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Clinical Trials/NCT03341364
NCT03341364
Withdrawn
Not Applicable

Acceptance and Commitment Based Group Therapy for Cancer Patients: a Pilot Study Comparing ACT-group Therapy With Individual ACT Therapy for Cancer Patients Experiencing Psychological Distress

Region Skane1 site in 1 countrySeptember 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Region Skane
Locations
1
Primary Endpoint
Change in Swedish Acceptance and Action Questionnaire (SAAQ)
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Detailed Description

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. Participants will be recruited from referrals to the Cancer Rehabilitation Unit at Helsingborg Hospital, Sweden. A total number of 12-20 participants will be assigned to either the experimental group, receiving ACT group therapy, or the Active Control group, receiving individual ACT therapy. Both therapy interventions aim at increasing psychological flexibility. Sociodemographic as well as Medical information regarding their somatic disease will be collected at baseline assessment.

Registry
clinicaltrials.gov
Start Date
September 10, 2020
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in Swedish Acceptance and Action Questionnaire (SAAQ)

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

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.

Secondary Outcomes

  • 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)(End of treatment (baseline+3-16 weeks) and follow up (6 weeks after end of treatment))
  • Change in Patient Health Questionnaire 9 (PHQ-9)(Baseline and end of treatment (baseline + 3-16 weeks))
  • Change in RAND 36-item Health Survey (RAND-36)(End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment))

Study Sites (1)

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