercial funding: Diabetes Research and Wellness Foundation Publication status: dissertation submitted in partial fulfilment of the requirements for the degree of Doctor of Psychology |
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Stated aim for study | Quote from publication: "The goal of this research was to evaluate the effectiveness of both interventions at improving seniors' perceived psychological well‐being, increasing their self‐efficacy, and alleviating the severity of diabetes symptoms improving through self‐management skills." | |
Notes | No mention of missing data handling, probably no imputation of missing values | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote from publication: "The diabetes educator coded all names on the list, and all participants were randomly assigned to ... In the interest of convenience... reassign[ed] 4 seniors to the group nearest their home." Comment: probably done |
Allocation concealment (selection bias) | Low risk |
Quote from publication: "The diabetes educator coded all names on the list, and all participants were randomly assigned to ..." Comment: probably done |
Blinding of participants and personnel (performance bias) Adverse events | Low risk |
Quote from publication: "If you are still upset we encourage you to call and talk to the researcher or the diabetes educator." Comment: self‐reported outcome measurement |
Blinding of outcome assessment (detection bias) Adverse events | Low risk |
Quote from publication: "If you are still upset we encourage you to call and talk to the researcher or the diabetes educator." Comment: self‐reported outcome measurement |
Incomplete outcome data (attrition bias) Adverse events | Low risk |
Expressive writing Quote from publication: "Four seniors dropped this program after the 2nd week because they did not want to write. " Comment: dropouts reported but not explained Cognitive behavioural therapy Quote from publication: "1 person stating a distinct dislike for the class. The 3 dropouts occurred because of hospitalisation for medical problems." Comment: reported and reasons explained |
Selective reporting (reporting bias) | Unclear risk | Comment: adverse events were reported by participants in programme evaluation and during debriefing session |
Other bias | Unclear risk | Comment: some of the results were incomplete for 2 of the 3 intervention groups |