Skip to main content
OpenTrials
Completed

NCT Number: NCT00854984

Pilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease

A feasibility pilot trial of the self-help, "Cognitive behavioural therapy" based "Living Life to the Full" Materials for use by patients with diabetes type 2 and / or coronary heart disease.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health and Social Care, Garthdee Campus, Robert Gordon University, Aberdeen, United Kingdom

Loading trial locations.

About this study

Depressed mood is common in patients with chronic disease and physical disability. It adversely affects quality of life, adherence to treatment and clinical outcome. Depression is expensive to the person, their family, employers and society. Recent developments in the UK General Practitioners' Contract mean that patients with two chronic diseases (Coronary Heart Disease- CHD and Diabetes - DM) are routinely screened for depression using a simple screening tool. We propose a study using an existing self help intervention in the specific context of patients with mild to moderately severe depression identified in this way.

This RCT is the second phase of a 2 phase mixed methods study examining the feasibility of a Full RCT. The first involved focus group with patients and health practitioners.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease.
  • Be aged 35 or over.
  • Be attending a participating primary care practice.
  • Have a depression severity scale rating indicating moderate to moderately severe depression, such as:Prime-MD-PHQ9 of 10-21; HADS-D of 8-15;BDI-2 of 23-44

Exclusion criteria

  • Unable to provide informed consent to participate
  • Already receiving psychological treatment for their depression
  • Have commenced treatment with an SSRI within the past 8 weeks
  • Likely to have difficulty communicating by telephone
  • Likely to have difficulty completing the forms and questionnaires
  • Have a serious physical disorder
  • Have a serious mental disorder
  • Express significant suicidal thoughts (PHQ9 or BDI-2 question 9 scoring >1)
  • Took part in an earlier related focus group

Treatment and study plan

Living Life to the Full

Behavioral

A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats.

Other names: Five Areas

Primary outcomes

  1. The obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients.

    Time frame: 13 weeks

Secondary outcomes

  1. The proportion of patients would prefer or require a non-computerised treatment alternative to treatment (i.e. a book or DVD based form of the treatment).

    Time frame: 13 weeks

  2. The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses.

    Time frame: 13 weeks

  3. A change in depression (BDI-2), anxiety , social function (WASAS), quality of life (Euroqol 5D) or illness perception (IPQ-R) from participation in a self help programme.

    Time frame: 13 weeks

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Chief Scientist Office of the Scottish Government
  • Robert Gordon University
  • University of Glasgow
  • University of Stirling

Registry information

Official study title

Pilot Study of a Practice Nurse Supported Psychological Self-help Intervention for Patients With Diabetes or Coronary Heart Disease and Co-morbid Depression

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 3, 2009
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.