Effects of a Lay-led Anxiety and Depression Self-management Program for Cancer Patients (ADSMP-C)

March 2, 2026 updated by: University of Aarhus

Effects on Anxiety and Depression of a Lay-led Transdiagnostic Self-management Program (ADSMP-C) for Patients Recently Treated for Cancer With Curative Intent: A Randomized Controlled Trial

The investigators aim to evaluate a peer-to-peer patient self-management program targeting symptoms of anxiety and depression in a randomized trial. A total of 234 cancer patients recently having completed primary treatment with curative intent in central Region Denmark will be included. The intervention is a lay-led, group-based transdiagnostic patient education program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression. The intervention is highly structured and manualized.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Recent evidence suggest that transdiagnostic interventions may be just as effective as traditional diagnosis specific interventions when treating symptoms of depression and anxiety. Brief lay-led transdiagnostic self-management interventions may therefore offer an efficient alternative to traditional symptom specific interventions (e.g. CBT) when targeting symptoms of depression and anxiety in cancer.

The present study aim to evaluate The Anxiety and Depression Symptom Management Program (ADSMP) in a cancer setting (ADSMP-C). The ADSMP is a Danish adaptation of The Stanford University Chronic Disease Self-Management Program (CDSMP) and is developed by the Danish Health Information Committee (In Danish: Komiteen for Sundhedsoplysning in collaboration with The Expert Patient Program Community Interest Company (EPPCIC), the English Health Service (NHS) and Stanford University.

The ADSMP-C is a lay-led, group-based transdiagnostic patient education program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression concluded with a networking session. The intervention is highly structured and manualized. Sub-group analyses on participants with a history of cancer in a larger trial of ADSMP conducted by members of the study group on behalf of the Danish National Board of Health showed promising results. However, a larger study is needed to establish sound scientific evidence on the effectiveness of the program in a cancer setting.

A total 234 cancer patients recently having completed primary treatment with curative intent in central Region Denmark will be randomized (2:1) to ADSMP-C or a control arm respectively. As a part of the recruitment procedure patients will be screened with The "Distress-Thermometer" at the departments of oncology at the two largest hospitals in Central Region, Denmark following primary treatment or at a follow-up (< 1yrs. after primary treatment).

Participants completes online questionnaires (REDCap) at baseline (pre-randomization), at post-intervention, and at three (primary follow-up) and six months post-intervention, including the Beck's Depression Inventory (BDI-II) and Spielbergers State-Trait Anxiety Inventory (STAI-state) (primary outcomes). In addition, all participants will be interviewed at 7 month post-intervention. Outcome assessors, blind to group allocation, will perform observer-based Hamilton A6 and D6 short-form ratings at the interview (secondary outcomes).

Data will be evaluated by mixed-effects regression analyses (intention-to-treat).

The current study will be the first to evaluate the efficacy of ADSMP in a cancer setting.

Study Type

Interventional

Enrollment (Estimated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Dep. Oncology, Aarhus University Hospital
      • Herning, Denmark, 7400
        • Dep. Oncology, Regional Hospital West Jutland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Treated in Central Region Denmark
  • Recently completed (< 1 yr.) primary treatment for cancer with curative intent
  • BDI-II score >=14 and/or STAI-state score >=40

Exclusion Criteria:

  • Not sufficient Danish language skills to fill Questionnaires and participate in a group based intervention
  • Psychosis
  • Aggressive behavior
  • Imminent suicidal risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
ADSMP-C
Behavioral: ADSMP-C
A transdiagnostic, lay-led, group-based self-management program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression in cancer (ADSMP-C)
No Intervention: Control Group
Wait-list control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depressive Symptoms
Time Frame: Baseline and 3 months post-intervention
Beck Depression Inventory (BDI-II)
Baseline and 3 months post-intervention
Change in Anxiety Symptoms
Time Frame: Baseline and 3 months post-intervention
Spielberger State-Trait Inventory (STAI). State subscale.
Baseline and 3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Symptoms
Time Frame: Baseline and 6 months post-intervention
Spielberger State-Trait Inventory (STAI). State subscale.
Baseline and 6 months post-intervention
Change in Depressive Symptoms
Time Frame: Baseline and 6 months post-intervention
Beck Depression Inventory (BDI-II)
Baseline and 6 months post-intervention
Change in Anxiety (observer-rated)
Time Frame: Baseline and 7 months post-intervention
Hamilton Anxiety Rating Scale (HAM-A6)
Baseline and 7 months post-intervention
Change in Depression (observer-rated)
Time Frame: Baseline and 7 months post-intervention
Hamilton Depression Rating Scale (HAM-D6)
Baseline and 7 months post-intervention
Change in Fear of cancer recurrence
Time Frame: Baseline and 3 months post-intervention
Concerns About Recurrence Questionaire (CARQ-4)
Baseline and 3 months post-intervention
Change in Self-efficacy - Personal control
Time Frame: Baseline and 3 months post-intervention
The Revised Illness Perception Questionnaire (IPQ-R). Personal Control subscale.
Baseline and 3 months post-intervention
Change in Self-efficacy - Social support
Time Frame: Baseline, and 3 months post-intervention
Obtain Help from Community, Family, Friends Scale (SECD-Ssup)
Baseline, and 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
TrygFonden, Denmark
Komiteen for Sundhedsoplysning

Investigators

  • Principal Investigator: Soren Christensen, MSc., Dep. Psychology, Aarhus University, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124941, TrygFonden
  • 2016-051-000001, ID 1174 (Other Identifier: Aarhus University, Denmark)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At the present the policy of Aarhus University does not allow the sharing of data according to GDPR rules. However this policy may be subject to change

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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