NCT03341364

Brief Summary

This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based group therapy compared to individual ACT-therapy for adult cancer patients suffering from psychological distress. Half of the participants will receive ACT in a group setting, while the other half will receive individual ACT.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2020

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
2.8 years until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

October 25, 2017

Last Update Submit

October 20, 2023

Conditions

CancerPsychological Distress

Outcome Measures

Primary Outcomes (1)

  • Change in Swedish Acceptance and Action Questionnaire (SAAQ)

    Measures self-reported psychological flexibility on a 7-point likert scale. The questionnaire includes a total of 6 items. Each item is scored 1-7 (1=never true, 7=always true), yielding a total between 7 and 42 where a higher number indicates lower psychological flexibility.

    Baseline and end of treatment (baseline+3-16 weeks)

Secondary Outcomes (11)

  • Change in Swedish Acceptance and Action Questionnaire (SAAQ)

    Baseline and follow up (6 weeks after end of treatment)

  • Change in Swedish Acceptance and Action Questionnaire (SAAQ)

    End of treatment (baseline + 3-16 weeks) and follow up (6 weeks after end of treatment)

  • Change in Generalized Anxiety Disorder 7 (GAD-7)

    Baseline and end of treatment (baseline+3-16 weeks)

  • Change in Generalized Anxiety Disorder 7 (GAD-7)

    Baseline and follow up (6 weeks after end of treatment)

  • Change in Generalized Anxiety Disorder 7 (GAD-7)

    End of treatment (baseline+3-16 weeks) and follow up (6 weeks after end of treatment)

  • +6 more secondary outcomes

Study Arms (2)

ACT group treatment

EXPERIMENTAL

Participants receiving the ACT-based group therapy.

Behavioral: ACT-based group therapy

ACT individual

ACTIVE COMPARATOR

Participants receiving individual ACT-based therapy.

Behavioral: ACT individual treatment

Interventions

ACT-based group therapyBEHAVIORAL

6 group therapy sessions over 6 weeks (one session à 2 hours weekly), plus one follow-up session 6 weeks after last session. The sessions are lead by a psychologist and a social worker. Each session containing discussions, experimental exercises and home-work assignment.

ACT group treatment
ACT individual treatmentBEHAVIORAL

3-12 individual therapy sessions over 3-16 weeks, plus one follow-up session 6 weeks after last session, lead by a clinical psychologist. Each session containing discussion, experimental exercises and home-work assignment.

ACT individual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Able to speak and understand the Swedish language
  • Cancer patients at hospitals in Skånevård Sund (geographical area)
  • Experience of psychological distress related to cancer diagnosis or cancer treatment
  • Stable and planned cancer treatment or no ongoing treatment

You may not qualify if:

  • Severe cognitive problems
  • Severe psychiatric disorder
  • Ongoing substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancerrehabiliteringsmottagningen Helsingborg

Helsingborg, Skåne County, 25187, Sweden

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Beatrice Nystrom, PhD

    Region Skane

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Recruitment of participants to the group intervention will start first. When a maximum of 10 participants have been recruited to the group intervention and/or one week before start of group intervention, recruitment to the Active Control group will start. The individual therapies will start at different times, depending on the flow of referrals.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 14, 2017

Study Start

September 10, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)