Acceptance and Commitment Based Group Therapy for Cancer Patients

Not Applicable

Withdrawn

• Conditions: Cancer; Psychological Distress
• Interventions: Behavioral: ACT-based group therapy; Behavioral: ACT individual treatment

• Registration Number: NCT03341364
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-14
• Study Start: 2020-09-10
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ACT group treatment	ACT-based group therapy	Participants receiving the ACT-based group therapy.
ACT individual	ACT individual treatment	Participants receiving individual ACT-based therapy.

Primary Outcome Measures

Name	Time	Method
Change in Swedish Acceptance and Action Questionnaire (SAAQ)	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 Outcome Measures

Name	Time	Method
Change in Swedish Acceptance and Action Questionnaire (SAAQ)	End of treatment (baseline + 3-16 weeks) and follow up (6 weeks after end of treatment)	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.
Change in Generalized Anxiety Disorder 7 (GAD-7)	End of treatment (baseline+3-16 weeks) and follow up (6 weeks after end of treatment)	Measures self-reported severity and frequency of symptoms of generalized anxiety disorder over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 7 items. Each item is scored from 0-3 (0=never, 3=daily), yielding a total between 0 and 21 where a higher number indicates a higher severity of the patient's anxiety.
Change in Patient Health Questionnaire 9 (PHQ-9)	Baseline and end of treatment (baseline + 3-16 weeks)	Measures self-reported presence and severity of symptoms of depression over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 9 items. Each item is scored from 0-3 (0=not at all, 3=nearly every day), yielding a total between 0 and 27 where a higher number indicates more severe symptoms of depression.
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)	Measures self-reported health related quality of life. The questionnaire includes a total of 35 items within 8 subscales (physical function, physical role-function, emotional role-function, social function, psychological well-bering, vitality, pain and general health). For each scale, using the standardised score calculation, a scale score is given between 0 and 100, where 0 is worse and 100 is best.

Trial Locations

Locations (1)

Cancerrehabiliteringsmottagningen Helsingborg; 🇸🇪 Helsingborg, Skåne, Sweden