Acceptance and Commitment Based Group Therapy for Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancer, Psychological Distress

Intervention / Treatment
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* Behavioral: ACT-based group therapy
* Behavioral: ACT individual treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT group treatment<br>Participants receiving the ACT-based group therapy. | Behavioral: ACT-based group therapy<br>* 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.<br>|
| Active Comparator: ACT individual<br>Participants receiving individual ACT-based therapy. | Behavioral: ACT individual treatment<br>* 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.<br>|

What is the study measuring?
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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) |