NCT00854984

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
10 days until next milestone

Study Start

First participant enrolled

March 13, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2009

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

March 2, 2009

Last Update Submit

May 21, 2024

Conditions

DepressionDiabetes Mellitus Type 2Coronary Heart Disease

Keywords

DepressiondiabetesCoronary heart diseaseCBTCognitive behavioural therapy

Outcome Measures

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.

    13 weeks

Secondary Outcomes (3)

  • 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).

    13 weeks

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

    13 weeks

  • 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.

    13 weeks

Study Arms (2)

Self-help CBT

EXPERIMENTAL

A nurse supported self-help CBT intervention in addition to usual care.

Behavioral: Living Life to the Full

Usual care

NO INTERVENTION

Interventions

Living Life to the FullBEHAVIORAL

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

Also known as: Five Areas
Self-help CBT

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Aberdeen, AB10 7QG, United Kingdom

Location

Community Health Sciences, GP Section, University of Edinburgh

Edinburgh, EH8 9DX, United Kingdom

Location

MeSH Terms

Conditions

DepressionDiabetes Mellitus, Type 2Coronary DiseaseDiabetes Mellitus

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Margaret Maxwell, PhD

    University of Stirling

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 3, 2009

Study Start

March 13, 2009

Primary Completion

September 30, 2009

Study Completion

September 30, 2009

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

GB(2)