Improving Mental Health in Diabetes: A Guided Self-Help Study

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01473017

Enrollment

Registered

2011-11-17

Start date

2011-11-30

Completion date

2013-09-30

Last updated

2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Type 2 Diabetes

Brief summary

This study employs a Randomised Controlled Trial design to investigate whether a CBT-based guided self-help intervention can improve anxiety, depression, psychological well-being, quality of life, Diabetic self-care and adherence; as compared to controls. The study aims to recruit 42 individuals with Diabetes and mild to moderate anxiety or depression. Anxiety and depression are common in patients with Type 2 Diabetes, and has been shown to affect Diabetes control. Literature suggests that CBT can benefit individuals with Diabetes and comorbid mental ill-health, however little research has been done to date on the effect of guided self-help in this population. It is expected that this intervention will improve patient's mental health, as well as extend the limited knowledge-base on guided self-help in chronic illness.

Interventions

BEHAVIORALCBT-based Guided Self-Help

CBT-based booklet tailored to anxiety and/or depression in Type 2 Diabetes to enhance mood and Diabetes self-care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Individuals with a diagnosis of Type 2 Diabetes with mild-moderate anxiety and/or depression (scoring 8 to 15 on the HADS scale) will be recruited, provided they do not meet any one of the

Exclusion criteria

listed below. Patients will be able to provide written informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Anxiety and/or depression in Type 2 Diabetes	18 weeks	To see whether a CBT based guided self-help book improves anxiety and/or depression in participants with Type 2 Diabetes

Secondary

Measure	Time frame	Description
Quality of life	18 weeks	To see whether the intervention enhances quality of life, psychological well-being and self-reported diabetes management.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026