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Completed

NCT Number: NCT01989247

How to Cope With Anxiety and Depression. A Randomized Controlled Trial.

The purpose of this study is to investigate whether citizens experiencing symptoms of anxiety and depression will benefit from a self-management training program with respect to: 1) Self-efficacy, and 2) Symptoms of anxiety and depression, and 3) Self reported measures of Health Related Quality of Life (HRQoL)

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Key information

Conditions

Depression Adherence Interventions Anxiety Anxiety Disorders Behavior Behavioral Symptoms Health Behavior Health Education Medication Adherence Mental Disorders Patient Acceptance of Health Care Patient Compliance Self Efficacy Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Municipality, Aalborg, Denmark

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About this study

  • The intervention is a Danish adaption of The Chronic Disease Self-Management Program developed by The Stanford Patient Education Research Center, The Expert Patient Program Community Interest Company (EPPCIC), and The English National Health Service (NHS).
  • The Danish adaptation has been performed by The Danish Committee for Health Education.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • >= 18 years of age
  • Suffering from anxiety and/or depressive symptoms
  • Voluntary participation

Exclusion criteria

  • Potential suicidal behavior
  • Potential aggressive behavior
  • Significant cognitive impairment

Treatment and study plan

Self-management programme

Behavioral

Seven weekly group-based sessions for people with anxiety and depressive symptoms

Primary outcomes

  1. Depressive Symptoms (Beck's Depression Inventory (BDI-II))

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

  2. State Anxiety (Spielbergers State-Trait Anxiety Inventory (STAI))

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

    Only the State-anxiety subscale of the STAI is used

  3. Self-efficacy (Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

    Only the following subscale is used: "Obtain help from Community, Family, Friends Scale"

  4. Self-efficacy ("Personal control" from "The Revised Illness Perception Questionnaire" (IPQ-R))

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

    Only the following subscale from the IPQ-R is used: "Personal Control"

Secondary outcomes

  1. Sleep Quality (The Pittsburgh Sleep Quality Index)

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

  2. Exercise Behaviors (Stanford Patient Education Research Center)

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

  3. Health related symptoms

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

    Self related overall health: Stanford Patient Education Research Center (1 item).

    Fatigue: Visual Analogue Scale. Stanford Patient Education Research Center (1 Item).

    Pain: Visual Analogue Scale. Stanford Patient Education Research Center (1 item).

  4. Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

  5. Self-efficacy ("Control/Manage Depression Scale from: "Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

Other outcomes

  1. Common Mental Disorder Questionaire (CMDQ)

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

    The following subscales are included: Somatization SCL-SOM; SCL-ANX4; SCL-DEP6; SCL-8

  2. Well-being (WHO-5 Well Being Index)

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

  3. Coping (The Brief Cope)

    Time frame: Change from: 1) Pre-randomization, to 2) Three months post-intervention

  4. Health Care Utilization

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

    First two items from "Health Care Utilization" (Stanford Patient Education Research Center). Measured within the recent two months instead of six as used in the original scale.

  5. Social Constraints (lepore)

    Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

    Only the subscale refering to an "important other" was administered

  6. Use of Health benefits

    Time frame: Change from 1) The full year prior to start of intervention, to 2) The three months period following the intervention

    Data on health benefits will be obtained by a linkage with The Danish National Health Insurance Service Registry

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Danish Committee for Health Education
  • National Board of Health, Denmark

Registry information

Official study title

Self-management of Depression and Anxiety. A Randomized Controlled Trial.

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Nov 20, 2013
Registry last updated
Mar 8, 2016

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.

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