Acceptance and Commitment Based Group Therapy for Cancer Patients

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer; Psychological Distress
• Intervention / Treatment: Behavioral: ACT-based group therapy; Behavioral: ACT individual treatment

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Helsingborg, Skåne, Sweden, 25187
      • Cancerrehabiliteringsmottagningen Helsingborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT group treatment; Participants receiving the ACT-based group therapy.	Behavioral: ACT-based group therapy; 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.
Active Comparator: ACT individual; Participants receiving individual ACT-based therapy.	Behavioral: ACT individual treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 follow up (6 weeks after end of treatment)
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.	End of treatment (baseline + 3-16 weeks) and follow up (6 weeks after end of treatment)
Change in Generalized Anxiety Disorder 7 (GAD-7)	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.	Baseline and end of treatment (baseline+3-16 weeks)
Change in Generalized Anxiety Disorder 7 (GAD-7)	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.	Baseline and follow up (6 weeks after end of treatment)
Change in Generalized Anxiety Disorder 7 (GAD-7)	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.	End of treatment (baseline+3-16 weeks) and follow up (6 weeks after end of treatment)
Change in Patient Health Questionnaire 9 (PHQ-9)	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.	End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment)
Change in Patient Health Questionnaire 9 (PHQ-9)	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.	Baseline and follow-up (6 weeks after end of treatment)
Change in Patient Health Questionnaire 9 (PHQ-9)	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.	Baseline and end of treatment (baseline + 3-16 weeks)
Change in RAND 36-item Health Survey (RAND-36)	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.	Baseline and end of treatment (baseline + 3-16 weeks)
Change in RAND 36-item Health Survey (RAND-36)	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.	Baseline and follow up (6 weeks after end of treatment)
Change in RAND 36-item Health Survey (RAND-36)	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.	End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment)

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Beatrice Nystrom, PhD, Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Estimated): December 31, 2022

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2017/602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No