Clinical trial NCT03341364: Acceptance and Commitment Based Group Therapy for Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Psychological Distress
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Swedish Acceptance and Action Questionnaire (SAAQ)
timeFrame: Baseline and end of treatment (baseline+3-16 weeks)
Secondary outcomes:
measure: Change in Swedish Acceptance and Action Questionnaire (SAAQ)
timeFrame: Baseline and follow up (6 weeks after end of treatment)
measure: Change in Swedish Acceptance and Action Questionnaire (SAAQ)
timeFrame: End of treatment (baseline + 3-16 weeks) and follow up (6 weeks after end of treatment)
measure: Change in Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: Baseline and end of treatment (baseline+3-16 weeks)
measure: Change in Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: Baseline and follow up (6 weeks after end of treatment)
measure: Change in Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: End of treatment (baseline+3-16 weeks) and follow up (6 weeks after end of treatment)
measure: Change in Patient Health Questionnaire 9 (PHQ-9)
timeFrame: End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment)
measure: Change in Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline and follow-up (6 weeks after end of treatment)
measure: Change in Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline and end of treatment (baseline + 3-16 weeks)
measure: Change in RAND 36-item Health Survey (RAND-36)
timeFrame: Baseline and end of treatment (baseline + 3-16 weeks)
measure: Change in RAND 36-item Health Survey (RAND-36)
timeFrame: Baseline and follow up (6 weeks after end of treatment)
measure: Change in RAND 36-item Health Survey (RAND-36)
timeFrame: End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment)
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Cancerrehabiliteringsmottagningen Helsingborg
state: Skåne
Study officials:
affiliation: Region Skane
name: Beatrice Nystrom, PhD
role: PRINCIPAL_INVESTIGATOR
References: